Allergan's cash cow Botox is already seeing slower growth amid the rollout of Evolus and Daewoong's rival med Jeuveau, and to make it worse, a U.S. judge has ordered the company to hand over manufacturing details. U.S. Senator Chuck Grassley suggests the FDA run unannounced inspections of foreign drug plants, especially in India and China. Daiichi Sankyo's oncology ambitions took a step forward as the FDA approved Turalio, the Japanese pharma's first new cancer drug since 2011. And more.
A U.S. International Trade Commission judge ordered Allergan to hand over details of its Botox manufacturing to Evolus and South Korea’s Daewoong Pharmaceutical, the makers of rival wrinkle-fighter Jeuveau. The ruling comes as Allergan and partner Medytox accuse their competitors of stealing trade secrets—and as Juveau, launched in mid-May in the U.S., eats into Botox’s growth momentum. U.S. second-quarter sales of cosmetic Botox grew 6.7%, much slower than the 16.7% rate it posted in the first quarter. Daewoong said its Q2 neurotoxin sales to the U.S. were $12.6 million.
Republican Sen. Chuck Grassley, a vocal proponent of drug importation as a measure to reduce drug costs for the U.S., has called on the FDA to run surprise inspections on pharmaceutical production sites especially in India and China, which supply the biggest share of APIs for drugs used in the U.S.
Amid a big pivot from primary care to oncology, Daiichi Sankyo nabbed its first U.S. cancer nod since 2011, when it was co-promoting BRAF inhibitor Zelboraf with Genentech. The FDA gave a green light to Turalio (pexidartinib) for adults with a rare joint tumor, but slapped it with a boxed warning for liver toxicity risks. It's one of seven new cancer therapies the company aims to launch by 2025.
With the trade war ramping up, the Defense Health Agency has raised concerns that increased use of Chinese-made APIs could be a potential national security risk to the U.S. The scrutiny is prompted by the year-long recall of popular “sartan” heart drugs made with APIs from China.
Rakuten Medical, formerly known as Aspyrian, raised $100 million to advance its photo-immunotherapy oncology pipeline. The California-headquartered biotech got the money and its name from Japanese e-commerce giant Rakuten. Mickey Mikitani, the Japanese billionaire behind Rakuten and CEO of Rakuten Medical, is now planning strategic connections between the two firms.
Takeda Korea’s labor union accused the Japanese pharma’s Korean operation of favoring Shire employees in its merger. Since former Shire Korea CEO Moon Hee-seok took on the local leadership, original Takeda Korea employees allegedly faced unfair changes in their roles and got different incentive plans during the integration, the union said. Takeda denied the allegation.
Fujifilm has been steadily adding to its biologics CDMO capacity. Fujifilm Diosynth Biotechnologies, a partnership between Fujifilm and Mitsubishi, completed an $890 million buyout of Biogen’s biologics plant in Hillerød, Denmark. The site will continue to supply Biogen meds, including the multiple sclerosis drug Tysabri.
Takeda and Sosei Heptares inked an R&D agreement focused on GPCR-based drug designs for gastrointestinal targets. Sosei will receive $26 million in up front and near-term payments, plus up to $1.2 billion in milestones. The partnership could also expand to other therapeutic areas.
It wasn’t long ago that the Philippines pulled Sanofi’s Dengvaxia off the market amid allegations that the shot caused deaths in children. Now, authorities are considering reintroducing the vaccine to fight an ongoing outbreak that has caused 450 deaths.