| | Digital Pharma East
October 18-20, 2022 | Philadelphia, PA Explore how life science companies can augment their marketing and commercialization efforts and deliver improved value to customers by leveraging digital channels and technologies. Register Now! |
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Vertex's Type 1 diabetes cell therapy heads back to clinic after FDA hold lifted Biotech’s women leaders decry US abortion ban: ‘We will not stand by silently’ The top biotech hubs in 2022 Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management TeneoTwo, put in play by Amgen, lands $100M AstraZeneca buyout on back of blood cancer bispecific After former CEO’s abrupt resignation, Adagio selects permanent leader Dyne another day: DMD therapy back on track after FDA lifts clinical hold Buying Tyme: Syros inks $190M merger, Flagship-backed financing to extend cash runway into 2025 Japan's Mitsubishi Tanabe and EditForce sign $146M deal to discover CNS gene therapies New study adds to growing evidence that immune system may not be source of Type 1 diabetes after all Gun-shy on accelerated approvals, FDA will convene a 2nd expert panel meeting to reconsider Amylyx’s ALS candidate 'Dramatic' surprise discovery finds cancer drug delays muscular dystrophy progression in mice With Cerebral in the spotlight, DOJ, regulators to ramp up scrutiny of telehealth startups, former prosecutor says After its own vaccine flop, CureVac sues Pfizer partner BioNTech for patent infringement How antibiotics may shut down cancer metastasis Featured Story | By Max Bayer Vertex is restarting the engine of the phase 1/2 trial of its Type 1 diabetes med after the FDA lifted a clinical hold placed in May. The trial was originally paused after the agency said it didn't have enough evidence to support dose escalation. read more |
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Top Stories By Annalee Armstrong More than 70 women in biotech are lending their voices to the outcry of opposition to the Supreme Court’s decision to strike down Roe v. Wade, casting reproductive rights for women and pregnant people into doubt around the nation. read more By Annalee Armstrong It’s a tough time for biotech. A market correction underway. Layoffs have beset the sector. And funding as well as M&A are down across the board. But that doesn’t mean there isn’t plenty going on in labs around the country. We recap the top biotech hubs across the U.S. read more Sponsored By: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By Nick Paul Taylor AstraZeneca is making moves to challenge Amgen’s bispecific T-cell engager unit, paying $100 million to acquire a candidate designed to improve on the CD19xCD3 incumbent Blincyto. read more By Gabrielle Masson Adagio Therapeutics’ David Hering is shedding his interim status—as well as his chief operating officer title—stepping into the role of permanent CEO more than four months after the infectious disease biotech’s founding chief executive suddenly resigned. read more By James Waldron Duchenne muscular dystrophy-focused Dyne Therapeutics is back on track to move its first asset into the clinic in the coming weeks after the FDA lifted a clinical hold on the drug. read more By Nick Paul Taylor Syros Pharmaceuticals has bought itself that most prized of assets in today’s biotech market: time. By merging with the floundering Tyme Technologies and tapping investors including Flagship Pioneering, the gene expression biotech has extended its cash runway out into 2025. read more By James Waldron Mitsubishi Tanabe Pharma has pledged up to $146 million to fellow Japanese company EditForce to pursue gene therapies for central nervous system disorders. read more By Max Bayer A new study has added to a growing body of evidence that the immune system may not be the source of Type 1 diabetes after all, but rather beta cells themselves. The findings could have critical implications for future treatments and efforts to stymie disease progression. read more By Kevin Dunleavy On Tuesday, the FDA took the unusual step of announcing a second advisory committee meeting to discuss the merits and risks of Amylyx's amyotrophic lateral sclerosis drug AMX0035. The meeting is set for September 7, three weeks before an approval decision is due. read more By Gabrielle Masson A new surprise discovery could hold big implications for muscular dystrophy patients, with researchers finding that an existing cancer drug may delay progression of the hard-to-treat disease. read more By Heather Landi In the wake of DOJ and FTC investigations into Cerebral, U.S. regulators will ramp up their scrutiny of other telehealth companies, a former federal prosecutor says. Meanwhile, mental health experts are increasingly concerned about online mental health companies' practices and the quality of patient care. read more By Kevin Dunleavy A year after a high-profile flop with its COVID-19 vaccine candidate, CureVac is still trying to get a piece of the action. On Monday, the company revealed that it is suing fellow German mRNA pioneer BioNTech for infringement of its intellectual property in development of the Pfizer-partnered COVID shot Comirnaty. In its lawsuit, CureVac identifies four patents which relate to the engineering of mRNA molecules. read more By Angus Liu A team led by the German Cancer Research Center has fingered certain modifications in mitochondrial RNA as culprits behind cancer metastasis. Interestingly, certain available antibiotics were found to inhibit this driving force behind the spread of tumors. read more | | New Product Planning Summit September 19-20, 2022 | Boston, MA Join us for the ONLY conference for defining how the new product planning role and related functions make informed, value-based, data-driven decisions about products in the pipeline. Register now! |
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Resources Sponsored by: Lumanity Check out our 22 on-demand panels, featuring 100+ speakers. Tap into discussions of scientific progress in oncology around development, regulatory, clinical, commercial and investment perspectives. Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent 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 Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Fierce Biotech Summit September 19-20, 2022 | Boston, MA 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 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 | 