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Manufacturing capacity and ingredients shortages are the main bottlenecks to expanding COVID-19 vaccine production, several global drug groups said...not patents that some critics are demanding be removed...“IP (intellectual property) rights is not the issue,” said Thomas Cueni, who heads the International Federation of Pharmaceutical Manufacturers and Associations...“The bottlenecks are the capacity, the scarcity of raw materials, scarcity of ingredients, and it is about the know-how.”...READ MORE

The Government Accountability Office has concerns about the FDA's widening inspection backlog. COVID-19 certainly amplified the problem, but the issues had been mounting long before last March...As the FDA looks to honor lockdown rules and protect its staffers, the agency has largely paused inspections since the pandemic started last spring, conducting only those deemed “mission-critical.” In fact, the FDA was unable to complete more than 1,000 planned inspections in 2020—and that backlog will likely grow with time, the U.S. Government Accountability Office (GAO) said in a release...READ MORE

The first single-dose Covid-19 vaccine, a shot from Johnson & Johnson, was authorized for use...the third issued by the U.S. Food and Drug Administration, will give health authorities a desperately needed new source of doses as they scramble to ramp up inoculations ahead of elusive emerging strains...J&J said it has begun shipping the vaccine to the U.S. government, which is managing allocation and distribution. That indicates first doses could be administered during the coming week...READ MORE

Johnson & Johnson has been battling for years against lawsuits claiming its talc powders cause cancer, but now investors are getting a sense of what the litigation could cost the drug giant...In an annual filing with the Securities and Exchange Commission, J&J said its multibillion-dollar 2020 litigation expense is “primarily associated with talc related reserves and certain settlements” worth $3.9 billion. The company faces 25,000 lawsuits alleging the household products cause cancer...READ MORE

A large majority of American adults prefer to get their prescription drugs from a local pharmacist instead of a mail order service, mainly because of the personal relationship, according to a new national survey released today by the National Community Pharmacists Association...“Most Americans clearly are not willing to substitute personal care for the perception of convenience,”...When asked why, 36 percent say their pharmacist knows them better than a mail order company. Thirty-two percent say their pharmacist answers questions and provides counsel on how to use the drugs. Another 15 percent worry their drugs will get lost in the mail, exposed to the elements, or stolen...READ MORE

Gilead Sciences’ new business service center is a win for North Carolina but comes with some losses for the company's home state of California...The Foster City-based pharma plans to cut 178 jobs in California effective May 30...It’s “the latest example of a major Bay Area company moving workers to a cheaper location”...Half of the jobs are expected to shift to Gilead's now-underway Research Triangle Park service center in North Carolina...Under a North Carolina economic development and jobs grant program, Gilead can earn up to $10 million in reimbursement payments over 12 years through the project. North Carolina estimates it will see an annual economic gain of more than $39 million...READ MORE

The Food and Drug Administration advisory committee endorsed Johnson & Johnson’s coronavirus vaccine late Friday afternoon...The vaccine appears widely effective against the virus and is especially good at preventing severe cases...And because the vaccine is given as a single dose and is easy to ship, it presents an appealing profile for public health officials struggling to vaccinate hard-to-reach or skeptical populations...READ MORE

Alexa, show me the future of drug advertising? Bayer Consumer Health's first-ever Alexa interactive ad allows consumers to buy an OTC product by talking to the Amazon device—and may foreshadow broader trends in the industry...The U.K. ad for Bayer’s Berocca Boost, a vitamin and caffeine tablet, is running as a trial during programming streamed by Global...Launching the app brings up voice options to either order the product or hear more information about it. If the listener chooses to order, Alexa asks whether they’d like to use a default payment method and address. One yes later, Berrocca Boost is on its way and the original radio program returns...While dropping an OTC product into an Amazon cart via voice app is a long way from fulfilling a physician-ordered prescription medicine the same way, the Bayer trial foreshadows what's possible even in the more regulated pharma world...READ MORE

CVS, Walgreens and Walmart are enrolling customers in patient systems in order for them to book vaccine appointments...Perk of data allows these chains to use information to promote their stores and services, which includes coupons and promotions, and tailor marketing...After customers create profiles for Walgreens, they get marketing emails and agree to let Walgreens 'automatically collect information about you'...READ MORE

It’s lights, camera, action for Pfizer and BioNTech vaccine scientists and executives. They're starring in “Mission Possible,” a branded content film from Pfizer and National Geographic that tracks the COVID-19 vaccine's journey to market...The movie-length product placement is a behind-the-scenes look at Comirnaty, the now-authorized coronavirus shot Pfizer developed and produced in concert with its partner BioNTech. Pfizer provided National Geographic's scientific storytellers “unprecedented access” to the vaccine's development...READ MORE