| | | |   | Good morning, all. Damian here with the fallout from China, the next test for Gilead Sciences, and the latest evolution in drug ads. | | | Is the era of Sino-American biotech over? The last decade has given rise to a generation of biotech companies that straddle the U.S. and China, founded on the notion that it would be possible — and, eventually, profitable — to conduct the business of drug development in both countries at once. Yesterday, as President Xi Jinping tightened his control of China, investors panicked that the era of Sino-American biotech might be at risk.
Zai Lab, headquartered in Shanghai and San Francisco, lost 20% of its value on the Nasdaq and 12% on the Hong Kong index. Wuxi Biologics fell 10% in New York and 7% in Hong Kong, while BeiGene declined 14% on the Nasdaq and 6% on the HKEX. Hong Kong's Hang Seng Index, which includes tech and biotech companies, had its biggest one-day decline since the global financial crisis, according to the Wall Street Journal.
The underlying fear is that Xi’s third term in power will escalate state control at the expense of the private-sector, which, combined with the White House’s efforts to reduce the U.S.’s dependence on China, will leave Sino-American biotech companies caught in the middle with no master to serve. | Myovant and the virtue of conviction In early October, Japanese drugmaker Sumitomo Pharma offered to pay $22.75 for the roughly 48% of Myovant Sciences it did not already own. Myovant, maker of treatments for uterine fibroids and endometriosis, decided that offer “significantly undervalues the company” and said no, setting in motion a negotiation that seemed to lean in favor of Sumitomo by virtue of its majority stake.
And yet it worked. Yesterday, Myovant said it had accepted an offer of $27 per share, which is about 20% higher than the first offer and represents a roughly 50% premium to where the company was trading on Sept. 30.
The merger, expected to close in the first quarter of 2023, would be a lucrative conclusion for Myovant, which has had an up-and-down path through the development, approval, and marketing of its medicines. The company went public in 2016 at $16 a share and has reached the $27 threshold only a handful of times in its history. | Explore the mysteries hidden in the world’s largest genomic database Regeneron Genetics Center is home to the world’s largest and most diverse database of genomes. By tapping into this vast data resource, scientists at Regeneron are able to make discoveries about human health and genetics that may accelerate the drug development process and uncover new ways to prevent, treat, and cure diseases. The secret to unlocking these new insights is within us — in our DNA. Learn more. | Gilead’s chance to right a misstep Gilead Sciences believes lenacapavir, a long-acting HIV drug, could become the backbone of combination treatments for years to come, making it a multibillion-dollar asset in waiting. But after a manufacturing issue derailed the drug’s expected approval earlier this year, the company will face questions about whether a delayed launch will affect its potential.
Lenacapavir will likely take center stage when Gilead reports its quarterly earnings on Thursday. The drug, rejected in March, is again up for approval on Dec. 27. In the meantime, Cabenuva, a competing long-acting drug from GSK, has had more time on the market, and analysts will be curious as to how Gilead intends to make up lost ground if and when lenacapavir makes it through the FDA.
Beyond HIV, Gilead will likely face questions about its latest endeavor in oncology, a medicine aimed at a seemingly promising biological target called TIGIT. Data from rival TIGIT programs, including high-profile disappointment from Roche, have dampened enthusiasm for the whole field, and Gilead’s partner on the TIGIT-targeting domvanalimab recently delayed expected results by a few months, giving the company plenty to talk about. | How telemedicine blurs the lines in pharmaceutical advertising For decades, TV drug ads have concluded with a familiar invitation to ask your doctor if a given product is right for you. Now, thanks to the combination of digital advertising and online prescribing, the doctor in question can be a few clicks away. And while pharma companies promise the new model will improve access for patients, health policy experts worry that gaps in regulatory oversight leave patients vulnerable to the unique risks of the approach.
As STAT’s Katie Palmer reports, the drug industry’s escalating interest in direct-to-consumer telehealth seems to fall into a regulatory gray zone. The FDA regulates product labels and what companies can say in ads, but states regulate the actual process of prescribing.
“There’s no bright line,” said Ohio State University food and drug law professor Patti Zettler. “FDA does a ton of things that regulate prescribing and dispensing, and states also try to kind of blur into the product space. But this really blurs that distinction.”
Read more. | More reads - Merck locates frozen batch of undisclosed Ebola vaccine, will donate for testing in Uganda’s outbreak, Science
- Tricida collapses 95%, Vaxcyte skyrockets as drug trials diverge, Bloomberg
| Thanks for reading! Until tomorrow,  | | | |
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