Regulatory

A recent report from the House Oversight and Reform Committee concluded that AbbVie (NYSE:ABBV) aggressively increased prices of popular drugs, including the bestseller Humira (adalimumab), which brought in close to $20 billion last year. Approximately $16 billion of those sales were in the U.S. In recent years, the company also repeatedly increased the price of…

Aurobindo Pharma has received approval from FDA for its abbreviated new drug application for the glaucoma medication dorzolamide hydrochloride (HCl) and timolol maleate ophthalmic solution in 2% and 0.5% concentrations.  The product is a generic equivalent to the reference listed drug Cosopt ophthalmic solution, from Akorn Operating Company. FDA indicates the drug to reduce intraocular…

Canada’s National Advisory Council on Immunization (NACI) has recommended that Canadians wait to receive the messenger RNA (mRNA) vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) when feasible. The advice stands in contrast to prior guidance that Canadians seek the first-available vaccines. “What we’re saying and what we’ve said all along is that mRNA vaccines are the…

FDA has sent its first notice of noncompliance to Acceleron Pharma (NSDQ:XLRN), accusing the company of failing to submit summary results information to ClinicalTrials.gov for a Phase 2 trial. The agency sent the company a letter warning of potential noncompliance in July 2020. The National Library of Medicine, a part of the National Institutes of Health, operates the…

Biogen (NASDAQ: BIIB) posted first-quarter results that beat the Wall Street consensus forecast, with the company raising its 2021 earnings guidance. However, Biogen’s outlook for the rest of the year largely hinges on FDA decisions regarding its pipeline drugs aducanumab and zuranolone. The Cambridge, Mass.-based biotech earned $410 million, or $2.69 per share, off sales…

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and…

The third vaccine to win emergency use authorization in the U.S. could reappear after a 10-day pause, according to Dr. Anthony Fauci, the nation’s top disease expert. FDA and CDC had recommended temporarily suspending the use of the Johnson & Johnson (NYSE:JNJ) vaccine after six women developed serious blood clots within weeks of vaccination. Fauci…

The European Union has decided to exercise an option to purchase additional doses of the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The two companies will deliver 600 million doses of the vaccine to the EU in 2021.  The Continent’s mass-vaccination efforts have sputtered for much of early 2021, given supply constraints related…

Eli Lilly (NYSE:LLY) announced that it had amended purchase agreements with the U.S. government to prioritize using two monoclonal antibodies — bamlanivimab and etesevimab — in tandem. In March, the U.S. government announced that it would stop using bamlanivimab alone, given its reduced efficacy against some SARS-CoV-2 variants. But pairing anti-SARS-CoV-2 monoclonal antibodies together can offer more…

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility. The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines. New Brunswick, N.J.–based J&J’s single-dose vaccine was authorized…