Tag: Biologics
US FDA issues observations for Biocon Biologics sites
At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site
Juniper Biologics acquires cell-mediated gene therapy for treatment of knee osteoarthritis
The US$ 600 million acquisition will see Juniper Biologics offer the world's first cell-mediated gene therapy to an estimated 300 million patients in Asia Pacific, Middle East and Africa
Lupin gets US-FDA nod for its Pegfilgrastim biosimilar application
The Biologics License Application (BLA) submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies........................
Biocon Biologics to offer its oncology biosimilars in over 30 countries
The company's agreement with the Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars will enable access to Trastuzumab and Pegfilgrastim in Africa and Asia...................
RDIF & Hetero agree to produce 100 million doses of the...
Currently, Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India..........................
High adoption of biologics to drive Arthritis Therapeutics market gains
Constant rise in the prices of popular drugs such as Humira and Enbrel could shift the focus of patients towards complementary and alternative therapies, thereby narrowing the growth of the arthritis therapeutics market..................
IDBS expands operations in India to capitalize on R&D growth
To manage the firm’s market presence in India, IDBS has appointed Manish Manakchand as Commercial Director and Braj Thakur as National Sales Manager.................
Report points to bright future for biologics & biosimilars
A report on the new review released as part of the ongoing international meet on biotechnology - Global Bio India 2019, noted that the Indian pharmaceutical industry in the country was well geared to take advantage of the emerging situation.............
India’s biosimilars market stays buoyant
The entire gamut of biologic drugs, of which biosimilars are crucial, is set to become an integral part of the future healthcare landscape, writes Shveta Garg while taking us through the current status of the market and future perspectives...............
Role of biologics as advanced treatment option for Psoriatic Arthritis
Overall, studies indicate that biologics remains an effective and safer treatment for longer treatment periods, writes Dr Chandrashekara. S, Professor and Managing Director, ChanRe Rheumatology and Immunology Center and Research, Bengaluru..............