Boehringer Ingelheim is stepping up its external innovation work in China with a new Shanghai hub. Trends from China suggest a shift to digital engagement amid COVID-19 will change pharma forever. Evolus and South Korean partner Daewoong could be banned from selling their Botox rival Jeuveau in the U.S. for 10 years as a judge is set to rule in favor of Allergan and its collaborator Medytox. And more.
Boehringer Ingelheim has opened a new hub in Shanghai focused on external R&D collaborations and investments. The company told Shanghai Daily it will invest €451 million ($509 million) in China over the next five years, covering clinical development, expansion of manufacturing sites and research partnerships to be handled by the new Shanghai site.
China was the first hit by the novel coronavirus and was recently among the first to reopen its economy. That experience offers insight into the pandemic’s effects on the pharma industry. WPP Health’s Claire Gillis and WG Market Access’ Yi Han both agreed the most immediate and lasting impact is the shift to digital engagement across the industry, from pharma sales reps to healthcare appointments to patient communications.
Evolus and South Korea’s Daewoong has Jeuveau, a rival to Allergan’s Botox. But a judge with the U.S. International Trade Commission preliminarily ruled that the new med was developed using trade secrets stolen by a former employee at Allergan’s South Korean partner Medytox. If the ruling holds up in a final decision scheduled for November, Jeuveau could be banned in the U.S. for 10 years.
An application for Merck & Co. and Eisai’s Keytruda-Lenvima combo in newly diagnosed liver cancer was rejected by the FDA. The pair filed based on phase 1 tumor response data, but competitor Roche in late May won approval after showing its Tecentriq-Avastin regimen could help patients live longer. Now, Merck and Eisai hope Keytruda-Lenvima could do the same in their phase 3 Leap-002 study.
The FDA recently noticed high levels of a probable carcinogen, NDMA, in some metformin products—and Lupin was one of five firms the agency put on notice. Now, the Indian drugmaker has pulled all lots of its metformin distributed between early November and late May but stressed that it hasn’t received any reports of serious adverse events.
The Coalition for Epidemic Preparedness Innovations has expanded its partnership with China’s Clover Biopharmaceuticals with an additional investment of $66 million upfront to support the company’s S-Trimer subunit COVID-19 vaccine candidate. The money will go toward development and manufacturing scale-up of the vaccine to potentially 1 billion doses per year.
Takeda has tapped Twist Bioscience to help with its biologics R&D. The DNA services company will offer its phage display libraries for the discovery, validation and optimization of antibodies for Takeda’s pipeline products across its focus areas.
In a warning letter, the FDA blasted Vega Life Sciences’ facility in Telangana, India, after inspectors noticed missing raw testing data on company computers that appeared to have been deleted by staff. Besides, the company failed to adequately test its products or its solvent batches recovered for reuse in manufacturing active ingredients, the FDA found.