Brian Buntz

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…

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)…

The pharmaceutical industry is warming to the concept of smart manufacturing — and predictive maintenance in particular. The reason for that trend is partly financial. A single hour of downtime can potentially cost millions of dollars in lost productivity, and predictive maintenance promises to make maintenance more efficient and effective. One traditional barrier to predictive…

A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine.  The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C. engaged in a host of unsanitary practices. A letter to President Biden from the U.S.…

Employees at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded. A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality…

The spread of SARS-CoV-2 variants has convinced the U.S. government to stop using Lilly’s COVID-19 monoclonal antibody therapy bamlanivimab when used alone. The U.S. government will continue using bamlanivimab when paired with etesevimab, another monoclonal antibody. The government pointed to the rising number of SARS-CoV-2 variants across the country as the reasoning behind the decision.…