Industry News

Dr. Reddy's Laboratories Ltd.announced that it has acquired a portfolio of branded and generic injectable products from Deer Park, Illinois, based Eton Pharmaceuticals, Inc.

U.S. FDA has issued Form 483 with six observations after an inspection at Glenmark Pharma's formulation manufacturing facility based out of Baddi, India between June 13, 2022 and June 22, 2022.

Harish Kuber, Company Secretary & Compliance Officer, Glenmark Pharma said, The Company is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

Inaugurating a two-day biotechnology start-up expo and launching a portal for biotech products at Pragati Maidan here on Thursday, Prime Minister Narendra Modi expressed confidence that India was on the verge of becoming part of the top 10 countries in biotechnology. “India's bio-economy has grown eight times in the last eight years. We have grown from 10 billion dollar to 80 billion dollar. India is not too far off from reaching the league of top-10 countries in Biotech's global ecosystem”, he said.

BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide today announced that its BTK inhibitor BRUKINSA™ (zanubrutinib) has been approved by the Ministry of Health in Kuwait, the National Health Regulatory Authority in Bahrain and the Ministry of Public Health in Qatar for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.  The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day.

Novartis announced long-term results from the ELIANA pivotal clinical trial of Kymriah® (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL), with a maximum survival follow-up of 5.9 years. For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months.

The Joint Action Forum of Pharmaceutical Organisations expressed concern to take note on the development of sale of medicines through online mode as well as enhancement of medicine prices in recent periods.

The Joint Action Forum of Pharmaceutical Organisations (JAFPO) comprising the Chemists & Druggists Association of Assam, Centre of Medical & sales Representative union, North East Region, Association of Advanced Pharmacy Practitioners & Assam Pharmaceutical Association.

Olema Pharmaceuticals, Inc. and Aurigene Discovery Technologies Limited announced an exclusive global license agreement to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company (BMS).