India Exempts Clinical Trials for Drugs Approved in Major Markets

The government no longer requires clinical trials for new drugs that offer major improvements over current standard care and already have regulatory approval in the US, UK, Japan, Australia, Canada or the European Union. The CDSCO stated that...

Indian Diagnostics Industry To expand at 14% CAGR

Praxis Global Alliance states that the Indian diagnostics sector, currently worth approximately $13 billion in FY23, is expected to experience a growth rate of about 14% per year over the next five years. The Indian healthcare industry is on the...

Daiichi Sankyo and Merck Sign Pact For DXd Antibody Drug

Daiichi Sankyo and Merck, also known as MSD internationally, have broadened their current global collaboration agreement to include Merck's MK-6070, an experimental T-cell engager aimed at delta-like ligand 3 (DLL3), alongside three...

Ocugen Secures US FDA Nod of Expanded Access Programme

Ocugen, Inc., a biotech company specializing in innovative gene and cell therapies and vaccines, disclosed that FDA has granted approval to initiate its expanded access program for using OCU400 on adult patients, 18 years and above, with retinitis...

CVC To Buy Mallinckrodt's Therakos Business for USD 925 million

Mallinckrodt plc, a worldwide specialty pharmaceutical company, and CVC Capital Partners, a top investment firm, have confirmed a deal where CVC Capital Partners Fund IX will buy the company's Therakos business for $925 million with standard...

US FDA Nods Tecelra To treat adults with Metastatic Synovial Sarcoma

Tecelra (afamitresgene autoleucel), a gene therapy, has been approved by the FDA for treating adults with unresectable or metastatic synovial sarcoma. Patients must have received prior chemotherapy, be positive for specific HLA antigens, and have...

EMA Unveils new Pilot Programme to Support Orphan Medical Devices

European Medicines Agency (EMA) initiated a pilot program for expert panels to assist in the creation and evaluation of rare medical devices in the EU. The pilot program provides free guidance from medical device expert panels to specific...

Taiwan FDA Nods Chugai's Alecensa To Treat ALK positive NSCLC

Chugai Pharmaceutical Co., Ltd. reported the announcement of Chugai Pharma Taiwan Ltd. Chugai's subsidiary CPT received a license from TFDA to import Alecensa for ALK-positive NSCLC patients post-tumour resection. CPT manages the development...

MiRus Secures US FDA Breakthrough Device Designation for Spine Implant

MiRus, a company in the life sciences industry, has been granted Breakthrough Device Designation by the FDA for its EUROPA Posterior Cervical System, which uses its unique rhenium alloys, to treat issues in the cervical and upper thoracic spine...

NeuroBo Pharma Inks Pact with MThera Pharma To treat Diabetic Neuropathy

NeuroBo Pharmaceuticals, Inc., a biotech company in the clinical stage that specializes in addressing cardiometabolic diseases, revealed the completion of a unique licensing deal with MThera Pharma Co., Ltd. (MTHERA) has the rights to NB-01 for...

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