| 09.02.22 | Novo CEO tout s ‘risky’ semaglutide R&D effort; Fitbit launches afib detection in smartwatch

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Webinar: Chromatography modeling trends: digital twins and beyond

Tuesday, September 6, 2022 | 10am ET | 7am PT

In this talk, we’ll show how digital twins can intensify downstream process development by enabling many thousands of experiments to be simulated based upon sparse experimental data, and we’ll look at examples from several industrial case studies. Register now.

WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

While Novo Nordisk’s semaglutide is making commercial waves in obesity and diabetes, the company is also testing the drug’s promise in Alzheimer’s disease and nonalcoholic steatohepatitis, two fields that have eluded the industry over the years. Plus, ahead of Fierce Biotech’s annual Fierce 15 report, the team gives an update on the Fierce 15 class of 2012. Meanwhile, as Novartis heads toward a Sandoz spinoff, it’s cutting manufacturing jobs in North Carolina. Those stories, plus headlines from Gilead, Bristol Myers Squibb, AstraZeneca and more made this week’s digest.

Featured Story

A pharmaceutical jack of all trades? Novo CEO touts semaglutide's potential in NASH, Alzheimer's and its hot start in obesity

By Fraiser Kansteiner

Novo Nordisk’s recent growth renaissance has flourished thanks in no small part to semaglutide—the GLP-1 molecule behind the company’s leading trio of Ozempic, Rybelsus and Wegovy. But even as the drug's metabolic empire prospers, Novo Nordisk isn’t letting its GLP-1 rest on its laurels.


This week's sponsor is Fierce Biotech.

Where are they now? Tracking down 2012's Fierce 15

By Gabrielle Masson

It’s the 20th year we’ve sought out the most innovative private biotechs, which also means we've entered the second decade we've been checking in on our past honorees.

Fitbit debuts afib detection in health-tracking smartwatch

By Andrea Park

Just a few months after Fitbit roped in FDA clearance for an algorithm that could be embedded into its eponymous health-tracking wearables to detect atrial fibrillation, the technology is ready to hit the ground running.

Novartis cuts manufacturing jobs, closes North Carolina plant ahead of Sandoz spinoff

By Fraiser Kansteiner

By the end of 2023, Novartis plans to shutter its Sandoz oral solid dosage plant in Wilson, North Carolina, where the company’s soon-to-be-spun-off generics division makes products like tablets and capsules for Canada and the U.S. The site’s roughly 246 employees have already been alerted to the closure, the company said.

ESC 2022: BMS, J&J's secondary stroke med falls short in phase 2, but companies see enough potential to push forward

By Max Bayer

A new interim analysis of Bristol Myers Squibb's anticoagulant milvexian as a treatment for secondary strokes shows a mixed bag of data. The drug failed its primary endpoint, but a reduction in stroke incidence among three dosing groups beat the company's expectations.

'The Top Line': Depth in the Alzheimer's pipeline, the staying power of 2012's Fierce 15 honorees and more

By Querida Anderson

This week on "The Top Line," we discuss just how deep—and broad—the Alzheimer’s pipeline is despite major players dominating the headlines. We also chat about our research into the 2012 class of Fierce 15 and where those biotechs are now.

Gilead hits back at Bristol Myers' Supreme Court petition in CAR-T patent feud

By Fraiser Kansteiner

More shots have been fired in the patent proxy war between CAR-T giants Gilead Sciences and Bristol Myers Squibb as Gilead moved to parry a recent BMS petition to the U.S.’ high court.

Beam sheds more light on clinical hold slapped on gene-edited CAR-T

By Max Bayer

Beam Therapeutics is disclosing more details about a clinical hold placed on its phase 1-ready CAR-T. The FDA's questions centered on more data from controls and results from off-target editing tests.

AstraZeneca CEO Soriot questions value of annual COVID boosters in healthy people

By Kevin Dunleavy

AstraZeneca CEO Pascal Soriot told The Telegraph that annual COVID-19 booster shots are “not a good use” of taxpayer money in all people. His comments come a week after Soriot said that the company was considering getting out of the vaccine business altogether.

Medtronic picks up BioIntelliSense's round-the-clock vital sign monitor in distribution deal

By Andrea Park

Situating the BioButton under Medtronic’s umbrella will be especially beneficial in helping hospitals navigate the growing shortage of healthcare workers and rising healthcare costs, per BioIntelliSense CEO James Mault, M.D.

ESC 2022: AstraZeneca's Farxiga is first heart failure drug to show across-the-board mortality benefit

By Kevin Dunleavy

At the European Society of Cardiology’s annual meeting, AstraZeneca presented data that could boost Farxiga in the competitive heart failure market. It is the first heart failure drug to show it can reduce the risk of death in patients regardless of their ejection fraction status.

Takeda returns 2 inflammatory bowel prospects back to Finch's nest

By Max Bayer

Takeda is handing the rights of two assets back over to Finch, including one that the two have collaborated on for more than five years. Finch says it will try and find new partners for the programs.

Sandoz, Amneal and Rhodes join Teva in nationwide generic Adderall shortage as demand spikes

By Fraiser Kansteiner

Alongside Teva, Amneal Pharmaceutical, Purdue subsidiary Rhodes Pharmaceuticals and Novartis’ soon-to-be-spun-off generics unit Sandoz have generic extended-released Adderall on back order, according to a recent supply update from the American Society of Health-System Pharmacists, which tracks drug shortages.

Power debuts with $7M seed funding, focus on clinical trials

By Joseph Keenan

Power, which is focused on improving access to clinical trial studies, debuted with $7 million in seed funding to break through barriers that currently hamper patient recruiting efforts.

United Therapeutics lands blow in inhaled drug patent dispute, pushing back approval of generic rival

By Nick Paul Taylor

United Therapeutics has struck a blow to Liquidia Technologies’ generic formulation of Tyvaso. With a court ruling the generic infringes a United patent, Liquidia faces the prospect of being kept off the market until 2027—unless it gets the decision overturned or prevails in a related dispute.

Webinar: Make Market Access Your Brand's Super Power

Wednesday, September 21, 2022 | 2pm ET / 11am PT

In this webinar, you’ll hear about the most threatening market access challenges pharma brand leaders face today, real-world stories of how top brands overcome these challenges and grow market share, and more. Register now.