Today's Big News Sep 19, 2022 Just one month after the FDA approved bluebird bio’s beta thalassemia gene therapy Zynteglo, the company has scored a second key approval. With the new approval, bluebird’s Skysona becomes the costliest medicine in the world at $3 million per treatment. It’s been a bruising 18 months in the biotech business, but some stakeholders now see signs of a rebound. Reflecting on the recent challenges, investors and others discussed the “new normal” and lessons from the bear market. President Joe Biden on Sunday delivered the news that so many have waited to hear. The pandemic is "over,” he told 60 Minutes. Still, his declaration caught some of his own medical experts by surprise. - Eric Sagonowsky Featured | | By Angus Liu The title of the world’s most expensive treatment has changed hands within one company in a single month. On the heels of $2.8 million price tag for gene therapy Zynteglo, bluebird bio will charge $3 million for freshly FDA-approved Skysona, and it won't have an outcomes-based payment structure. |
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Top Stories By Max Bayer After more than a year of a brutal biotech bear market, industry stakeholders say there are signs that the financial storm clouds may be parting. The discussion at the Fierce Biotech Summit came as private financing has rebounded in September. By Frank Diamond President Joe Biden on Sunday night said that the COVID-19 pandemic is over. Experts also point to promising signs, but caution about a fall surge. By Kevin Dunleavy Johnson & Johnson revealed a 100 million euro ($100 million) expansion of its National Technology Park facility in Limerick which will add up to 80 new jobs in operations, engineering and quality control. The contact lens plant currently employs about 1,600. By Zoey Becker Teva's CEO Kare Schultz said he likely won't re-up his CEO contract next year. Meanwhile, the company is set to begin paying off a multibillion-dollar opioid settlement next year. By Dave Muoio Providers responding to a recent request for information reported an average 4.2 extreme weather events during the past five years, the costs of which ran anywhere from $28,000 to $22 million. By James Waldron Less than a month after Everest revealed that CEO Kerry Blanchard had resigned, the Chinese drug developer unveiled his replacement as pharma veteran Rogers Yongqing Luo. By Conor Hale A randomized trial of Boston Scientific’s netlike Sentinel device—a miniature strainer designed to catch floating debris in the bloodstream before it can lodge itself within the brain and cause a stroke—failed to meet its primary endpoint as a protective barrier during heart procedures. By Nick Paul Taylor Genfit’s pivot to acute-on-chronic liver failure has led it to the deal table. Having granted Ipsen global rights to its lead candidate late last year, the French biotech is using some of the proceeds to buy Versantis for 40 million Swiss francs ($41 million) upfront to bag a phase 2-ready ACLF drug candidate. By Kevin Dunleavy Multidistrict litigation is looming for several pharma companies—including GSK, Sanofi, Pfizer, Boehringer Ingelheim and Thermo Fisher—that manufactured and marketed Zantac. The federal litigation targets five types of cancers allegedly caused by consumption of the heartburn medicine. But now, in state-side litigation, plaintiffs who used Zantac are filing lawsuits that cover other types of cancers. By Frank Diamond Survivors of sexual assault often find themselves billed over $3,600 for emergency room medical treatment they receive because of those attacks, according to an analysis of ED visits. Public health experts are pushing lawmakers to strengthen the provisions of the Violence Against Women Act of 1994 to include coverage for therapeutic services for survivors and not just the collection of evidence. By Conor Hale The TAVR implant first received approval to treat aortic stenosis from the FDA in August 2021, and has been available through a limited release that began earlier this year. By Nick Paul Taylor Virios Therapeutics’ antiviral fibromyalgia drug candidate IMC-1 has flunked a midphase clinical trial. But, while the prospect failed to improve pain more than placebo in the overall population, Virios is making the case that it was effective after the emergence of the omicron variant of COVID-19. By Andrea Park Amid a growing wave of evidence demonstrating how pulse oximeters regularly deliver inaccurate readings for people with darker skin tones, the FDA is stepping in. Fierce podcasts Don't miss an episode | | This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA. |
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| Tuesday, October 4, 2022 | 2pm ET / 11am PT In this webinar we will cover the challenges that this collaboration aims to solve and how the partnership is poised to enable significant scientific outcomes. We will also take your questions live about this exciting advancement. Register now.
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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. Sponsored by: Thermo Fisher Scientific Research TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Unlearn AI eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent Whitepaper Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 Virtual U.S. Healthcare Compliance Certificate Program October 10-13, 2022 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 | 