After taking into account the arguments made by Sanofi India Ltd, the Organization of Pharmaceutical Producers of India (OPPI), and the US-India Strategic Partnership Forum, the National Pharmaceutical Pricing Authority (NPPA) has established separate ceiling prices for insulin glargine 100…
Tag: Pharma Info
All makers of the 16 fixed dose combinations (FDCs) that were previously deemed to be illogical in a report by an expert panel have been requested by the Central Drugs Standard Control Organization (CDSCO) to submit the information in the…
According to a pilot study conducted by NITI Aayog and Terumo Blood and Cell Technologies (TBCT), the public-private partnerships (PPP) model has improved the functioning of blood transfusion services by 37% in districts of Uttar Pradesh (UP). The areas that…
The Organisation of Rare Diseases of India (ORDI) now argues that the Union government would need to simplify the documentation process for all imported medicines that are free from customs duties. A recent announcement from the Union government allowed complete…
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine®1 Tablets, 5 mg and 10 mg, of GlaxoSmithKline, have been given final approval by the United States Food & Drug Administration (U.S. FDA). Glenmark Pharmaceuticals Ltd….
Hutchmed (China) Limited reports that it has finished the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib, a highly potent and selective oral inhibitor of VEGFR-1, -2, and -3, for…
The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon start developing pharmacopoeia standards for the Ayurvedic, Siddha, Unani, and Homoeopathic medications under the “One Herb One Standard” (OHOS) among other projects during the budget year 2023–2024. According to…
The US Food and Drug Administration has approved the company’s investigational new drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy that contains the 4-1BB protein, according to Cabaletta Bio, Inc., a clinical-stage biotechnology company focused…
The phase 2 recruitment for Hansa Biopharma’s imlifidase research in Guillain-Barré syndrome has been completed, according to the company, a pioneer in enzyme technology for uncommon immunological disorders (GBS). The second half of 2023 is anticipated to see the release…
In a patent dispute involving the former’s diabetes drug linagliptin, a single judge of the Delhi High Court declined to grant an interim injunction in favour of German pharmaceutical giant Boehringer Ingelheim against Indian generic manufacturers, noting that the patent…