Reports of DOJ probe into Cassava ‘old news in new fish wrapper,’ CEO says Illumina's quest for Grail potentially blocked for good, as EU jacks up legal pressure: report Feeling the pressure, Bristol Myers pushes back timeline for production of Breyanzi Humana launches reorganization, hunts for new insurance division chief Pfizer sends 'enhanced' COVID shot to clinic under strategy for next generation of vaccines Healthcare data breach costs reach record high at $10M per attack: IBM report Teva, with a $4.25B opioid settlement in hand, eyes return to growth by 2027 Viz.ai, Hyperfine team up to add image-reading AI to bedside MRI scanners BMS-Ambrx collab runs out of steam after FA relaxin med canned Mayo Clinic retains top hospital title while other big names shuffle throughout U.S. News' top 20 With ominous FDA talks, ObsEva scraps lead women's health drug, plots layoffs in major restructuring BD, CerTest begin rolling out research-use-only monkeypox PCR test Editas notches milestones for sickle cell disease therapy as FDA lifts partial clinical hold Argenx needs some 'aggressive' doc education on Vyvgart to beat AZ's Ultomiris: analyst Rapid Medical speeds through FDA review of tiny brain clot removal device Featured Story | By Annalee Armstrong Cassava Sciences CEO Remi Barbier called reports of a new Department of Justice criminal investigation into the Alzheimer’s disease biotech’s scientific practices “old news in [a] new fish wrapper.” read more |
| |
|---|
|
Top Stories By Conor Hale In increasing legal peril, Illumina had extended yet another olive branch to the European antitrust regulators adjudicating its premature acquisition of Grail, Reuters reports. The watchdogs aren't convinced. read more By Kevin Dunleavy A month ago, when Breyanzi won a coveted FDA approval for use as a second-line treatment in B-cell lymphoma, Bristol Myers Squibb said it would be able to increase production capacity in the second half of this year. But on Wednesday, BMS said the timeline has been pushed back to the first quarter of 2023. read more By Paige Minemyer The results surpassed Wall Street analysts' expectations on both profit and revenue, according to Zacks Investment Research. read more By James Waldron Pfizer just raised the stakes of the COVID-19 vaccine business. The Big Pharma has launched a midstage trial of the first in a series of next-generation, variant-busting vaccines that the drugmaker is working on alongside BioNTech. read more By Heather Landi The unrelenting barrage of cyber attacks against healthcare organizations is causing major financial damage as health systems struggle to mitigate the costs of data breaches. A healthcare data breach now comes with a record-high price tag—to the tune of $10.10 million on average. read more By Fraiser Kansteiner With thousands of U.S. opioid lawsuits set to enter the rearview, Teva Pharmaceutical is turning back to its bread-and-butter businesses in generics and biosimilars. The timing couldn’t be better, Teva’s CEO told investors Wednesday, as the markets for both small molecule and biologic copycats look poised to swell in the coming years. read more By Andrea Park In what seems to be a match made in high-tech heaven, Viz.ai and Hyperfine will bring together their respective technologies designed to speed up the process of detecting signs of stroke and other neurological conditions. read more By Max Bayer More than 10 years after Bristol Myers Squibb and Ambrx teamed up to develop a couple of programs in type 2 diabetes and heart failure, prospects from the partnership have washed away. read more By Dave Muoio This year's rankings considered 15 specialties and 20 procedures and conditions across more than 4,500 hospitals. The 2022-23 list marks Mayo Clinic's seventh consecutive year at the top. read more By Angus Liu An approval decision for ObsEva's uterine fibroids candidate, linzagolix, isn’t likely to happen on time. After getting that bleak hint from the FDA, women’s health specialist ObsEva is taking a sharp turn. read more By Andrea Park Amid the World Health Organization’s declaration of the ongoing monkeypox outbreak as a global health emergency, testmakers are kicking their work to develop diagnostics for the disease into high gear. read more By Annalee Armstrong Editas Medicine has confirmed that a gene editing therapy for sickle cell disease has successfully engrafted into the first patient dosed in a phase 1/2 trial. The gene editing company also announced that a partial clinical hold on the efficacy portion of the RUBY trial for EDIT-301 has now been lifted. read more By Ben Adams Argenx is riding high on rosy second-quarter sales estimates for its newly launched rare disease drug Vyvgart, but an analyst warns that a new rival—in the form of AstraZeneca's Ultomiris—could knock its trajectory off course. read more By Andrea Park FDA clearance for the TigerTriever 13 system comes several years after it was given the go-ahead with CE mark approval in Europe in 2018. read more Resources Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. | 