| |   | Despite the downturn in the biotech market, we see some high-dollar deals — but also a Covid-related setback for Beigene. Have a great weekend. -Meghana | | | Beigene’s review delayed due to Covid The FDA is delaying its review of tislelizumab, a PD-1 cancer immunotherapy from BeiGene and Novartis meant to target esophageal squamous cell carcinoma. The reason? Covid-related travel restrictions, the agency said, which prevented regulators from inspections in China. Although a stateside decision on the drug, which already has been approved in China, was expected Tuesday, the FDA hasn’t yet given a new date for its decision. “The FDA stated that they are monitoring the public health situation and travel restrictions and actively working to schedule outstanding inspections,” a spokesperson for BeiGene told FiercePharma. Notably, BeiGene recently started to build a 42-acre biologics manufacturing and R&D site in New Jersey to help expand in the U.S. market, but the first phase of the construction isn’t expected until the middle of next year. | Can CRISPR edit out a heart attack? What happens on #GutTok? And is health care recession-proof? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Sek Kathiresan, cardiologist and CEO of Verve Therapeutics, joins us to explain the company’s work on preventing heart disease with genome editing. Then, STAT’s Isabella Cueto joins us to discuss “Hot girls have IBS,” an internet in-joke that evolved into a movement for people with chronic illness. We also break down the latest news in the life sciences, including a long-awaited victory for Novavax and ostensible good news for biotech. Listen here. | Join us as we host silo-breaking discussions on the most important topics in health care. Over two days this November, you’ll hear from some of the leading minds in the industry. Don’t miss out, and enjoy early-bird pricing on your pass until July 22. | Royalty Pharma makes a massive royalty deal Royalty Pharma is shelling out $1.1 billion — and even more in milestone-related biobucks — to buy the royalty rights for Trelegy Ellipta, a top-selling asthma and COPD drug developed by GSK. It’s actually making the deal with Theravance Biopharma, which owns 85% of the drug’s royalty rights. Theravance plans to use the dollars to eliminate outstanding debt, pay their shareholders, and reinvest in their pipeline. On top of that, Royalty will invest up to $40 million to develop Theravance’s late-stage drug, ampreloxetine, for multiple system atrophy — kicking off a phase 3 study for the drug early next year. Theravance is testing the experimental drug in neurogenic orthostatic hypotension. Royalty raised nearly $2.2 billion in a 2020 IPO and, as its name suggests, has a wide portfolio of royalty rights for marketed therapies, including a number of blockbuster medicines, BioPharma Dive writes. | Novo Nordisk buys Marinus’ priority review voucher for $110 million Marinus Pharma is selling its priority review voucher, granted for pediatric rare diseases, to Novo Nordisk for $110 million — helping the company extend its cash reserves so it can operate through the end of 2023. Marinus was given the voucher after the approval of its epilepsy drug Ztalmy. Instead of using the regulatory pass, the company will use the windfall to fund two phase 3 studies in status epilepticus and tuberous sclerosis — as well as help launch Ztalmy this month. The company’s shares dropped about 5% on the news. Priority review vouchers tend to shave the review time for approval applications from 10 months to six. Novo Nordisk hasn’t yet disclosed how it’ll use its new voucher, but said it’ll decide in the “near future,” Fierce Biotech writes. | More reads - EU adds severe allergies as a side effect of Novavax Covid vaccine, Reuters
- Why elephants so rarely get cancer, The Economist
- CytomX lays off staff, joining growing list of biotechs restructuring, BioPharma Dive
- Supreme Court review of patent issue would change the way pharma claims discoveries, STAT
| Thanks for reading! Until next week,  | | | |
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