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Bluebird taps Lonza to boost manufacturing capacity for its gene therapies Zynteglo, Skysona

Fierce Pharma

As bluebird bio’s pricey gene therapy launches take flight, the company is boosting manufacturing capacity with Swiss CDMO Lonza. Under the updated deal, Lonza has agreed to increase manufacturing capacity for bluebird’s therapies Zynteglo and Skysona, according to a SEC filing published Wednesday.

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UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

Fierce Pharma

After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.

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Samsung Biologics adds to BMS manufacturing partnership with new $242M antibody agreement

Fierce Pharma

After inking and expanding a biosimilar production partnership with Pfizer this summer, Korea’s Samsung Biologics is boosting yet another Big Pharma manufacturing agreement. The partners have already been working together on antibody manufacturing and have expanded their relationship over time.

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Eli Lilly moves to settle with whistleblower who flagged alleged manufacturing shortfalls

Fierce Pharma

After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlem | After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production (..)

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GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns

Fierce Pharma

GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns esagonowsky Mon, 09/25/2023 - 12:26

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Spanish drugmaker Serra Pamies suffers manufacturing clampdown by EMA

Fierce Pharma

Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency (EMA) to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, f | Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency to put the kibosh on manufacturing (..)

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FDA, manufacturers make progress in resolving key cancer drug shortages: White House

Fierce Pharma

Efforts from regulators and manufacturers have brought the U.S. While there's certainly more work to do, the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.