Industry News

Advanced Radiation Therapy, LLC (ART) and Apollo Healthcare have today announced a strategic partnership aimed at easing the challenge radiation oncology clinics have in pre-authorizing patients for insurance coverage for innovative radiation cancer therapies.

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo  (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or wet age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.

Swedish Social Insurance Agency (Försäkringskassan), has granted Aino Health approval to provide proactive and rehabilitative efforts in the workplace. In collaboration with Swedish Social Insurance Agency, Aino Health can offer support investigating, planning, implementing and following up on work-oriented measures.  

The purpose of the grant is to prevent sick leave and make it easier for employees to return to work after sick leave. 

PARIS and TARRYTOWN, N.Y. – October 22, 2021 - A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions, met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch.

LumiraDx a next-generation point of care diagnostics testing company announced it has received emergency use approval by India’s Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.

Dr. Reddys Laboratories Ltd announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID® (lenalidomide) Capsules, from the U.S. Food and Drug Administration (USFDA). With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

The Subject Expert Committee (SEC) of CDSCO has granted emergency use approval (EUA) to Covaxin for children in the 2-18 years age group. Covaxin is developed by Hyderabad based Bharat Biotech.

Caovaxin had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs Controller General of India (DCGI) at the start of this month.