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STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

STAT

Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. The issues prompted the agency to delay distribution of Moderna booster shots, although their release has now reportedly been authorized. the same plant where the company helps produce two Covid-19 vaccines.

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STAT+: Pharmalittle: Drug-wholesaler owner indicted for alleged role in diverting HIV medicines; Catalent linked to Regeneron drug rejection

STAT

authorities are now targeting an extensive scheme that pumped the medicines into the pharmaceutical supply chain , STAT reports. Steven Problems at a Catalent production facility led U.S. Our in basket is always open.  Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

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Biopharmaceuticals contributing to manufacturing outsourcing trend

European Pharmaceutical Review

This is due to these companies looking to meet to the varied needs of pharmaceutical developers, according to the authors. The report noted that there has been “considerable” merger and acquisition activity in recent years within the pharmaceutical contract manufacturing market.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Covid-19 vaccines stay in the spotlight.

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CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology

The EMA had provided a positive opinion for this marketing authorization back in July. Catalent has been engaged in the parenteral manufacturing and packaging of the anti-IL-4/IL-13 antibody. In the case of Bristol Myers Squibb’s Zeposia (ozanimod), the authority supported its use to treat moderate to severe ulcerative colitis.

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Report highlights trends in the aseptic fill finish market

European Pharmaceutical Review

This trend is unlikely to change during the forecast period, the authors noted. Trends within the global aseptic fill finish services market The authors highlighted that many players in the market are using automated equipment in their fill finish operations.

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Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

Last October, the health authority rejected importing Russia’s Sputnik V vaccine due to problems regarding the vaccine’s development, safety and manufacturing. Apart from Covid-19, other infectious diseases such as dengue fever represent a considerable threat to Brazilian public health.