WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST As the WHO elevated monkeypox to a public health emergency this week, the vaccine maker Bavarian Nordic received an extended approval in Europe for its shot—after only applying just last month. Known as Jynneos in the U.S. and Imvanex in the European Union, the hot commodity has also been supplied to other unnamed countries. Meanwhile, Vertex has received the go-ahead to move its opioid-free painkiller into phase 3 trials, including two placebo-controlled studies evaluating patients with acute pain. Those stories, plus all of our top reads of the week, follow below. | |
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Featured Story | By Zoey Becker As the monkeypox outbreak presses on, the World Health Organization has declared the disease a public health emergency. Meanwhile, the EU granted the company's vaccine an approval to prevent monkeypox. read more |
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Top Stories Of The Week By Gabrielle Masson After talks with the FDA, Vertex Pharmaceuticals has been given the go ahead to advance its non-opioid pain killer into phase 3 trials, which are set to begin in the last quarter of this year. read more By Zoey Becker Biogen is trying to escape the dark cloud that controversial drug Aduhelm brought in. In a recent SEC filing, the company wrote off $233 million of the drug's inventory. read more By Max Bayer New research from UCLA dives deeper into the biology of acne, showing how the root issue may be broken macrophages. The science provides clarity into how one common treatment actually works. read more By Angus Liu After winning a standing ovation at the recent ASCO event, Enhertu’s HER2-low breast cancer data are now getting the VIP treatment at the FDA. And AstraZeneca and Daiichi Sankyo are targeting an ambitiously broad patient population. read more By Andrea Park The nerve repair process just got a lot simpler, thanks to a new FDA 510(k) clearance for a device that essentially amounts to a piece of Scotch tape that can quickly and effectively rejoin nerve ends. read more By James Waldron Zymergen aimed to leave its well-publicized woes behind through a new-year transformation into a biotech. Now the company has been picked up by Ginkgo Bioworks, which will look for “strategic alternatives” for the new drug discovery business once the sale is complete. read more By Annalee Armstrong Will any of the three leading Alzheimer's disease therapies make it through their upcoming readouts? Executives from Biogen and Roche seem to be tempering expectations in second-quarter earnings updates. Lilly is the next to report. read more By Ben Adams Roche is hyping up the early financials coming in for its eye disease therapy Vabysmo as the Swiss major looks to take on the might of Regeneron and Bayer’s major blockbuster, Eylea. Despite only being approved at the start of the year and the launch coming several months later, Roche saw Q2 sales hit a healthy CHF 109 million ($112 million). 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 Teresa Carey This week on "The Top Line," we discuss how to move forward from Alzheimer's latest drug development setback and what the industry needs to do to make a real environmental difference. We also chat about how AI in drug R&D is growing up and ways to handle the cell and gene therapies' sticker shock. 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: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. Sponsored by: Nexelis Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book. 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 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 What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities 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. | 
