Trandolapril

FDA approvals for Vyvanse generics, a Keytruda-Lenvima clinical trial flop and a dead deal between Adagene and ADC Therapeutics made our news this week. 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.

Glenmark USA and Baxter Healthcare issue separate voluntary recalls for blood pressure tables and an injectable cancer drug, respectively. Glenmark Pharmaceuticals USA and Baxter Healthcare issued separate recalls citing out-of-specification tests and problems with labels for drugs used to treat hypertension and cancer, respectively. Both recalls are designated as Class III, meaning the products in question violate federal regulations but are unlikely to cause adverse health consequences. Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure. In a notice, the company said an assay test at the three-month time point found the drug to be subpotent. The company produced the medicine at one of its sites in India. The tablets had been distributed nationwide in the U.S.  Baxter, meanwhile, recently issued a voluntary recall for 13,502 vials of bendamustine HCl injection, which is used to treat cancers such as lymphoma and chronic lymphocytic leukemia. The drug is being recalled after a customer complaint flagged issues with labels falling off the vials. India-based Glenmark is no stranger to FDA scrutiny and recalls. Late last year, an FDA warning letter flagged issues with batch failures, lab controls, record-keeping and more at a site in Colvale, India. A separate assay test by the company had prompted a prior recall in June 2022. As for Baxter, the company recently sold its biopharma solutions unit to private equity firms Warburg Pincus and Advent International in a $4.25 billion deal. That standalone company just named a new CEO in Franco Negron.