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Breaking News on Contract Research, Manufacturing & Clinical Trials

Avista completes $4m facility expansion at former Microtest Labs

27-Mar-2017 - The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.

DCAT WEEK '17

CDMOs outline new initiatives, investments at DCAT Week

21-Mar-2017 - Manufacturers are investing in capacity and technology to help close the “market gap” for services while expanding to new locations across the globe.

DCAT WEEK '17

DCAT 17: Outsourcing-Pharma goes to New York

21-Mar-2017 - Didn't make it to New York, New York? Outsourcing-Pharma did and we bring you the best of Twitter from this CDMO-heavy event:

Ideal Cures 'building business' with PE investment

15-Mar-2017 - Idea Cures has announced an investment from the global private equity firm, TA Associates, as it aims to grow its manufacturing business.

Nicox resubmits AC-170 NDA after API supplier resolves GMP issues

09-Mar-2017 - Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug...

Mithra CDMO signs up a second Estrogen drug in 20-year Fuji deal

06-Mar-2017 - Mithra CDMO has entered a second agreement for Fuji Pharma to commercialise Donesta in Asia, another of Mithra’s estrogen-based hormone drugs.

Brexit and EU regulations motivate Quotient US buyouts

02-Mar-2017 - UK-based Quotient Clinical’s CEO cites Brexit and upcoming changes in European trial regulations as the motivation for acquiring US CDMO businesses.

PEOPLE ON THE MOVE

Outsourcing-Pharma's Hiring and Firing Roundup February '17

28-Feb-2017 - Outsourcing-Pharma presents this month's roundup of who is moving where in the contract research and manufacturing industry.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 - Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

Selecta hires Lonza to make synthetic vector delivered gene therapy

17-Feb-2017 - Selecta Biosciences Inc. has hired Swiss contractor Lonza to make a gene therapy candidate for the metabolic disease, Methylmalonic Acidemia (MMA).

Teewinot ups cannabinoid production capabilities

16-Feb-2017 - Teewinot Life Sciences Corporation’s cannabinoids are now available for research and development as the company looks to establish new partnerships.

Charles River splits off and divests CDMO business

16-Feb-2017 - Charles River Laboratories International Inc. has sold off its CDMO business QS Pharma LLC, saying the small-molecule manufacturing business was “not optimized” within the firm's portfolio.

Is the return of the one-stop-shop model just a CMO marketing ploy?

16-Feb-2017 - End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.

Quotient buys QS Pharma in latest US expansion move

15-Feb-2017 - Quotient Clinical Ltd. has bought Charles River Laboratories’ contract manufacturing business, QS Pharma LLC.

Bio-outsourcing share to drop as Big Pharma invests heavily in-house, analyst

15-Feb-2017 - CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.

Evotec to hire across all sites with new €90m Novo investment

13-Feb-2017 - Novo A/S is buying an additional €90m of shares in Evotec AG to accelerate and expand the German CRO’s outsourcing services.

BriaCell files CMC amendment and preps for breast cancer vaccine trial

10-Feb-2017 - BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer. 

AUTOLOGUS CELL THERAPY

Opexa 'eliminates major liabilities' by selling Texas facility to KBI

06-Feb-2017 - CDMO KBI Biopharma, Inc. has acquired the lease and assets of Opexa Therapeutics’ facility in Texas after the firm’s lead MS candidate failed Ph IIb.

CDMO Rentschler looks to highlight importance of drug formulation

06-Feb-2017 - Rentschler Biotechnologie has announced a strategic alliance with Leukocare through which the CDMO hopes to emphasize drug formulation as a “key success factor” in drug development.

Patheon well placed if Trump succeeds in bringing manufacturing home, analyst

02-Feb-2017 - Patheon could reap the benefits of President Donald Trump’s call for increased drug production in the US by upping capacity utilisation an analyst says.

Key Industry Events