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Pharmaceuticals, health and wellness

AstraZeneca’s $39B Alexion buyout scores EU blessing but still awaits key nod from the UK

AstraZeneca’s $39 billion takeover of rare disease specialist Alexion has another regulatory blessing in the bag, but the pair are still holding out for a key nod from the U.K. to settle the deal.  AstraZeneca on Tuesday said that the European Union has approved its acquisition of Boston-based Alexion, inching closer toward its goal of […]

With ‘evolved’ treatment landscape, Merck pulls Keytruda’s FDA nod in third-line stomach cancer

Two months after a key FDA panel voted down Merck’s conditional nod for Keytruda as a third-line treatment for certain stomach cancer patients, the company says it’s pulling the plug on the indication.  Following consultation with the FDA, Merck on Thursday said it will voluntarily withdraw its U.S. accelerated approval for Keytruda as a third-line […]

AGC Biologics expands further in Colorado with purchase of Novartis Gene Therapies plant

As the cell and gene revolution heats up, contract manufacturer AGC Biologics is getting ahead of the curve with plans for its second commercial plant in Colorado. Angling to bolster cell and gene production, AGC has clinched a deal for a commercial Novartis Gene Therapies factory in Longmont, Colorado. Located just 16 miles from AGC’s […]

Lupin’s Novel Laboratories knocked by FDA for cleanliness, quality issues at New Jersey plant

One warning letter is bad enough, but when citations multiply across a company’s sites in just four years, a pattern starts to emerge. FDA investigators are charging Lupin’s Novel Laboratories with a raft of cleanliness, consistency and quality control problems at a New Jersey factory despite a prior scolding from the regulator in November. Novel […]

Fierce Pharma Asia—Fujifilm, WuXi STA plan major expansions; Hanmi’s GLP-1 posts heart data; BeiGene plots $3B China IPO

Fujifilm and WuXi STA are investing heavily on expanding their CDMO capacities in Western countries. Hanmi’s GLP-1 diabetes drug, once partnered with Sanofi, has reported positive cardiovascular outcomes data. BeiGene has scored a green light for a $3 billion IPO on China’s Nasdaq-like STAR market. And more. 1. Fujifilm’s multibillion-dollar expansion spree rolls on with […]

Mylan sues generic rival Teva over ‘sophisticated scheme’ to block Copaxone copycats

Teva Pharmaceutical is facing down plenty of lawsuits. Now, one of its chief rivals in the generics field is adding another case to Teva’s plate.  Mylan, which has merged with Pfizer’s Upjohn to form Viatris, is taking Teva to court over claims the Israeli-American drugmaker used anticompetitive practices to guard its branded multiple sclerosis med Copaxone from generics. In the lawsuit, […]

Biogen’s $56K price tag on Aduhelm? Think again, ICER says, calling for discounts of around 90%

Even though Biogen’s Alzheimer’s disease drug Aduhelm scored a hotly debated, wide-labeled FDA nod earlier this month, the treatment still isn’t worth more than a mere 15% of the annual $56,000 list price the company is charging, a prominent U.S. drug cost watchdog argues.   The Institute for Clinical and Economic Review (ICER) said in a […]

AbbVie’s Rinvoq marches toward blockbuster ulcerative colitis nod even as JAK delays drag on

AbbVie has pegged much of its post-Humira hopes on its next-gen immunology med Rinvoq, which now appears one step closer toward what could be a $2 billion indication in ulcerative colitis.  The Chicago-based pharma said on Tuesday that its rheumatoid arthritis drug “significantly” topped placebo at helping moderate to severe ulcerative colitis patients reach clinical remission after a […]

Pfizer, CDC experts don’t see eye to eye on COVID-19 boosters, threatening key revenue stream: analysts

When will someone need a COVID-19 booster? Not only is it a pertinent question among the vaccinated, but also among analysts eager to track pandemic vaccine sales for years to come.  In Pfizer’s eyes, it could be that those inoculated with the drugmaker’s BioNTech-partnered shot will need a dose as early as this fall. However, […]

ADA 2021: Novo trumpets higher-dose Ozempic data as Lilly competitors loom

Novo Nordisk’s semaglutide franchise has taken off in a big way. Type 2 diabetes med Ozempic smashed the blockbuster barrier in 2019, the same year the company launched its oral option, Rybelsus. Now, the Danish diabetes major is touting data on a higher-dose prospect. In a late-stage trial, Ozempic 2 mg trumped its 1-mg predecessor on blood […]

Congressional Democrats launch probe into Biogen’s Aduhelm FDA approval, citing ‘serious concerns’

The rumblings on Capitol Hill over Biogen Alzheimer’s drug Aduhelm have been growing louder in recent days as lawmakers began speaking out about its lofty price tag and controversial FDA win. Now two high-ranking Democrats want answers. The House Committee on Oversight and Reform announced Friday that it will launch an investigation into the Alzheimer’s […]

Lilly’s COVID antibody combo halted nationwide, dealing huge blow to blockbuster program

Eli Lilly’s COVID-19 antibody cocktail has already been on the outs in several states over fears of reduced variant efficacy. Now, the U.S. has decided to extend that policy nationwide. With a pair of troubling coronavirus variants on the rise, the U.S. is pausing the national distribution of Eli Lilly’s COVID-19 antibody combo of bamlanivimab and […]