Industry News

SOUTH SAN FRANCISCO, Calif., July 28, 2021 (GLOBENEWSWIRE) Satsuma Pharmaceuticals, Inc a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.

BDR Pharma gets license pact with the Defence Research and Development Organisation (DRDO) to manufacture, distribute, and market COVID-19 drug 2-Deoxy-D-Glucose (2-DG) in the country.

Last month, the Drugs Controller General of India (DCGI) had approved the oral medication for emergency usage as adjuvant therapy in mild to severe COVID-19 patients.

Saniona a clinical stage biopharmaceutical company focused on rare diseases announced that the U.S. Food and Drug Administration has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity. Tesomet is the first and only investigational treatment for HO to receive orphan drug designation. Saniona is preparing to initiate two Phase 2b studies of Tesomet in the second half of this year, one in HO and the other in Prader-Willi syndrome, for which Tesomet has already received orphan drug status.

Sun Pharma and and Cassiopea SpA, a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action to address long-standing essential dermatological conditions today announced the signing of License and Supply Agreements for Winlevi (clascoterone cream 1%) in the United States and Canada. Winlevi  has been approved by the United States Food and Drug Administration FDA as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older.

Established in 2009 in the Bay Area, LakePharma applies its range of technology platforms to advance projects from discovery to development to manufacturing, namely cell-line development, bioexpression systems and viral vector production systems. Almost a quarter of its employees hold Ph.D.s, bringing expertise in all major biologics segments: mammalian, microbial, plasmid DNA, mRNA, monoclonal antibodies, and viral vector, including cell and gene therapy.

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

AstraZenecas proposed acquisition of Alexion Pharmaceuticals, Inc.has achieved an important step towards completion by having cleared the European Commission review.

The clearance follows competition clearances in the United States, Japan and other countries globally, with a complete list available on astrazeneca.com. Regulatory clearance in the UK is pending and remains a requirement to complete the deal.

National Pharmaceutical Pricing Authority (NPPA) allows price hikes of essential medicines like Carbamazepine, Ranitidine and ibuprofen by 50 percent. They have included 9 strengths of these medicines and allows manufacturers to increase pricing after being advised by the Standing Committee on Affordable Medicines and Health Products (SCAMHP), Niti Aayog, Government of India.

Niramai Health Analytix, a Deeptech health startup raised research funding from impact investor CDC for NIRAMAI FeverTest, which was launched last year.

With leveraging of computer vision and AI to analyze and monitor crowd compliance to COVID-19 guidelines, NIRAMAI FeverTest’s smart software enables screening for COVID-19 symptoms in public places.