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Pharmaceuticals, health and wellness

Johnson & Johnson told to throw out 60M COVID-19 shots made at troubled Emergent site: report

The manufacturing debacle at Emergent BioSolutions’ Baltimore plant keeps getting worse. After spending weeks inspecting the site, the FDA has instructed COVID-19 vaccine maker Johnson & Johnson and its production partner Emergent BioSolutions to throw out 60 million vaccine doses, The New York Times reports, citing people familiar with the matter. This comes after a manufacturing […]

Bayer pledges $300M to boost production in world’s ‘contraceptive capital’

Bayer, currently in the midst of a gung-ho cell therapy expansion in the U.S., is turning its attention back to Europe as it looks to beef up its birth control manufacturing in the world’s “contraceptive capital.” The company has designs on a €250 million ($303 million) investment for a new production plant in Turku, Finland, which […]

Incyte hits 2nd FDA delay in span of days, this time for atopic dermatitis hopeful ruxolitinib cream

Despite back-to-back phase 3 trial wins in atopic dermatitis, Incyte’s ruxolitinib cream isn’t immune to class-wide JAK inhibitor safety scrutiny.  Incyte on Friday disclosed that the FDA has put off its decision for ruxolitinib cream in atopic dermatitis by three months, making the drug’s new decision date September 21. The move comes just days after the agency pushed back its decision on the oral version of ruxolitinib—Jakafi—in chronic graft-versus-host disease.  […]

Johnson & Johnson’s COVID-19 vaccine scores longer shelf life just as millions of doses were set to expire

Just as states were scrambling to administer millions of Johnson & Johnson COVID-19 doses set to expire by the end of June, the FDA has swooped in to give the jabs a bit more time on the shelf. The U.S. FDA has extended the shelf life for J&J’s single-shot vaccine from three months to four and […]

Novartis extends operations at U.K. plant for another year, keeping some 200 workers on board

As Novartis shifts away from the production of older, less profitable drugs, the drugmaker has placed a slew of production facilities in the cost-cutting crosshairs. But with the company facing increased demand for two unnamed products, one plant is set to keep on churning through next year. More than 200 Novartis manufacturing workers will keep their jobs for […]

Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD

The entire JAK inhibitor family of medicines is feeling the ripple effects from a safety signal flagged for Pfizer’s Xeljanz. Now, the first marketed drug in the class is encountering increased scrutiny from the FDA. The FDA has pushed back a decision for Incyte’s application for Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) by three months, the […]

Biogen’s ‘shockingly broad’ Aduhelm label—and $56K price—set up a $10B launch, analysts say

Biogen didn’t just win the most closely watched FDA green light of the year. Its newly minted Alzheimer’s drug, Aduhelm, snared an approval that covers all Alzheimer’s patients, not just a select group of them, meaning millions could be eligible. And it set an aggressive price tag, in the words of one analyst, that’s several times […]

Fueled by COVID drug manufacturing revenues, CDMO Jubilant HollisterStier invests in upgrades, expansion

Since the onset of the coronavirus pandemic, Jubilant HollisterStier has been busy churning out COVID-19 treatments and more recently vaccines. Now it’s turning those revenues from the increased business into an investment in the future. The Spokane, Washington-based CDMO revealed a $92 million expansion plan this week that includes a high-speed injectable fill line with isolator […]

Novo Nordisk’s semaglutide set to tackle obesity with hotly-anticipated FDA green light

With obesity widespread, undertreated and largely misunderstood, Novo Nordisk has been gunning to overhaul the field with semaglutide, a drug originally approved to treat diabetes. On Friday, it won its coveted FDA green light in obesity.  Now christened Wegovy, the drug has been under FDA review just since December—a speedy trip through the agency, thanks […]

After breakout year, Moderna on track to generate $15B+ in 2022 thanks to more demand, higher prices: analysts

Moderna is hard at work ramping up production of its mRNA COVID-19 vaccine, which is projected to reap over $19 billion for the company by year’s end. But given that the pandemic is easing in parts of the world, what’s less certain is how 2022 will play out. After a breakout year, Moderna sees strong reason […]

Roche’s oral SMA med Evrysdi turned down by U.K. cost watchdog—despite prior nods for Zolgensma and Spinraza

For now, Roche’s oral spinal muscular atrophy (SMA) drug is too costly to gain the go ahead from England’s drug-price watchdogs.  The National Institutes for Health and Care Excellence (NICE) published draft guidance on Wednesday that recommends against the use of Roche’s risdiplam, marketed as Evrysdi, for people with types 1, 2 and 3 SMA. […]

It’s not just pricing and patenting. Now, AbbVie’s taxes are the target of congressional scrutiny

AbbVie has spent years responding to a congressional probe over its drug pricing and patenting strategies, with the findings just becoming public late last month. Now, in a newly unveiled probe, congressional Democrats are zeroing in on the company’s tax payments.  In a letter to CEO Richard Gonzalez dated Wednesday, Sen. Ron Wyden, D-Oregon, chairman of the Senate […]