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  • Pfizer and BioNTech submits EUA for adapted bivalent COVID-19 vaccine in Children

    Pfizer Inc and BioNTech SE announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.

  • Lupin Launches Rufinamide Tablets USP in the United States

    Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

  • FDA lays aside Lillys Bebtelovimab in the U.S.

    FDA lays aside Lilly's bebtelovimab in the U.S. for emergency use treatment of mild-to-moderate COVID-19 in adults and pediatric patients. Over the last several months, prevalence of COVID variant sublineages vary by state, region and even country, and can change rapidly.

    Lilly said that it agrees with the FDA that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US.

  • Alembic Pharma receives USFDA Approval for Diclofenac Sodium Topical Solution

    Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

  • Gland Pharma acquires Europe based Cenexi Group

    The Singapore based subsidiary of Gland Pharma has acquired Europe based Cenexi Group which is engaged primarily in the business of Contract Development & Manufacturing Organisation (CDMO) of pharmaceutical products with expertise in sterile liquid and lyophilized fill- finished drugs, including capabilities on oncology and complex products.

    The Gland Pharma entered into a put option agreement to acquire 100 percent of Cenexi Group for an Equity Value not exceeding Euro 120 Mn (Enterprise Value of Euro 230 Mn).

  • Boston Scientific Announces agreement to acquire Apollo Endosurgery, Inc.

    Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Apollo Endosurgery, Inc for a cash price of 10 USD per share, reflecting an enterprise value of approximately 615 million USD.

  • AstraZeneca to sale its US based plant

    AstraZeneca announces the sale of its West Chester site in Ohio, US, to National Resilience, Inc. (Resilience), a technology-focused manufacturing company dedicated to broadening access to complex medicines.

  • Roche withdraws Tecentric against a bladder cancer

    Roche voluntarily withdraws the U.S. indication of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma, a bladder cancer.

    An estimated 81,000 cases of bladder cancer will be diagnosed in the United States in 2022. Urothelial carcinoma, which develops in the cells of the bladder lining, is the most common type of bladder cancer, accounting for about 90% of all cases. In total, 30% of cases are considered advanced based on muscle-invasive or metastatic disease.

  • Bharat Biotech Intranasal vaccine receives CDSCO nod for booster

    Bharat Biotech International Limited a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that iNCOVACC® (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Rcstrictcd Use in Emcrgcncy Situation for ages 18 and above, in India, for heterologous booster doses.

  • AstraZeneca Pharma India get CDSCO nod for Dapagliflozin tablets

    AstraZeneca Pharma India has received an import and market permission in Form CT-20 (subsequent new drug approval) from the Central Drugs Standard Control Organisation for Dapagliflozin tablets of 10 mg.

    Through this approval, the Company is permitted to deal in Dapagliflozin (Forxiga®) tablets of 10 mg in additional/expanded indication to reduce the risk of sustained eGFR and kidney disease, cardiovascular death and hospitalization for heart failure in adult with chronic kidney disease at risk of progression with condition.

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