Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene. Plus more.
1. Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse
The FDA has approved a slate of generics to Takeda’s ADHD drug Vyvanse. Teva, Sun Pharma, Actavis, Mylan and Hikma are among those that won the FDA’s blessing. The Takeda originator went into short supply a few weeks ago amid increased demand and a manufacturing hiccup.
2. Another Keytruda-Lenvima ambition is dashed as Merck, Eisai end head and neck cancer trial
Merck and Eisai’s plan to combine Keytruda and Lenvima has suffered another setback. The companies decided to end a phase 3 trial in newly diagnosed PD-L1-positive head and neck cancer early. After reviewing interim data, they figured the combo likely won’t be able to outdo Keytruda alone at extending patients' lives.
3. ADC Therapeutics calls it quits on solid tumor collaboration with Adagene
ADC Therapeutics has decided not to opt in on Chinese biotech Adagene’s antibody-drug conjugate program. The two teamed up in 2019 to combine Adagene’s antibody platform with ADC’s payload. ADC recently cut 17% of its workforce to save costs and to focus on FDA-approved Zynlonta and low-risk R&D projects.
4. Fujifilm Diosynth, planning for fast growth, reveals new structure and names unit leadership
Fujifilm Diosynth Biotechnologies has reshaped its business structure. The company now has a large-scale strategic business unit headed by Kenneth Bilenberg in charge of the CDMO’s large facilities in Denmark and North Carolina supporting customers with large volume needs. Lee Kingsbury will oversee the company's small-scale production unit.
5. Glenmark, Baxter issue separate recalls for hypertension and cancer drugs
Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets produced at a site in India. The drugs are used to treat high blood pressure but were found to be subpotent in a three-month test.
6. Genexine's weekly growth hormone equal to Novo shot in phase 3, teeing up filing in China
South Korean biotech Genexine said its once-weekly growth hormone, eftansomatropin alfa, matched Novo Nordisk’s daily Norditropin in a phase 3 trial in Chinese children with growth hormone deficiency. I-Mab, through its acquisition of Tasgen Biotech, owns rights to eftansomatropin alfa in China.
7. CanSino paused mRNA COVID vaccine development, looks for more CDMO deals (Reuters)
China’s CanSino Biologics has paused development of mRNA COVID vaccines, co-founder and CEO Xuefeng Yu told Reuters. For its newly built mRNA facility in Shanghai, CanSino is now looking to manufacture vaccines for other companies, just as in its recent deal with AstraZeneca.