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Pfizer, Novartis sign on to accelerate gene therapies for rare diseases with US agencies

By Annalee Armstrong

A cadre of big and small biotechs and pharmas plus nonprofit organizations have signed on to a new U.S. federal government initiative to go after gene therapies for rare diseases.

Sanofi's €10B sales target for Dupixent? The 'megabrand' is more than halfway there, exec says

By Eric Sagonowsky

Shortly after Sanofi CEO Paul Hudson joined the company in 2019, he laid out an ambition to invest as much as necessary to turn the Regeneron-partnered antibody drug Dupixent into a megablockbuster. Two years later, Sanofi is well on its way.

Drug price reforms appear to be out of infrastructure bill

By Robert King

Drug pricing provisions such as Medicare negotiation powers and Part D benefit redesign appear to be nixed from a massive infrastructure package which would also get rid of a controversial drug rebate rule.

FDA adds new restrictions, warning labels for breast implants following reports of cancer

By Conor Hale

The agency curbed the sale and distribution of both saline- and silicone gel-filled breast implants, including products from Allergan, Johnson & Johnson’s Mentor division, Sientra and Ideal Implant.

Alnylam founding CEO Maraganore steps down after pioneering RNA interference therapy

By Angus Liu

Alnylam’s founding CEO John Maraganore is leaving after a near 20-year run, handing the reins to Yvonne Greenstreet, currently the company’s president and chief operating officer. The longtime Alnylam chief seems to already have the next stop of his career planned out.

Sanofi hit by filing delays for key drugs, drops an early Sangamo thalassemia asset

By Ben Adams

Sanofi, in its third-quarter financials posted early Thursday morning, outlined a list of delays for a number of key assets as it dropped a biotech-partnered drug.

FDA outlines best practices for healthcare AI, alongside Canada, U.K. regulators

By Conor Hale

The 10 principles aim to underline what the agencies describe as “Good Machine Learning Practice” in the same vein as the industry quality standards centered around product manufacturing or clinical testing.

Hinge Health bags $600M investment from Coatue, Tiger Global, boosting valuation to $6.2B

By Heather Landi

Fast-growing digital health company Hinge Health clinched $400 million in a financing round amid soaring demand for virtual physical therapy services. Hinge Health reports that its customer base has more than doubled year-over-year to over 575 enterprise customers as the company keeps pace with growing demand from millions of Americans seeking accessible care for back and joint pain.

Merck's big earnings in Q3 play second fiddle to enthusiasm for COVID pill's potential

By Kevin Dunleavy

On Thursday, when Merck reported third-quarter earnings that significantly exceeded expectations, the good news was almost an afterthought as the tantalizing future of COVID-19 oral treatment molnupiravir was the dominant topic of an investors call.

Telecom tycoon's phase 3 pancreatic cancer bet flames out, sending stock to the basement

By Nick Paul Taylor

Rafael Pharmaceuticals' bet on the rock-hard pancreatic cancer indication has blown up in its face. The pivotal trial found devimistat had no effect on overall survival—and, as a kicker, another phase 3 in a blood cancer was stopped early for futility.

BCBSA, Nemours Children’s and Cityblock Health join cross-industry health equity pledge

By Anastassia Gliadkovskaya

The Health Equity Pledge was developed over the past year by the Health Evolution Forum, a collective of payer, provider and life science leaders aiming to accelerate equity in healthcare and outcomes.

Science 37 partners with two CROs in Japan as part of decentralized trials push

By Kyle LaHucik

Three weeks after going public, Science 37 is beefing up its presence in Asia via partnerships with two CROs in Japan. The collaborations with CMIC and 3H Medi Solution aim to expand access to virtual clinical trials in the region and elsewhere in Asia-Pacific.

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