API facility issues cause FDA to reject Pozen drug candidates
Deficiencies of at an unnamed API supplier caused the US FDA to reject Pozen’s aspirin-based drug candidates with a complete response letter (CRL).
Archives for April 28, 2014
Biopharma turns to outsourcing for more common, simple tasks, survey finds
Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.
Orphan drug market offers opportunities for direct-to-patient logistics firms
As regulators incentivise the development of orphan medicines and high price tags for the drugs continue to rise, logistics specialists are offering new ways to get the drugs to the increasingly small patient populations.
CRO shares drop after Pfizer AstraZeneca merger rumours
The recent rumours of mega-mergers are behind a sudden drop in the share value of contract research organisations (CROs) but should bring long-term benefits, says an analyst.
'No longer simply a capsule provider' - Capsugel wins oral peptide contract
Capsugel is no longer a simple capsule provider but a differentiated player in the CDMO industry, the firm says as it wins a scale-up manufacturing contract for Chiasma and Roche’s oral octreotide candidate.
Crown and SNBL partner for challenging Japanese CRO market
Crown Bioscience has teamed up with Shin Nippon Biomedical Laboratories (SNBL) to navigate obstacles in the Japanese outsourcing market.
Swiss gold delivers hope as carrier for cancer drugs
Researchers in Switzerland have devised a form of gold nanoparticle that shows promise as a weapon against tumours and as a delivery vehicle for drugs.