Industry News

The U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Novartis announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]).

Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability and delay clinical worsening.

Drugmakers are seeking to limit their reliance on Chinese contractors who produce drugs used in clinical trials and early-stage manufacturing, a move that is benefiting rivals in India, according to interviews with 10 industry executives and experts.

Cell Biology Lab was inaugurated at Kumar Organic Products Research Centre on 15th November 2023 by Prof. Dr. Samir K Brahmachari , Former Director General, CSIR.

Biocon Biologics Limited a subsidiary of Biocon Ltd. has announced that MHRA, Medicines and Healthcare products Regulatory Agency in the UK, has granted marketing authorization for YESAFILI®, a biosimilar of Aflibercept.

In September, YESAFILI®, received marketing authorization approval from the European Commission (EC) for the European Union (EU).

Sage Therapeutics has priced the oral postpartum depression medicine at USD 15,900 for a full 14-day course of treatment which is developed with Biogen. The pricing of medicine has been announced recently, whereas the drug was approved by the FDA in August.

Zydus Lifesciences Limited a discovery-driven, global lifesciences company and Lupin Limited (Lupin), a global pharma major, announced that they have entered into a licensing and supply agreement to co-market, Saroglitazar Mg for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steato Hepatitis (NASH) in India. With a once daily, 4mg dose regimen, Saroglitazar Mg enables better compliance, reduces the pill burden and offers the patient more convenience.