KENILWORTH & WOODCLIFF, N.J.–(BUSINESS WIRE) July 22, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by
Drugs
The alliance is aimed at advancing GentiBio’s immune tolerance platform; that company is developing engineered regulatory T cells (Tregs) that are programmed to treat autoimmune, alloimmune, autoinflammatory, and allergic diseases. Forge, which is a contract and development manufacturing organization (CDMO) focused on accelerating cell and gene therapy (CGT) programs from preclinical through clinical and commercial
July 20, 2021 Audience: Patient, Health Professional, Pharmacy What safety information is FDA announcing? The U.S. Food and Drug Administration (FDA) is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. We have conducted a comprehensive
Kineta’s KVA12.1 is in development for the treatment of solid tumors. VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function.
FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) BOSTON, July 20, 2021 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in
In acquiring the facility from Kite-owner Gilead, BioNTech is both expanding its manufacturing footprint into North America, as well as expanding its work in individualized cell therapies. BioNTech already has a cell therapy manufacturing facility in IdarOberstein, Germany: and the US facility will be used to support clinical trials stateside. The deal will nalso support
July 19, 2021 Audience: Consumer July 19, 2021 — Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable
The new contract will establish a suspension-based manufacturing platform and allow for the production of a variety of viral vectors for gene therapies and viral vector-based vaccines. Exothera recently announced a significant expansion of its manufacturing capabilities, with two new GMP facilities built at the company’s Jumet site near Brussels, Belgium. Those sites, which include
PARAMUS, N.J.–(BUSINESS WIRE) July 20, 2021 –The U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The FDA approval is based on the results
tenapanor Treatment for Hyperphosphatemia of Renal Failure Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment
July 19, 2021 — The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg.Fexinidazole was developed as part of an innovative
The pre-clinical in vivo study assessed the neutralization effect of CT-P59 against the Delta variant or B.1.617.2, the SARS-CoV-2 strain first identified in India, using a clinically relevant dose, according to the South Korean biopharma group. The trial, said the firm, demonstrated that CT-P59 treatment results in a 100% survival rate from COVID-19 compared to
Treatment for Seizure Clusters Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that
The Italian biotech, headquartered in Rome, has developed its vaccine on a novel and proprietary replication-defective simian (gorilla) adenoviral vector (called GRAd) encoding the full-length coronavirus spike protein. Preliminary Phase 2 data showed an antibody response against the SARS-CoV-2 spike protein in 93% of volunteers after the first dose; reaching 00% after the second dose.
The $39bn deal, announced in December 2020, will support AstraZeneca’s ambitions to develop novel medicines in immunology. Boston-based biotech Alexion has pioneered complement inhibition for a broad spectrum of immune-mediated rare diseases caused by uncontrolled activation of the complement system, a vital part of the immune system. The green light from the UK Competition and
Patient perspective key to any redesign of clinical trial protocols to suit decentralized approach Dawn Anderson, managing director of life sciences, Deloitte, was speaking about developments in decentralized trials leading up to and post-pandemic at last month’s virtual DIA annual meeting. We caught up with her to hear more. “As an industry we have made
roxadustat Treatment for Anemia Associated with Chronic Renal Failure Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease 16 July 2021 — The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval
The ‘TRAILBLAZER-ALZ 3’ trial will evaluate whether treatment with donanemab can slow the clincial progression of Alzheimer’s diseases in participants. Donanemab is an investigational antibody that targets a modified form of beta amyloid called N3pG. Phase 2 data, published in March, showed the monoclonal antibody ‘met its primary endpoint and showed significant slowing of decline’ in cognitive
FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults KENILWORTH, N.J.–(BUSINESS WIRE)– (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive
FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD) NEW YORK, NY / ACCESSWIRE / July 16, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients
Headquartered in Belgium, the contract development and manufacturing organization (CDMO) works across several sites in the Netherlands, Sweden and Latvia. It tends to assist small-to-mid sized biopharma with services spanning the full development life cycle. The company said it is to significantly widen drug product services in Belgium. “The Belgian site for drug product formulation and
July 14, 2021 Audience: Consumer NEW BRUNSWICK, N.J., JULY 14, 2021 – Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five Neutrogena® and Aveeno® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected
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