Industry News

Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to market Pemetrexed for Injection, in the strengths of 100 mg/vial,500 mg/vial, and 1000 mg/vial Single-Dose Vials (USRLD: Alimta). Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma.

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab), used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

LumiraDx Limited a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization (WHO) in their latest response effort to combat COVID-19.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO) announced a major expansion of capabilities and capacity in aseptic liquid fill-finish and sterile lyophilization technology, an important manufacturing process commonly used with injectable and biologic therapies, with the investment of 100 Million USD into the construction and enhancement of world-class facilities, at its Bedford, New Hampshire campus.

Aurobindo Pharma receives 6 observations after inspection of Aurobindo Pharma Jedcherla plant.

The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from 2nd to 10th May 2022.

US FDA has conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited Halol facility Gujarat from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.

US Pharma giant Pfizer has set up its global drug development centre at the Indian Institute of Technology-Madras Research Park with an investment of around 150 crore. This facility employs more than 250 scientists and professionals from a range of scientific disciplines, including Formulation Scientists and Pharmacists, Analytical Scientists, Life Science specialists such as Microbiologists and Biotechnologists, Chemical Engineers, Data Scientists and Program Managers.

Biocon Biologics Limited a subsidiary of Biocon Ltd announced that its subsidiary Biocon Sdn. Bhd. in Malaysia has been awarded a three-year contract, valued at USD 90 million* (MYR 375 million), for its recombinant human insulin brand Insugen®, by the Ministry of Health (MoH), Malaysia.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. Food and Drug Administration and that similar requests are underway with international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.