23-Jun-2016 - Cobra Biologics has been re-contracted by Alligator Bioscience to support cell line development for an immune-oncology antibody.
22-Jun-2016 - AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.
22-Jun-2016 - Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.
21-Jun-2016 - Mitsubishi Gas Chemical and Nippon Kayaku have said they will start making monoclonal antibody drugs at a site in Niigata, Japan within two years.
17-Jun-2016 - The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
16-Jun-2016 - A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).
15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).
15-Jun-2016 - Famar will buy a Roche solid dose manufacturing facility in Spain in an agreement that will also see it make drugs for the Swiss pharmaceutical giant.
14-Jun-2016 - The global contract development and manufacturing organization (CDMO) announced that its Durham, North Carolina-based facility completed a successful US Food and Drug Administration (FDA) inspection.
13-Jun-2016 - CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection...
13-Jun-2016 - The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
09-Jun-2016 - Hovoine has opened a sales office in Osaka, Japan citing growing demand for generic APIs and manufacturing services.
08-Jun-2016 - The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.
08-Jun-2016 - With problems in forecasting capacity demand, biopharma is looking to a number of new models from third-party manufacturers according to Patheon.
07-Jun-2016 - A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.
07-Jun-2016 - Cobra Biologics has teamed up with Touchlight to test an AAV vector production platform they claim will make manufacturing gene therapies for trials cheaper and faster.
07-Jun-2016 - The global contract research organization (CRO) announced the formal launch at BIO International, which takes place this week in San Francisco, CA.
02-Jun-2016 - CMC Biologics as upped its production capacity at its Copenhagen facility with plans to have equivalent capacity on both sides of the Atlantic in 2017.
01-Jun-2016 - The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US...
31-May-2016 - A Granules API plant in Hyderabad which received a Form 483 with three observations has been given the all clear by the US FDA.
31-May-2016 - Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.
30-May-2016 - The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.
27-May-2016 - TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.
26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.