Bluebird bio's $2.8M gene therapy Zynteglo wins FDA backing. Will its US launch take flight? Are SERDs dead? 'Good question,' says Sanofi R&D chief, after French pharma's late-stage pipeline takes a beating Regulatory filing details Amazon, CVS bidding war for One Medical as primary care in M&A crosshairs Qiagen joins monkeypox test-making efforts with 6-in-one assay As vaccine makers gear up for a busy season, Seqirus exec says influenza is poised for a return Amgen backs Global Healthy Living Foundation's new psoriasis education campaign Uncertainty at Ambrx as biotech loses CEO, takes hard look at pipeline Musculoskeletal conditions are huge healthcare cost drivers. Here's what Evernorth says payers can do Philips recall sparks 48K complaints to FDA in three months, including 44 deaths Amid overwhelming opioid litigation, Endo files for bankruptcy and inks $450M settlement AbbVie stops 2nd CD47 study early, dropping out of AML race it joined in $2B biobuck deal Providence logs yet another quarter of major losses, promises reorg will bring financial stability Abbott teams with WeightWatchers for a digital diabetes journey Visibly, now seeing eye-to-eye with the FDA, brings online vision test back to market Featured Story | By Fraiser Kansteiner Ahead of a much awaited FDA decision deadline Friday, the agency endorsed bluebird bio's gene therapy Zynteglo. It'll carry a $2.8 million price tag and is the first gene therapy for this rare disease. read more |
| |
|---|
|
Top Stories By James Waldron Was the problem with amcenestrant, or are SERDs another dead end for cancer drug development? “It's a good question,” says John Reed. “I would say that the preponderance of data so far with the oral SERD has not been overwhelming.” read more By Heather Landi Tech-enabled primary care players are now prime targets for M&A deals as retailers like CVS, Walgreens and Walmart look to expand their reach into healthcare. Here's how the Amazon-One Medical deal came together. read more By Andrea Park As the number of monkeypox cases around the world has ballooned since early May, so too has the list of diagnostic developers rapidly churning out tests for the virus. read more By Zoey Becker Flu may have slipped the public's mind over the past two years as COVID-19 took center stage, but Seqirus didn't forget. The influenza vaccine specialist is gearing up to supply more than 50 million doses to the U.S. read more By Ben Adams August is Psoriasis Awareness Month, and the Global Healthy Living Foundation is pulling out all the stops to put the spotlight on the skin condition. A new collaboration with Amgen is aimed at helping patients access drugs. read more By James Waldron Two months after revealing that a heart failure collaboration with Bristol Myers Squibb had hit the buffers, Ambrx Biopharma has lost its CEO and announced a “strategic review” of its pipeline. read more By Paige Minemyer Musculoskeletal conditions are a massive source of health spending—accounting for $420 billion in 2018—and a new report from Evernorth aims to pinpoint where health plans could cut down on costs. read more By Andrea Park In only a little over a year, the FDA has racked up more than 69,000 complaints linked to Philips’ recall of millions of its breathing support devices—after receiving only 30 such reports in the entire decade preceding the start of the recall in June 2021. read more By Angus Liu Endo has decided to file for bankruptcy in the face of opioid lawsuits to focus on its transformation. Further, the company reached a broad settlement to resolve allegations that it falsely marketed its opioid painkillers. read more By Nick Paul Taylor AbbVie is stopping another early-phase clinical trial of anti-CD47 antibody lemzoparlimab. Weeks after pulling the plug on a multiple myeloma trial, AbbVie is halting a phase 1b trial that is testing the prospect in combination with azacitidine and venetoclax. read more By Dave Muoio The quarter's $424 million operating loss follows pandemic-long financial struggles at the nonprofit, which recently trimmed down its leadership team to cut costs. read more By Ben Adams Abbott is joining forces with WeightWatchers to boost diabetes patients’ overall health with a focus on weight loss and controlling blood sugar levels using new digital tools. read more By Andrea Park The FDA has given the go-ahead to Visibly's eye test, which requires only a smartphone and a computer and can be performed from the comfort of a user’s own home. read more Resources Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Thermo Fisher Scientific Set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Triangle Insights Group, LLC The TrialCard/Triangle Insights Group platform is uniquely positioned to support you as your asset progresses through the value chain, by integrating strategic commercialization and market access insights with comprehensive patient and provider support services. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. 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. | 