Shkreli must stay mum on pharma after judge upholds lifetime industry ban 'Not afraid of not transacting': SPAC appetite sharply declines in larger battering of biotech stocks Withings grabs health and fitness app 8fit to dig deeper into consumer-centric tech Zimmer Biomet plots $1B revenue for spine, dental spinoff ZimVie, sets launch date FDA must shore up plans for surprise foreign inspections, rev up hiring of overseas investigators, GAO says CANbridge, targeting gaps in AstraZeneca's rare disease coverage, posts early-phase data on C5 inhibitor Abbott delivers first implant of its dual-chamber leadless pacemaker in a clinical study Insurers offer initial praise of CMS' Medicare Advantage, Part D notice Endeavor snags $101M to go after Boehringer, Roche in lung scarring—and do some asset shopping Citing 'milder' omicron variant, 16 states reignite legal battle against CMS' vaccine mandate FDA probes TG Therapeutics' Ukoniq over potential for elevated death risks 1 year after drug's approval HeartFlow halts SPAC deal, citing 'current unfavorable market conditions' J&J, plowing ahead with talc bankruptcy strategy, faces investor push to pull product worldwide Featured Story | By Fraiser Kansteiner Judge Denise Cote of New York’s Southern District upheld Martin Shkreli’s exile from the industry and clarified exactly what sort of actions the former CEO is barred from taking part in. Shkreli is not only prohibited from working in biopharma—he can’t talk to industry friends or wax poetic about it on his blog, either, Cote said in a 10-page opinion filed Friday. read more |
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Top Stories By Kyle LaHucik Fewer biotechs are merging with special purpose acquisition companies as drug developers get more "realistic and pragmatic" about the market. read more By Rebecca Torrence Withings has acquired health and fitness app 8fit, the device maker's second acquisition in a month as the company looks to expand further into consumer-driven health solutions. read more By Andrea Park For all of 2022, ZimVie is expecting to rake in revenues of $1 billion, the same amount the dental and spine businesses registered under the Zimmer Biomet umbrella in 2021. read more By Fraiser Kansteiner To tackle three big hurdles facing its inspection work overseas, the FDA needs to develop “tailored strategies and time frames” to recruit investigators for its foreign inspection workforce, the Government Accountability Office said Monday. Likewise, the regulator needs to make a roadmap for surprise foreign inspections, the agency said. read more By Nick Paul Taylor CANbridge is coming for the anti-C5 market. With access to Soliris and Ultomiris limited in parts of the world, CANbridge has taken a rival C5 inhibitor through a phase 1 study, teeing it up to start an early test of the efficacy of the molecule. read more By Conor Hale Abbott has taken a major step in the development of its dual-chamber leadless pacemaker technology, with the company’s first patient receiving two miniaturized, wirelessly synced devices in different areas of the heart. read more By Paige Minemyer Insurers could secure a nearly 8% rate increase in Medicare Advantage for 2023, so it's little surprise that the response from the industry to the Biden administration's proposal has been largely positive. read more By Kyle LaHucik Endeavor Biomedicines will deploy $101 million on midstage trials of its small molecule in certain cancers and idiopathic pulmonary fibrosis, a lung-scarring disease with two approved meds from Roche and Boehringer. Endeavor's CEO led his previous biotech, Impact Biomedicines, to a $1.1 billion sale to Bristol Myers' Celgene in 2018. read more By Dave Muoio After their initial bid was shot down by the Supreme Court, 16 attorneys general argued in a new filing that 'the situation has changed' with the rise of a more vaccine-resistant variant. read more By Kevin Dunleavy Hyped as a safer version of other drugs in its class upon its approval for two types of lymphoma last February, TG Therapeutics’ Ukoniq is now under scrutiny as the FDA is investigating whether it increases the risk of death. read more By Andrea Park In a move that may not bode well for the SPAC deal’s recent dominance in medtech, HeartFlow’s plan to go public has been halted. read more By Fraiser Kansteiner Activist investor platform Tulipshare wants to leverage a vote to stop J&J from selling its talc-based powder around the world. J&J faces nearly 40,000 lawsuits related to talc safety concerns, which hinge on the product’s potential to cause cancer. Not content to play sitting duck, J&J has asked the U.S. Securities and Exchange Commission (SEC) to exclude Tulipshare’s proposal from its upcoming annual meeting. read more | | Whitepaper: Reimagining Oncology Clinical Trials with Digital Biomarkers Health metrics enabled by wearables are a big untapped opportunity in oncology clinical trials. Yet, sponsors of cancer clinical trials have been slower to embrace digital outcome measures than their peers in other therapeutic areas. In this paper, we look at the perceived barriers to the adoption of wearables—and the major benefits that await sponsors that overcome them. Download Now. |
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