Glenmark Pharmaceuticals Inc | October 19, 2020
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune®1 Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV. According to IQVIATM sales data for the 12 month period ending August 2020, the Rapamune® Tablets, 0.5 mg, 1 mg and 2 mg market2 achieved annual sales of approximately $119.7 million*. Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Johnson & Johnson | August 06, 2020
With leading COVID-19 vaccines in late-stage testing, companies have been inking supply deals with the U.S. government for a quick rollout if their programs succeed. Now, Johnson & Johnson is getting into the act. The pharma giant struck a deal to supply 100 million doses of its candidate, Ad26.COV2.S, if the shot is cleared for use by the FDA. The U.S. government is committing just over $1 billion under the agreement for a price per dose of about $10. That compares with a lower price-per-dose of $4 for AstraZeneca and a higher figure of $19.50 for Pfizer and BioNTech under agreements between those drugmakers and the U.S. government. J&J and AZ have pledged to provide their vaccines under a not-for-profit basis during the pandemic. Under the new J&J deal, which stipulates manufacturing in the U.S., the feds could later buy another 200 million doses under a separate agreement. The company previously won $456 million in funding to support its R&D and manufacturing scale-up, according to a government database.
Orion Biotechnology Canada Ltd | October 16, 2020
Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering GPCR-targeted therapeutics, today announced the results of their Phase 1 study of OB-002H which is an investigational candidate microbicide for HIV prevention. The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel. OB-002, a highly potent chemokine analog of CCL5 (a ligand for the CCR5 HIV co-receptor), has previously been shown to be completely protective in a non-human primate model of vaginal HIV transmission (Veazey R et al. JID 2009). The Phase 1 study design included open-label single-dose (vaginal and rectal) and multi-dose product (vaginal) administration of OB-002H gel to study participants followed by a randomised, double-blind, placebo-controlled multi-dose (vaginal) phase of product administration. During the multi-dose phase of the study, participants received study product once daily for five days. The study enrolled a total of 30 healthy volunteers in Warsaw, Poland at the BioVirtus Phase 1 Research Site. The product was well tolerated, and product-related genital adverse events were mild (Grade 1) or moderate (Grade 2) and transient.