Biotech
Biocon settles with Janssen to commercialise biosimilar products in Europe, Canada, Japan
Biocon Biologics has entered into a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson to launch Bmab 1200, a biosimilar to Stelara, in Europe, the UK, Canada, and Japan. This deal resolves patent disputes and secures future market entry, pending regulatory approvals.
Bharat Biotech launches oral cholera vaccine Hillchol after positive phase 3 trial
Bharat Biotech unveiled Hillchol, a new single-strain oral cholera vaccine, developed with Hilleman Laboratories. Addressing the high global demand for cholera vaccines, the company can produce up to 200 million doses annually. Phase 3 trials validated its safety and effectiveness. The vaccine is administered orally to individuals over one year old.
India aims to lead next industrial revolution with biomanufacturing policy: DBT
India introduced the BioE3 policy to tackle challenges related to food, energy, and climate. Approved by the Union Cabinet, the policy focuses on enhancing innovation in biomanufacturing, covering everything from medicines to bio-plastics. The initiative is expected to create job opportunities and promote sustainable development. The policy aligns with India's aim to become a developed nation by 2047, providing alternatives to traditional resources and addressing environmental concerns.
Centre approves 'BioE3' policy for boosting innovation-driven support to R&D
The Union Cabinet has approved the Biotechnology for Economy, Environment, and Employment (BioE3) policy. This initiative aims to enhance research and development, as well as entrepreneurship, in the biotechnology sector. The policy also seeks to generate job opportunities through establishing biomanufacturing hubs and addressing crucial issues like climate change, food security, and human health.
Zydus Lifesciences to acquire 50 pc stake in Sterling Biotech from Perfect Day
Zydus Lifesciences announced an agreement with Perfect Day Inc to acquire a 50 per cent stake in Sterling Biotech. The partnership aims to establish a manufacturing facility for animal-free protein production. This move signifies Zydus' expansion into specialized biotech products catering to health and nutrition markets, particularly for those preferring animal-free or lactose-intolerant options.
WHO says partners can start talks to buy mpox vaccines before its approval
WHO has allowed Gavi and Unicef to procure mpox vaccines ahead of its formal approval to quickly deliver them to Africa amidst a growing outbreak. Vaccines by Bavarian Nordic and KM Biologics, already approved in the U.S. and Japan, are anticipated to receive WHO emergency approval in September to speed up distribution.
Maharashtra government to bring new law to crack down on bogus pathology labs
The issue concerns the urban development, public health and medical education departments, Samant said. BJP MLA Ashish Shelar said bogus pathology labs were looting money and playing with people's lives. Several collection centres that have come up over the years should be registered, he said, demanding criminal cases against violators.
Biocon gets 4 observations from USFDA for Andhra Pradesh facility
Biocon received four observations from the US health regulator after a GMP inspection at its API facility in Andhra Pradesh.
Ajooni Biotech ties up with Avalon Bioenergy for sustainable moringa processing
Ajooni Biotech has partnered with Avalon Bioenergy, an Indian subsidiary of the US-based Avalon Energy Group, to establish processing plants for the sustainable processing of moringa seeds and leaves in India. Avalon will extract oil for further processing and marketing, while Ajooni will use the remaining oil cake to create animal feed products for further processing and distribution within India and for exports.
Emcure and its subsidiary Gennova settle legal dispute with HDT Bio over mRNA technology
Emcure Pharmaceuticals and its subsidiary Gennova have resolved all legal disputes with US-based HDT Bio Corp. The parties have entered into a long-term agreement to develop mRNA vaccines against various infectious diseases in India and other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT's patented mRNA vaccine technology in multiple fields
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Cipla gets USFDA nod to market Lanreotide injection
Cipla has received approval from the US FDA to market its Lanreotide injection, a generic medication for treating acromegaly and other conditions. The product is a therapeutic equivalent of Somatuline Depot Injection, which had sales of around USD 898 million in the US for the 12-month period ending March 2024.
ICMR draws flak from experts over call for BHU study retraction
Universal Health Organisation (UHO) criticizes ICMR for questioning BHU researchers over Covaxin study, calling for academic freedom and data transparency. Study on Covaxin's side effects faces ICMR scrutiny, urging transparency and data access from ICMR. BHU study on Covid-19 vaccine side effects challenges academic censorship by ICMR. UHO condemns ICMR's censorship attempts on BHU's Covaxin study.
JB Pharma expects India business to grow above market growth rate in FY25: CEO Nikhil Chopra
JB Pharma, led by CEO Nikhil Chopra, forecasts 12-14% revenue growth and aims to increase Ebitda margins by 27-28% in FY25. The growth is driven by a focus on chronic portfolio, CDMO business expansion, and upcoming acquisition of an ophthalmology drugs portfolio from Novartis. The company's financial performance in FY24 was strong with revenue reaching Rs 3,484 crore.
ICMR distances itself from BHU's Covaxin study, asks to explain why it should not seek Iegal and administrative action
The Indian Council of Medical Research (ICMR) has criticised Banaras Hindu University (BHU) researchers for incorrectly associating them with an observational study on the side effects of Bharat Biotech's Covid-19 vaccine, Covaxin. The study, which covered a one-year period after the vaccine was administered, found that nearly a third of the 926 participants reported adverse events of special interest (AESI).
Acceleration of biosimilar business, debt reduction to be key priorties in FY25: Biocon Chief
Kiran Mazumdar-Shaw of Biocon aims to consolidate, accelerate biosimilar business, and reduce debt after Viatris acquisition in FY25. Mazumdar-Shaw anticipates expanding its market share for biosimilar products across the US, Europe, and emerging markets, coupled with the possibility of introducing new products in the fiscal year 2025.
Disclosed all information on Covishield’s side effects in 2021, says SII
The Serum Institute of India (SII) has stated that the safety of vaccines remains "paramount" and that all information about the side effects of its Covishield vaccine against Covid-19 was disclosed in its packaging insert in 2021. The statement comes after a group of parents whose children died during the pandemic filed a case against the company. SII manufactured and supplied the vaccine under license from AstraZeneca, which admitted in court that the vaccine could cause a rare side effect.
