| Editor’s Note: Fierce Biotech will be taking a break for the Independence Day holiday. We’ll be back in your inboxes on Wednesday, July 5. |
Today's Big NewsJun 30, 2023 |
| By James Waldron First-generation mRNA vaccines for flu “will not win,” Sanofi executives have admitted as they set out plans to develop more advanced candidates they believe will overcome the technology’s existing shortfalls. |
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| July 18-19, 2023 | Jersey City, NJ |  |
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By Max Bayer Cyteir has elected to close up shop, making plans to dissolve pending a shareholder vote after months of cost cutting. A peek at phase 1 data of the company's lead cancer med found it was not worth developing further. |
By Max Bayer,Gabrielle Masson AbbVie's president named COO months after succession plan teased. Emergent CEO Kramer retires for a second time after rocky pandemic work. Lundbeck CEO Dunsire to leave after record quarter. |
Sponsored by Context Therapeutics Inc. In the ongoing search for new cancer treatments, companies including Context Therapeutics are developing potential therapies focused on the emerging novel oncology target Claudin 6. |
By Nick Paul Taylor Ipsen and Genfit are coming for Intercept Pharmaceuticals. With their phase 3 rare disease trial hitting its primary endpoint, the partners plan to seek U.S. and European approvals of elafibranor, their rival to Intercept’s Ocaliva. |
Sponsored by Sciensus Are you considering expanding your orphan drug in Europe? Discover key strategies to identify, engage and support rare disease patients, ensuring treatment adherence that makes a real difference. |
By Nick Paul Taylor PTC Therapeutics’ vatiquinone has chalked up back-to-back failures. Weeks after reporting that the drug candidate failed to move the needle in Friedreich's ataxia, the biotech has revealed the prospect was no better than placebo in a rare seizure disorder. |
By Annalee Armstrong,Max Bayer,Gabrielle Masson Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
By Teresa Carey This week on "The Top Line," we discuss the American Diabetes Association's annual conference, plus a statement about transgender care, light therapy, and the rest of the week's headlines. |
By Angus Liu After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. |
By Kevin Dunleavy The SEC has revealed insider trading charges against five—including former Alexion vice president Joseph Dupont and a Massachusetts police chief—who allegedly took advantage of prior knowledge of Alexion’s 2020 acquisition of Portola Pharmaceuticals. |
By Andrea Park After its allotted six months to regain compliance with the Nasdaq’s listing rules passed by without success, PAVmed has bought a bit of extra time to return to the stock exchange’s good graces. |
By Kevin Dunleavy A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid. |
By Heather Landi The SCOTUS rulings Thursday will have far-reaching consequences for the healthcare industry and its collective efforts to address diversity in the workforce and health inequities among underrepresented groups. |
By Angus Liu Shionogi will pay $100 million upfront to purchase an infectious disease company. Takeda unveiled more data to back its enzyme replacement therapy for a rare heart disease. AbbVie's BTK patent infringement lawsuit against BeiGene may have merit, according to a patent expert. And more. |
Fierce podcasts Don't miss an episode |
| This week on "Podnosis," we talk about the role commercial insurers play in Medicaid eligibility determinations. Also under discussion is healthcare for the LGBTQ+ community. |
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September 26-28, 2023 | Philadelphia, PA Hear how to drive greater sponsor-CRO-site collaboration and communication, and the latest on oversight approaches for external stakeholders. Save $400 on Registration with the Early Bird Rate! 
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Whitepaper Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
Whitepaper Autoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
eBook See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
Whitepaper This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| July 18-19, 2023 | Jersey City, NJ |
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