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EU Proposes Drug Manufacturing Overhaul, Faces Pushback

The European Union on April 26 has released a draft of the probable and proposed revamp of its drug manufacturing laws. The changes have gone on to cause controversy among the manufacturers, with some even opining that they might...

IVI Cholera Jab From Korea To Undergo Swedish Clinical Trial

The South Korea-based International Vaccine Institute- IVI has gone ahead with the clinical manufacturing of DuoChol, a new low-cost oral vaccine for cholera in capsule form. The development has received funding support from the Wellcome Trust as well as...

Alcami Completes Expansion of cGMP Biostorage Facility in Amherst, NH

Alcami Corp., a CDMO, has completed the Phase III expansion of its cGMP biostorage facility in Amherst, NH, creating a total of 160,000 ft² of ambient cGMP biostorage capacity with 21,000 pallet locations. It is now fully operational to...

Arranta Bio, MIT Partner to Develop Rapid Manufacturing of mRNA Therapeutics

Arranta Bio, part of Recipharm’s biologics business, has signed a contract with MIT to develop a continuous manufacturing technology for mRNA therapeutics. The contract is part of the FDA’s initiative to have a fully integrated, continuous manufacturing production line...

Steriline Unveils Robotic Technologies for Small Batch Aseptic Filling

Responding to customer demands for robotic applications for primary packaging of cell and gene therapies, Steriline introduced its new robotic nest filling machine at Interphex 2023. The robotic systems are designed to provide a high level of safety and flexibility...

US FDA approves Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for children

Pfizer Inc. announced  that the U.S. FDA has approved PREVNAR 20 (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks...

Japans Astellas Pharma acquires US-based Iveric Bio for $5.9 B

Japan headquartered Astellas Pharma Inc. and US-based Iveric Bio have entered into a definitive agreement under which Astellas through Berry Merger Sub, Inc., a wholly-owned subsidiary of Astellas US Holding, Inc., has agreed to acquire 100% of the outstanding...

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