Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprinoia, Astellas, Astrazeneca, Daiichi Sankyo, Insmed, Passage, Qualigen, Revision, Taysha Gene Therapies.

Kala Pharmaceuticals Inc.’s anticipated win with Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (DED) didn’t help shares (NASDAQ:KALA), which closed Oct. 27 at $6.28, down $1.44, or 18.7%, on word of the FDA approval.

The latest global regulatory news, changes and updates affecting biopharma, including: FDA clarifies terms for generics; FDA to hold public meeting on DSCSA; Russia updates COVID-19 guidelines; First Circuit: Prescriber’s perk indeed a kickback; Companies warned for documentation, FAR violations.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atai Life, Cytodyn, Edigene, Exelixis, Kala, Moderna, Nektar, Pfizer, Prevail, RDIF, Vanda.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Bayer, Bioinvent, Bioxcel, Forte, Janssen, Nicox, Nitric Oxide Innovations, Passage, Santen, Sesen, Spectrum, Tracon, Y-mabs.

The latest global regulatory news, changes and updates affecting biopharma, including: MOU to help with compounding oversight; MHRA advises on MA transition; CMS delays date for radiation oncology bundle; NRC issues advisory letter to INIS.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Astrazeneca, Evgen, Kezar.

Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir).

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Adicet, F2G, Gilead, Leo, Nevakar, Reven.

To end criminal and civil claims stemming from its marketing of Oxycontin (oxycodone hydrochloride) and other opioid products, Purdue Pharma LP agreed Oct. 21 to pay more than $8 billion and to cease operating as a for-profit private company – provided the court presiding over its bankruptcy agrees.