Featured Story | By Annalee Armstrong The Delta variant driving up COVID-19 infections in the U.S. will certainly cast a pall over earnings, but biotechs saw a boost in the second quarter with some new gene editing results that reinvigorated interest in companies developing the technology. But gene therapy had a moment in the sun, too—one that might have been too bright. read more |
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Top Stories By Kyle LaHucik Sanofi and GlaxoSmithKline passed a small phase 2 COVID-19 vaccine test in mid-May and began enrollment for a global phase 3 later that month, with hopes for a fourth quarter approval. That process picked up steam Tuesday with the European Medicines Agency saying it started a rolling review of the potential vaccine. read more By Annalee Armstrong As U.S. officials practically beg the unvaccinated to roll up their sleeves to gain protection from COVID-19, a new report is calling on pharmaceutical companies to be more transparent with their clinical trials and data sharing among peers to build trust in the medical system. A group of Yale bioethicists has found that the largest pharmaceutical companies are better at clinical trial transparency and sharing data amongst their peers and smaller companies could be doing more to catch up. read more By Ben Adams Novartis is culling an eye disease asset but has got an FDA approval date for its troubled The Medicines Company heart drug, while also sending off for review its Bosulif-rivalling blood cancer hopeful. read more By Amirah Al Idrus Drug development for the liver condition alpha-1 antitrypsin deficiency (AATD) has had its ups and downs lately, with Arrowhead Pharmaceuticals and Takeda posting phase 2 success and Vertex reporting two failures in less than a year. Now, Dicerna is revealing promising early results for its RNA-silencing drug for liver disease stemming from the rare, genetic disorder. read more By Nick Paul Taylor Coave Therapeutics has added €21.2 million ($25.0 million) to its series B round, setting the French biotech up to move a gene therapy against PDE6b inherited retinal dystrophies toward pivotal trials. read more By Nick Paul Taylor Vedanta Biosciences has raised $68 million to take a microbiome candidate into phase 3. The biotech also used the series D update to reveal the failure of its Bristol Myers Squibb checkpoint inhibitor alliance to generate data to support further development. read more By Kyle LaHucik Magenta Therapeutics has been asked by the FDA to pump the brakes on a trial for its blood cancer med before it even got started. The FDA would like the biotech to develop an additional test to inform dose escalation and safety monitoring in the proposed phase 1/2 clinical trial read more By Amirah Al Idrus As Lexeo Therapeutics ushers two gene therapies toward the clinic, the company is adding another three heart disease programs to its already busy pipeline. The assets come through Lexeo’s acquisition of Stelios Therapeutics, which was founded on research out of the University of California, San Diego. read more By Amirah Al Idrus Turnstone Biologics kicked off the year with a buyout that brought a tumor-infiltrating lymphocyte (TIL) platform under its roof. Now, it’s banking $80 million from a laundry list of backers to get its leading TIL program, along with its most advanced cancer-killing virus treatment, through the clinic. read more By Kyle LaHucik IM Therapeutics reported positive results across safety, tolerability and mechanism of action in a phase 1b trial of its lead drug candidate for patients with Type 1 diabetes. The oral drug is meant to block a specific genetic trait, HLA-DQ8, which increases the risk of the disease and is present in many patients. read more By Beth Snyder Bulik Team USA Olympic-sponsor Eli Lilly showcases its first-ever corporate ad campaign during the opening ceremony of the Tokyo Games on Friday. However, unlike typical athletic triumph ads, Lilly’s TV ad offers a reality check on American healthcare. read more By Dave Muoio A new JAMA study estimated a mean medical debt of $429 per American as of June 2020, although that average increases among those living in the South, lower-income communities and Medicaid non-expansion states. read more By Noah Higgins-Dunn Despite the ambush of negative press against Biogen’s Aduhelm and the uncertainty shrouding its benefit to patients, there’s still reason to believe the controversial Alzheimer’s treatment will hit blockbuster status next year, Piper Sandler analysts said in a note on Monday. read more Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. 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