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  • Alor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone acetonide cream

    Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.A. Inc.

  • Takeda Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

    Takeda announced that the European Medicines Agency (EMA) has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60. Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.

  • RDIF and Stelis Biopharma partner to supply 200 million doses of the Sputnik V vaccine

    The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Stelis Biopharma Pvt. Ltd., the biopharmaceutical division of Strides, a global pharmaceutical company headquartered in India, have partnered to produce, and supply a minimum of 200 million doses of the Russian Sputnik V vaccine against coronavirus sufficient to vaccinate 100 million people. The agreement between RDIF and Stelis Biopharma was reached under the aegis of Enso Healthcare LLP (part of Enso Group), RDIF's coordination partner for sourcing Sputnik V vaccines in India.

  • MHRA response to the precautionary suspensions of COVID-19 Vaccine AstraZeneca

    It has not been confirmed that the reports of blood clots were caused by the AstraZeneca COVID-19 vaccine. People should still go and get their COVID-19 vaccine when asked to do so.

    Dr Phil Bryan, MHRA Vaccines Safety Lead said:
    The benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, far outweigh the risks of side effects. People should go and get their COVID-19 vaccine when asked to do so

  • Daiichi Sankyo to manufacture AstraZeneca COVID-19 vaccine in Japan

    Daiichi Sankyo Company, Limited is pleased to announce that it recently entered into an outsourcing agreement with AstraZeneca K.K. (hereinafter, AstraZeneca) to manufacture the AstraZeneca-developed COVID-19 vaccine, AZD1222, in Japan.

  • Pfizer withdraws application for COVID-19 vaccine from India

    Pfizer has decided to withdraw the application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India. Pfizer was amongst the other industries like Dr. Reddy's Lab and Zydus Cadila which was seeking DCGI approval for their COVID-19 vaccine for EUA.

    Pfizer India was the first company to apply for EUA in India on 4th December 2020 for it's mRNA Covid-19 vaccine just after it had received an emergency approval in the United Kingdom.

  • Gilead Sciences and Gritstone Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure

    Gilead Sciences, Inc and Gritstone Oncology, Inc a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced that the companies have entered into a collaboration, option and license agreement to research and develop a vaccine-based immunotherapy as part of Gilead’s efforts to find a curative treatment for human immunodeficiency virus (HIV) infection.

  • Zydus granted Orphan Drug Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC)

    United States Food and Drug Administration (USFDA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar for the treatment of patients with Primary Biliary Cholangitis (PBC). Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.

  • FDA approves Cabenuva as long acting regimen of HIV treatment

    ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.

  • NextPharma Set to Acquire Two Lonza Sites Specialized in Lipid Oral Dosage Forms

    “NextPharma is an established and well-respected company, with extensive experience in oral and topical finished dosage forms. As such, it is the ideal buyer given the technologies available at the Ploermel and Edinburgh sites. We are confident that the capabilities and experience at the two sites are a complementary fit with NextPharma’s portfolio and that it is ideally placed to develop both to their full potential.

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