Healthcare Roundup – FDA OKs ViiV Healthcare’s fostemsavir, UNITY Biotechnology announces upcoming catalysts for its lead programs
FDA OKs ViiV Healthcare’s fostemsavir for HIV-1
ViiV Healthcare, majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the FDA nod for Rukobia (fostemsavir), a human immunodeficiency virus type 1 gp120-directed attachment inhibitor, in combination with other antiretrovirals, for HIV-1 infection
The approval of 600 mg extended-release tablets, is for heavily treated adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Fostemsavir is currently under review by the European Medicines Agency and additional submissions to regulatory authorities in other countries are planned throughout 2020 and 2021.
UNITY Biotechnology announces upcoming catalysts for its lead programs
UNITY Biotechnology (UBX +4.2%) expects to announce 12-week results from Phase 2 study of UBX0101, a p53/MDM2 interaction inhibitor, in painful osteoarthritis of the knee, in Q3. Enrollment for the study was completed in Feb 2020.
Last year in June, the company reported positive early-stage data for UBX0101.
The company also said to commence first-in-human study for its lead ophthalmology molecule, UBX1325 in age-related eye diseases, in 2H 2020, and obtain initial results from the study in 2021.
UBX1325, is a senolytic, small molecule inhibitor of the anti-apoptotic Bcl-2 family member, Bcl-xL.
FDA OKs emergency use of Centogene COVID-19 molecular diagnostic test
The FDA has issued Emergency Use Authorization (EUA) for Centogene’s (NASDAQ:CNTG) SARS-CoV-2 RT-PCR test.
The company’s SARS-CoV-2 RT-PCR test is intended to be used with samples of the upper respiratory tract (oropharyngeal swabs).
Teva could be next DOJ target
Teva Pharmaceuticals (NYSE:TEVA) had a rough session yesterday after the DOJ charged generic pharmaceutical giant Glenmark (OTC:GLKQY, OTCPK:GLRKF) with price manipulation for drugs sold in the U.S.
SVB Leerink analyst Ami Fadia says it’s no coincidence Teva tumbled nearly 7% on the news, and believes it could be the next company charged by the DOJ.
Bernstein’s Ronny Gal agrees, and calls a criminal case against Teva increasingly likely.
Teva is up 2.15% premarket.
Merck Animal Health completes acquisition of U.S. rights to Sentinel brand
Merck (NYSE:MRK) division, Merck Animal Health has completed its acquisition of the U.S. rights to Sentinel Flavor Tabs and Sentinel Spectrum Chews in the Companion Animal category from Virbac (OTC:VRBCF).
“Our veterinary medicines, including parasiticides, and vaccines continue to transform the animal health industry and further solidify our position in the U.S. Companion Animal category,” said Rick DeLuca, president, Merck Animal Health.