Managed marketplaces and reality TV: How a new generation of gatekeepers are opening biotech up to amateur investors In an unusual crossover, Gilead hires Arcus CMO Grossman, putting him in charge of cancer pact with his former biotech Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug Bayer’s billion-dollar Parkinson’s disease bet snags FDA fast-track tag Rivus’ fat-trimming therapy nabs $35M to harness our own biology against a host of diseases IAS: En route to FDA decision, Gilead’s long-acting drug keeps HIV down in patients ‘at the end of options’ Amylyx raises $135M to gear up for potential Canadian launch of ALS drug IAS: Merck’s long-acting HIV med hits protective levels in phase 2 Panakès moves into biotech investing with new €150M fund Surprise genetic discovery in macular degeneration points to new treatment strategy Even within the same hospital, Black patients endure more harm than white patients Johnson & Johnson weighs talc bankruptcy as billions in legal costs pile up: report High-profile Biogen ads hype early Alzheimer's detection as hospitals reject Aduhelm prescriptions Featured Story | By Amirah Al Idrus The average person will never get the chance to invest in a future unicorn like Moderna: The type of private equity deals that brought the now-famous biotech to the world are done in country clubs and coffee houses in a select few places, leaving anyone who is not a hedge fund manager, venture capitalist or disgustingly rich individual out of the game. read more |
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Top Stories By Nick Paul Taylor Bill Grossman is leaving Arcus Biosciences to take up a position at Gilead, putting him in charge of the Big Pharma's collaboration with his former employers. read more By Ben Adams Shares in Ardelyx are in freefall after the FDA found a series of “deficiencies” with Ardelyx’s application for the kidney disease hopeful tenapanor. In what CEO Mike Raab said was an “extremely disheartening and disappointing communication from the FDA,” the U.S. regulator, which has already delayed the decision date for the therapy once to the end of the month, is now heaping more pressure on the med. read more By Amirah Al Idrus Six weeks after landing in the clinic, Bayer’s stem cell therapy for Parkinson’s disease is getting into the fast lane. The German pharma picked up the treatment, DA01, by buying Versant Ventures out of their regenerative medicine joint venture BlueRock Therapeutics in a deal worth about $1 billion. read more By Ben Adams Type 2 diabetes; severe hypertriglyceridemia (SHTG); non-alcoholic steatohepatitis (NASH); and heart failure with preserved ejection fraction (HFpEF) are just the start for the little biotech Rivus Pharmaceuticals as it nabs $35 million for a big push into the clinic. read more By Amirah Al Idrus Three weeks after Gilead filed its long-acting HIV drug for FDA approval, the new antiviral is padding its case. After six months, lenacapavir, along with other antiretroviral drugs, drove HIV down to undetectable levels in 81% of 36 patients in a phase 3 study. read more By Kyle LaHucik A month after filing for Canadian approval for its lead ALS candidate, Amylyx Pharmaceuticals has picked up $135 million to bankroll a potential commercial launch and support a pipeline of other candidates for neurodegenerative diseases, including the one causing a stir this summer: Alzheimer's disease. read more By Amirah Al Idrus Two dose levels of Merck's drug, islatravir, quickly reached protective levels in the blood of adults at low risk of contracting HIV-1, the most widespread type of HIV. The drug also stayed at those protective levels throughout the monthly dosing cycle and beyond. read more By Nick Paul Taylor Panakès has raised a €150 million ($177 million) fund that will extend its focus beyond medtech and into biotech. The VC shop will mainly use the money to invest in the series A rounds of European biotech and medtech startups, with a particular focus on its home country of Italy. read more By Arlene Weintraub The protein produced by the gene HTRA1 naturally increases with age and has long been thought to contribute to age-related macular degeneration (AMD) and other diseases of aging. But researchers at University of Utah Health believe that in some cases, the HTRA1 protein might be protective, not destructive—and augmenting it could be a new treatment strategy. read more By Dave Muoio A new Urban Institute analysis found a higher incidence of adverse safety events among Black patients and white patients receiving care at the same hospital. The disparity lessened, but persisted, regardless of the patients' insurance coverage, hospital demographics or hospital resources. read more By Kevin Dunleavy Facing astronomical costs over talc lawsuits, Johnson & Johnson is exploring the possibility of starting a new company to absorb the litigation liabilities and declare bankruptcy, according to Reuters. read more By Noah Higgins-Dunn With Aduhelm facing troubles with prescribers, Biogen and Japanese partner Eisai are pushing a new Alzheimer's ad campaign focused on the importance of early disease detection. 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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