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Pfizer, alone among its peers, has faced fever-pitch scrutiny over the stringent cold storage requirements for its COVID-19 vaccine—and the logistical challenges that could pose. Looking to ease the doubters' concerns, Pfizer has now shipped its first doses by air to the U.S., and distributors are watching closely...Late last week, United Airlines started ferrying Pfizer’s COVID-19 vaccine hopeful from the Brussels International Airport in Belgium to Chicago O'Hare...marking the first “mass air shipment” of a coronavirus vaccine...READ MORE

More than 40 years since setting up shop in a rented warehouse as the modern world’s first biotech company, Roche’s Genentech is now up for a major expansion at its South San Francisco home in California...the local city council approved Genentech’s expansion proposal, which aims to almost double its headquarters’ building space to 9 million square feet from the current 4.7 million square feet...That extra buildout, all within the boundary of its existing 207-acre campus, allows the Roche unit to add as many as 12,550 employees at the HQ on top of the 10,000 or so who are there right now, according to the master plan...READ MORE

A new Aetna pilot program aims to harness its parent company's pharmacy reach to help address members' social needs...Through the HealthTag initiative, CVS Health pharmacists and pharmacy employees are empowered to offer more personalized information when Aetna Medicaid members come to pick up prescriptions, providing the members with health information beyond how to take their medications appropriately...Inside the prescription bag, members are provided additional details on how to access community services to address social concerns like food, housing or transportation. The network of these organizations is backed by Unite Us, a social care coordination program...Aetna will pilot the program at CVS pharmacies in West Virginia and Louisiana...READ MORE

Regeneron’s COVID-19 antibody cocktail, one of the drugs President Donald Trump was given after he was infected with the SARS-CoV-02 virus, has been cleared for emergency use by the FDA. And, despite looming rollout of vaccines, one analyst still sees the therapy as a steady $1 billion-plus business...The emergency use authorization for REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, marks the second for an antibody therapy. The first one went to Eli Lilly’s bamlanivimab, which was given an EUA a few days ago...READ MORE

Days after grabbing headlines with its COVID-19 “vaccine for the world”, AstraZeneca is facing tricky questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval...Several scientists have raised doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose...“All we have to go on is a limited data release,” said Peter Openshaw, a professor of experimental medicine at Imperial College London. “We have to wait for the full data and to see how the regulators view the results,” he said, adding that U.S. and European regulators “might possibly take a different view” from each other...READ MORE

...the contract manufacturing market has seen a wave of investment in the U.S. amid the COVID-19 pandemic and a call for "onshore" drug production...Baxter Biopharma Solutions, the CDMO arm of healthcare giant Baxter, will shell out $50 million in an expansion to its fill-finish manufacturing plant in Bloomington, Indiana, that will eventually bring 100 new positions on board...The expansion will add a 25,000-square-foot warehouse; a new filling line for flexible plastic containers; a high-speed automated syringe fill line capable of filling up to 600 units per minute; and a new high-speed, automated visual inspection line...READ MORE

Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013, also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode...“The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one,”...READ MORE

What will it take to distribute the first 6.4 million doses of Pfizer’s COVID-19 mRNA vaccine, if all goes according to plan and they ship in mid-December?...Alex Azar, secretary of health and human services, acknowledged...that the logistics—which include the need for ultra-cold storage—will be far from easy...To pull off the ambitious plan, Warp Speed has enlisted Pfizer, which has been running “dry rehearsals” at more than 50 vaccine distribution sites across the country, said Gen. Gustave Perna, who is leading the effort...The company is running the sites through the process of receiving the vaccines, opening them, and administering them, even going so far as to create YouTube videos for staffers to consult along the way...READ MORE

On November 9, Pfizer announced that its COVID-19 vaccine candidate demonstrated efficacy of over 90% based on the mix of 94 cases between the placebo and vaccine groups in its Phase 3 clinical trial...Some of us had wondered about the timing of the announcement, given that the results far exceeded the primary efficacy endpoint of only 50% (with appropriate statistical confidence intervals) set by the FDA for a successful vaccine, and Dr. Fauci's concurrence that 50% would be acceptable...READ MORE

Indian Prime Minister Narendra Modi has urged states that are witnessing a surge in coronavirus cases to establish cold storage facilities for COVID-19 vaccines...India is home to some of the world’s biggest vaccine makers and there are five vaccine candidates under different phases of trial here. But the state-run cold chain facilities used to keep some vaccines consistently refrigerated would be inadequate for the enormous challenge of rolling out a COVID-19 vaccine...READ MORE