Artiva’s new 52,000-square-foot facility will support the development and manufacture of allogeneic natural killer (NK) cell therapy and CAR-NK cell therapies. The additional facility will complement the 300,000-square-feet of space that Artiva holds in South Korea, at GC LabCell’s location, for R&D and manufacture. The new 52,000-square-foot facility will include research and process development laboratories
Drugs
17 August 2021 Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% across dMMR solid tumors 95% of responders had a duration of response of ≥6 months GlaxoSmithKline (GSK) plc today announced the US Food and Drug Administration (FDA) approved a new indication for Jemperli (dostarlimab-gxly), a programmed
mitapivat Treatment for Pyruvate Kinase Deficiency Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today announced
Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV, according to the partners. Higher antibody neutralizing capacity was observed with CV2CoV across all selected variants, including the Beta,
The World Health Organization (WHO) is ready for the next phase in its Solidarity trial, designed to come up with viable drug candidates to treat COVID-19. The Solidarity PLUS study is poised to enroll hospitalized COVID-19 patients in 52 different countries in order to test three therapies: artesunate, imatinib, and infliximab. Candidate selection According to
FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors KENILWORTH, N.J.–(BUSINESS WIRE) August 13, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Welireg, an oral hypoxia-inducible factor-2 alpha
FDA Approves TicoVac (tick-borne encephalitis vaccine) to Prevent Tick-Borne Encephalitis (TBE) NEW YORK–(BUSINESS WIRE) August 13, 2021 — Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TicoVac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older.1 TicoVac is the
Treatment for Bladder Cancer Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs) CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 13, 2021– Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding
palovarotene Treatment for Fibrodysplasia Ossificans Progressiva Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses Paris (France), Friday 13 August, 2021 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene. This
DUBLIN, Aug. 12, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.1 The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following
The 75,000 square foot facility will ultimately host more than 180 life science professionals, and is expected to be completed in Q4 2022. It will be located at 1055 Vernon Drive, in the Evolution Block building, in the False Creek Flats area of Vancouver, Canada. Proprietary platform Precision NanoSystems, a company dedicated to the development
August 10, 2021 Audience: Health Professional, Pharmacy August 10, 2021 — SterRx, LLC today announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous
According to research from Bristol Myers Squibb (BMS), Black people count for about 12% of the US adult population, but just 7% of the pharma workforce and a mere 3% of executive teams. To help bring about a more representative, equitable pharma workforce, the company has joined with five historically black colleges and universities (HBCUs)
Moderna says it is already in discussions with other governments about such collaborations: and a facility in Australia could be next in line. Vaccines for COVID-19 and beyond The new Canadian facility will manufacture a portfolio of mRNA vaccines against respiratory viruses. Such vaccines will include those against COVID-19, seasonal influenza, RSV and other
roxadustat Treatment for Anemia Associated with Chronic Renal Failure FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat
tapinarof Treatment for Plaque Psoriasis, Atopic Dermatitis Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis LONG BEACH, Calif. & BASEL, Switzerland–(BUSINESS WIRE) August 10, 2021 –Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today
Treatment for Bacterial Vaginosis Daré Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing
Having announced the deal earlier this year, the company has now finalized the acquisition of the facility from Novartis Gene Therapies. The Longmont site will give AGC Biologics 622,000 square feet of operations and office space primarily planned for CGT activities. The facility – located just 16 miles from AGC’s large-scale stainless-steel mammalian facility in
August 6, 2021 Audience: Health Professional, Pharmacy KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely
The response to vaccination in the elderly has been found to be considerably weaker than in younger adults, due to deterioration in the function of the immune system, known as immunosenescence. A number of polysaccharide compounds from plants, bacteria, fungi, and synthetic sources have emerged as promising vaccine adjuvant candidates. Among these, the non-digestible polysaccharides
FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease PARIS – August 6, 2021 – The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder that impairs a person’s ability to move
Report: expect the future of US pharma market to be exciting The COVID-19 pandemic has certainly had a tremendous impact on the pharmaceutical business. How this impact will affect the industry in the coming month will be a point of discussion during the upcoming CPhI North America hybrid event (taking place online and in Philadelphia
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