Today's Big News Sep 13, 2022 The saga of Bayer’s beleaguered CEO Werner Baumann may soon come to a close as a hunt for his successor quietly kicks off, reports Bloomberg News. The American Medical Association has joined a class-action lawsuit against Cigna. The lawsuit, initially filed in June, alleges that the insurer underpaid for claims filed by providers in the contracted MultiPlan network. After a data review, Rubius Therapeutics is dropping its lead assets and laying off 75% of staff. The biotech ended January with 269 full-time employees, suggesting around 200 people will lose their jobs. - Gabrielle Masson Lumanity’s research scientists and data luminaries can identify fit-for-purpose RWD and design studies to generate the strongest evidence to meet stakeholder needs. Learn more. | Featured | By Fraiser Kansteiner Following years of investor push-and-pull over Bayer's CEO, a hunt for Werner Baumann’s successor has quietly kicked off, Bloomberg News reported Tuesday, citing people close to the matter. The new CEO search may portend an early departure for Baumann, whose contract with Bayer isn’t set to expire until April 2024. |
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| Top Stories By Paige Minemyer The American Medical Association has joined a class-action lawsuit against Cigna, alleging that the insurer underpaid for claims filed by providers in the contracted MultiPlan network. By Nick Paul Taylor Rubius Therapeutics has torn up its strategy. After reviewing human data on its lead candidates, the cell therapy biotech concluded investment in its two clinical prospects “is no longer justified,” leading it to stop studies and lay off 75% of its workforce. Shares in Rubius fell 25% to $0.80. By Conor Hale After the FDA opened the door to over-the-counter hearing aids last month, Sony is walking through it, in partnership with the Denmark-based WS Audiology. By Eric Sagonowsky AstraZeneca stumbled several times during the testing and rollout process for its COVID-19 vaccine and never secured authorization in the U.S. Upset over investing losses, some AZ shareholders opted to sue the drugmaker, but their effort has now been rebuffed. By Gabrielle Masson Oramed Pharmaceuticals has posted encouraging phase 2 results for its oral insulin candidate designed to treat diabetes and non-alcoholic steatohepatitis. The company now awaits phase 3 readouts for the candidate that holds potential to become the first commercial oral insulin capsule for treating diabetes. By Nick Paul Taylor Akero Therapeutics has delivered the strongest evidence yet that its nonalcoholic steatohepatitis candidate can improve liver fibrosis. After impressing investors with liver scarring data in phase 2a, the biotech has followed up with a primary endpoint hit against fibrosis in a larger midphase study. By Angus Liu Riding on fast growth after a temporary pandemic-related slowdown, Takeda’s plasma-derived therapies department is investing heavily to boost its manufacturing capabilities. By Annie Burky Most doctors are confused about what constitutes a "life-saving emergency" to overrule state abortion bans, a recent Sermo poll found. In the poll, 70% indicated they were unclear about what constitutes a “life-threatening emergency” allowing a physician to legally perform an abortion in states where the procedure is otherwise banned. Currently, 12 states have banned the procedure entirely, with Georgia and Ohio instituting six-week bans. By Conor Hale Edwards Lifesciences has received an FDA approval for the latest generation of its Sapien 3 transcatheter aortic valve, equipped with materials the company says will form the basis of its heart valve implants going forward. By Fraiser Kansteiner The Biden Administration, after setting its sights on America’s pharmaceutical supply chains last winter, is telegraphing its next move to restore the United States' drugmaking prowess. By James Waldron Any biotech that can rake in half a billion dollars from investors in 12 months is clearly doing something right. The $300 million series C funding round Acelryin announced this morning means the inflammatory-disease-focused drug developer has reached that marker and now has its sights set on entering late-stage trials. By Heather Landi YouTube on Monday rolled out a new program to help nonprofit organizations create educational videos about health inequities in mental health, maternal care and health access. Fierce podcasts Don't miss an episode | This week on "The Top Line," we discuss Sarepta's phase 2 Duchenne muscular dystrophy clinical trial that was green-lit earlier this week after a clinical hold in June. We also chat the opposing results on either side of the pond for Illumina quest for Grail. |
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| Wednesday, September 28, 2022 | 2pm ET / 11am PT Explore the top line items every SMB marketer should focus on when commercializing new-to-market products, including shifts in the way that HCPs interact with pharma companies post-pandemic, and more. Register now. | Resources eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx eBook Improve patient engagement, adherence, and outcomes Sponsored by: Health Catalyst Whitepaper Supporting your product development programme through experience, expertise, and efficiency. Sponsored by: Almac Pharma Services Video Can an optimized research process--including AI-powered workflow and process automation tools--help get breakthrough drugs to market faster? Sponsored by: Proscia Video Learn how a centralized platform for pathology images, metadata, and analysis results can connect previously siloed research initiatives and advance our collective understanding of tissue. 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Sponsored by: Catalent Biologics Whitepaper How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: ReachBio | The Cell Biology Experts™ Whitepaper Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens. Sponsored by: DocuSign Research Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: Genpact Custom Resource Center Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: JLL Executive Summary How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Sponsored by: Cognizant Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent Whitepaper Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Catalent Whitepaper This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences Whitepaper Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation. 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Sponsored by: Catalent Industry Events European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 20-22, 2022 | San Diego, CA Fierce New Product Planning Summit September 19-20, 2022 | Boston, MA Medical Affairs Strategic Summit West (MASS West) September 20-22, 2022 | San Diego, CA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Good Clinical Practice Summit (GCP): Part of the Fierce Clinical Collective October 24-26, 2022 | Philadelphia, PA | Presented by Fierce Pharma Clinical Quality Oversight Forum: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia PA | Presented by: Fierce Pharma Decentralized Clinical Trials Summit: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia, PA | Presented by: Fierce Pharma Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Free Virtual Event |