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Japanese pharma Astellas and its new biotech buyout Audentes got a Christmas gift from the FDA when the agency lifted a clinical hold on its gene therapy. It’s been a tough 12 months for Audentes. Soon after the high of one year ago, when Astellas spent $3 billion to snap up the Californian biotech, several patients died in a trial of the company’s leading hope, AT132, a gene therapy for the rare disorder known as X-linked myotubular myopathy (XLMTM). AT132 uses an AAV8 vector to deliver a working copy of the myotubularin 1 gene. Previous trials showed it could improve neuromuscular function and reduce dependence…

The National Institutes of Health (NIH) awarded over $107 million for what it describes as “radical approaches” to testing for COVID-19 and tracking the spread of the disease—including cutting-edge technologies that could make regular coronavirus testing less intrusive and part of our daily lives.This includes nontraditional and repurposed technologies to address the current gaps in the current nationwide surveillance effort as well as methods that may be deployed against future outbreaks of the coronavirus and other diseases. In total, the awards will fund 49 projects at 43 U.S. research institutions. Examples include the development of breathalyzers capable of diagnosing a…

A phase 3 clinical trial of Amgen and AstraZeneca’s asthma candidate tezepelumab has missed its primary endpoint. The failure comes weeks after tezepelumab hit the endpoint in another phase 3, leaving the partners with a mixed data set they still plan to use to seek regulatory approvals next year. Last month, Amgen and AstraZeneca chalked up a win when they said thymic stromal lymphopoietin inhibitor tezepelumab drove reductions in exacerbations in patients with low levels of eosinophils, positioning them to target a market poorly served by existing drugs such as Dupixent and Fasenra. Now, a readout from a second phase…

In a typical year, I’d compile our annual roundup of top stories while searching for photos of gold confetti and festive ribbons—champagne, maybe, or some fireworks—while the tune of “Auld Lang Syne” runs through my head, hoping to evoke an air of happy celebration and offer, in our small way, a salute to the accomplishments of the medtech industry during our last trip around the sun.This year? Not so much. But despite everything 2020 and COVID-19 brought us and took away—with immeasurable losses of life and ways of living—accomplishments abound. This is no time at all for old acquaintances to be…

Vertex has secured exclusive options to license Skyhawk Therapeutics’ candidates that modulate RNA splicing. The deal will see Vertex pay Skyhawk $40 million upfront and commit to up to $2.2 billion in milestones to secure options on multiple small molecules. Skyhawk, led by Bill Haney, has landed deals with a who’s who of leading biopharma companies on the strength of a platform that generates drugs designed to modify expression of genes once thought to be undruggable. Biogen, Bristol Myers Squibb, Merck, Roche and Takeda have all signed up to work with Skyhawk to access the fruits of the platform. Now,…

In the final act of the 2011 film “Contagion,” people wore bar-coded wristbands to prove they had been inoculated against the deadly, pandemic virus. But in 2021, of course, the vaccinated will be able to use a blockchain-powered smartphone app, according to IBM and Salesforce.The two tech giants are partnering up to help businesses and public spaces smoothly reopen as newly authorized COVID-19 vaccines become more available by integrating IBM’s Digital Health Pass with Salesforce’s web-based employee management platform. “At the start of the pandemic, many organizations deployed simple COVID-19 screenings, such as self-reported health surveys, to support re-entry to…

Beckman Coulter plans to launch a $4 coronavirus antigen test designed for mass screening, with the goal of shipping up to 25 million per month by March.The Access antigen assay is designed for high-throughput laboratory hardware and can deliver individual results in 30 minutes while processing up to 200 samples per hour. The company said it is currently submitting the test to the FDA for emergency review. In addition, the $4 price tag holds for all healthcare providers—as well as public and private institutions such as schools, businesses, government agencies and nonprofit organizations—to help encourage repeated COVID-19 screenings. Sponsored by…

San Diego biotech Janux Therapeutics has penned a major biobucks R&D pact focused on next generation T-cell engager immunotherapies in cancer.Merck will tap Janux’s so-called Tumor Activated T Cell Engager (TRACTr) tech to engineer new, T-cell engager drug candidates against two cancer targets selected by Merck. Merck gets exclusive worldwide license to products and intellectual property from the collab, and, in return, Janux could get as much as $500.5 million per target in upfront and milestone payments, plus royalties on sales of any products derived from the collaboration. Webinar Compliantly Digitize Your Global Operations and Quality Process with a Remote…

Philips aims to broaden the reach of its digital patient monitoring platforms, from inside the hospital out to the home, through a $2.8 billion acquisition deal for BioTelemetry and its wearable heart-tracking devices.BioTelemetry, alongside its artificial intelligence-based analytics and other services, helps remotely monitor and diagnose at least 1 million cardiac patients each year. It’s a business that brought in $439 million in sales in 2019, and one that Philips expects to grow by more than 20% in the next four years—especially as the COVID-19 pandemic continues to push patients away from clinics and hospitals and toward telehealth solutions. Philips…

Google’s life science-focused sibling company Verily has raised a mammoth $700 million investment round to help rapidly expand the commercial reach of its health programs. This includes broadening its digital platform for gathering clinical study participants, known as Project Baseline, as well as its efforts supporting the personal management of chronic diseases, such as its Onduo virtual diabetes clinic. The proceeds will also help advance Verily’s research programs in digital surgery, pathology and immunology, plus its population health initiatives that include COVID-19 testing in the workplace and universities. Sponsored by Medidata Your Guide to Maximizing the Benefits of a Unified…