// Biotech and Pharma Therapeutics
Merck sees up to $7B in coming sales of coronavirus pill
Executives based their projections on contracts already in place for the drug, known as molnupiravir. But sales could climb even higher if it works as a preventive treatment too.
With approval plans underway, Lilly’s next move is to test its Alzheimer’s drug against Biogen’s
Alongside a new earnings report, Lilly announced plans for a late-stage study to evaluate whether donanemab is better than Aduhelm at clearing amyloid beta plaques.
BioSpace Movers & Shakers, Oct. 29 | BioSpace
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
Sanofi’s €10B sales target for Dupixent? The ‘megabrand’ is more than halfway there, exec says
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.
As Lilly gears up for key 2022 launches, Trulicity, Taltz and more drive solid growth
While Eli Lilly’s Alzheimer’s disease hopeful donanemab stole most of the headlines for the drugmaker on Tuesday, the company’s stable of approved drugs continued on their growth path. The company posted a double-digit sales increase in the third quarter and is getting ready for some highly anticipa…
// 4th Industrial Revolution
Notable regulatory approvals of emerging technologies over the past 30 days
A new startup initiative in Israel aims to create and invest in startups that use artificial intelligence to address challenges in drug discovery and development. Called AION Labs, this innovation lab stems from an economic development effort from the Israeli government and will have contributions f…
Teladoc plans to take on risk in primary care, expand program to hospital clients
It’s unlikely the vendor will step into fully capitated contracts right away, but its CEO said there are degrees of risk Teladoc will take on: moving from clinical measures of care, to risk corridors and ultimately into capitation.
Bayer, One Drop release digital health program for heart disease - MedCity News
The app lets people track their metrics through connected devices, and access health coaching and educational materials. It’s one of multiple that Bayer and One Drop plan to develop together in the future.
Are supercomputers set to transform pharma R&D?
Tech company NVIDIA this year launched the UK’s most powerful supercomputer to help researchers in pharma solve pressing medical challenges.
// Business & Markets
Hinge Health raises $600M, taps ex-Amazon, Google execs for leadership team
Hinge Health, a digital musculoskeletal clinic in San Francisco, raised $400 million in its latest fundraising round and secured a $200 million secondary investment, the company said Oct. 28.
Takeda reels in a cell therapy research partner with ‘build-to-buy’ deal
The Japanese drugmaker is acquiring GammaDelta Therapeutics, a partner since 2017, and its research on allogeneic cell therapy for cancer.
Better Therapeutics closes SPAC merger, debuts on Nasdaq - Drug Delivery Business
Better Therapeutics announced today that it completed its merger with Mountain Crest Acquisition Corp and has gone public on the Nasdaq.
Gilead taps brakes on $4.9B bet after rival’s failure, pushing blood cancer data out to 2022
Gilead’s $4.9 billion bet on Forty Seven has run into a delay. Weeks after Takeda’s rival drug flunked a pivotal trial, Gilead has pushed back the release of data from a phase 1b study designed to support accelerated approval.
Decentralized clinical trials platform Medable now valued at $2.1B - MedCity News
Medable recently raised $304 million, its fourth funding round in the past two years. The company’s software can be used to virtually consent patients into clinical trials and run telehealth visits as part of a trial.
// Legal & Regulatory
An Allergan psychiatric drug failed late-stage depression studies — but AbbVie is going for approval anyway
Cariprazine, the Allergan-turned-AbbVie drug for bipolar depression and schizophrenia, had a rocky road through clinical trials before its approvals. And as AbbVie attempts to further expand into major depressive disorder, it’s facing similar challenges. Early Friday morning, AbbVie reported largely…
Dexcom raises guidance ahead of G7 launch, FDA submission imminent - Drug Delivery Business
Dexcom shares are up more than 9% on the news that it will soon formally seek FDA clearance for its next-generation G7 system.
Sanofi hit by filing delays for key drugs, drops an early Sangamo thalassemia asset
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.
Health App Companies May Be Surprised FTC Is Watching Them
Companies with health apps that collect information from customers should understand a recent policy statement from the FTC about the health breach notification rule. They may be surprised the rule applies to the data they collect and they need to prepare for possible enforcement actions, say Wilmer…
// Research & Development
Alnylam and AbbVie Each Reveal Influential Phase III Results | BioSpace
After first reporting that its investigational RNAi drug vutrisiran hit its 9-month Phase III endpoints, Alnylam announced it continues to demonstrate positive results at the 18-month mark.
Daiichi jettisons ADC after flunking early solid tumor test
Daiichi Sankyo’s antibody-drug conjugate team has hit a rare bump in the road, dumping a gastrointestinal stromal tumor candidate after seeing “no clear responses” in a phase 1 trial.
Pfizer, Novartis sign on to accelerate gene therapies for rare diseases with US agencies
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.
Novartis looks for silver lining in $2B canakinumab repurposing after 2nd lung cancer failure
Is autoinflammatory disease treatment Ilaris a potential new therapy for non-small cell lung cancer? After two pivotal trial failures, the answer seems to be no, but Novartis is still seeing a glimmer of hope.
Mozart Therapeutics makes its official debut, jumping into the hot Treg R&D field with some big-name investors backing it
Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few. Now, there’s a new Treg player jumping in that want…
Federal security officials warn that ‘Made in China’ could one day go for tech-dependent US healthcare
President Joe Biden conceded that opposition from centrist Democrats could make it doubtful to add dental, vision and hearing benefits to Medicare as part of a major infrastructure package.
Biden’s HHS to withdraw controversial Trump-era regulatory reform rule
The so-called SUNSET rule would have required the Department of Health and Human Services to review its regulations once a decade.
Drug price restraints dropped as Biden prioritizes other measures
Despite majority control of Congress, it appears unlikely the Biden administration will be able to pass meaningful pricing reform, though a slimmed-down bill may still be in the works.
Pharma campaign cash delivered to key lawmakers with surgical precision - MedCity News
Contributions covering the first half of this year show that some of its biggest donations were delivered with surgical-strike precision to sympathetic or moderate Democratic lawmakers the industry needs to remain in its corner.