Agios’ pivot to late-stage projects results in loss of 50 jobs
Agios Pharmaceuticals is cutting the company’s staff numbers by 50 as part of plans to lay low on exploratory research efforts to focus on the success of late-stage initiatives.
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Evotec, Sernova striving for functional diabetes cure
/in Beta cells, Business, Chronic Diseases, Clinical Trials, Collaboration, Collaborations, Diabetes, Insulin, Life Sciences, Pancreatic beta cells, Partnerships, R&DTwo life sciences powerhouses are coming together to develop an off-the-shelf beta cell replacement therapy for insulin-dependent diabetes patients, which they hope will become a functional cure for both types of the disease.
Baby formula makers ramp up U.S. supplies to tackle shortage
/in Abbott, Bacterial Infections, Business, Facilities/Sites/Manufacturing, FDA, Infant Formulas, Supermarkets, TherapeuticsTop baby formula makers Reckitt Benckiser and Nestle ramped up supplies to the United States to resolve a shortage that has emptied shelves and caused panic among parents. Leading U.S. manufacturer Abbott Laboratories on May 16 announced an agreement with the Food and Drug Administration to resume production of baby formula at the company’s Michigan plant, marking a major step towards resolving the nationwide shortage.
AstraZeneca boosts COVID portfolio with RQ Bio deal
/in Acquisitions, AstraZeneca, Biotech, Business, Coronavirus Vaccines, COVID-19 Antibodies, COVID-19 shots, COVID-19 Therapeutic, COVID-19 therapeutic candidates, COVID-19 Therapeutics, COVID-19 Therapies, COVID-19 Vaccines, Evusheld (AstraZeneca), Evusheld (tixagevimab and cilgavimab; AstraZeneca), Licensing, R&D, Therapeutics, Vaxzevria (previously COVID-19 Vaccine AstraZeneca)AstraZeneca moved to bolster the company’s COVID-19 portfolio of antibodies on May 17 with a $157 million licensing deal for experimental therapies developed by newly launched biotech RQ Bio.
U.S. to allow baby formula imports amid nationwide shortage
/in Abbott, Babies, Business, Congress, Facilities, FDA, Imports, Infant Formulas, Ireland, United States, White HouseThe United States will allow baby formula imports from foreign makers that do not usually sell their products here, the Food and Drug Administration said on May 16, as it tries to ease a nationwide shortage that has left parents scrambling to feed their babies.
Coronavirus may be linked to cases of severe hepatitis in children
/in Children, COVID-19 Studies, Hospitalized COVID-19 Patients, JAMA, Kids, Liver dysfunction, Medical Journals, Oxygen Therapy, R&D, Researchers, SARS-CoV-2 virus, Severe hepatitis, The Lancet Gastroenterology & HepatologyA chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.
FDA declines to authorize common antidepressant as COVID treatment
/in Antidepressants, Brazil, Coronavirus Disease 2019 (COVID-19), Covid-19 Data, FDA, Fluvoxamine, Generics, Selective Serotonin Reuptake Inhibitors (SSRIs), TherapeuticsThe U.S. Food and Drug Administration decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying the data has not shown the drug to be an effective therapeutic for fighting the virus.
FDA to soon authorize Pfizer’s COVID booster shot for younger kids – NYT
/in BNT162b2 (Pfizer and BioNTech), CDC, Children 5-11 Years, Clinical Trials, COVID-19 booster shots, Covid-19 Data, COVID-19 Vaccines, Emergency Use Authorization (EUA), FDA, New York Times, R&DU.S. health regulators are expected to authorize a booster shot of Pfizer/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as May 17, the New York Times reported on May 16, citing people familiar with the matter.
Abbott Enters into Consent Decree with U.S. Food and Drug Administration for its Sturgis, Mich., Plant; Agreement Creates Pathway to Reopen Facility
/in Abbott, Business, FDA, Healthcare Companies, Infant Formulas, Infants, Ireland, Manufacturing Plants, Michigan, U.S. Department of Agriculture.Abbott agreed to enter into a consent decree with the U.S. Food and Drug Administration related to the company’s Sturgis, Mich., infant formula plant. The decree is an agreement between the FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.
Lacking vaccines, North Korea battles COVID with antibiotics, home remedies
/in Antibiotics, Coronavirus, Coronavirus, COVID-19 cases, Epidemics, Medical Supplies, North Korea, OutbreaksStanding tall in bright red hazmat suits, five North Korean health workers stride towards an ambulance to do battle with a COVID-19 outbreak that – in the presumed absence of vaccines – the country is using antibiotics and home remedies to treat. The isolated state is one of only two countries yet to begin a vaccination campaign and, until last week, had insisted it was COVID-free. Now North Korea is mobilizing forces including the army and a public information campaign to combat what authorities have acknowledged is an “explosive” outbreak.