Month: August 2021

STAT+: Two top FDA officials in charge of Covid-19 vaccines to leave agency this fall

WASHINGTON — The two officials in charge of leading the FDA’s review of coronavirus vaccine applications will leave the agency this fall, according to an internal email announcing the departures, obtained by STAT. The officials, Marion Gruber and Phil Krause, collectively have more than 42 years of experience at the FDA. Gruber has served as […]

STAT+: Pharmalittle: BIO wrestles with inner turmoil; J&J HIV vaccine failed to prevent infection

Hello, everyone, and how are you today? We are doing just fine, thank you, despite the mugginess descending on the Pharmalot campus this morning. Our official mascot is settling down for a morning snooze and we are foraging for tidbits, which still feels like a game of catch up following our recent holiday break. Nonetheless, […]

STAT+: STAT+ Conversation: Theranos returns

Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET. Every week, STAT+ subscribers get access to exclusive conversations with biotech, pharma, and health tech leaders. This week, STAT senior writer of medicine and editorial director of events Matthew Herper will be joined by STAT co-founder and executive editor Rick […]

Johnson & Johnson’s HIV vaccine fails first efficacy trial

An HIV vaccine using the same basic technology as Johnson & Johnson’s Covid shot failed to prevent infection, the company said Tuesday, dealing yet another blow to efforts to create a vaccine against the virus. The study, called Imbokodo, enrolled 2,600 women in southern Africa who were at very high risk of HIV infection. J&J […]

Opinion: ‘This Is My Story’: connecting clinicians with hospitalized patients who can’t speak for themselves

During the maelstrom of Covid-19 in April 2020, I assisted in a birth at Johns Hopkins Hospital, where I work. It was for an idea, not a baby, but I hope it will grow, and develop, and flourish as an infant does. On that day I was interviewing Brian Garibaldi, a critical care physician in […]

Watch: As Elizabeth Holmes stands trial on fraud charges, catch up on the Theranos saga

Elizabeth Holmes was poised to become the next college-dropout-turned-tech-billionaire. But there was only one problem: Her technology didn’t work. Holmes, the founder of the blood-testing company Theranos, will now finally stand trial for allegedly defrauding doctors, patients, and investors. She and her business partner and ex-boyfriend, Ramesh “Sunny” Balwani, were indicted by a federal grand […]

Opinion: Liquid biopsy: misplaced faith in early cancer detection?

The trial of Theranos CEO Elizabeth Holmes for defrauding investors about the company’s blood tests highlights a more general reality: huge sums of money are being devoted to develop and promote diagnostic technologies with little evidence they work as advertised. In Holmes’s case, the technology was a sham, albeit one that lured in high-profile investors, […]

STAT+: ‘Change is messy’: Inside the tumultuous efforts to stabilize BIO, the biotech lobby

WASHINGTON — The Biotechnology Innovation Organization, the lobbying group that represents roughly 1,000 biotech companies, is wrestling with inner turmoil that threatens its ability to navigate a Washington that is eager to reform drug prices. Five of the organization’s top lobbyists have left within the last eight months, including the executive who led the organization’s […]

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