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Thursday, January 20, 2022

Merck's COVID-19 pill to be produced by more than two dozen drugmakers

 Medicines Patent Pool, an organization supported by the U.N., announced on Thursday that over two dozen generic drug makers will soon begin producing Merck's COVID-19 pill to make the treatment more accessible in developing countries.

The organization said that 27 generic drug makers would produce the pill for 105 developing countries. Specifically, agreements the companies signed allow them to make both molnupiravir's raw ingredients as well as the final product.

Molnupiravir is the COVID-19 treatment developed by Merck and Ridgeback Therapeutics. For patients with early signs of COVID-19, the pill is believed to cut the hospitalization rates in half.

The drug makers producing the generic pills come from 11 countries including Bangladesh, China, Egypt, Vietnam, Kenya and South Africa, the organization said.

“This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment,” Medicines Patent Pool's executive director Charles Gore said in a statement.

Former FDA Commissioner Scott Gottlieb has previously referred to molnupiravir as a "game changer." 

Earlier this week, Merck announced that it had agreed to provide the United Nations Children’s Fund (UNICEF) with up to 3 million courses of its antiviral pill.

“I am proud of the fact that patients in these low- and middle-income countries will gain access at the same time as patients in countries with higher incomes,” Merck’s CEO and President Robert Davis said in a statement at the time. 

https://thehill.com/policy/healthcare/590562-mercks-covid-19-pill-to-be-produced-by-more-than-two-dozen-drugmakers

ChromaDex and Designs for Health Partner for New Product Development on Niagen

 ChromaDex Corp. (NASDAQ:CDXC) today announced a supply agreement with Designs for Health, a U.S.-based manufacturer of premium dietary supplements for healthcare practitioners (HCPs). ChromaDex’s proprietary healthy aging ingredient Niagen®, the world’s first and only FDA-safety reviewed and patented form of nicotinamide riboside, will be added to multi-ingredient Designs for Health formulas. The new products will be available exclusively through the company’s extensive healthcare practitioner (HCP) network.

https://finance.yahoo.com/news/chromadex-designs-health-partner-product-113300897.html

argenx: VYVGART™ Approval in Japan for Myasthenia Gravis

 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVGART™ (efgartigimod alfa) intravenous infusion for the treatment of adult patients with generalized myasthenia gravis (gMG) who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker approved in Japan.

https://finance.yahoo.com/news/argenx-announces-vyvgart-approval-japan-070000535.html

LYSARC Partners with Veeva to Accelerate Innovation for Lymphoma Treatments

  Veeva Systems (NYSE: VEEV) today announced that the Lymphoma Academic Research Organization (LYSARC) selected Veeva Development Cloud to improve operational efficiency across its lymphoma therapy research. LYSARC will use applications in Vault ClinicalVault Quality, and Vault Safety suites to build a robust, connected technology foundation that enables faster execution, higher quality data, and better trial oversight.

https://finance.yahoo.com/news/lysarc-partners-veeva-accelerate-innovation-120300448.html

Hims & Hers and Walmart To Expand Availability Of Hair Care Offerings

 Hims & Hers Health, Inc. ("Hims & Hers", NYSE: HIMS), the multi-specialty telehealth platform focused on providing modern personalized health and wellness experiences to consumers, announced today the launch of its high quality hair care solutions at select Walmart retail locations nationwide and on walmart.com.

https://finance.yahoo.com/news/hims-hers-walmart-collaborate-expand-135700451.html

HCW Lead Candidate Aids Anti-Tumor Activity, Cuts Chemo Side Effects

 Preclinical Data for HCW 9218 Included in Pivotal Scientific Paper Published in Molecular Therapy

 HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today announced the publication of a scientific paper, authored by the Company’s scientific research team, in the peer-reviewed journal, Molecular Therapy. The paper is entitled, “Immunotherapeutic HCW9218 augments anti-tumor activity of chemotherapy via NK cell mediated reduction of therapy-induced senescent cells.” It highlights preclinical data from in vivo animal studies demonstrating the ability of the Company’s lead investigational candidate, HCW9218, to both enhance the anti-tumor efficacy of chemotherapy drugs and diminish their harmful side effects by reducing therapy-induced senescence (TIS).

Cellular senescence is an essential mechanism for tumor suppression. However, an increasing body of evidence has shown that chemotherapy and radiation, standard-of-care anti-cancer regimens, cause the accumulation of senescent cells both in tumor and normal tissue. Paradoxically, cellular senescence protects non-dividing cancer cells by limiting the effect of chemotherapeutic drugs and radiation and contributes to chemoresistance, radiation resistance, disease relapse, and systemic side effects. The Company’s data presented in this publication shows that HCW9218 activated immune response can significantly reduce cellular senescence induced by current chemotherapy to improve the anti-tumor efficacy and alleviate the unwanted side effects.

Dr. Hing C. Wong, the Founder and CEO of HCW Biologics, and the corresponding author of this published article, stated, “We believe our preclinical research findings are groundbreaking and among the very first studies that show our immunotherapeutic can enhance the efficacy of chemotherapy. We are also interested in the collateral damage caused by chemotherapy treatment that has such a detrimental impact on health span and quality of life for millions of cancer patients.”

Aptorum Gets Orphan Drug Tag for Repurposed Drug For Neuroblastoma

 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, is pleased to announce that the United States Food and Drug Administration (FDA) Office has granted Orphan Drug Designation to SACT-1, a repurposed small molecule compound for the treatment of patients with Neuroblastoma. Aptorum Group plans to file an Investigational New Drug Application (IND) to commence a phase 1b/2a clinical trial for SACT-1 to test the drug in neuroblastoma patients in 2022.

Mr. Darren Lui, President and Executive Director of Aptorum Group says, "The granting of orphan drug designation for SACT-1 for the treatment of neuroblastoma is another important step forward in the development of our drug candidate and reflects both the FDA’s and Aptorum’s commitment to addressing the unmet clinical needs of patients with neuroblastoma." Further to our recently announced completion of Phase 1 clinical trial and patent grant for SACT-1, we are currently focusing on our IND preparation for entering into the exciting Phase Ib/2a clinical trials for SACT-1 in the United States."

https://finance.yahoo.com/news/aptorum-group-receives-fda-orphan-130000549.html