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Breaking News on Contract Research, Manufacturing & Clinical Trials

The patent lives in Hospira v MedCo: good news for CMOs

21-Jul-2016 - The Medicines Company announced last week  that its Angiomax patent has been upheld – an 'important court decision' which affirms that working with CMOs won’t invalidate a company's patent....

Patheon will list on NYSE today

21-Jul-2016 - API and drug maker Patheon will begin trading on the New York Stock Exchange under the symbol PTHN later today.

Johnson Matthey: Q1 API revenues down on order timings

20-Jul-2016 - Johnson Matthey said a slight decrease in API sales during the first quarter of its fiscal year was due to the timing of customer orders.

MilliporeSigma investing $115m in new North American hub

19-Jul-2016 - The 280,000-square-foot facility will be built in Burlington, Massachusetts and will include a customer collaboration laboratory and training center, in addition to office space.

Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech

19-Jul-2016 - A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.

FDA adds 4 API manufacturers to 'Red List'

19-Jul-2016 - Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”

CDMO Vetter to invest $320m in US-based manufacturing facility

13-Jul-2016 - The new manufacturing facility is the first of its kind to be developed outside of the company’s headquarters in Germany.

Cambrex makes 'Pharma 3' plant operational after equipment delivery delays

13-Jul-2016 - Cambrex has brought a delayed Iowa API facility online and completed work on a shell plant that can be tailored to specific projects. 

Apax: Latest generics takeover Invent Farma will include API division Inke

13-Jul-2016 - Private equity fund Apax Partners will take control of Spanish API manufacturer Inke when it completes the acquisition of Invent Farma later this year.

AMRI completes €315m Euticals takeover to add capacity to API business

12-Jul-2016 - AMRI has completed the acquisition of Italian API firm Euticals for €315m ($350m).

News in brief

Patheon launches IPO

12-Jul-2016 - Patheon NV has launched its IPO a year after announcing its intention to go public.

Exclusive interview

Regulatory changes 'defining' serialization processes: key considerations and opportunities

11-Jul-2016 - With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.

French plant transfers to Vectura Group as Aenova's lease ends

05-Jul-2016 - Aenova’s lease of a manufacturing plant in France has ended and the facility has been transferred back to SkyePharma, now part of the Vectura Group.

Serialisation regulations to impact all corners of pharma, says Recipharm

27-Jun-2016 - The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.

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.

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