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Breaking News on Contract Research, Manufacturing & Clinical Trials

Compound interest? US FDA sets up compounding pharmacy advisory committee

17-Dec-2014 - The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

We’ll needle more space: Vetter ready for early-stage syringe filling

12-Dec-2014 - German contract development and manufacturing organisation (CDMO) Vetter has built a facility for pre-clinical and clinical syringe filling in Chicago.

'Off the shelf' stem cell firm to benefit from in-house facility, says analyst

12-Dec-2014 - Analyst firm N+1Singer has endorsed stem cell manufacturer Reneuron based on its “off-the-shelf” therapy pipeline and a new facility that will reduce the need to outsource.

After AZ R&D exit, CMOs anxious to keep pharma in the country

11-Dec-2014 - Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.

Peregrine expanding own CMO to make mAb candidate rather than outsource

11-Dec-2014 - Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.

US government offers legal immunity to Ebola vaccine manufacturers, CMOs

10-Dec-2014 - Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.

Meda cuts Recipharm contract: Swedish plant and jobs under threat

04-Dec-2014 - Meda has terminated a manufacturing contract with Recipharm which says a facility in Sweden and up to 60 jobs could be at threat.

CMO use to grow despite Big Biopharma's in-house spend, say experts

02-Dec-2014 - Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”

Mylan in tech transfer to make Gilead's HIV drugs for developing world

01-Dec-2014 - Mylan will manufacture and distribute Gilead's antiretroviral HIV drugs, following a tech transfer, in order to increase access in developing countries.

Recipharm adds French plant and drug delivery tech in strategic deal with Flamel

27-Nov-2014 - Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies. 

AMRI re-opens troubled sterile injectable facility in New Mexico

25-Nov-2014 - AMRI’s Albuquerque, New Mexico sterile injectable facility has resumed full manufacturing operations following an environmental deviation. 

German CMO looks to grow US biz through rise in SMEs and virtual pharma

24-Nov-2014 - Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO....

$15k and API info: FDA releases guide to registering drug compounders

24-Nov-2014 - The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.

Dispatches from the FT Global Healthcare and biotech conference

Experts: Outsourcing levels could push 80% if CMOs seize future demands

20-Nov-2014 - Catering for low value, high volume customers as well as the growing number of firms developing complex drugs will be a big challenge in the era of personalised medicine according...

'Killer experiments' and reimbursement are the keys to VC backing says Index

17-Nov-2014 - Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are much more attractive.

Catalent to tap particle size engineering industry with Micron buy

17-Nov-2014 - Last week CDMO Catalent acquired Micron Technologies, a provider of particle size engineering technologies, with the aim of improving its early stage tech offering.

Recipharm eyes Portugal and opthalmics with SEK1bn Lusomedicamenta buy

17-Nov-2014 - Recipharm has bought Portugal-based contractor Lusomedicamenta for SEK1bn ($1349m) following up on the plan to add manufacturing capacity that it outlined after going public this summer .

Wuxi manufacturing continues to roll, two new facilities on the way

17-Nov-2014 - With biologics declared as its main driver over the next few years, CDMO Wuxi is seeing rapid manufacturing growth and planning two new facilities in the next two years.

In-house manufacturing investments ‘trounce’ outsourcing spend, report finds

13-Nov-2014 - Biopharma companies are not likely to outsource a larger chunk of their manufacturing than they have in the past 10 years, according to a new report from PharmSource.

Aseptic manufacturers must invest in latest GMP compliance, says UK CMO

11-Nov-2014 - Investing in GMP compliance regulations is key to success in sterile manufacturing says UK-based Symbiosis which is looking to capitalise on gaps left by recent CMO pullouts.

API shipment delays, New Mexico site issues hamper AMRI Q3 earnings

11-Nov-2014 - Power interruptions and remediation work at AMRI’s Albuquerque, New Mexico facility, as well as unexpected delays to API shipments have driven down the company’s Q3 profits.

Dispatches from AAPS 2014

GSK ‘moves best people’ to keep Ebola vaccine manufacture in-house

07-Nov-2014 - GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.

Dispatches from AAPS

Encapsulating the problem? Machinery could save drugmakers up to $1m, says Capsugel

06-Nov-2014 - Using encapsulation machinery that is well serviced and appropriate to the type of powder being used can save drugmakers hundreds of thousands of dollars, according to Capsugel

Dispatches from AAPS

Kemwell announces Cirrus to produce trial supplies in 'flexi suite'

05-Nov-2014 - Kemwell’s daughter company Cirrus will start manufacturing pharmaceuticals for clinical trials out of a GMP suite set to open in North Carolina.

Warburg Pincus buys 32% stake in Laurus citing ARVs and global opportunities

03-Nov-2014 - Warburg Pincus has bought a 32% stake in Indian API maker Laurus Labs Private Limited citing the ARV drug ingredients market and international opportunities as drivers.

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