FDA Archives

News and Trends 4 Aug 2022

First of its kind drug, to reverse effects of cocaine intoxication, awarded grant

An enzyme that efficiently degrades and metabolizes cocaine has been given a ‘cooperative agreement grant’ from the National Institute on Drug Abuse (NIDA) part of the National Institutes of Health. The recombinant enzyme is a double-mutant cocaine esterase 200 mg intravenous (IV) solution and treats cocaine intoxication, which refers to the state of when cocaine […]

August 4, 2022 - 3 minutesmins - By Liza Laws

News and Trends 4 Aug 2022

Deal worth $3.7B sealed as Amgen buys biopharma ChemoCentryx

A company producing drugs including TAVNEOS to treat autoimmune diseases, plus others dealing with inflammatory disorders and cancer has been bought by biopharmaceutical company, Amgen for $52 per share. ChemoCentryx and Amgen have entered a definitive agreement worth approximately $3.7 billion. Robert Bradway, chairman and chief executive officer at Amgen, said: “The acquisition of ChemoCentryx […]

August 4, 2022 - 3 minutesmins - By Liza Laws

News and Trends 4 Aug 2022

PolyPid to receive millions for commercialization of infection-fighting drug

A drug to prevent surgical site infections (SSIs) in abdominal and cardiac surgeries in Europe is to be commercialized after two companies entered an exclusive licensing agreement. Israel-based PolyPid Ltd and UK-based ADVANZ PHARMA Corp. announced the agreement for lead drug candidate D-PLEX100 yesterday (August 3). Topline results Under the terms of the agreement, PolyPid will receive […]

August 4, 2022 - 3 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Patients with advanced cancer set to benefit from ProfoundBio’s new drug

Patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma could benefit from an antibody drug conjugate (ADC) after clearance of an investigational new drug (IND) was approved by the US Food and Drug Administration (FDA). ProfoundBio received the FDA’s ‘study may proceed’ letter today (August 3) to evaluate PRO1184, a folate receptor […]

August 3, 2022 - 2 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Full label approval given by FDA for eye disease drug, CIMERLI

Age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases can now be treated after the U.S. Food and Drug Administration (FDA) approved a biosimilar product interchangeable with an injection. The approval of CIMERLI (ranibizumab-eqrn) interchangeable with Lucentis, a ranibizumab injection was jointly announced by Polpharma Biologics BV, Formycon AG and Bioeq AG today […]

August 3, 2022 - 4 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Ascletis announces FDA clearance of oral drug to conduct study in mild to moderate COVID-19 patients

A randomized, placebo-controlled study in mild to moderate COVID-19 patients has been approved by the US Food and Drug Administration (FDA). The Investigational New Drug (IND) application for ASC10, an oral drug candidate targeting RNA-dependent RNA polymerase (RdRp) for COVID-19 was granted to China-based Ascletis Pharma Inc today (August 3), to conduct a Phase 1b […]

August 3, 2022 - 2 minutesmins - By Liza Laws

Sanofi drops amcenestrant clinical development program

News and Trends 3 Aug 2022

Allarity Therapeutics drug no longer commercially viable or in shareholders’ best interest

Allarity Therapeutics, after meeting with the US Food and Drug Administration (FDA), has decided a growth factor receptor drug it licensed from Novartis is no longer commercially viable or in the best interests of its shareholders. A type C advisory meeting was held between Allarity and the FDA to discuss a development path for dovitinib. […]

August 3, 2022 - 4 minutesmins - By Liza Laws

car-t therapy, combination therapy, car-t cell therapy, cancer therapy, blood cancer

More News! 3 Aug 2022

Allarity Therapeutics takes advice from its board and switches focus to combination therapies

US-based Allarity Therapeutics has made a decision to change tack and focus on combination therapy approaches while making the most of its current assets. The company says the new strategy, driven by its board of directors, aligns with the ongoing shift in oncology standard-of-care moving away from monotherapies. Instead it will veer towards more promising […]

August 3, 2022 - 3 minutesmins - By Liza Laws

News and Trends 2 Aug 2022

SNIPR Biome announces new patent granted for applications targeting E. coli infections

SNIPR Biome has today (August 2) announced that it has been granted a patent for medical applications supporting the company’s lead program – a bacteriophage cocktail targeting E.coli infections. Granted by the US Patent and Trademark Office (USPTO), the patent adds to its intellectual property portfolio that contains more than 20 granted patents in the […]

August 2, 2022 - 2 minutesmins - By Liza Laws

News and Trends 1 Aug 2022

Clinical hold on trial for colorectal cancer drug lifted by FDA

A clinical hold has been lifted by the US Food and Drug Administration (FDA) on a trial for a treatment for colorectal cancer after changes were made by the company responsible. Belgium-based Celyad Oncology SA is a clinical biotech company focused on finding and developing chimeric antigen receptor T cell (CAR T) therapies for cancer. […]

August 1, 2022 - 2 minutesmins - By Liza Laws

News and Trends 28 Jul 2022

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

A drug to target a rare genetic form of a neurological disease that affects the nerve cells, leading to the loss of everyday functions, could be the first of its kind available if approved. The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Massachusetts-based Biogen Inc. for tofersen, an […]

July 28, 2022 - 4 minutesmins - By Liza Laws

News and Trends 28 Jul 2022

First of a kind multiple sclerosis biosimilar natalizumab accepted by US Food and Drug Association

Sandoz, a global pharmaceutical company working in generic and biosimilar medicines, announced this week that the US Food and Drug Administration (FDA) has accepted its biologics application (BLA) for treatment for people with multiple sclerosis (MS). The application is for a biosimilar natalizumab developed by Polpharma Biologics and includes all indications covered by the reference […]

July 28, 2022 - 3 minutesmins - By Liza Laws

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FDA

First of its kind drug, to reverse effects of cocaine intoxication, awarded grant

Deal worth $3.7B sealed as Amgen buys biopharma ChemoCentryx

PolyPid to receive millions for commercialization of infection-fighting drug

Patients with advanced cancer set to benefit from ProfoundBio’s new drug

Full label approval given by FDA for eye disease drug, CIMERLI

Ascletis announces FDA clearance of oral drug to conduct study in mild to moderate COVID-19 patients

Allarity Therapeutics drug no longer commercially viable or in shareholders’ best interest

Allarity Therapeutics takes advice from its board and switches focus to combination therapies

SNIPR Biome announces new patent granted for applications targeting E. coli infections

Clinical hold on trial for colorectal cancer drug lifted by FDA

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

First of a kind multiple sclerosis biosimilar natalizumab accepted by US Food and Drug Association

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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