AstraZeneca wields ax, scrapping midphase programs from $1B takeover, Heptares pact in latest quarterly cull Cortexyme picks a lower dose for nebulous Alzheimer's drug after phase 2/3 flop At the eleventh hour, Woodcock shunned by Biden as Califf reportedly set to become FDA commish nominee Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success Adaptimmune's TCR T-cell therapy clears efficacy bar in rare cancers, teeing up landmark solid tumor filing Gerngross biotech Ankyra Therapeutics nabs $45M series B to jump into the clinic, hires new CMO Biogen posts more Aduhelm biomarker data and a 'correlation' with Alzheimer's clinical benefit Johnson & Johnson to spin out consumer health business in new publicly traded company Using CRISPR to find a new drug target for multiple sclerosis, inflammatory bowel disease Report: Nursing homes shed 221K jobs since start of pandemic while other sectors have recovered C2N's amyloid blood test for Alzheimer's risk matches up to PET scans in study Fierce Pharma Asia—Takeda's Alunbrig pricing pact; Merck, Japan COVID pill deal; SK Biopharm's Chinese JV Chutes & Ladders—J&J's outgoing CEO already has a new role: Apple board member Featured Story | By Nick Paul Taylor AstraZeneca has completed a clearout of its midphase pipeline, dumping a clutch of cancer, diabetes and cardiovascular disease drugs it picked up in deals including its $1 billion takeover of Ardea Biosciences. read more |
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Top Stories By Annalee Armstrong Just over two weeks after boldly deciding to forge on with an Alzheimer’s drug despite a failed phase 2/3 clinical trial, Cortexyme now says it will use a lower dose in studies to come. read more By Ben Adams Reports are coming in that President Joe Biden is on the cusp of nominating former Obama pick Robert Califf M.D. as his new FDA commissioner. read more Sponsored by: IPM.ai Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention. read more By Nick Paul Taylor Adaptimmune Therapeutics is on track to bring the first engineered T-cell therapy to market in a solid tumor indication. With the response rate above the target threshold at the interim analysis, the biotech is certain the study will hit its primary endpoint and deliver the data needed to seek approval next year. read more By Ben Adams Little startup Ankyra has grabbed a relatively small $45 million B round as it plots getting its leading oncology hopeful into the clinic. read more By Angus Liu Biogen has been in hot water lately thanks to the contentious FDA approval of Alzheimer’s disease therapy Aduhelm based on a debatable biomarker. Now, the Big Biotech has turned in data on another biomarker plus an analysis the company says suggests association with a slowing of disease progression. read more By Kevin Dunleavy Continuing a trend, especially among the largest firms in the pharmaceutical industry, Johnson & Johnson will form a new company to handle its consumer health business. The launch of the new publicly traded company is expected in 18 to 24 months. read more By Kyle LaHucik Vanderbilt researchers used CRISPR gene editing to pinpoint a metabolic enzyme that they believe could be blocked to treat MS and other inflammatory diseases. The target had been investigated in cancer before but never made it into clinical trials. read more By Robert King Nursing homes have lost 221,000 jobs since the start of the pandemic even as other healthcare industries have been able to recover from job losses. read more By Conor Hale A study of C2N Diagnostics’ blood test showed it could help predict which people may be at an increased risk for Alzheimer’s disease based on the level of amyloid proteins found in the brain—a task that has traditionally requires PET scans, spinal taps or biopsies for cerebrospinal fluid. read more By Angus Liu Takeda launched a value-based pricing program for lung cancer drug Alunbrig. Merck penned a $1.2 billion COVID-19 pill supply deal with Japan. SK Biopharm is establishing Chinese operations with a new joint venture. And more. read more By Kyle LaHucik Before he could pack up his belongings, Johnson & Johnson's outgoing CEO Alex Gorsky already has another role for his resume: board member of Apple. Ancora Bio will attempt to revive a Taisho depression drug with Sage Therapeutics Chief Medical Officer Stephen Kanes at the helm. And former Merck KGaA global oncology leader Zhen Su parachutes to the new startup scene as CEO of Marengo Therapeutics. read more Resources Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. Sponsored by: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics 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: Blue Matter Consulting Paper describing how the chronic insomnia market offers big lessons for any biopharma company thinking about getting into digital therapeutics in any therapeutic area. Sponsored by: TransPerfect Life Science Every detail is important when selecting a new eCOA solution; learn more about the current eCOA landscape, best practices, and crucial considerations for successful eCOA solution deployment in this white paper. Sponsored by: Informa Pharma Intelligence and Oracle Health Sciences New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. 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. Pharma Meeting Pros Summit November 3-4, 2021 | Atlantic City, NJ & Virtual Drug Development Boot Camp® 2021 VIRTUAL November 17-18, 2021 Learn impact of pricing, competitive assessment, epidemiology November 17-18, 2021 | Live & Online Fierce New Product Planning Summit December 1-2, 2021 | Boston, MA Fierce Launch Readiness for Medical Affairs & Communications Teams December 1-2, 2021 | Boston, MA Learn how therapeutics are successfully launched and commercialized December 1-2, 2021 | Live & Online 2nd Annual Symposium on Translational Medicine and Biomanufacturing December 2—3, 2021 Fierce Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week 2022 January 11, 2022 | San Francisco, CA
January 18-20, 2022 | Virtual Event Virtual European Healthcare Compliance Certificate Program January 24-28, 2022 Fierce Pharma Drug Safety Summit February 8-9, 2022 | Location TBD Fierce Business Development and Licensing Summit March 15, 2022 | San Francisco, CA Fierce Medical Affairs Strategic Summit (MASS) East April 2022 | New Jersey Fierce Trial Master File Summit May 2022 | Location TBD Fierce Promotional Review Committee Compliance and Best Practices Summit April 2022 | New Jersey Fierce Digital Pharma Innovation Week June 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce Biotech Forum October 2022 | Location TBD | 