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Today’s Big News

Mar 4, 2024

Perrigo's over-the-counter birth control launch takes flight in the US


Bayer pays $310M for European rights to BridgeBio's Vyndaqel rival


SPECIAL REPORT—Fierce Medtech's Fierce 15 of 2023


Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question


C4 brings the Mercks to the yard, with Merck KGaA paying $16M to join protein degrader hunt


Baxter weighs potential private equity sale in lieu of planned Vantive kidney care spinout

 

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Perrigo's over-the-counter birth control launch takes flight in the US

A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.”
 

Top Stories

Bayer pays $310M for European rights to BridgeBio's Vyndaqel rival

With the FDA mulling whether to approve BridgeBio’s acoramidis as a rival to Pfizer’s blockbuster heart disease drug Vyndaqel, Bayer has decided to pay out $310 million to scoop up the European rights.

Fierce Medtech's Fierce 15 of 2023

It’s one thing to design an experiment that succeeds in the lab. It’s another to design one that works in every lab—and every hospital, every doctor’s office, every home, or in the hands of every surgeon, every nurse and every patient.

Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question

Less than three months after completing its $43 billion acquisition of Seagen, Pfizer has confirmed a report that it is shutting down construction of a $350 million manufacturing facility in Everett, Washington. The decision will affect 120 employees working on the initial setup of the site, the company said.

C4 brings the Mercks to the yard, with Merck KGaA paying $16M to join protein degrader hunt

Apparently C4 Therapeutics' protein degradation tech brings all the Mercks to the yard. The Massachusetts biotech has signed on Merck KGaA in a $740 million biobucks partnership to find two degraders for cancer. 

Baxter weighs potential private equity sale in lieu of planned Vantive kidney care spinout

Baxter disclosed that its long-gestating plans to spin out its dialysis care operations into an independent company may be dropped, in favor of a sale later this year.

Vivoryon ‘profoundly disappointed’ by phase 2 Alzheimer’s fail as stock crashes

The notoriously tricky indication of Alzheimer’s disease has defeated another candidate, with Vivoryon Therapeutic’s lead asset missing all endpoints in a phase 2 trial and sending the company’s stock plunging 90%.

With Takeda out of the picture, J&J’s Rybrevant moves into first line in lung cancer subtype

Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients.

Boston Scientific claims first US approval for drug-coated coronary balloon

Boston Scientific has received FDA approval for its Agent drug-coated balloon sized to fit within blocked or constricted coronary arteries, nearly a decade after it made its European debut.

RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

Medtronic gets FDA green light for upgraded bone tumor ablation system

The OsteoCool 2.0 system delivers radiofrequency ablation to treat bone tumors, including cancer metastases as well as benign lesions such as osteoid osteomas.

Fierce Biotech Layoff Tracker 2024: Moderna manufacturing cuts lead to layoffs; Arrakis trims team by 20%

We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. 
 
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CAR-T boxed warnings: What comes next?

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This week on "The Top Line," Fierce Pharma’s Angus Liu talks with regulatory experts to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line.
 

Resources

Whitepaper

CNS Market Outlook, 2024

This paper assesses the current state of the broad CNS market, reviewing key expectations for 2024. It addresses Alzheimer’s disease, biomarkers, and advances in psychiatry in detail. It also provides a high-level look at the pain market and the evolving regulatory environment.

 

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