Drug Research
European Medicines Agency recommends bimekizumab in two new indications
UCB, a global biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions recommending granting marketing authorization for bimekizumab in the European Union (EU) for the...
Drug Research
FDA approves the manufacture of new microbiome-based therapeutic VOWSTTM at Recipharm site
Recipharm, a Global contract development and manufacturing organization (CDMO), has announced today that its subsidiary, GenIbet Biopharmaceuticals, has been approved by the US FDA as a manufacturing site of VOWST, a breakthrough orally administered fecal microbiota product for the...
Drug Research
Critical Medicines Act Proposed By EU To Boost Drug Access
A group involving 19 European Union member countries is pushing for steps to lessen the bloc’s dependence when it comes to Chinese imports as far as pharmaceutical ingredients are concerned, according to a paper dated May 2.
This move comes...
Drug Research
EU Drug Regulation Proposal Sparks Pushback From Industry
The EU's drug regulations can get a major makeover soon. In a set of proposals, the European Commission looks to address numerous shortfalls troubling the $148 billion pharmaceutical industry. The proposed upgrades give out the most significant revisions across...
Drug Research
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...
Drug Research
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...
Drug Research
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...
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