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Pharmaceuticals, health and wellness

Pandemic’s spotlight on pharma resurfaces longstanding contradictions: report

Thanks to the pandemic, everyone is looking at the pharma industry again—but many are seeing the same old contradictions. Along with new appreciation for the industry and its quick pandemic response comes a less favorable spotlight on longstanding problems with pricing, access and the complex U.S. healthcare system, says a new report from WARC, the global marketing insights company. The report examines […]

Activist Elliott, in investor call, questioned whether GSK CEO Walmsley is the best fit for the job: report

GlaxoSmithKline appeared to dodge a potential shakeup last week when activist investor Elliott Management said it wouldn’t angle for a sale or push the company to slash R&D spending. But now the activist firm is reportedly raising questions about the British pharma’s top executive. In private talks with Glaxo shareholders, Elliott has reportedly questioned whether CEO […]

Biogen’s Alzheimer’s drug aducanumab, if approved, may face extra hurdles, slow sales ramp: analysts

Just a handful of days are left until patients, families, investors and Biogen executives will know the next chapter for the company’s controversial Alzheimer’s disease drug candidate aducanumab. But even if the drug scores its coveted FDA nod, a quick rollout is no sure thing, analysts say. Confusion among physicians, resistance from payers and even the need for frequent follow-ups could […]

2nd time’s the charm? Novo Nordisk reups bid for high-dose Ozempic after March FDA snub

Novo Nordisk is back for round two with a new Ozempic dosing regimen. The diabetes specialist resubmitted to the FDA on Friday after a March snub, renewing its bid to compete with Eli Lilly’s already approved higher dose. Novo’s resubmission aims to nab an approval for a once-weekly, 2-mg dose for Ozempic, a GLP-1 drug already approved for weekly dosing at […]

Surprise! Amgen’s hot KRAS drug seals early FDA approval, winning a shot against ‘undruggable’ cancer

What was once considered the “Achilles heel” of lung cancer tumors, as Amgen puts it, now has an FDA-approved treatment in the company’s KRAS inhibitor, Lumakras.  The agency approved Lumakras on Friday, three months ahead of schedule, as the first treatment for non-small cell lung cancer (NSCLC) with a particular genetic mutation called KRAS G12C. Once considered […]

Is pharma ready to talk cure in cancer? Maybe with equitable access, more screening, ASCO preview panel says

As the American Society of Clinical Oncology conference preps to open this week, AstraZeneca asked cancer experts what they think about mentioning the C-word—in this case, cure—in talking about cancer treatment.  The panel of cancer experts, oncologists, researchers and patient advocate leaders offered many perspectives and personal examples, but not surprisingly, didn’t come to a […]

J&J homes in on manufacturing restart at Emergent plant behind 15M discarded COVID-19 doses

With production on pause and millions of COVID-19 vaccine doses in limbo, Johnson & Johnson has been hustling to right the ship at CDMO Emergent BioSolutions’ troubled Baltimore manufacturing facility. Now, it looks as if relief is in sight. In a matter of days, Johnson & Johnson and the U.S. FDA expect to announce that […]

Fierce Pharma Asia—Moderna-Samsung COVID vaccine pact; Astellas’ 5-year plan; more Novo investment

Moderna partnered with Samsung Biologics to help it with fill-finish work of its mRNA COVID-19 vaccine for supply to locations outside the U.S. Astellas dialed up peak sales estimates for cancer drugs Xtandi and Padcev in a new five-year plan. Novo Holdings co-led a $200 million investment round in Singapore-based Esco Lifesciences, which plans to build a cell […]

With latest FDA nod, Biohaven’s Nurtec becomes first migraine med to prevent—and treat—attacks

When Biohaven Pharmaceuticals’ Nurtec ODT launched last year, it joined a class of other medicines from Allergan and Eli Lilly aimed at providing migraine patients immediate pain relief. But with an approval Thursday, the drug becomes the first option to both prevent and treat migraines. The FDA approved Biohaven’s dissolvable Nurtec ODT, or rimegepant, for preventive treatment […]

J&J, Legend Biotech’s multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS’ Abecma

When Bristol Myers Squibb and bluebird bio scored an FDA nod for their multiple myeloma CAR-T drug Abecma in March, industry watchers knew a competitor from Johnson & Johnson and Legend Biotech wasn’t too far behind. Now, that rival is in the FDA’s fast lane. J&J and Legend’s ciltacabtagene autoleucel, otherwise known as cilta-cel, scored an FDA priority […]

Viatris telegraphs closure of decades-old West Virginia plant, where more than 1,400 will lose jobs: report

Months after Pfizer and Mylan’s generics spinoff Viatris sketched out a $1 billion cost-cutting initiative, the company is telegraphing details around the closure of a major U.S. plant formerly operated by Mylan.  Viatris is due to shutter manufacturing operations at its oral solid dose plant in Morgantown, West Virginia, on July 31. That same day, a majority of some […]

Teva launches first DTC for Austedo into competitive tardive dyskinesia 2-drug market

Teva’s first DTC campaign for tardive dyskinesia (TD) drug Austedo launches into a suddenly competitive TV ad space for the rare condition. It joins Neurocrine Biosciences’ Ingrezza campaign that began in April. While both drugs were approved in 2017—Ingrezza in April and Austedo in August—both only recently began branded TV advertising. TD is a movement disorder caused […]