To TIGIT or not to TIGIT? Roche's latest trial flop casts shadow on Big Pharma's $6B bet Sponsored: Q&A: Steve Thompson on Compliant, Hands-Free Validation Sponsored: mRNA Unlocked: How Technology Convergence Is Driving the Next Wave From Redditors to creditors: Orphazyme's wild ride ends with $13M sale to satisfy bankruptcy court AskBio and you shall receive as the Bayer-backed gene therapy maker touts early phase 1 data AbbVie coughs up nearly $50M for Cugene's autoimmune med in a bid to shore up life post-Humira Kriya cashes in $270M series C to further finance all-in-one gene therapy biz Shionogi splashes $100M on F2G's rare fungal disease drug to unlock new class of medicine VC firm Sofinnova banks $1B from Apollo to invest in early-stage biotech solutions AstraZeneca puts further $75M up for grabs in expanded Proteros cancer drug deal Most influential people in biopharma—the entrepreneurs Medtronic makes FTC-mandated sale to close Intersect ENT deal and scores FDA nod to boot Otsuka drops beleaguered Akebia after FDA snub. Will AstraZeneca follow suit with FibroGen? RaDonda Vaught sentenced to 3 years probation for fatal medication error Seagen CEO Siegall resigns after domestic abuse arrest Featured Story | By James Waldron Once hailed as the future of immuno-oncology, it looks like TIGITs could now be in trouble. Roche admitted last week to a second phase 3 trial failure for tiragolumab, which was unable to demonstrate the progression-free survival achieved by Tecentriq alone in patients with non-small cell lung cancer. read more |
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| Sponsored By: ValGenesis Inc. AR-driven hands-free validation isn’t just a futuristic concept. It’s available now, and it has the power to transform the life sciences. Read more. read more |
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| Sponsored By: Danaher Corporation The Life Sciences companies at Danaher are setting the template for end-to-end creation of new mRNA medicines, with innovations in plasmid DNA, RNA oligonucleotides, lipid nanoparticles and more. read more |
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Top Stories By Nick Paul Taylor Orphazyme’s vertiginous decline is over. Having briefly commanded a market cap of $2.7 billion in June 2021, the Danish meme stock is now selling substantially all of its assets and business activities to KemPharm for $12.8 million in cash. read more By Max Bayer AskBio's gene therapy to treat congestive heart failure is showing promise in initial data from an open-label phase 1 trial. Among three patients, there were no safety concerns through one year of treatment, and all three showed clinical improvement. read more By Max Bayer AbbVie is spending nearly $50 million in upfront cash to have first dibs at Cugene's autoimmune med nearing a phase 1b study. The drug is a concerted effort by AbbVie to plan for life after Humira's patent expiration. read more By Max Bayer Kriya Therapeutics has reeled in a whopping $270 million from its series C round, surpassing the $180 million raised in total over the last two years and solidifying ample financing to build out its all-in-one gene therapy business. read more By Nick Paul Taylor Shionogi is betting $100 million upfront on a new class of antifungal medicine, teaming up with F2G to land the Asian and European rights to a late-phase drug candidate that could help immunocompromised patients failed by existing therapies. read more By Gabrielle Masson Biotechs may be seeing their valuations plummet, but Apollo Global Management still wants in. The asset manager has committed up to 1 billion euros ($1.04 billion) in capital commitments to Sofinnova Partners, one of Europe’s largest early-stage healthcare venture capital funds, to expand its presence in the sector. read more By Gabrielle Masson AstraZeneca is extending its oncology partnership with Proteros biostructures, adding a new drug discovery program and boosting the potential biobucks payout for the German life sciences company by $75 million. read more By Eric Sagonowsky,Fraiser Kansteiner,Andrea Park,Annalee Armstrong,Kevin Dunleavy The leaders in this week's Most Influential People in Biopharma category have led companies of all types in this industry—and they're still building today. While they may have scientific and medical expertise, the Fierce team felt their contributions to the business aspects of biopharma made them worth featuring this week. read more By Andrea Park It may have taken an order from the FTC to get there, and Medtronic may be getting less bang for its buck than initially expected, but the medtech giant’s acquisition of Intersect ENT is finally complete. read more By Angus Liu Akebia Therapeutics is slipping into even more trouble after the FDA's surprise rejection of its oral anemia drug vadadustat. After a round of layoffs, the beleaguered biotech has found its partner Otsuka and the Nasdaq stock exchange rubbing salt in its wounds. read more By Dave Muoio The lenient sentence was applauded by healthcare workers observing outside of the courthouse as well as professional organizations, which warned that "criminalization of medical errors will not preserve safe patient care environments." read more By Kevin Dunleavy Less than a month after he was arrested and charged with domestic abuse, Seagen CEO and co-founder Clay Siegall, M.D., has resigned from the Seattle-area biotech that he helped build into one of the most successful in the world. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce Biotech Next Gen June 29-30, 2022 | Free Virtual Event Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event 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 Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ 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 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 