Takeda snags 2nd FDA nod of the week

Today’s Big News

Nov 9, 2023

AstraZeneca pays $185M upfront to reenter oral obesity gold rush, drops phase 2 sickle cell drug 


Cancer drugs buttress AstraZeneca as questions swirl around new indications 


Takeda scores second FDA approval this week with green light for rare blood clotting disorder drug Adzynma  


Acutus Medical lays off two-thirds of staff to focus solely on left-heart access deal with Medtronic  


Fierce Biotech Layoff Tracker 2023: Novavax to cut more staff in new $300M savings plan; Regenxbio, Gilead and more

 

Featured

AstraZeneca pays $185M upfront to reenter oral obesity gold rush, drops phase 2 sickle cell drug

AstraZeneca is buying its way back into the obesity drug gold rush. Months after dropping its own oral GLP-1 agonist, the Big Pharma has agreed to pay Eccogene $185 million for a similar small molecule that it believes can stake a claim to a market targeted by Eli Lilly, Novo Nordisk, Pfizer and others.
 

Top Stories

Cancer drugs buttress AstraZeneca as questions swirl around new indications

Cancer drugs constituted about 40% of AstraZeneca's third-quarter revenue. But several key oncology products fell short of analysts’ expectations.

Takeda scores second FDA approval this week with green light for rare blood clotting disorder drug Adzynma

The FDA has given a green light to Takeda’s Adzynma, the first recombinant protein product as a preventative or on demand enzyme replacement therapy in adults and kids with congenital thrombotic thrombocytopenic purpura.

Acutus Medical lays off two-thirds of staff to focus solely on left-heart access deal with Medtronic

Acutus Medical is planning to cut a majority of its jobs as it narrows its focus to only the most potentially profitable pursuits.

Fierce Biotech Layoff Tracker 2023: Novavax to cut more staff in new $300M savings plan; Regenxbio, Gilead and more

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.

Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed

In 2018, Hutchmed’s fruquintinib became the first domestically developed drug for a major cancer type to be approved in China. Five years later, Takeda has scored an FDA approval for the VEGF inhibitor for adults with metastatic colorectal cancer (mCRC) as a third-line treatment.

Dream come true: Owlet soars to FDA nod for over-the-counter infant pulse oximeter

Owlet is surely flying high after finally securing FDA clearance for its Dream Sock baby monitoring system that alerts parents and other caregivers if a child’s vital signs leave healthy ranges—a feature that previously landed the company in hot water with the regulator.

'Difficult, but necessary, steps': SQZ lays off 80% of staff, Regenxbio cuts 15%

By far the most brutal cutbacks were at SQZ, which is letting go of fully 80% of its workforce as the cell therapy company seeks a long-term survival plan.

Novavax plans for second round of layoffs, cost cuts as weak vaccine uptake pummels manufacturers

Novavax is looking to shave off an additional $300 million in costs in addition to reductions announced six months ago. The company's R&D and SG&A spend on the year is expected to be roughly 30% lower than in 2022.

It's the end of the line for Bayer's PI3K Aliqopa and Novo's insulin Levemir after 2 market pulls

While Bayer's PI3K Aliqopa couldn't prove its worth in a confirmatory trial, Novo's Levemir faced manufacturing issues and troubles with patient coverage, leading the two to separately withdraw their products.

Adaptimmune, Monte Rosa and Intellia discontinue programs

Adaptimmune Therapeutics, Monte Rosa Therapeutics and Intellia Therapeutics are all throwing programs to the discard pile.

BD posts revenue gains, FY24 forecast as it closes in on 2025 strategy

As it closes in on its multi-year plan to spur long-term growth by the end of its 2025 fiscal year, BD posted increases in revenues despite the continuing erosion of COVID-19 diagnostic sales.
 
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'The Top Line': Exploring the promise of earlier Alzheimer's treatment

While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident. In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky talks with the study lead, Reisa Sperling, M.D., to learn more. 
 

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