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Lilly adds on to biomarker bombardment in Alzheimer's with two new donanemab analyses Surprise! Pfizer jumps the queue and leaps into RSV vax contention as COVID helps turbo charge work Another day, another billion-dollar deal for PeptiDream, this time with Alnylam Sponsored: Medical Cannabis from Colombia Can Change Lives IGM poaches Gilead cancer chief Takimoto at pivotal moment for both companies Takeda allies with Frazier to spin out late-phase norovirus vaccinei Alector bolsters 'immuno-neurology' approach—and GSK's $700M bet—with early phase 2 data Astellas to pay Minovia $20M upfront, with $420M on the table per product, for mitochondrial cell therapies Ardelyx's FDA rejection points to long path back for CKD drug People of color want to participate in Alzheimer's research. The NIA has a new tool to make it happen Immune system protein prompts obese mice to 'sweat' out fat, inspiring new treatment target Fierce Pharma Asia—AstraZeneca's China growth; Takeda's $3.5B neuro pact; Biocon, Viatris' historic biosimilar nod Chutes & Ladders—Bayer picks up Roche vet Ruettinger to lead early cancer R&D Featured Story | By Annalee Armstrong Ever since the FDA approved Biogen and Eisai’s Alzheimer’s disease treatment Aduhelm, the buzzword in Alzheimer’s has been “biomarker.” And that’s just what Eli Lilly has to offer with two new analyses on their candidate donanemab. Lilly rolled out the new exploratory analyses of a phase 2 clinical trial called Trailblazer at the Alzheimer's Association International Conference Thursday. read more |
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Top Stories By Ben Adams Watch out GlaxoSmithKline and Johnson & Johnson, Pfizer is steaming into the respiratory syncytial virus (RSV) vaccine race in what looks like a late break that could soon become gold. read more By Annalee Armstrong Apparently a licensing agreement with Takeda worth a potential $3.5 billion wasn’t enough for PeptiDream this week. The biopharmaceutical company, which has a peptide-based drug discovery platform, has now inked a similar deal with Alnylam worth a potential $2.2 billion. read more Sponsored By: Clever Leaves Medical cannabis from Colombia can change lives. read more By Annalee Armstrong IGM Biosciences has lured away Gilead’s oncology chief Chris Takimoto, M.D., Ph.D., to become chief medical officer, where he will oversee a pipeline of early-stage cancer assets. Takimoto will join the biotech after years working at Gilead, and before that serving as CMO at its biotech buy out Forty Seven. read more By Nick Paul Taylor Takeda has spun out its norovirus vaccine prospect to create a biotech: HilleVax. Frazier Healthcare Partners has teamed up with Takeda to found HilleVax, providing investor support for a program that cleared phase 2b back in 2018. read more By Amirah Al Idrus Weeks after GlaxoSmithKline ponied up $700 million to work with Alector on a pair of “immuno-neurology” drugs, the neurodegenerative disease biotech pulled the curtain on early data showing its approach could slow the progression of an inherited form of dementia. read more By Kyle LaHucik Atellas Pharma and Minovia Therapeutics are linking arms on researching and developing novel cell therapies for diseases caused by dysfunction of the mitochondria. The deal sees Astellas pay Minovia $20 million upfront with the potential for up to $420 million in biobucks for each product. read more By Nick Paul Taylor The FDA has hit Ardelyx’s chronic kidney disease drug candidate tenapanor with a complete response letter. Ardelyx disclosed the setback 10 days after revealing the FDA had identified concerns with the treatment effect and its clinical relevance. read more By Kyle LaHucik The newly approved Alzheimer's disease drug Aduhelm was tested in mostly white individuals, and yet the disease disproportionately impacts people of color. The National Institute on Aging wants to change that with a new tool to help researchers and clinicians raise awareness and participation in their trials for the disease. read more By Arlene Weintraub University of Pennsylvania researchers found that boosting levels of the cytokine TSLP in obese mice reduced their risk of developing Type 2 diabetes and caused them to lose 44% of their weight in 28 days. The weight loss was caused by the release of oil from the skin, making the "sweating out" of fat a potential strategy in treating obesity, they suggested. read more By Angus Liu AstraZeneca expects slower growth from its China business moving forward. Takeda signed a neurodegenerative diseases R&D pact with PeptiDream worth up to $3.5 billion. Biocon and Viatris won the first FDA interchangeable biosimilar tag for their copy of Sanofi's Lantus. And more. read more By Kyle LaHucik Bayer named Roche oncology veteran Dominik Ruettinger, M.D., Ph.D., as head of research and early development for oncology. Bayer also made moves with subsidiary BlueRock Therapeutics promoting chief scientific officer Seth Ettenberg, Ph.D., to the role of CEO. And ex-Kiadis Chief Business Officer Ray Barlow became SynOx Therapeutics CEO. read more Resources Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. 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Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Diversity, Equity & Inclusion Week August 9-11, 2021 | Virtual Event Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA | 