Infrastructure bill pauses controversial rebate rule

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Today's Rundown

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Pfizer, US in talks for 'multibillion-dollar' supply deal for COVID-19 pill: WaPo

Pfizer has already reeled in tens of billions with its COVID-19 vaccine during the pandemic. Now, it's reportedly on the verge of striking a major deal to supply its therapeutic hopeful to the United States.

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UPDATE: Sandrock makes a sharp exit, retiring as Biogen R&D chief amid fallout from Aduhelm approval

Al Sandrock is retiring as head of R&D at Biogen. After 23 years at the company, the scientist will clear his desk by the end of the year, leaving behind a legacy of big R&D successes that are currently overshadowed by the controversial development and approval of Aduhelm.

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Biden signs into law infrastructure bill that pauses controversial rebate rule

President Biden signed into law a roughly $1 trillion infrastructure bill that pauses a controversial rebate rule from taking effect.

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HHS reinstates FDA authority over lab-developed tests, COVID diagnostics

More than a year later, the Department of Health and Human Services has rolled back a Trump-era policy that had limited the FDA’s oversight of lab-developed tests, or LDTs, which include a wide range of in vitro diagnostics that while limited in scope, have grown in use over the past two decades.

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Viatris launched two versions of its interchangeable insulin biosimilar. Why?

It's official: Biocon and Viatris have launched their historic interchangeable insulin biosimilar, Semglee. The drug, which references Sanofi's blockbuster diabetes med Lantus, will roll out in a branded and unbranded format, and either version can be substituted for Sanofi's med at the pharmacy counter. But the company is using an unusual pricing strategy in a bid to pick up market share.

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Novartis-partnered DARPin flames out in COVID-19 study, sending Molecular Partners' stock into nosedive

ACTIV-3 has claimed yet another victim. Molecular Partners and Novartis are the latest companies to fail to clear the efficacy bar in the NIH-sponsored COVID-19 study, leaving their hopes for ensovibep resting on a separate trial in non-hospitalized patients.

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Rocky road ahead for hospitals in 2022 with rising labor costs, tougher negotiations with payers

Between rising hourly rates of respiratory therapists and the global supply chain crisis, expenses at hospitals continue to pile up, leaving a grim view of 2022.

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Accelus sizes up $482M SPAC deal to take its minimally invasive spinal surgery tech public

Accelus was formed earlier this year after a merger between Integrity Implants and Fusion Robotics, both of which have spent years developing technology to improve minimally invasive spinal surgeries.

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Cell and gene therapy player CBM plots expansion, 2,000 new hires with funding from South Korean partner

The Center for Breakthrough Medicines, a CDMO founded in 2019, is getting financial backing from South Korean financial group SK Inc. to expand its manufacturing capacity.

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AavantiBio snags another bluebird bio VP with gene therapy chops as sixth executive hire this year

AavantiBio has hired its sixth key executive this year with the addition of former bluebird bio VP Jenny Marlowe as chief scientific officer. Marlowe joins the one-year-old startup after helping bluebird submit its request to the FDA to approve a gene therapy for a certain blood disorder.

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Improper Medicare payments down $20.7B since 2014, CMS data show

The number of improper payments made under Medicare fee-for-service declined by $20.72 billion since 2014, according to new figures from the Biden administration.

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Medtronic nets FDA capsule camera clearance for at-home gastrointestinal screenings

Medtronic secured an FDA clearance for the newest generation of its ingestible digital camera. It will serve as the basis for at-home remote diagnostics programs, which are in high-demand since the beginning of the COVID-19 pandemic.

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Pharma-backed ‘Destination Healthy Skin’ RV nears end of 2021 road tour

The Skin Cancer Foundation wanted an excuse-proof way to encourage people to get checked for melanoma and other skin cancers. So, in 2017, it launched “Destination Healthy Skin,” an RV-turned-dermatologist-office that would crisscross the country bringing free full-body skin check-ups and sunscreen samples to the masses.

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Geneoscopy nabs $105M to advance RNA-based gut tests for early colorectal cancer screening

With colonoscopy rates plummeting amid the COVID-19 pandemic, it’s time for a new early screening method for colorectal cancer that’s less invasive and more easily accessible, while also being just as accurate as the standard test.

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