Amgen cuts 450 more staffers
 

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Ruling on Elizabeth Holmes' prison delay, restitution to Theranos investors pushed back

During a hearing that lasted just under 90 minutes on Friday, Judge Edward Davila stopped short of offering a definitive ruling on Elizabeth Holmes' dual bids to stay out of prison while awaiting an appeal and to avoid paying restitution for her four felony convictions.
 

Top Stories

Amgen cuts 450 workers, cites drug pricing pressure and inflation

After a late January round of layoffs affecting 300, Amgen axed another 450 jobs citing drug pressure and inflation. The cuts come after an investor lawsuit alleging the company hid a massive $10.7 billion tax bill from its investors.

Biogen, Novartis deliver one-two punch to Sangamo, walking away from deals in quick succession

For Sangamo, last week is probably one to forget. Late on Friday, the gene-based therapy biotech revealed it had lost two partners in quick succession, with Biogen and Novartis walking away from partnerships collectively worth billions of dollars in milestones within days of each other. 

'The Top Line': Fierce Medtech's annual Fierce 15 honorees, plus this week's headlines

This week on "The Top Line," we discuss Fierce Medtech’s annual Fierce 15 report and startups that made the cut. We also cover Illumina and Carl Icahn's proxy battle and more of this week's top headlines.

Fierce Medtech's 2022 Fierce 15

Since its humble beginnings back in 2012, the Fierce 15 has made a point of spotlighting the most exciting startups in medtech—those not only challenging the limits of both the tech and healthcare industries but also making real progress toward their lofty goals. The companies on this year’s list—which kicks off the second decade of Fierce Medtech’s Fierce 15—are setting the bar even higher.

Return of the megaround: Is biotech back from the brink? 

$100 million for Rapport Therapeutics. $112 million for Noema Pharma. $108 million for Bicara Therapeutics. The megaround has come roaring back in the past few weeks, but is biotech really healing? 

#FierceMadness 2023: After AbbVie, Pfizer lose in the opening round, your Sweet 16 bracket awaits

If it’s March, it must be #FierceMadness, Fierce Pharma Marketing’s annual take on the March Madness NCAA basketball tournament and bracket mania—with a pharma twist.

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

In what’s expected to be one of AbbVie’s “biggest new product launches” in the coming years, the company has hit a snag. The FDA rejected AbbVie’s Parkinson’s disease combo therapy over questions about its delivery pump.

Pear market: Digital therapeutics maker eyeing a sale in last-ditch money-saving move after layoffs, stock sale

Health tech investors and companies shopping for a new M&A target this year may want to check out the produce section.

FDA shocks Sarepta, ordering AdComm for DMD gene therapy in sudden change of heart

A sudden change of heart at the FDA has sunk Sarepta’s stock. Two weeks after saying the FDA would assess its gene therapy without an advisory committee meeting, Sarepta has revealed the agency will now convene experts to dig into the data on its Duchenne muscular dystrophy (DMD) submission.

Eli Lilly CEO racked up $21.4M in 2022 pay as stock price hit all-time high

Under David Ricks’ leadership, Eli Lilly’s stock price reached a record high in 2022. But the CEO’s pay decreased slightly last year.

Fierce Biotech Layoff Tracker 2023: Another layoff wave at Evofem; Neoleukin cuts 70% of staff, CEO

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.

Olympus hit with 3rd FDA warning letter in 5-month span over endoscope manufacturing

The letter follows an early November inspection of one of Olympus’ Tokyo facilities, during which the FDA concluded that some of the company's endoscopes and endoscope accessories are “adulterated” due to improper manufacturing practices.

Genentech turns out lights at first commercial biologics plant, laying off 265 staffers

Genentech is winding down operations at its production facility in South San Francisco, the company told Fierce Pharma. The site wrapped up its final production runs several weeks ago and is now in the decommissioning phase, which will take some six to 12 months.

Astellas enjoys warm glow of success as antibody against hot cancer target hits again in phase 3

Astellas Pharma’s zolbetuximab has gone two for two, chalking up a second phase 3 win to cement its status as the front-runner in the race to deliver a drug against one of the hottest targets in cancer today.

BD, Visby Medical snag updated FDA nods for women's health PCR tests

The FDA cleared a pair of tests this week both aimed specifically at improving diagnoses of women’s health conditions.
 
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'The Top Line': Fierce Medtech's annual Fierce 15 honorees

This week on "The Top Line," we discuss Fierce Medtech’s annual Fierce 15 report and startups that made the cut. We also cover Illumina and Carl Icahn's proxy battle and more of this week's top headlines.

 

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Three Considerations to Expand Physicians’ Bandwidth and Improve Real-World Safety Reporting

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Answering your specific questions about mRNA/saRNA manufacturing

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Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications.

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Step-wise strategy to address process characterization and late phase development

Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development.

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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
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A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

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Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
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A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

 

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