Regulatory

FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final, while another two are draft guidance.  “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of…

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md. FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and…

This week, bipartisan lawmakers in the House and Senate introduced legislation known as the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. The bill would make changes to fees tied to direct and indirect remuneration, or DIR, under Medicare Part D. The National Association of Specialty Pharmacy (NASP) released a statement applauding the proposed…

In an SEC filing, Eli Lilly (NYSE:LLY.N) revealed that it had received a subpoena from the U.S. Department of Justice connected to a manufacturing site in New Jersey that produces bamlanivimab, one of two COVID-19 monoclonal antibodies it produces. The plant also produces the blockbuster Trulicity and cancer drugs. Lilly did not state which types…

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…