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Arcturus and Meiji Seika Pharma Report the EMA’s Positive Opinion of Kostaive for COVID-19 

  Shots:     The EMA’s CHMP has granted positive opinion to Kostaive (zepomeran) for active immunization to prevent COVID-19 in subjects of age ≥18yrs.  The EC’s decision on marketing authorization will follow subsequently  Kostaive is a self-amplifying mRNA vaccine that codes for the SARS-CoV-2 spike protein to provide active immunization against COVID-19  Ref: Arcturus Therapeutics and Meiji…

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Insights+ Key Biosimilars Events of June 2024

Insights+ Key Biosimilars Events of June 2024

Shots:    Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency     Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients     The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…

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The EC Approves Biogen’s Tofidence (Biosimilar, Roactemra) for Treating Arthritis and COVID-19 

   Shots:  The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19  The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…

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Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)

Shots:  The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19  The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU…

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Spotlight Interview: David A. Dodd, CEO at GeoVax Labs, in an Engaging Conversation with PharmaShots

PharmaShots’ Spotlight offers a unique platform for biopharma, life sciences, and healthcare companies, allowing them to connect with their target audiences and like-minded people.  This week at the Spotlight, we had a riveting discussion with David A. Dodd, Chairman, President & CEO, at GeoVax Labs.  David eloquently highlighted GeoVax’s extraordinary journey over the years from…

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Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Shots: Simon spoke about the enrollment of the first participant in Japan in the P-III (SCORPIO-PEP) study to evaluate the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection He mentioned how this study will supplement data from the pivotal SCORPIO-SR trial's P-III segment which showed ensitrelvir's effectiveness in treating mild-to-moderate COVID-19…

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8 Major Reasons Behind the Soaring Layoffs in the Pharmaceutical Industry

Shots: In the wake of International Labour Day, PharmaShots presents a detailed take on the recent layoffs in the Pharmaceutical Sector with an illustrative graphical analysis Like any sector, the pharmaceutical industry operates on some nuance and intricate aspects that ensure smooth operations. Factors like digitalization, patent expiry, growing competition, and others put direct or…

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