Sarepta defuses concerns about Duchenne clinical hold with vow to meet FDA's request within days M&A is down, but Big Pharma likely to line up 'multiple shots on goal' in 2nd half, PwC says Beta-vax: Sanofi, GSK hail phase 3 omicron win to throw down gauntlet in COVID-19 vaccine format war Galapagos says out with the old, in with the new, as respiratory drug sent back to Molecure FDA unveils 5-year action plan for neurodegenerative drugs, with focus on ALS BioNTech's solid tumor CAR-T hits prime time with EU regulatory tag Florence raises another $27M to fund trial software and network expansion Labcorp moves to bolster RWD offering with HealthVerity collaboration Manipulating T-cell fate to improve CAR-T therapy in solid tumors AstraZeneca launches first Evusheld DTC, but without full approval it comes with a different feel 'The Top Line' podcast: Why we need an Alzheimer's moonshot, a controversial take on diversity in biotech, plus this week's headlines Chutes & Ladders—Merck vet Guindo returns to the fold after Biogen marketing stint Fierce Pharma Asia—Biocon bribery allegations; AstraZeneca's China investment; Shionogi's COVID pill delay Featured Story | By Nick Paul Taylor Sarepta Therapeutics has successfully defused concerns about a FDA clinical hold on one of its Duchenne muscular dystrophy clinical trials. After initially plunging, the biotech’s share price stabilized when it reassured investors it could satisfy the regulator’s requests “in the next few days” and convinced analysts of the likelihood of a speedy resolution. read more |
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Top Stories By Annalee Armstrong Deal values are down by 58% and volume has decreased by 33%, but fear not, the pharmaceutical and life sciences industry is poised for a “flurry of deals” in the second half, according to PwC. read more By Nick Paul Taylor After lagging the leaders in the original COVID-19 vaccine race, Sanofi and GSK have now claimed a first in the push to protect people from omicron. The partners hailed the first successful efficacy study against omicron after their beta-specific vaccine achieved 72% protection versus the now-dominant variant. read more By Annalee Armstrong While Galapagos is stocking its pipeline by way of two acquisitions, the biotech is also cleaning house, sending the rights for a respiratory disease drug back to Molecure. read more By Annalee Armstrong There’s an urgent need to improve and extend the lives of patients with rare neurodegenerative diseases, and the FDA is hoping a new five-year action plan, which has a specific detailed blueprint for amyotrophic lateral sclerosis (ALS), can help accelerate new medicines. read more By Annalee Armstrong Just a couple months after showcasing a small data set, BioNTech’s solid tumor CAR-T cell therapy is ready for prime time. BNT211 has been granted a priority medicines, or PRIME, designation from the European Medicines Agency, giving the famed German biotech extra help during the regulatory process. read more By Gareth Macdonald Florence Healthcare has raised $27 million to expand its clinical trial document management software business. read more By Gareth Macdonald Labcorp has partnered with real-world data tech firm HealthVerity, citing growing drug industry demand for patient insights. read more By Angus Liu Inhibiting a protein could boost the efficacy of CAR-T cells by letting newly activated T cells preferentially differentiate toward long-lasting memory T cells rather than the short-living effector cells, scientists at St. Jude Children’s Research Hospital have shown. read more By Ben Adams AstraZeneca launched the first ever COVID drug DTC for its prevention antibody, Evusheld, and it’s one of the most unusual and unique commercials you will see this year. read more By Teresa Carey This week on "The Top Line," we discuss why scientists say we need an Alzheimer's moonshot. We also talk about a controversial take on diversity during a panel at the BIO conference. Plus, we'll hear award-winning ads that tug at our heartstrings. read more By Fraiser Kansteiner A Biogen marketing exec is returning to his Merck & Co. roots. PathAI's co-founder is taking on a similar role at Iterative Scopes. And American Gene Technologies is tapping Ellume's U.S. president as its new chief science officer. read more By Angus Liu Biocon is embroiled in a bribery allegation in India around an insulin product. AstraZeneca is betting on more in China with a new manufacturing plant and a rare disease-focused innovation center. Japanese authorities have postponed a decision on Shionogi's COVID-19 pill. And more. read more Resources Sponsored by: Blue Matter, strategic consultants in the life sciences Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. 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