05-Aug-2015 - The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel...
05-Aug-2015 - With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio , two Aptuit facilities and a UK aseptic facility pay off.
04-Aug-2015 - Baxter’s contract manufacturing business is expected to take a nearly 10% hit as one of its "major customers" has elected to self-manufacture products previously made by the CMO (contract manufacturing...
04-Aug-2015 - French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.
03-Aug-2015 - CDMO (contract development and manufacturing organization) Xcelience has made a structured cash investment in Pennsylvania-based Powdersize, which specializes in milling, micronization and powder size classification.
27-Jul-2015 - A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO...
24-Jul-2015 - Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.
24-Jul-2015 - Patheon has sold a production plant in Italy to LIVIA and agreed to a management buyout at a site in Austria as it prepares to go public.
23-Jul-2015 - Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).
23-Jul-2015 - Contract manufacturing organisation Regis Technologies has added an HPAPI (highly potent active pharmaceutical ingredient) service.
22-Jul-2015 - Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
22-Jul-2015 - Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
21-Jul-2015 - Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.
20-Jul-2015 - AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.
20-Jul-2015 - API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental...
17-Jul-2015 - Goodwin Biotechnology says making trial supplies of Q Therapeutics’ amyotrophic lateral sclerosis (ALS) cell therapy meant overcoming considerable technical hurdles.
17-Jul-2015 - Eisai has agreed to transfer ownership of its Research Triangle Park (RTP) manufacturing campus to Biogen, which will continue to manufacture oral solid-dose products and parenteral products at the sites...
16-Jul-2015 - Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialise its breast cancer candidate.
16-Jul-2015 - Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.
16-Jul-2015 - Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.
15-Jul-2015 - The almost-private China-based CDMO (contract development and manufacturing organization) WuXi is looking to reap larger rewards from investing in US and China pharma and biotech firms.
14-Jul-2015 - CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial...
14-Jul-2015 - CiMaas BV, a company developing cellular immunotherapies to treat cancer, has selected CMO (contract manufacturing organization) PharmaCell, to help in the clinical development and manufacturing of CiMaas’ ATMPs (Advanced Therapy...
13-Jul-2015 - Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.
13-Jul-2015 - Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483 with six observations.