Shenzhen Pregene Biopharma Co. Ltd. has outlicensed its internally developed anti-BCMA CAR T-cell therapy candidate, PRG-1801, to Indian pharma giant Dr. Reddy's Laboratories Ltd. in a $162.5 million deal to develop and commercialize it in India. The candidate, which is being developed by Pregene to treat relapsed/refractory multiple myeloma, is now in a phase I trial in China after anIND approval in March 2020.
HONG KONG – Laboring under the burden of a new wave of COVID-19 infections that have raised its case total to 15.3 million, second only to the U.S., India is ramping up its vaccination efforts by opening up COVID-19 vaccine availability to citizens 18 years or older from May 1, according to the Ministry of Health and Family Welfare. However, ensuring a steady vaccine supply for the world's second most populous country, with nearly 1.4 billion people, might prove to be an issue. So far, India has administered just over 124 million COVID-19 vaccine doses.
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.”
NEW DELHI – Significant disruptions to supplies of active pharmaceutical ingredients (APIs) from China caused by the COVID-19 pandemic have led India to fundamentally rethink its supply chains and the structure of its pharmaceutical industry, according to industry executives and consultants.
NEW DELHI – India, which has the highest incidence of tuberculosis (TB) in the world and the second highest of COVID-19, is looking to artificial intelligence (AI) to help detect and classify cases of both and lower the cost of diagnosis.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII).
HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion.
HONG KONG – Votis Subdermal Imaging Technologies Ltd. is developing a diagnostics solution that could prevent the loss of feet among India’s impoverished due to affects of peripheral artery disease (PAD). The company has entered an agreement with India’s Ii Ventures Pte. Ltd. (iiV) to develop a system to screen the largely rural Indian population for PAD.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials.
NEW DELHI – Recent changes to India’s rules on medical devices have evoked mixed reaction among industry and legal experts with concerns over their impact on patenting of innovations tinged with a welcome reception of a new clause for mandatory registration and licensing of medical devices in the country to improve adherence to quality requirements.