Pfizer, US in talks for 'multibillion-dollar' supply deal for COVID-19 pill: WaPo UPDATE: Sandrock makes a sharp exit, retiring as Biogen R&D chief amid fallout from Aduhelm approval Biden signs into law infrastructure bill that pauses controversial rebate rule HHS reinstates FDA authority over lab-developed tests, COVID diagnostics Viatris launched two versions of its interchangeable insulin biosimilar. Why? Novartis-partnered DARPin flames out in COVID-19 study, sending Molecular Partners' stock into nosedive Rocky road ahead for hospitals in 2022 with rising labor costs, tougher negotiations with payers Accelus sizes up $482M SPAC deal to take its minimally invasive spinal surgery tech public Cell and gene therapy player CBM plots expansion, 2,000 new hires with funding from South Korean partner AavantiBio snags another bluebird bio VP with gene therapy chops as sixth executive hire this year Improper Medicare payments down $20.7B since 2014, CMS data show Medtronic nets FDA capsule camera clearance for at-home gastrointestinal screenings Pharma-backed ‘Destination Healthy Skin’ RV nears end of 2021 road tour Geneoscopy nabs $105M to advance RNA-based gut tests for early colorectal cancer screening Featured Story By Fraiser Kansteiner 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. read more |
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| | Spinal Muscular Atrophy: Overview & Outlook SMA is a rare and devastating disease. This 2-part series provides an overview of SMA and current therapies. It also provides an outlook on potential advancements that could affect the therapeutic and commercial landscapes. Download now. | Top Stories By Nick Paul Taylor 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. read more By Robert King President Biden signed into law a roughly $1 trillion infrastructure bill that pauses a controversial rebate rule from taking effect. read more By Conor Hale 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. read more By Fraiser Kansteiner 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. read more By Nick Paul Taylor 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. read more By Anastassia Gliadkovskaya 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. read more By Andrea Park 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. read more By Joseph Keenan 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. read more By Kyle LaHucik 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. read more By Heather Landi 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. read more By Conor Hale 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. read more By Natalie Missakian 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. read more By Andrea Park 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. read more |