Breaking News on Contract Research, Manufacturing & Clinical Trials

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. 


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.

Outsourcing companies to see 'significant investments' from private equity

02-Feb-2017 - Outsourcing companies are expected to witness “significant investments” from private equity and venture capital, despite decreasing investment in the overall healthcare industry.

Chinese CDMO group buys New Jersey J-STAR for $26m

02-Feb-2017 - A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organisation, J-STAR Research, Inc. 

Saudi CDMO’s fill/finish plant to offer Big Biopharma access to local benefits

01-Feb-2017 - Saudi Biotech Manufacturing has selected Swedish engineering firm KeyPlants to design and build a fill/finish plant for biological APIs.


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

31-Jan-2017 - Outsourcing-Pharma presents this month's round up of who is moving where in the contract research and manufacturing industry.

German CDMO migrates 800 staff to newly opened €100m packaging site

26-Jan-2017 - Vetter will close one facility and migrate staff to the now open €100m expansion center for aseptic packaging of injectables at its headquarters in Ravensburg, Germany.


J&J buying Actelion for $30bn, but should CMOs be concerned?

26-Jan-2017 - With no production sites of its own, we question whether Johnson & Johnson’s manufacturing network is likely to incorporate Actelion’s substantial product portfolio.

SGS expands E&L testing services at New Jersey facility

26-Jan-2017 - SGS SA has expanded its Extractables and Leachables testing services with new equipment and specialist analysts at its facility in New Jersey, US.

Wuxi Biologics files IPO prospectus aiming to be gateway to China

25-Jan-2017 - Wuxi Biologics has confirmed its intention to go public in an IPO application that reveals the contracter has seen revenue double and profits increase three-fold since 2014. 

ADMA to buy US Biotest plant and fix problems that derailed RI-002

24-Jan-2017 - ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.

Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab

23-Jan-2017 - Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.


Servier universal CAR-T therapy outsourced to Belgian CDMO

18-Jan-2017 - Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.

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