Fierce Biotech’s top 10 data readouts in 2022
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Biogen halves Aduhelm's price and plots cost cuts as Medicare decision on controversial Alzheimer's drug nears

As the Centers for Medicare & Medicaid Services is expected to make a coverage decision on Biogen’s controversial Alzheimer’s drug Aduhelm, the biotech is making an unexpected goodwill gesture—and an expected restructuring—as it faces pressure from all fronts.

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Oracle snags Cerner in $28B deal to gain a foothold in healthcare cloud market

Oracle is buying electronic medical records firm Cerner in a deal valued at $28.3 billion, one of the software company’s biggest acquisitions ever and one of the largest takeovers this year. 

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Novartis brings on first TIGIT drug in massive billion-dollar biobucks deal with BeiGene

After watching Gilead and Roche dive deeper into TIGIT immunotherapies, Novartis is heading straight for the senior class. The Swiss pharma is getting in on the game via a blockbuster deal with BeiGene, which could ultimately net $1 billion for a late-stage asset.

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Amgen, AstraZeneca score FDA nod for blockbuster hopeful asthma drug Tezspire

With an ahead-of-schedule FDA approval for asthma treatment Tezspire, Amgen and AstraZeneca have a chance to cut into the dominance of Regeneron and Sanofi’s Dupixent. The drug has a chance to reach blockbuster status quickly, analysts say.

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Fierce Biotech’s top 10 data readouts in 2022

There are a number of potential blockbuster drugs on the list, but it’s not all about revenue potential. Many of the compounds are high-risk, high-reward candidates trying to push the boundaries of drug treatment.

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Amazon taps former Prime executive to oversee virtual care, pharmacy and diagnostics businesses

Amazon tapped a former Prime executive to oversee its combined healthcare efforts, including pharmacy, Amazon Care and diagnostics. The consolidated healthcare structure will help Amazon as it works to develop "more customer-centric ways for patients to get the healthcare services, products and medications they need," an Amazon spokesperson said.

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BD lands CE marks for infectious disease diagnostic hardware and the tool's first lab test

They say good things happen in threes, and BD seems to be hoping that adage rings true for its Cor molecular diagnostic platform.

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No data, no problem. Senti will go public in $296M SPAC deal before hitting the clinic

Senti Biosciences is hopping on the SPAC track with a deal that will provide $296 million in proceeds for the preclinical biotech to move its gene circuit engineered cell and gene therapies toward human trials.

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This is just the Spark: Roche's new gene therapy manufacturing center leaves space for growth

Since coming under the Roche banner in 2019, Spark Therapeutics has been working towards a massive expansion of its manufacturing capacity. Those efforts came to fruition Friday, and the companies intend to leave a few rooms open in the new $575 million facility for future growth.

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FDA clears Koios Medical’s ultrasound-reading AI that spots breast, thyroid cancer in two seconds

In the grand tradition of the inquisitive Greek titan that it’s named for, Koios Medical is asking big questions of current medical practices—then developing the advanced artificial intelligence technology to answer them.

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Novo Nordisk's weight loss drug Wegovy to run short amid contract manufacturer hiccup

Demand for Novo Nordisk’s obesity medicine Wegovy is high, but a manufacturing hitch with one of the Danish company’s partners has put near-term supply in jeopardy. A contract manufacturer in charge of syringe filling for Wegovy pens in the U.S. had temporarily halted deliveries following issues with good manufacturing practices. 

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Aptose finally ditches APTO-253 after 3-year clinical hold, phase 1 dud

The writing was perhaps on the wall for this one back in 2018: Aptose Biosciences has decided to end clinical development of the c-Myc inhibitor APTO-253, a therapy that was the subject of a three-year FDA clinical hold.

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Edwards grabs FDA approval for Sapien 3 pulmonary replacement valve with stabilizing prestent

The FDA approved a new version of Edwards Lifesciences’ Sapien 3 transcatheter heart valve. The extra hardware surrounds the valve and helps compensate for differences in the size and shape of a heart’s right ventricular outflow tract, including in adults and children with congenital heart disease.

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Mental health startup Cerebral teams with Alto Neuroscience to bring 'precision psychiatry' to patients' homes

Mental health startup Cerebral has inked a partnership with Alto Neuroscience to bring clinical trials for depression to patients’ homes. Through the collaboration, Cerebral is able to offer its network of members the opportunity to participate in at-home clinical research utilizing Alto’s biomarker platform and targeted drug candidates.

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