Daiichi Sankyo and partner AstraZeneca are eying a second-quarter 2020 decision for their HER2-targeting antibody-drug conjugate after an FDA "priority review" designation. The FDA lambasted Torrent Pharma for manufacturing violations that led to suspected cancer-causing impurities in certain "sartan" drugs. Aiming to pay down debt and focus on more innovative therapies, Takeda is selling some 30 drugs in the Middle East and Africa to emerging markets-focused Swiss drugmaker Acino International for $200 million. And more.
1. AstraZeneca gets Q2 2020 PDUFA date for breast cancer ADC
Half a year after AstraZeneca put down a hefty $1.35 billion upfront for Daiichi Sankyo’s lead antibody-drug conjugate, [fam-] trastuzumab deruxtecan, an application for the HER2 drug in breast cancer has been accepted by the FDA and put under priority review, with a decision set for the second quarter of 2020. The pair previously said a phase 2 trial had hit its primary endpoint.
2. FDA tags Torrent as key offender in production of tainted blood pressure meds
Last week, India’s Torrent Pharma acknowledged it had gotten an FDA warning letter for its facility in Taluka-Kadi, Indrad, Gujarat. Now, the FDA has called out the drugmaker as one of the main culprits in the ongoing global recall of heart drugs due to suspected carcinogen impurities. In an update, the agency said the warning letter found manufacturing violations at Torrent that led to the production of tainted valsartan, losartan and irbesartan.
3. Takeda wraps 30 emerging markets drugs in $200M selloff to Swiss pharma Acino
Takeda is selling some 30 over-the-counter and prescription drugs in the Middle East and Africa to Switzerland’s Acino International for more than $200 million. The products are “primarily” outside of Takeda’s chosen focus areas, with the exceptions of rights in certain countries to two older stomach drugs. The deal allows Takeda to pay down debt and focus on launching 16 innovative medicines in the region over the next three years.
4. Sanofi aims to save 1,100 jobs in Bangladesh by selling its local stake: report
Sanofi has decided to leave Bangladesh within 12 to 18 months, local managing director Muin Uddin Mazumder reportedly said. The company will sell its 54.64% stake in the local outfit, but only to a buyer that pledges to keep the 1,100 employees on the payroll, he said. It hasn’t been in touch with any potential buyers, he added.
5. Shionogi, Hsiri Therapeutics build out lung disease R&D pact
Last year, Shionogi and Hsiri Therapeutics penned a licensing and R&D deal focused on tuberculosis and other lung infections. Now, in expanding the deal, the Japanese company is licensing a new technology, which Hsiri said could be more effective than standard treatments for mycobacterial infections.
6. Chinese CRO dMed raises $50 million in series B for global expansion (release)
Chinese CRO dMed Biopharmaceutical has raised nearly $50 million in a series B, led by Vivo Capital and joined by local investors Legend Capital, Qiming Venture Partners and Lilly Asia Ventures. The company recently acquired New York-based CRO Target Health, and now it plans to use the money to further expand its global footprint and add new technologies to its offering.