WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Though our annual list of the Fierce 15 has always focused on private biotechs in the past, this year we’ve had to ditch that particular criterion because so many early-stage and pre-clinical companies have been riding the waves of optimism in the life sciences and making the jump to Wall Street. Regardless, we only want truly innovative biotechs to fall under our spotlight, and this year features some of the most—including companies that have continued to navigate the COVID-19 pandemic while raising cash, running trials, hiring staff, keeping them safe, and making deals during an incredibly difficult 18 months. The full list of the 2021 Fierce 15 follows below, along with our other top stories of the week. | |
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Featured Story | By Ben Adams COVID-19 was inevitably the focus of Fierce 15 last year. This year, it’s pretty much more of the same as we see how the sector has and continues to navigate the pandemic while raising cash, running trials, hiring staff, keeping them safe, and making deals during an incredibly difficult 18 months. read more |
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Top Stories Of The Week By Eric Sagonowsky For years, federal prosecutors have gone after drug companies for allegedly using charity contributions as a way to boost sales. Biogen was among the pharma players to ink a federal settlement, but, now, insurance giant Humana is targeting the company’s charity giving with a new lawsuit. read more By Noah Higgins-Dunn A handful of new lawsuits claim a number of Big Pharma companies, including Gilead and Merck, engaged in what’s known as “pay-for-delay” deals, settling with up-and-coming generic rivals to stall their market entry and costing drug buyers hundreds of millions in lost savings. read more By Nick Paul Taylor Applied Genetic Technologies Corporation has run into safety problems after escalating the dose in its pediatric gene therapy trial. Sixty percent of subjects in the small high-dose cohort suffered suspected unexpected serious adverse reactions after being treated for a rare eye disease. read more By Annalee Armstrong Pfizer is tightening up the criteria for Duchenne muscular dystrophy patients to participate in a phase 3 clinical trial for an experimental gene therapy after three serious adverse events were seen in ongoing studies. read more By Angus Liu Merck has emerged as a finalist to acquire Acceleron for around $11 billion. The deal dovetails with the Big Pharma company’s plan to diversify beyond Keytruda, but overlapping businesses could attract antitrust scrutiny, analysts say. read more By Conor Hale Biocorp’s Mallya digital device clips directly onto prefilled insulin injectors and logs delivery amounts and times by linking to a smartphone via Bluetooth. read more By Angus Liu Keytruda’s use in previously treated liver cancer was one of several accelerated approvals the FDA recently targeted for failure to confirm clinical benefit. But a new trial win looks like a lifeline for the Merck immunotherapy. read more By Nick Paul Taylor The ink on Sanofi’s $3.2 billion takeover of Translate Bio is barely dry, but the French big pharma is already tweaking its plans, dumping a COVID-19 vaccine prospect after seeing interim phase 1/2 data and accelerating its switch to modified mRNA. read more By Arlene Weintraub Investors are enthusiastic about the next generation of gene-focused treatments, most notably in vivo gene editing, which recently got a major boost from Intellia's positive first-in-human data. But all of these companies are advancing their gene therapies at a time when safety concerns are dogging developers of first-generation products. read more By Kevin Dunleavy The FDA has slapped a Biocon manufacturing facility in Malaysia with six Form 483 observations. The facility, which has been cited several times by the FDA, produces insulin for the Indian generics giant. read more |  | Webinar: Building a robust FIH biologics regulatory CMC package Thursday, October 7 | 2pm ET / 11am PT When you enter the clinical trial stage of your molecule’s development, you must prepare a dossier to support conducting the clinical research. Join us to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules. Learn More. |
Resources Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Blue Matter This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. | 
