| AstraZeneca is nearly ready to seek approval for its COVID-19 antibody. Can it stick the landing? Novartis' BTK inhibitor steps up where other Big Pharmas have failed in autoimmune diseases GSK's $4.2B bet on Merck KGaA's cancer drug goes up in smoke as pharmas cut ties after series of flops Sponsored: Navigating the complexities of oncology clinical trials in an increasingly competitive landscape Lilly adds liver fat, CGM blood sugar data to mountain of evidence on hot diabetes prospect tirzepatide Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success Sunovion pens $890M Otsuka pact for a clutch of neuropsychiatric drugs Bausch will test FDA waters in 2022 for dry eye disease drop after 2nd phase 3 confirms effect Biotech incubator Sporos' new CEO arrives from Ovid with Biogen, Bristol Myers experience How exploiting a protective gene mutation might protect the brain from Alzheimer's disease FDA alerts HCPs to higher risk for women with stroke-preventing heart implant Verily's Onduo inks partnership with Fitbit to integrate fitness trackers with virtual clinic Merck CEO downplays PAH drug's antitrust threat as it wades deeper into cardiovascular disease with $11.5B Acceleron buy Featured Story | By Nick Paul Taylor Across the first phase of the pandemic, AstraZeneca went from being a good example of how pharma can step up in times of need to a warning that no good deed goes unpunished. Now, AstraZeneca has a shot at putting its vaccine woes behind it by carving out a space for a product that may address one of the remaining unmet COVID-19 needs in the West. read more |
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Top Stories By Annalee Armstrong After a string of Big Pharmas reported failures for their BTK inhibitors in autoimmune disorders, Novartis finally appears to have a winner. The Swiss pharma reported that remibrutinib has succeeded in controlling the autoimmune condition chronic spontaneous urticaria, or CSU, which causes unpredictable hives and swelling that can be painful and itchy. read more By Annalee Armstrong Merck KGaA and GlaxoSmithKline are ending a partnership for the oncology asset bintrafusp alfa which could have netted billions for the German pharma if successful. read more By Premier Research With the shift from traditional chemotherapy agents to innovative immuno-oncology drugs and cell and gene therapies, oncology clinical trials have increased in complexity. read more By Nick Paul Taylor Eli Lilly has added to the mountain of data it is piling up in support of diabetes prospect tirzepatide. The latest additions to the pile come from two phase 3 sub-studies that linked the dual GIP/GLP-1 agonist to improvements in patients using continuous glucose monitors and reductions in liver fat. 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 Ben Adams Sunovion, owned by Japan’s Sumitomo Dainippon Pharma, has signed a near $1 billion upfront/biobucks mix deal with fellow Japanese native Otsuka. read more By Kyle LaHucik Patients with dry eye disease taking Bausch + Lomb and Novaliq's eye drop saw an improvement in the severity of eye dryness and damage to the eye during a phase 3 clinical trial. read more By Kyle LaHucik Amit Rakhit, M.D., is ready for his next venture after leaving Ovid Therapeutics last month following a lead therapy failure in April. His next stop is leading Houston biotech incubator Sporos Bioventures. read more By Angus Liu A mutation in the APOE3 gene increases the formation of fatty molecules that are critical for preserving nerve cell functioning and that may reduce the toxic aggregation of protein clumps in the brain, a Mayo Clinic team has found. Targeting this process with drugs could protect against Alzheimer's disease, they suggested. read more By Conor Hale The agency alerted providers about findings published in JAMA Cardiology, which tracked procedures with Boston Scientific’s Watchman device. read more By Heather Landi Verily's Onduo is teaming up with Google-owned Fitbit to provide wearable devices to support members' chronic condition management and overall health and wellness. It marks the first official collaboration between Onduo, a virtual clinic housed within Alphabet's life sciences arm Verily, with wearable giant Fitbit, which Google officially acquired in January. read more By Angus Liu Days after market rumors, Merck unveiled that it will shell out $11.5 billion to acquire Acceleron. Merck’s newly minted CEO Rob Davis spun the takeover as an opportunity to grow the company’s cardiovascular portfolio, with a special interest in Acceleron’s expertise in the TGF-beta family of proteins. read more Resources Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. 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: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. 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. Let A Digital Sherpa Uncomplicate The Path for Patients Recorded on September 15, 2021 Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA The MedTech Conference 2021 September 27 - 30, 2021 Pharma PR & Communications Summit October 4-5, 2021 | Jersey City, NJ Fierce Biotech Cell & Gene Therapy October 19, 2021 | Virtual Event Fierce Health Payer Summit October 26, 2021 | Virtual Event Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Fierce Biotech Forum 2022 | Virtual Event | 