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Breaking News on Contract Research, Manufacturing & Clinical Trials

Cobra Biologics and Alligator Bioscience extend partnership

23-Jun-2016 - Cobra Biologics has been re-contracted by Alligator Bioscience to support cell line development for an immune-oncology antibody.

AMRI licenses Teewinot's cannabinoid analytical standard production tech

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.

Juniper invests in tablet technology for UK site

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.

Japanese firms form monoclonal antibody manufacturing JV with an eye on biosims

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.

Phalanx Labs banned from shipping APIs to US after refusing inspection

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.

Indian drug advisory board backs proposed API import license fee hike

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).

correction

The strife of Pii: UK MHRA finds GMP deviations at two facilities

15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).

Famar to buy Spain formulation plant from Roche

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.

Update

Almac facility successfully passes FDA inspection

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.

CDSCO renews API firms' 'written confirmations' days after industry raises trade concerns

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...

updated

MHRA says Akums' cannot prove progesterone made at Hardiwar plant is sterile

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.

Hovione aims to be big in Japan, citing growing demand for generic APIs

09-Jun-2016 - Hovoine has opened a sales office in Osaka, Japan citing growing demand for generic APIs and manufacturing services.

Dispatches from BIO 2016

Brammer Bio opens new cell and gene therapy manufacturing facility

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.

Dispatches from BIO

Dedicated or condominium? Patheon talks 'creative' capacity models at BIO

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.

CORRECTION - Dispatches from BIO 2016

Merck & Co. and Fujifilm team to share capabilities at new $60m microbial plant

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.

update

Cobra and Touchlight aim to make AAV vector production faster and cheaper

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.

Dispatches from BIO 2016

BioDuro launches as CDMO at BIO International

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.

CMC Biologics expands GMP manufacturing capacity in Denmark

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.

Megafine must investigate data faking at banned API plant says US FDA

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...

Granules 483-hit API plant receives all clear from US FDA

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.

Oasmia reviewing proposals from firms interested in API solubility enchancement tech

31-May-2016 - Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.

US FDA warns CordenPharma about Italian antibiotic API and cancer injectables plant

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.

Safety board clears TxCell to restart Ovasave study that was halted 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.

Xellia starts work on testing lab at Hungary API plant citing growing demand

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.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.

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