Skip to main content

Company News

 

Clinical courses

  • Lupin Goa manufacturing plant receives EIR from US FDA

    Lupin Limited (Lupin) has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

  • Icure Acquires Drug Product Approval for World's First Donepezil Patch for Treating Dementia of the Alzheimer Type in Korea

    Icure Pharmaceutical Inc a biopharmaceutical company in Korea, announced that its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea.

    The drug product approval process took 7 months after it filed an application in April 2021. With the approval, Icure marks the first commercialization of the donepezil patch in the world.

  • Glenmark concludes post marketing surveillance study on Favipiravir

    Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, today announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu®) in India. The PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1083 patients were enrolled in the prospective, open label, multicentre, single arm study.

  • Zydus Cadila’s Sitagliptin base tablets receives Tentative Approval from FDA

    Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and  vaccines.  The  group  employs  23000  people  worldwide  and  is  dedicated  to  creating  healthier communities globally.

  • Boston Scientific Closes Acquisition Of Lumenis LTD

    Boston Scientific announced the close of its acquisition of the global surgical business of Lumenis LTD., a privately-held company that develops and commercializes energy-based medical solutions, from an affiliate of Baring Private Equity Asia (BPEA). The Lumenis surgical business includes premier laser systems, fibers and accessories used for urology and otolaryngology procedures with total revenue anticipated to be approximately USD 200 million for full year 2021.

  • Abbott acquire Walk Vascular, LLC

    Abbott announced that it has acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots. Walk Vascular's peripheral thrombectomy systems will be incorporated into Abbott's existing endovascular product portfolio. Financial terms were not disclosed.

  • Zydus Cadila receives tentative approval from the USFDA for Ibrutinib Tablets

    Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

  • Junshi Biosciences and Immorna collaborate to develop mRNA therapeutics and vaccines

    Junshi Biosciences a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced that the company has established a joint venture with Immorna, a fast-growing biotechnology company focusing on the process development and optimization of mRNA and delivery vehicles and the research and development of new nucleic acid drugs, to develop and commercialize new drugs for the global market in the fields of cancer, infectious diseases, rare diseases, and other diseases, based on the mRNA te

  • Recruitment for Phase 2 Trial of Lyme Disease Vaccine completed by Pfizer

    Valneva SE a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.

  • Torrent Pharmaceutical gets exemption of DPCO for their formulation Tapentadol Nasal Spray

    National Pharmaceutical Pricing Authority (NPPA) grants exemption from Drugs Price Control Order (DPCO) 2013 to Torrent Pharmaceuticals for their formulation of Tapentadol Nasal Spray.

Subscribe to Company News