| | 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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AbbVie dumps Alector's Alzheimer's immunotherapy after phase 1 review Schrödinger eyes 'hundreds' of programs over a decade amid clinical-stage evolution Athersys loses $100M funding deal as C-suite exits allow backer to turn tail Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management Adverum lays off 78 employees, bets it all on embattled eye treatment Dynacure calls it quits on top asset to the dismay of the myotubular myopathy community Provention snags $60M in private placement as future of diabetes therapy hangs in the balance CASI pockets $5M for autoimmune drug deal as China's Precision secures $21M funding Ex-Theranos President Balwani found guilty on all 12 fraud charges Amid drug pricing debate, feds reveal plan to crack down on 'incremental' patents Scientists explore 'mosaic' nanoparticles, inhaled COVID-19 vaccine options More than 600 providers impacted by ransomware attack on payment vendor Blood thinner's ability to boost fat burning could inspire new obesity therapies 'The Top Line' podcast: Biotech's beef with FDA's accelerated approval reforms, plus this week's headlines Chutes & Ladders—Catalent taps new CEO, execs play C-suite musical chairs Fierce Pharma Asia—BeiGene R&D chief's I-O ambitions; Legend scraps CAR-T program Featured Story | By Nick Paul Taylor Alector’s new approach to amyloid beta has ended the way of many of the old ideas for how to tackle the troublesome peptide. After going over data including phase 1 results, AbbVie has severed its ties to the potential Alzheimer’s disease immunotherapy—and the asset has vanished from Alector’s pipeline. read more |
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Top Stories By Max Bayer Led by former top Merck scientist Karen Akinsanya, Schrödinger is expanding its horizons, developing wholly-owned, clinical-stage assets for the first time. But even as phase 1 nears, the company is realistic about its commercial-stage ambitions. read more By Nick Paul Taylor Athersys’ jettisoning of three members of its C-suite has cost it a $100 million financing package. Given an opportunity to cut and run in the wake of the departures, Aspire Capital Fund has terminated the deal and left Athersys looking for a new source of funding. 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 Gabrielle Masson Adverum Biotechnologies is slashing its workforce by nearly 40%, cutting 78 employees under a new restructuring plan that will funnel resources to ixo-vec, a wet age-related macular degeneration (AMD) treatment candidate. read more By Max Bayer Dynacure is winding down work on its top asset to treat myotubular and centronuclear myopathies, a decision that's made the team "overwhelmed with disappointment." The news came in a letter published by an advocacy and research organization focused on the rare diseases. read more By Gabrielle Masson Provention Bio may be waiting a bit longer for the FDA's decision on its diabetes prevention drug teplizumab, but at least the biotech has $60 million cash in the meantime to work through launch preparations. read more By James Waldron Precision Autoimmune Therapeutics has scooped up $21 million in first-round financing, allowing the Chinese company to make good on the promise of a delayed payment to U.S.-based CASI Pharmaceuticals for the license of a autoimmune disease drug. read more By Andrea Park Another chapter in the saga of disgraced blood testing company Theranos has drawn to a close after a California jury on Thursday delivered its verdict in the criminal fraud trial of Ramesh “Sunny” Balwani, the startup’s former president and chief operating officer. read more By Zoey Becker Watch out, pharma—the federal government has its eye on add-on drug patents that can lead to higher prices. In a new effort, the FDA and the U.S. Patent and Trademark Office are teaming up to take a close look at patenting procedures. read more By James Waldron Scientists are continuing to explore fresh ways to deliver COVID-19 vaccinations, including recent research into so-called mosaic nanoparticles and easy-to-store inhaled options. read more By Heather Landi A payment vendor was hit with a ransomware attack back in February that may have exposed patient data from more than 600 healthcare providers and organizations. Also this week, federal officials issued a warning that hackers sponsored by North Korea's government have been using the Maui ransomware to target healthcare and public health services providers since last May. read more By Angus Liu Scientists in Germany have identified a molecular mechanism by which brown fat increases energy expenditure and showed how an anticoagulant may stimulate that process in mice. read more By Teresa Carey This week on "The Top Line," we discuss proposed reforms to FDA’s accelerated approval program—and what the biotech industry has to say about them. The Fierce team gets creative with our own biopharma competition. Plus, news from Vertex, Biogen and Eisai, Orchestra and more. read more By Gabrielle Masson Catalent's new chief executive Alessandro Maselli is taking the reins from longtime CEO John Chiminski, who will assume the role of executive chair for the manufacturer’s board of directors. read more By Angus Liu BeiGene's R&D chief talks about the company's PD-1 and TIGIT programs. Legend Biotech nixed an early CAR-T program after coming off an FDA clinical hold. Eisai and Biogen scored an FDA priority review for their Alzheimer's follow-up drug. And more. 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: Catalent Pharmaceutical drug developers continue to realize the strong therapeutic potential of highly potent active pharmaceutical ingredients (HPAPIs). This is particularly true for therapeutic areas such as oncology, where highly potent drugs are becoming more commonplace. 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: Catalent Pharmaceutical development companies face several challenges when developing orally bioavailable formulations of active pharmaceutical ingredients. Up to 70% of new drug molecules are poorly soluble in gastrointestinal fluids and can exhibit poor absorption across the gut wall. 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? Decentralized Clinical Trials Forum July 26, 2022 | Free Virtual Event Fierce Biotech Summit September 19-20, 2022 | Boston, MA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Health Payer Forum October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Biotech Cell & Gene Therapy Forum October 19, 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 Diversity, Equity & Inclusion Forum November 15-16, 2022 | Free Virtual Event 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 Fierce Clinical Trial Billing & Research Compliance Summit February 2023 | Location TBD Fierce BD&L Summit for Life Sciences March 14-15, 2023 | San Francisco, CA | 