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Pharmaceuticals, health and wellness

FDA won’t require manufacturing inspections for emergency COVID-19 vaccine use: Bloomberg

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections. COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections, agency official Jerry Weir said at the FDA’s open […]

Former Indivior CEO gets 6 months in jail for role in Suboxone marketing scheme

Battling a longrunning federal probe into marketing of its opioid addiction therapy Suboxone Film, Indivior and a former parent company have been rocked by a series of massive settlements in recent years. Now, a former executive who headed the scheme is facing jail time and a hefty fine for his role.  Shaun Thaxter, a former […]

Deaths rattle South Korea’s seasonal flu vaccination, but authority presses ahead with free scheme

South Korea is preparing to fight two infectious diseases this winter: the novel coronavirus and the flu. But reports of deaths after flu shot vaccination may jeopardize the second effort. As of Friday afternoon local time, 36 people have died in Korea after getting flu shots, including a 17-year-old high schooler, Korea Biomedical Review reported. […]

Merck, Pfizer pneumonia vaccines running low in EU as researchers fight COVID-19: report

As COVID-19 continues to rage worldwide, health authorities worry that a perfect storm of the novel coronavirus, pneumonia and seasonal flu could overtake hospital systems. Now, two major pneumococcal vaccines are already seeing shortages in the EU, which could be an ill omen for the coming months. Merck & Co.’s Pneumovax 23 and Pfizer’s Prevnar […]

FDA study finds fear and distrust among front-line workers and minority groups around COVID-19 vaccines

Powerful, illuminating and sobering—that’s the description from a research group summing up its initial listening sessions with front-line workers and minority groups about a vaccine. Tasked with tapping key audiences to learn their questions and concerns about a COVID-19 vaccine—and determine how the FDA might best respond—the nonprofit Reagan-Udall Foundation for the FDA is currently in listening mode on […]

Novartis taps celeb dancer and ‘Ellen’ show DJ to headline Adakveo social challenge

So you think you can dance—for Adakveo? Novartis’ latest campaign asks people to bust a move to raise awareness around sickle cell anemia and its branded treatment. Led by well-known hip-hop dancer Stephen “tWitch” Boss, who also appears on “The Ellen DeGeneres Show” as a DJ, the “Do U” campaign invites the public to create […]

What will FDA’s experts review at their first COVID-19 vaccine hearing? Agency documents set the tone

The countdown to the FDA’s first coronavirus vaccine hearing has begun. More than seven months into the COVID-19 pandemic, with several vaccines in late-stage testing and developers preparing to file for widespread use, the FDA unveiled its plan for a Thursday advisory panel confab. Unlike a typical AdComm meeting, this one won’t revolve around a […]

Pfizer plans to ditch Perth sterile injectables manufacturing site by 2024, endangering 470 positions

After years of manufacturing woes, Pfizer appeared to turn a corner earlier this year for its growing sterile injectables portfolio. But even with signs trending upward, Pfizer is preparing to exit an Australian site specializing in those drugs as part of a global reorganization effort.  Pfizer will walk away from its more than 50-year-old facility in […]

GlaxoSmithKline offloads Polish plant with 700 workers to French CDMO Delpharm

With plans to take its consumer healthcare joint venture with Pfizer public in the next few years, GlaxoSmithKline has been in Marie Kondo mode for some of its expansive global assets. After cutting a Canadian plant with 400 workers earlier this year, GSK is now hiving off an even bigger facility in Poland.  GSK has sold […]

FiercePharmaAsia—COVID-19 drug manufacturing; Roche’s China slowdown; Astellas’ Iota buy

Takeda and CSL Behring are scaling up manufacturing of their coronavirus hyperimmune drug, but its reliance on blood donations could be a bottleneck. Eli Lilly has signed on Fujifilm to help make its COVID-19 antibody therapy as part of a Bill & Melinda Gates Foundation initiative to bring drugs for low- and middle-income countries. Roche blames […]

4 AbbVie brands land on pharma’s top TV spenders list for September

Pharma TV advertising spiked in September, even without the usually ubiquitous football media to play it on. The top 10 brands spent $182 million, the highest monthly total since January, according to data from real-time TV ad tracker AbbVie’s Humira led the way as usual, but with an even bigger budget of $57.7 million, an increase of […]

No need to panic about COVID-19 trial halts, FDA chief says. They show the system is working

Headlines about COVID-19 vaccine and drug trial pauses may ring alarm bells for millions of people watching their progress, but FDA Commissioner Stephen Hahn, M.D., has another point of view. The breaks in the action actually show the development process is working as intended, Hahn told Bloomberg. “The system was designed to identify safety issues,” he […]