American scientists David Julius and Ardem Patapoutian won the 2021 Nobel Prize for Medicine on Oct. 4 for the discovery of receptors in the skin that sense temperature and touch and could pave the way for new pain-killers.
Is Your Quality Management System Ready for Fast Tracked Pandemic Related Drug Approvals?
Business, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Therapeutics, Current Goods and Manufacturing Practice (CGMP), Data, Fast Track, FDA, Investigational New Drug (INDs) submissions, IQVIA, Manufacturing, Medicines, New Drug Applications, New Drug Approvals, R&D, Virtual, Warning LettersMike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
AstraZeneca’s candidate breast cancer therapy Enhertu received a fourth Breakthrough Therapy Designation from the U.S. Food and Drug Administration after the health regulator issued another BTD based on a Phase III trial presented at the European Society for Medical Oncology Congress 2021.
Janssen Pharmaceutical’s experimental vaccine for a respiratory syncytial virus (RSV) demonstrated an 80 percent efficacy level in adults over the age of 65 years.
Four months after forging a collaboration to develop an experimental atopic dermatitis treatment, Amgen and Japan’s Kyowa Kirin are beginning to see the fruits of that deal with positive Phase II data for AMG 451/KHK4083, a potential first-in-class anti-OX40 monoclonal antibody.
Sage Therapeutics and Biogen announced positive and consistent results from their ongoing clinical trials on the efficacy and safety of zuranolone in treating major depressive disorder (MDD) and postpartum depression (PPD).
COVID-19 Update: J&J to Request Booster Authorization, Merck Antiviral Review a Priority
Antivirals, BioNTech, BNT162b2 (Pfizer and BioNTech), Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Antibodies, COVID-19 booster shots, COVID-19 Deaths, COVID-19 Vaccines, Dr. Anthony Fauci (Director), Molnupiravir, R&D, Scripps Research InstituteJohnson & Johnson is expected to ask the U.S. Food and Drug Administration to authorize a booster for the company’s one-shot Covid-19 vaccine this week. In other news, President Biden’s chief medical advisor Dr. Anthony Fauci told CNBC that they expect the FDA to review data on Merck and Ridgeback Biotherapeutics’ new oral antiviral against Covid-19 “as quickly as they possibly can.”
Noninvasive tests for colorectal cancer, prostate cancer and Covid-19 were among the highlights of the American Association for Clinical Chemistry (AACC) meeting September 26-30.
Germany’s Merck KGaA and Britain’s GlaxoSmithKline on Thursday ended their collaboration on the cancer treatment bintrafusp alfa, once seen as one of Merck’s most promising experimental drugs.
Merck & Co. is buying Acceleron Pharma Inc. for about $11.5 billion, broadening the company’s portfolio beyond the aging cancer drug Keytruda with potential treatments that could bring in fresh revenue.