Marinus parts with priority review voucher, selling skip-the-line pass to Novo Nordisk for $110M ContraFect halts phase 3 after antimicrobial fails futility test against MRSA CytomX slashes headcount by 40% after breast cancer setback, with later-stage development bearing the brunt Sponsored: Ramp up your AAV production with Lonza’s HEK 293 cell line and patented vectors technologies Back in the Manifold: George Church-founded protein therapeutics biotech tacks on $40M in series A funds Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management Summit will take scenic route up FDA mountain after regulator recommends more trials for C. diff therapy Novartis, BeiGene's PD-1 drug the latest to hit FDA wall as pandemic stalls another review NIH scientists move closer to vaccine holy grail: a universal flu shot BMS, Merck and Lilly share prices gained in the first half, while Roche, Pfizer and Moderna lost out: report Breaking the vicious itch-scratch cycle by targeting 'miswired' neurons Novavax, at long last, clinches FDA emergency nod for protein-based COVID shot Twist Bioscience intertwines with DNAnexus to bring analytics tools to sequencing data Teva warns 'skinny label' ruling could sow 'competition-killing uncertainty' for generics Featured Story | By Max Bayer Marinus is selling off a priority review voucher to Novo Nordisk for $110 million. The company plans to use the additional funds to pay for two ongoing phase 3 trials and the launch of its new seizure med, Ztalmy. read more |
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Top Stories By Nick Paul Taylor After keeping investors waiting for months, ContraFect has revealed its phase 3 clinical trial has failed an interim futility analysis. The inability of the direct lytic agent to beat placebo triggered the stoppage of the study and the cratering of the biotech’s share price. read more By Nick Paul Taylor First the setback, then the cuts. CytomX Therapeutics became the latest biotech to follow the rhythm of the industry late Wednesday when it set out plans to reduce its headcount by 40% to extend its cash runway after its lead candidate failed to meet the bar for moving into phase 3. read more Sponsored by: Lonza AG Advance your AAV-based therapeutics by leveraging Lonza expertise, using the same tools and technologies used for our platform processes. Balance risk and speed, while maintaining high AAV productivity read more By Max Bayer Manifold Bio is adding $40 million in series A funds to help finance its protein barcoding technology intended to rapidly speed up preclinical development. The company, founded in part by famed geneticist George Church, has already started to launch internal oncology programs. 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 Annalee Armstrong Summit Therapeutics’ troubled C. difficile medicine may have a path forward after the FDA cleared a section of trail—however, it’s going to be a steep climb. read more By Angus Liu New PD-1 cancer immunotherapies have had a hard time reaching the U.S. lately. For Novartis and BeiGene’s China-approved contender, the roadblock comes in the form of COVID-related travel restrictions. read more By Gabrielle Masson Researchers at the National Institutes of Health are moving closer to the holy grail of the vaccine world: a universal flu shot. read more By Zoey Becker Like many other businesses around the world, the biopharma industry has had a rough go of it in the first half of 2022. And drugmakers' share price changes largely reflected that tough environment, Evaluate Vantage reports. read more By Angus Liu In search of mechanisms driving increased itch sensation after scratching, scientists at Washington University School of Medicine have identified a “miswiring” of nerve fibers onto touch-sensing skin cells. read more By Fraiser Kansteiner Late Wednesday, the FDA gave the all-clear to Novavax’s protein-based shot, teeing up the nation’s fourth pandemic prophylactic behind those from Pfizer-BioNTech, Moderna and Johnson & Johnson. read more By Andrea Park A new partnership between Twist Bioscience and DNAnexus seeks to weave together two crucial pieces of the genomic sequencing puzzle. read more By Fraiser Kansteiner Teva's skinny label lawsuit, which hinges on a copycat version of GSK’s heart med Coreg, could have “enormous” implications for a common practice among generic drug makers, the company argues. That could in turn sow “competition-killing uncertainty” that the U.S. healthcare system “cannot sustain,” Teva said in a petition made public on Wednesday. read more Resources Sponsored by: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. Sponsored by: Nexelis Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book. 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. 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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? 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