Industry News

Pfizer Inc announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

Sanofi announced an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments. Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets.

Nicox SA an international ophthalmology company, today announced that patent EP 3,769,753, expiring in 2040 and covering the Company’s product candidate in development for blepharitis, NCX 4251, has been issued by the European Patent Office (EPO). The patent covers ophthalmic suspensions comprising a specific form of fluticasone propionate nanocrystals and the method for manufacturing the ophthalmic suspensions. Examination of corresponding patent applications providing exclusivity in the United States (U.S.), China, Japan and other territories is in process.

Zydus Cadila has received an order to supply one crore doses of ZyCoV-D, the world’s first Plasmid DNA Vaccine, to the Government of India at Rs. 265 per dose and the needle-free applicator being offered at Rs. 93 per dose, excluding GST. The pricing has been decided in consultation with the Government of India.

Zydus Cadila has received final approval from the USFDA to market Glycopyrrolate Injection in the strengths of 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-Dose Vials, (US RLD: Robinul). Glycopyrrolate is used before surgery to decrease the volume of secretions from mouth, lungs and stomach.

Iovance Biotherapeutics, Inc a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. A slide presentation is also available on the Iovance website.

Johnson & Johnson announced its intent to separate the Company’s Consumer Health business, creating a new publicly traded company. The planned separation would create two global leaders that are better positioned to deliver improved health outcomes for patients and consumers through innovation, pursue more targeted business strategies and accelerate growth.

AbbVie announced the U.S. Food and Drug Administration (FDA) approval of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.

Premas Biotech, a developer of novel biotherapeutic and vaccine candidates announced that Oravax Medical Inc., a US based company that Premas Biotech is a partner in, has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine; and preparations to begin the trials are now underway.