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Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Pharmaceutical Technology

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Why do large and mega-cap sponsors outsource?

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FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

Delveinsight

Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its commercialization in the market.

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UK’s NHS Backs World’s Costliest Drug for Treatment of MLD + Report Finds Increase in Pharma Cybersecurity Threats – Xtalks Life Science Podcast Ep. 48

XTalks

In this episode, Ayesha discussed the NHS’s recommendation of Libmeldy, a gene therapy for the treatment of the rare disease MLD, which is officially the world’s most expensive drug with a list price of almost $4 million USD. These include breaches and leakages of items like email addresses, passwords and even credit/banking information.

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Ocugen gets a black eye as FDA denies emergency OK for COVID jab

pharmaphorum

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. The Russian Sputnik V vaccine was approved for use in India in April. That includes the more transmissible B.1.617.2

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Top 10 Fastest Growing Biotech Companies in 2023

XTalks

These companies were identified through The Americas’ Fastest-Growing Companies 2023 list by the Financial Times. In 2023, Moderna is poised to achieve sales figures ranging from $6 billion to $8 billion, contingent on the prevailing COVID-19 vaccination rates in the US. vaccine, mRNA-1273.815.

Genetics 111
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Europe: Where is the drug discovery innovation?

Drug Discovery World

A more established Amsterdam-based enterprise is gene therapy company uniQure, developer of etranacogene dezaparvovec, the first gene therapy for haemophilia B, which was approved for use in the US in November 2022 and in the EU in February 2023. More than 400 companies now make up Lithuania’s life sciences sector 4.

Drugs 59
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HEOR and Market Access Strategies in Today’s Drug Development Landscape – Insights from AstraZeneca’s Dr. Heather McDonald

XTalks

Heather McDonald: My previous role at Bayer was a global-level role with a specific focus on cell and gene therapies. In my current role, I have country-level responsibility for AstraZeneca’s entire portfolio, including cardiovascular, respiratory, vaccines and oncology. Here are the endpoints that payers care about.

Marketing 105