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…

For any vaccine, some degree of waste is expected. The problem is inspiring supply-chain companies to explore new technologies that can address a longstanding struggle. “Before COVID-19, we often saw waste of about 8–10%,” said Ranjeet Banerjee, CEO of Cold Chain Technologies, which provides insulated packaging for drugs and biologics. A 2019 World Health Organization report citing…

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…

BioDelivery Sciences (NSDQ:BDSI) is a specialty pharmaceutical company that last year achieved a 617% growth rate, as shown in Deloitte’s 2020 Technology Fast 500 Rankings. The company is focused on meeting unmet needs of patients with chronic conditions. We interviewed Scott Plesha, the company’s president and chief commercial officer, to learn more about the company. In…

Catalent announced today that it completed the expansion of two new suites at its biologics manufacturing facility in Madison, Wis. Somserset, N.J.-based Catalent also commenced work on customer programs in addition to completing the expansion of the biologics drug substance development and manufacturing facility, according to a news release. The company now has five manufacturing…

Recent research from reputation data specialist RepTrak (Boston) indicates that the pharma industry had the largest year-over-year reputational improvement of any sector, according to its roundup of top 100 corporations. The sector saw significant gains in consumers’ perception of its citizenship and governance.  Now ranked eighth overall, the pharma industry came in just ahead of…

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 will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000.  The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes…

The recent spectacle surrounding Vaxzevria, the AstraZeneca (LON:AZN) COVID-19 vaccine, could exacerbate vaccine hesitancy, which is significant in many parts of the world. In the U.S., the independent data and safety monitoring board overseeing the Phase 3 trial contacted government authorities with concerns that the summary data were misleading. More recently, the European Medicines Agency (EMA)…