Eli Lilly ’ s Alzheimer ’s Drug Donanemab Fails to Get Early FDA Approval
Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy donanemab was rejected by U.S. regulators, an unexpected setback for the drugmaker. The Food and Drug Administration sent the company a complete response letter saying it would not give the early approval for the drug because not enough patients on the trial had received it for a full 12 months, Lilly said Thursday in a statement. The agency wanted Lilly to provide safety data on at least 100 patients who had been on the drug for a year. Lilly’s application for accelerated approval was based on a relatively small mid-stage trial...
Source: TIME: Health - January 20, 2023 Category: Consumer Health News Authors: Robert Langreth and Nacha Cattan/Bloomberg Tags: Uncategorized bloomberg wire Drugs Source Type: news

Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 9, 2023 Category: Drugs & Pharmacology Source Type: news

Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months
5 January 2023 -- Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi and is the first single-dose preventative option for the broad infant population, including those born healthy, at term or preterm, or... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 5, 2023 Category: Drugs & Pharmacology Source Type: news

Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis
FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 3, 2023 Category: Drugs & Pharmacology Source Type: news

The Petri Dish: Group eyes Biogen Alzheimer's drug price, FDA rejects psych drug application
The FDA has elected not to accept a new drug application from Minerva Neurosciences Inc., sending shares plummeting. Read this, and more, in the latest biotech news roundup, The Petri Dish. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 29, 2022 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news

Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
BURLINGTON, Mass., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2022 Category: Drugs & Pharmacology Source Type: news

Harm Reduction Therapeutics' New Drug Application for RiVive(TM) Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA
Low-cost, over-the-counter naloxone nasal spray advances to FDA review. Approval would increase access to this lifesaving medicine for the emergency treatment of opioid overdose. PITTSBURGH, Dec. 26, 2022 -- (Healthcare Sales & Marketing Network) -- Ha... Biopharmaceuticals, Drug Delivery, FDA Harm Reduction Therapeutics, RiVive, intranasal, naloxone (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 26, 2022 Category: Pharmaceuticals Source Type: news

Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC). The FDA's decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024. (Source: World Pharma News)
Source: World Pharma News - December 26, 2022 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Alembic Pharma gets USFDA nod for generic drug to treat breast cancer
The approval granted by the US Food& Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 26, 2022 Category: Pharmaceuticals Source Type: news

Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva
The CRL is related to the U.S. FDA’s previous request for additional information on palovarotene clinical trial data Ipsen anticipates responding to the request in the first quarter of 2023 PARIS, FRANCE, 23 December 2022– The... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2022 Category: Drugs & Pharmacology Source Type: news

Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), December 23, 2022– Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sunlenca (lenacapavir) Twice-Yearly Treatment for People Living With Multi-Drug Resistant HIV
Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates of Sustained Virologic Suppression in the CAPELLA Trial FOSTER CITY, Calif.--(BUSINESS WIRE) December... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2022 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis
Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile consistent with previous studies NEW YORK--(BUSINESS WIRE) December 21, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2022 Category: Drugs & Pharmacology Source Type: news

Idorsia submits a new drug application to the FDA By Reuters
Idorsia submits a new drug application to the FDA ZURICH (Reuters) - Swiss biotech company Idorsia has submitted a new application for approval of the drug aprocitentan to the U.S. Food and Drug Administration. Aprocitentan is intended to be used in the treatment of patients with…#idorsia #aprocitentan #fda (Source: Reuters: Health)
Source: Reuters: Health - December 20, 2022 Category: Consumer Health News Source Type: news

Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy
PARSIPPANY, N.J.--(BUSINESS WIRE)--Dec. 20, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the third and final part of its New Drug Application (NDA) for rolling review of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2022 Category: Drugs & Pharmacology Source Type: news