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Tag: FDA


FDA, Regulations

FDA panel shoots down Spectrum, Oncopeptides’ cancer drugs

September 23, 2022

Via: Pharmaphorum

It was already unlikely that the two companies would get a positive outcome from the Oncologic Drugs Advisory Committee (ODAC), after damning assessments by the FDA reviewer in documents published ahead of yesterday’s decisions, but shares in both firms still […]


FDA, Regulations

FDA Approves Bluebird Bio’s $3 Million CALD Treatment

September 21, 2022

Via: Biopharm International

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD. FDA announced that it had granted approval of SKYSONA (elivaldogene automecel) to bluebird bio for the treatment of […]


FDA, Mergers and Acquisitions, Regulations

FDA and NIH Enter Rare Neurodegenerative Diseases Partnership

September 21, 2022

Via: Biopharm International

FDA and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a public-private partnership, on Sept. 14, 2022. The goal of this partnership is to advance the understanding and develop treatments […]


Cell and Gene Therapy, Industry

Back-to-back gene therapy approvals give Bluebird shot at survival

September 19, 2022

Via: Biopharma Dive

Until this August, just two gene therapies for inherited diseases were available in the U.S. Now, in the span of one month, that count has doubled, with the Food and Drug Administration approving new treatments for a rare blood condition […]


FDA, Regulations

FDA Warns Against Overuse of TPOXX Monkeypox Drug

September 16, 2022

Via: Drugs.com

U.S. health officials are advising doctors not to overuse the only antiviral for monkeypox because there is a risk of the virus mutating and rendering the drug useless. TPOXX (tecovirimat) works by targeting just one protein found on monkeypox, as […]


Biotech, Industry

Biotechnology Gets $2 Billion Boost from the White House

September 15, 2022

Via: GEN

This week has been one of the most exciting that the biotechnology community has seen for some time. Plans that have been in the making for a decade are finally being brought to fruition by actions taken by the Biden […]


Mergers and Acquisitions

FDA and NIHR launch public-private partnership for rare neurodegenerative diseases

September 15, 2022

Via: PMLiVE

The goal of the partnership – the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – is to generate ‘actionable solutions that can tangibly accelerate’ drug development for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases, the FDA said in […]


FDA, Regulations

FDA starts review of first drug for alpha-mannosidosis, from Chiesi

September 13, 2022

Via: Pharmaphorum

The vanishingly rare, progressive, and debilitating disease is caused by a deficiency in the enzyme alpha-mannosidase, leading to a build-up of complex sugars that damage the central nervous system and organs of the body. Patients with alpha-mannosidosis are typically diagnosed […]


FDA, Regulations

Dogs Have Died After Licking a Common Chemotherapy Cream, FDA Warns

September 9, 2022

Via: Drugs.com

Your dog may like to lick your hand or face, but if you’re using a chemotherapy cream that treats certain skin conditions, you should not allow it, the U.S. Food and Drug Administration advises. The medication fluorouracil is fatal to […]


FDA, Regulations

FDA Approves Botox Competitor That Lasts Longer

September 9, 2022

Via: Drugs.com

People wanting to keep wrinkles at bay will soon have a new option now that the U.S. Food and Drug Administration has approved the first competitor for Botox in decades. Daxxify, made by Revance Therapeutics Inc. in Nashville, Tenn., is […]


FDA, Regulations

FDA grants Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus vaccine candidate

September 7, 2022

Via: World Pharma News

Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive GBS disease due to the vaccine […]


FDA, Regulations

FDA Panel Skeptical of Controversial ALS Drug Ahead of Vote

September 6, 2022

Via: Drugs.com

U.S. Food and Drug Administration panel will once again consider approval for an experimental drug for ALS, a rare second review for a disease that has no cure. The same panel that will meet Wednesday voted last March not to […]


FDA, Regulations

FDA gives AZ the nod for Imfinzi in biliary tract cancer

September 5, 2022

Via: Pharmaphorum

Imfinzi (durvalumab) has been cleared by the US regulator for the treatment of adult patients with locally advanced or metastatic BTC in combination with gemcitabine/cisplatin chemotherapy, extending the use of Imfinzi beyond lung cancer for the first time. The approval […]


Industry, Vaccines

EMA panel backs COVID-19 vaccines targeting Omicron BA.1

September 2, 2022

Via: Pharmaphorum

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The European Commission said it will move ahead with an accelerated authorisation […]


FDA, Regulations

Sanofi, after long research journey, wins FDA approval for rare disease drug

September 1, 2022

Via: Biopharma Dive

The approval comes after more than two decades of research and development by rare disease specialist Genzyme, which Sanofi bought in 2011 for $20.1 billion. Patients with ASMD suffer from a lack of an enzyme needed to break down a […]


FDA, Regulations

FDA Warns of Dangers From Skin Lightening Creams

September 1, 2022

Via: Drugs.com

Skin lightening products can be dangerous for consumers when they contain harmful ingredients that are illegal for over-the-counter sales, the U.S. Food and Drug Administration warned Wednesday. The potentially harmful ingredients are hydroquinone or mercury, the agency said in a […]


News

Dr. B: Expanding the business model from COVID vaccines to antiviral medications

September 1, 2022

Via: Pharmaphorum

Cyrus Massoumi, founder of Dr. B, tells us about his online platform that makes physician assessment readily available to patients and provides access to COVID-19 therapeutics that may otherwise be difficult to obtain. COVID-19 antiviral medications Paxlovid (nirmatrelvir/ritonavir) and Lagevrio […]


Industry, Vaccines

FDA clears updated COVID-19 boosters from Pfizer, Moderna

August 31, 2022

Via: Biopharma Dive

The Food and Drug Administration has authorized updated COVID-19 booster vaccines for emergency use, hoping the reformulated shots from partners Pfizer and BioNTech and Moderna can curb an expected wave of new infections this winter. The FDA on Wednesday cleared […]


Cell and Gene Therapy, Industry

Beam details reasons for FDA hold on base editing cancer therapy

August 31, 2022

Via: Biopharma Dive

FDA officials are proceeding with caution as the gene editing field advances. In another recent example, the agency had issued a partial clinical hold to Editas Medicine before this July allowing that company to proceed with testing of a sickle […]


Mergers and Acquisitions

Biotech startup Ocean pivots from IPO to SPAC merger

August 31, 2022

Via: Biopharma Dive

Ocean Biomedical, a small Rhode Island-based biotechnology company, will go public through a SPAC merger with Aesther Healthcare Acquisition Corp, pivoting from plans to list shares through a traditional initial public offering. Ocean Biomedical focuses on oncology, infectious diseases and […]