Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies Murky FDA feedback leaves Eiger COVID treatment in regulatory limbo Synaffix rustles up another ADC deal, allying with Emergence in $360M biobuck pact Iveric hits again in pivotal eye disease program, keeping it on Apellis' tail in race to market Hormone that could improve cognitive function in Down syndrome identified Owkin AI for identifying breast, colorectal cancer types score EU approval Virginia reels in $52.9M for manufacturing as part of government competition Prostate Cancer Foundation taps Olympic skier, runs AstraZeneca-backed webinar in 'Get Healthy' campaign Lonza, Touchlight partner on 'doggybone DNA' development CVS wins bidding war for Signify Health, will acquire company in $8B deal FDA's drug shortage prevention guidance draws fire from PhRMA, BIO and Bristol Myers Featured Story | By Gabrielle Masson Sarepta Therapeutics has broken free from an FDA hold—put in place this June—on its phase 2 Duchenne muscular dystrophy (DMD) clinical trial. read more |
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Top Stories By Max Bayer Arsenal Bio is reeled in $220 million in series B funds off the promise of its programmable autologous cell therapies. The latest fundraising was backed in part by Bristol Myers Squibb, which has partnered with the company on a number of programs. read more By Max Bayer Eiger and its COVID treatment are in a state of purgatory after murky FDA guidance suggests its unknown whether the company will nab emergency use authorization. In March, the company said the treatment passed a phase 3 test and slashed the risk of hospitalizations. read more By Nick Paul Taylor Synaffix has landed another antibody-drug conjugate partner. After inking deals with Genmab and MacroGenics this year alone, the Dutch biotech has landed a partnership with Emergence Therapeutics that could be worth $360 million. read more By Nick Paul Taylor Iveric Bio is coming for Apellis Pharmaceuticals. Tuesday, the biotech revealed its second late-phase geographic atrophy clinical trial has hit its primary endpoint and outlined plans to file for FDA approval in the eye disease by the end of the first quarter. read more By Helen Floersh A team of researchers from two French universities has found that the absence of gonadotropin-releasing hormone could be driving olfactory dysfunction and cognitive decline in people with Down syndrome. In a small, pilot study published in Science, the team also showed that restoring GnRH could improve cognitive performance. read more By Andrea Park In recent years, artificial intelligence developers have changed the face of medicine with algorithms capable of detecting the earliest signs of cancer. Owkin, meanwhile, is taking a slightly different approach with its own cancer-spotting AI. read more By Joseph Keenan Virginia’s Advanced Pharma Manufacturing and R&D Cluster is getting a $52.9 million boost. The funding comes as part of a $1 billion federal government competition to address critical manufacturing and supply issues in the U.S. read more By Ben Adams The Prostate Cancer Foundation is “challenging Americans” to show their support for men impacted by prostate cancer by getting active and eating healthfully during Prostate Cancer Awareness Month this September. read more By Joseph Keenan CDMO giant Lonza inked a deal with Touchlight to expand production and distribution of the biotech’s so-called doggybone DNA platform. read more By Paige Minemyer CVS Health has won the bidding war for home health and technology services company Signify Health. read more By Fraiser Kansteiner Several months after the FDA unveiled a framework to help manufacturers forge risk management plans aimed at combating drug shortages, two trade group heavyweights are sounding their discontent. read more Resources Sponsored by: Genpact Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: ReachBio | The Cell Biology Experts™ How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: ZS ZS helps life sciences companies shape the future of medicine by turning healthcare data into transformative insights. 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