Drug Licensing

Balaji Amines accused of making pharma-grade chemical without licence

Balaji said it had tested its PG using US and Indian pharma standards at the behest of its non-pharma clients, and this was the reason why those standards were mentioned in its PG labels

Glenmark Pharma signs $18 mn deal with Hengrui for cancer therapy drug

The agreement gives Glenmark exclusive rights to develop and commercialise cancer drug Trastuzumab Rezetecan outside China, the US, Europe, and other select markets

After Patanjali, state government, IMA comes under Supreme Court's scanner

The Supreme Court had earlier said that IMA needs to 'put its house in order'

Ichnos Sciences, Astria Therapeutics sign licensing deal for OX40 portfolio

Ichnos is set to receive $320 million upfront for development, regulatory and sales payments, coupled with low double-digit royalties

New National Medical Commission tag no game changer for medical students

Had the recognition not come, then students from several colleges may have found it difficult to appear for the USMLE if their college was not recognised by the WFME

Health ministry plans drug licensing changes to ensure drug safety

Proposals aim to standardise drug manufacturing practices after a few Indian medicines were flagged as 'substandard' by the WHO

FDA authorises third antibody drug for mild-to-moderate Covid-19 cases

U.S. health officials have granted emergency authorisation to a third antibody drug to help reduce hospitalisations and deaths due to Covid-19

Biocon and Equillium Inc. expand license agreement for itolizumab

The companies have expanded their collaboration and license agreement

Pharma industry divided as govt likely to increase drug licensing fee

Price hike likely to arrest the number of bogus drug registrations

Panel suggests one-time licensing for drugs

At present, the renewal of licences for each formulation rests with state regulators and is around 3 years