Stem Cell Clinic

The disease that wastes away boys muscles – Standard Digital

Fifteen years ago, Scholar Muthamia was getting ready to welcome her second child. The pregnancy had no complications at all and when her son Ferdinand Mutugi Njuguna was born, he weighed a healthy 3.9 kg.Mutugi was as precocious a toddler as can be, and all was fine in the Njuguna household until the boy developed a peculiar walking style.He would push his left foot ahead while walking and he didnt seem to quite stand up straight, Muthamia says.We thought it was a unique walking style he had developed, and let him be. And weirdly, when wearing a pair of shorts or trousers, he would pull them up with his arms while walking and many assumed we were buying him over-sized clothes, she says.Later, Ferdinand began falling while walking. He also started having a hard time standing up from a sitting position. Climbing stairs became a hardship and he couldnt run as fast as he used to.He would get tired very fast and even started walking on his toes. We took him to various hospitals and eventually ended up at Kenyatta National Hospital where he was diagnosed with Duchenne muscular dystrophy,she says.

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The disease that wastes away boys muscles - Standard Digital

Moderna Covid Drug Production Deal, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

Moderna Boosts Production with Lonza Deal

Moderna Therapeutics (MRNA) announced its new collaboration with Lonza for boosting its production capacity for mRNA 1273. The company had recently struck a deal with the federal government to focus on developing COVID 19 vaccine candidate. The company stands to receive $483 million from BARDA for accelerating the development of the vaccine. Moderna dosed the first patient under its Phase I clinical trial in March.

Under the latest deal with the Swiss firm, Moderna will be able to use Lonza manufacturing facilities in the United States and Switzerland. It is expected that the technology transfer may be started in June while the batch production in the United States may begin in July. Moderna CEO Stphane Bancel said, This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10 times, our manufacturing capacity for mRNA-1273 and additional products in Modernas large clinical portfolio. Lonzas global presence and expertise are critical as we scale at unprecedented speed." The agreed longevity of the deal is 10 years and will involve creations of manufacturing suites at various Lonza manufacturing sites.

Moderna also recently announced that it has submitted with the FDA its plan to start Phase 2 and later stage trials of the vaccine candidate. The company has received early feedback for its Phase 2 study design. It is anticipated that the dosing for Phase 2 may start during the second quarter. The company is looking to enroll 600 healthy subjects for assessing the safety and efficacy of the shot with doses administered 28 days apart. Currently, there are a number of pharma companies in the race to produce vaccine for fight against COVID 19.

In response to the latest deal, Lonza chairman and CEO ad interim Albert Baehny said, The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale. We are fully committed to leveraging our global network and experience in manufacturing technologies to support Modernas manufacture of mRNA-1273 as well as collaborating on future Moderna products.

Modernas collaboration with US Biomedical Advanced Research and Development Authority (BARDA) involves development of mRNA 1273, which is an mRNA vaccine that encodes for a prefusion stabilized form of the Spike (NYSE:S) protein. BARDA is a division of the Department of Health and Human Services and its funding will support late stage clinical development programs for the vaccine. In order to scale up, Moderna anticipates to hire up to 150 new employees, including engineers, clinical staff and manufacturing staff.

The companys new tie up with Lonza is expected to allow the manufacturing of up to a billion doses per year. Lonza is based out of Basel in Switzerland.

Marker Therapeutics (MRKR) announced that the FDA has granted Orphan Drug designation to its acute myeloid leukemia drug candidate MT 401. The orphan drug candidate offers several benefits such as tax credits for qualified clinical trials and 7 years of market exclusivity if the drug candidate is approved. The FDA generally grants this tag to novel biologics and drugs aiming to provide safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

MT 401 is a multi-tumor associated antigen-specific T cell based product developed for treating AML following allogeneic stem cell transplant. The company CEO and President Peter Hoang said, In investigator-sponsored trials, our MultiTAA-specific T cell product candidate was well-tolerated and we have observed clinical benefit across various liquid and solid tumors, suggesting the product candidate's ability to induce a patient's own T cells to expand for a more durable anti-tumor effect. The drug candidate has been given the tag for treating hematological malignancies and solid tumor indications.

Marker Therapeutics reported that it is planning to start its Phase 2 study in subjects with post allegeneic stem cell transplant AML. T cells are obtained from healthy donors and are made to undergo a two-step cell culture process. The process leads to creation of CD4 and CD8 cell mixture which is able to identify multiple tumor specific antigens.

Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for treating hematological malignancies and solid tumor indications. The companys technology relies upon selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens and kill tumor cells expressing those targets. However, Marker does not genetically engineer its T Cell therapies and therefore its drug candidates are expected to be less expensive to manufacture.

Jazz Pharmaceuticals Plc (JAZZ) reported that it has halted the enrolment in its Phase 3 clinical study of defibrotide. The company stated that the decision was taken on the recommendation of an Independent Data Monitoring Committee (IDMC) which opined that the study is highly unlikely to produce statistical significance for the primary endpoint of VOD-free survival at Day +30 post-HSCT in the final analysis.

Jazz Pharmaceuticals further stated that the IDMC reached the said recommendation after completing pre-planned interim analysis of the initial 280 patients and where the protocol-specified futility criteria were met. Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals said, "While enrollment has been discontinued, the trial will run to completion through the follow-up of the more than 370 patients enrolled. VOD is a rapidly progressive and devastating condition that can develop following stem-cell transplantation. As the only approved treatment with demonstrated efficacy based on survival at 100 days after HSCT, defibrotide is an important medicine for this patient population." The company has notified relevant authorities about the decision of discontinuance.

The company stated that the patients already enrolled in the study may be allowed to continue participation if deemed appropriate after further investigation. The relevant Phase 3 was not intended to further assess defibrotide for the treatment of VOD and does not impact the approved indication or other ongoing clinical studies. The Phase 3 study was a randomized, open-label, multi-center trial with an adaptive design. The main aim of the study is to compare the efficacy of defibrotide versus best supportive care in the prevention of hepatic VOD.

Jazz Pharmaceuticals mainly aims to develop medicines for critical diseases with limited treatment options. The main focus of the company is on neuroscience and oncology including movement disorders, sleep medicine and hematologic tumors.

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That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Moderna Covid Drug Production Deal, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha

Easing of restrictions is welcome, but they must be carried out carefully – The National

I write to you in reference to your article Coronavirus latest: WHO urges countries to ease lockdowns slowly (May 2). This is a meaningful and thought-provoking piece. Lockdown measures have been in place all over the world for a good while now, and many nations are ready to open up their economies. At the same time, if they do it too hastily, and people stop following physical distancing and hygiene rules overnight, experts have warned that it is likely a second wave of infections will hit. Eased restrictions must be carried out in stages, and with great care. The world economy has already been shattered, and prolonging the lockdowns will take a toll on both our morale and the economy. India is taking this challenge head-on and easing restrictions carefully. I hope that in the coming days, a sense of normalcy will return to India.

K Ragavan, Bengaluru

Rishi Kapoor: your legendary memory lives on

Please refer to the news item Beloved Bollywood star Rishi Kapoor dies aged 67 by Farah Andrews (April 30) about the sad passing away of Rishi Kapoor, a popular and versatile Indian actor. Kapoor was a beloved actor and an outspoken artist. He starred in numerous films, commencing with Mera Naam Joker and then later the cult film Bobby. He was the romantic hero of the 1970s and 80s, and his talents went beyond acting. Dancing also came naturally to him, as it did to all the members of his family. His book Khullam Khulla is an enriching read, too. Kapoor was loved by his fans. He had rivals, but no enemies.

He further proved his histrionic skills and talents in some of the films in which played major roles in the past decade, such as D-Company and Mulk. I am sure his son Ranbir Kapoor will carry on the great tradition of brilliant acting, for which the Kapoor dynasty is renowned. My condolences to his wonderful family.

Rajendra Aneja, Dubai

Abu Dhabi stem cell treatment gives us hope

I write to you in reference to a video posted on The National's Facebook page with the following caption: UAE researchers develop promising breakthrough Covid-19 treatment (May 2).

What an amazing achievement. We urgently need to find an effective treatment to combat the spread of this deadly virus.

Dr Rahmath Mohammad, Sri Lanka

I am confident this will be the best innovation in the fight against coronavirus, and is it all thanks to the UAE's rulers.

Mark Mich, Dubai

Updated: May 2, 2020 06:49 PM

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Easing of restrictions is welcome, but they must be carried out carefully - The National

U.S. Food and Drug Administration Approves DARZALEX FASPRO(TM) (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in…

HORSHAM, Pa., May 1, 2020 /PRNewswire/ --The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.As a fixed-dose formulation, DARZALEX FASPRO can be administered over approximately three to five minutes, significantly less time than DARZALEX,which is given intravenously over hours. In the Phase 3 COLUMBA study supporting the approval, DARZALEX FASPRO demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with intravenous DARZALEX in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX FASPRO compared to intravenous DARZALEX (13 percent vs. 34 percent, respectively).

"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are excited about the potential of this meaningful innovation in transforming the treatment experience for patients with multiple myeloma where DARZALEX FASPRO can be administered in approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over hours. Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies."

Click to Tweet: #NEWS: #FDA approves subcutaneous CD38-directed antibody for the treatment of multiple #myeloma. See here for more details: https://bit.ly/2VozhzY

The approval is based on data from the Phase 3 COLUMBA (MMY3012)and Phase 2 PLEIADES (MMY2040) studies.1,2 In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX FASPROas monotherapycompared to those taking intravenous DARZALEXas monotherapy (41 percent vs. 37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO versus intravenous DARZALEX (13 percent vs. 34 percent, respectively). In a pooled safety population of 490 patients who received DARZALEXFASPRO as monotherapy or in combination, the ARR rate wFas 11 percent. The safety profiles of intravenous DARZALEX and DARZALEX FASPRO were otherwise similar.1 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEX FASPRO in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.2

"The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF). "The approval of DARZALEXFASPRO marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy."

Click to Tweet: .@theMMRF talks about advancing treatments for multiple #myeloma and addressing patient needs with latest #FDA approval. Read more here: https://bit.ly/2VozhzY

"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff."

DARZALEX FASPROis co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme'sENHANZEdrug delivery technology].DARZALEX FASPRO will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX formulation will also remain available as an option for patients and their physicians.

DARZALEX FASPROis approved in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

The U.S. FDA approval of DARZALEX FASPRO marks the first approval for this innovative subcutaneous formulation globally, and Janssen continues to work with health authorities around the world in an effort to bring this new treatment option to patients living with multiple myeloma.

Access to DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)Janssen offers comprehensive access and support information, resources and services to assist U.S. patients in gaining access to DARZALEX FASPROthrough the Janssen CarePath Program. Through the program, eligible commercial patients pay no more than $5 per injection, regardless of individual income level. Information on the enrollment process is available online atwww.CarePathSavingsProgram.com/DARZALEX.

For more information, healthcare providers or patients can contact: 1-844-55DARZA (1-844-553-2792). Information will also be available atwww.DARZALEX.com. Dedicated case coordinators are available to work with both healthcare providers and patients.

About the COLUMBA Study 1The randomized, open-label, multicenter Phase 3 COLUMBA study (MMY3012) included 522 patients (median age of 67 years) with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD. In the arm that received DARZALEX FASPRO(n=263), patients received a fixed dose of DARZALEX FASPRO1,800 milligrams (mg), co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) 2,000 Units per milliliter (U/mL), subcutaneously weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. In the intravenous DARZALEXarm (n=259), patients received DARZALEXfor intravenous infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. In the arm that received DARZALEX FASPRO, itwas given in a fixed volume of 15 mL over three to five minutes; the median injection time was five minutes. In the arm that received theintravenous administration, the median durations of the first, second and subsequent intravenous DARZALEXinfusions were 7.0, 4.3 and 3.4 hours, respectively.Patients in both arms continued treatment until disease progression or unacceptable toxicity.

About the PLEIADES Study 2The non-randomized, open-label, parallel assignment Phase 2 PLEIADES study (MMY2040) included more than 240 adults with multiple myeloma, including 67 patients with newly diagnosed multiple myeloma who were treated with 1,800 mg of DARZALEX FASPROin combination with bortezomib, melphalan, and prednisone (D-VMP) and 65 patients with relapsed or refractory disease who were treated with 1,800 mg of DARZALEX FASPROplus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMP and D-Rd cohorts was overall response rate.

About DARZALEXand DARZALEX FASPROJanssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease. DARZALEX has been approved in seven indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

DARZALEX has become a backbone therapy in the treatment of multiple myeloma, having been used in the treatment of more than 58,000 patients in the U.S. alone since its U.S. FDA approval in 2015. DARZALEX is the first CD38-directed antibody approved globally to treat multiple myeloma and in 2020, DARZALEX FASPRO(daratumumab and hyaluronidase human-fihj) follows as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.2

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.4 DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death.5 DARZALEX may also have an effect on normal cells.3 Data across seven Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that DARZALEX-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 4,5,6,7,8,9,10,11 Additional studies are underway to assess the efficacy and safety of DARZALEXFASPRO in the treatment of other malignant and pre-malignant hematologic diseases in which CD38 is expressed, including smoldering myeloma and in amyloidosis.12,13

Key DARZALEX Milestones:

Please see full Prescribing Information at http://www.DARZALEX.com.

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 32,270 people will be diagnosed and 12,830 will die from the disease in the U.S.24 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.23

DARZALEX FASPROIMPORTANT SAFETY INFORMATION CONTRAINDICATIONSDARZALEX FASPRO is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity And Other Administration Reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO.

Systemic Reactions

In a pooled safety population of 490patients who received DARZALEX FASPROas monotherapy or in combination, 11% of patients experienced a systemic administration-related reaction (Grade 2: 3.9%, Grade 3: 1.4%). Systemic administration-related reactions occurred in 10% of patients with the first injection, 0.2% with the second injection, and cumulatively 0.8% with subsequent injections. The median time to onset was 3.7hours (range: 9minutes to 3.5days). Of the 84systemic administration-related reactions that occurred in 52patients, 73(87%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic administration-related reactions have occurred in less than 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension and tachycardia. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypotension.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade2 reactions in 0.6%. The most frequent (>1%) injection-site reaction was injection site erythema. These local reactions occurred a median of 7minutes (range: 0minutes to 4.7days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPRO can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO and for 3months after the last dose.

The combination of DARZALEX FASPRO with lenalidomide is contraindicated in pregnant women, because lenalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

Interference with Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting DARZALEX FASPRO.

Interference with Determination of Complete Response

Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO -treated patients with IgG kappa myeloma protein.

Adverse Reactions

The most common adverse reaction (20%) with DARZALEX FASPRO monotherapy is: upper respiratory tracts infection.

The most common adverse reactions (20%) with D-VMP are upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain. The most common adverse reactions (20%) with D-Rd are fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia and dyspnea.

The most common hematology laboratory abnormalities (40%) with DARZALEX FASPRO are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please see full Prescribing Information at http://www.DARZALEX.com.

DARZALEX IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSDARZALEX (daratumumab) is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONSInfusion Reactions DARZALEX can cause severe and/or serious infusion reactions, including anaphylactic reactions. In clinical trials, approximately half of all patients experienced an infusion reaction. Most infusion reactions occurred during the first infusion and were Grade 1-2. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX.Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema, and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care.For patients with Grade 1, 2, or 3reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients following DARZALEX infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Interference with Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX. Type and screen patients prior to starting DARZALEX.

Neutropenia and Thrombocytopenia DARZALEX may increase neutropenia and/or thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to the manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection.DARZALEX dose delay may be required to allow recovery of neutrophils and/or platelets. No dose reduction of DARZALEX is recommended. Consider supportive care with growth factors for neutropenia or transfusions for thrombocytopenia.

Interference with Determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Adverse Reactions The most frequently reported adverse reactions (incidence 20%) were: infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, bronchitis, pneumonia, and upper respiratory tract infection.

DARZALEX in combination with lenalidomide and dexamethasone (DRd): The most frequent (20%) adverse reactions for newly diagnosed or relapsed/refractory patients were, respectively, infusion reactions (41%, 48%), diarrhea (57%, 43%), nausea (32%, 24%), fatigue (40%, 35%), pyrexia (23%, 20%), upper respiratory tract infection (52%, 65%), muscle spasms (29%, 26%), dyspnea (32%, 21%), and cough (30%, 30%). In newly diagnosed patients, constipation (41%), peripheral edema (41%), back pain (34%), asthenia (32%), bronchitis (29%), pneumonia (26%), peripheral sensory neuropathy (24%), and decreased appetite (22%) were also reported. In newly diagnosed patients, serious adverse reactions (2% compared to Rd)were pneumonia (15%), bronchitis (4%), and dehydration (2%), and treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were neutropenia (56%), lymphopenia (52%), and leukopenia (35%). In relapsed/refractory patients, serious adverse reactions (2% compared to Rd)were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%), and pyrexia (3%), and treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were neutropenia (53%) and lymphopenia (52%).

DARZALEXin combination with bortezomib, melphalan, and prednisone (DVMP): The most frequently reported adverse reactions (20%) were upper respiratory tract infection (48%), infusion reactions (28%), and peripheral edema (21%). Serious adverse reactions (2% compared to the VMP arm) were pneumonia (11%), upper respiratory tract infection (5%), and pulmonary edema (2%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (58%), neutropenia (44%), and thrombocytopenia (38%).

DARZALEX in combination with bortezomib and dexamethasone (DVd): Themost frequently reported adverse reactions (20%) were peripheral sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%), cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions was 42%. Serious adverse reactions (2% compared to Vd) were upper respiratory tract infection (5%), diarrhea (2%), and atrial fibrillation (2%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (48%) and thrombocytopenia (47%).

DARZALEX in combination with bortezomib, thalidomide, and dexamethasone (DVTd): The most frequent adverse reactions (20%) were infusion reactions (35%), nausea (30%), upper respiratory tract infection (27%), pyrexia (26%), and bronchitis (20%). Serious adverse reactions (2% compared to the VTd arm) were bronchitis (DVTd 2% vs. VTd <1%)and pneumonia (DVTd 6% vs. VTd 4%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (59%), neutropenia (33%), and leukopenia (24%).

DARZALEX in combination with pomalidomide and dexamethasone (DPd): Themost frequent adverse reactions (>20%) were fatigue (50%), infusion reactions (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), constipation (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), back pain (25%), pyrexia (25%), insomnia (23%), arthralgia (22%), dizziness (21%), and vomiting (21%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions reported in 5% of patients included pneumonia (7%).Treatment-emergent Grade 3-4 hematologylaboratory abnormalities (20%) were neutropenia (82%), lymphopenia (71%), and anemia (30%).

DARZALEX as monotherapy: Themost frequently reported adverse reactions (20%) were infusion reactions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%). The overall incidence of serious adverse reactions was 33%. The most frequent serious adverse reactions were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%). Treatment-emergent Grade 3-4 hematology laboratory abnormalities (20%) were lymphopenia (40%) and neutropenia (20%).

Please see full Prescribing Information at http://www.DARZALEX.com.

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX FASPRO. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.comor on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

ENHANZEis a registered trademark of Halozyme.

1Mateos M-V et al. Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (pts) With Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA. 2019 American Society of Clinical Oncology Annual Meeting. June 2019.

2Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

32020Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFN Cytokines and Proliferation. Mediators Inflamm. 2013;564687.

4Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134 .

5Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009.

6Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383.

7Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479.

8Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172.

9Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.

10European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736

11Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688.

12Janssen Research & Development, LLC. A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106?term=smm2001&rank=1 Identifier: NCT02316106.

13Janssen Research & Development, LLC. An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489?term=lym2001&rank=1 Identifier: NCT02413489

14Janssen Biotech, Inc. "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab." Issued August 30, 2012.

15Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Issued November 16, 2015.

16Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy." Issued November 21, 2016.

17Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies." Issued June 16, 2017.

18Janssen Biotech, Inc. "Janssen Announces DARZALEX (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible." Issued May 7, 2018.

19Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible." Issued June 27, 2019.

20Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma." Issued September 26, 2019.

21Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.

22American Cancer Society. "What Is Multiple Myeloma?" Available at: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2019.

23American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed January 2020.

Media contacts:Bernadette KingPhone: +1 (215) 778-3027

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U.S. Food and Drug Administration Approves DARZALEX FASPRO(TM) (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in...

Stem Cell Therapy: Stay Young With A Marvel Of Medical Research – Latinos Health

May 02, 2020 11:50 AM EDT

(Photo : Stem Cell Therapy: Stay Young With A Marvel Of Medical Research)

Human beings, within the span of their lives, go through shifting phases. Once when they are infants, and cannot sustain themselves without external help, then the reckless days of youth, and finally old age. But within these periods, the time of youth is the most vibrant- one that decades of medical research have tried to preserve.

The question about delaying aging, and staying youthful for a major part of our lives has plagued genetics experts and medical professionals alike. Not until recently, this field remained filled with invasive surgeries, and extensive treatments, that were both painful and inefficacious, but with the breakthrough brought about by Stem Cell Therapy, the dream of finding the fountain of youth is closer than ever.

Before delving into the specifics of Stem Cell Therapy, and how it can help people resist the effects of aging, let us establish the basic science behind this seemingly complex phenomenon.

As the name suggests, Stem Cells become the raw material of the human body. These cells form the foundation of other more specialized cells such as nerve, blood, and muscle cells when they grow, repairing any dysfunction that might be caused because of a lack of specific tissue.

The most important aspect that enables them to fight the effects of aging is their ability to boost the restorative functions of our body. The tissues and cells in our system constantly undergo wear and tear, due to which they get damaged. With the help of Stem Cells, the body reacts by restoring these cells at a much faster pace.

Under the right conditions such as those of the body, and a laboratory, these cells multiply into daughter-cells as a preliminary phase to eventually generate more stem cells through a process of self-renewal, giving the body highly functional and specialized tissue for maintenance.

Aging is a process in which the rate at which are cells wear out is far greater than that at which they are replenished and restored. This leads to a frailing body condition, that is weak and feeble.

The biologists and medical professionals at Purtier have come with a trailblazing remedy to the dilemma of aging. Their treatment, known as the Riway Purtier Placenta Stem Cell Therapy utilizes the nutrition of a deer placenta, lycopene, essential minerals, and vitamins, and packages it in a capsule with living cells that are compatible with the human bio-system.

The formula of this capsule is packed with all necessary material required by the body to boost its restorative and regenerative function, boosting the pace of maintenance of specialized cells and tissues. This leads to the delaying of aging.

The exclusive property of stem cells to provide the body with extra raw material for repair and maintenance is making it an excellent medical find to treat a wide range of chronic conditions that stem from the natural process of old-age. Stem Cell Therapy might just be the fountain of youth every person can explore.

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Stem Cell Therapy: Stay Young With A Marvel Of Medical Research - Latinos Health

Stem Cell Drugs Market Size by Top Key Players, Growth Opportunities, Incremental Revenue , Outlook and Forecasts to 2026 – Latest Herald

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This section of the report lists various major manufacturers in the market. The competitive analysis helps the reader understand the strategies and collaborations that players focus on in order to survive in the market. The reader can identify the players fingerprints by knowing the companys total sales, the companys total price, and its production by company over the 2020-2026 forecast period.

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United States Animal Stem Cell Therapy Market Size, Growth Trends, Top Players, Application Potential and Forecast to 2025 – Latest Herald

The United States Animal Stem Cell Therapy market study added by Hongchun Research, exhibits a comprehensive analysis of the growth trends present in the global business scenario. The study further presents conclusive data referring to the commercialization aspects, industry size and profit estimation of the market. The study also illustrates the competitive standing of leading manufacturers in the projection timeline whilst incorporating their diverse portfolio and regional expansion endeavors.

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According to the Global Animal Stem Cell Therapy Market Report, the Animal Stem Cell Therapy Market is expected to witness steady to high growth rate owing to the increased demands from various industries, as well as the regions which are developing at a quick pace. The buying capability and rise in disposable incomes is also a major factor here affecting the Global Animal Stem Cell Therapy Market positively. The Global Animal Stem Cell Therapy Market Report covers the rest of the current trends / opportunities / challenges in substantial detail.

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Report Summary:The global Intelligent Intravenous Infusion Pumps market report is a comprehensive study that encompasses top manufacturers, prospective market share, revenue, purchaser volume with respect to dealing volume and global segmentation for the Intelligent Intravenous Infusion Pumps industry. The report further includes market classification and definitions, product and industry overview, manufacturing specifications and cost structure, included raw materials and so on.

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Market Analysis by PlayersBDAbbott LaboratoriesSmiths MedicalB. BraunHospiraBaxterMoogCareFusionMindrayZollIradimedTeleflexMedlineZyno MedicalMaxim

Market Analysis by Regions:The NortheastThe MidwestThe SouthwestThe SoutheastThe West

Market Analysis by Types:Constant Volume Control TypeSyringe Injection TypeOthers

Market Analysis by Applications:HospitalClinicOthers

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United States Animal Stem Cell Therapy Market Size, Growth Trends, Top Players, Application Potential and Forecast to 2025 - Latest Herald