Industry News

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).

Amneal Pharmaceuticals, Inc.announced that the U.S. Food and Drug Administration has approved the Company’s Biologics License Applicationfor pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.

Pfizer Inc announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizers investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).

Ahmedabad based Torrent Pharmaceuticals announced that it has entered into an agreement with Dr. Reddy's Laboratories Ltd. to acquire four of its brands "Styptovit-E", "Finast", "Finast-T", and "Dynapress".

A Mumbai-based pharmaceutical company Medley Pharma is up for sale and is expected to be sold for Rs 5,000 crore in a deal. According to a report in Times of India, drug giants Cipla, Dr Reddy's Lab, JB Chemicals, and Torrent, as well as prominent private equity firms Advent, Carlyle, and Blackstone, are all interested in buying the Rs 1,000-crore business.