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Breaking News on Contract Research, Manufacturing & Clinical Trials

Device advice: Intertek study shows its key to consider devices in formulation development

26-Aug-2015 - Pharma firms developing inhalable drugs often fail to test that their formulations are compatible with their intended delivery devices early enough according to the Intertek team behind research stressing the...

Recipharm to make 3-API drug for Israel’s RedHill

26-Aug-2015 - Swedish CDMO Recipharm will contract manufacture a three-drug combination antibiotic for emerging Israeli biopharma RedHill.

GSK backtracks on Memphis divestment plans, invests $2m

25-Aug-2015 - A GSK facility in Memphis Tennessee which was scheduled to be sold off will now receive $2m to improve its manufacturing infrastructure.

News in brief

CMO Regis Technologies opens potent API site

25-Aug-2015 - Regis Technologies has opened a site for manufacturing highly potent active pharmaceutical ingredients (HPAPIs) in Illinois.

Compound interest: QuVa buys Healix’s 503B outsourcing facility

24-Aug-2015 - QuVa Pharma has bought an outsourcing facility from Healix in the first step in an effort to establish a national compounding pharmacy chain.

Hemispherx secures replacement for blood cell supplier BioLife

24-Aug-2015 - Hemispherx has signed supply deals with US blood centres to address supply issues that delayed relaunch of genital wart drug, Alferon.

Pfizer’s $17bn Hospira deal set to close in September after US FTC clearance

24-Aug-2015 - Pfizer has received the final regulatory clearances to acquire Hospira but the US FTC says it must divests four sterile injectable products.

Unilife whistleblower case blows over; Ex-exec apologises

20-Aug-2015 - An erstwhile whistleblower who accused Unilife of fraud and violating US FDA validation regulations has apologised and withdrawn his allegations.

Xellia moves US HQ to North Carolina

20-Aug-2015 - Anti-infectives firm Xellia has moved its North American HQ to the lyophilisation plant in Raleigh, North Carolina that it bought from Fresenius Kabi last July .

Italy bans 7 APIs from compounding pharmacies after off-label abuse

20-Aug-2015 - The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.

Pharma plants strike in Pakistan to protest QC rule changes

19-Aug-2015 - Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.

Can nuclear deal make Iran a contract manufacturing destination?

19-Aug-2015 - There’s little chance US companies will consider Iran as a venue for pharmaceutical contract manufacturing, even in the current era of limited détente between the two countries, experts say....

Pfenex, Emergent win multi-million dollar US government contracts

18-Aug-2015 - Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.

Excipient manufacturers raise concerns over stability testing

13-Aug-2015 - Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.

CMC Biologics to manufacture mAbs for Malaria Vaccine Initiative

13-Aug-2015 - The Bill & Melinda Gates Foundation’s PATH Malaria Vaccine Initiative (MVI) has selected CMC Biologics for process development and manufacture of specific monoclonal antibodies (mAbs) to test for their capacity...

CMO use on the up, low margins ahead

12-Aug-2015 - Contract manufacturing will rise over the next five years as drugmakers feel the pressure to reduce supply chain time, and choose to focus on in-house R&D rather than conduct their...

WuXi finds success in pilot testing of edible microtags

11-Aug-2015 - Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.

Roundup of recent CRO, CDMO news

10-Aug-2015 - A host of recent small deals, expansions, office openings and other news from CDMOs (contract development and manufacturing organizations) and CROs (contract research organizations) around the world.

News in brief

CMO Amneal buys former J&J plant in Ireland

06-Aug-2015 - New Jersey-based generics CMO (contract manufacturing organization) Amneal Pharmaceuticals has purchased a 200,000 square foot facility in Cashel, Ireland. 

News in brief

US FDA to review new drug application using Catalent softgel drug delivery tech

05-Aug-2015 - The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel...

AMRI acquisitions driving up contract revenue in Q2

05-Aug-2015 - With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio , two Aptuit facilities and a UK aseptic facility pay off.

Update

Baxter CMO business to decline 10% after loss of ‘major customer’

04-Aug-2015 - Baxter’s contract manufacturing business is expected to take a nearly 10% hit as one of its "major customers" has elected to self-manufacture products previously made by the CMO (contract manufacturing...

TxCell: we’ll continue to use CMO even after we get back our GMP

04-Aug-2015 - French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.

Xcelience invests in CMO Powdersize

03-Aug-2015 - CDMO (contract development and manufacturing organization) Xcelience has made a structured cash investment in Pennsylvania-based Powdersize, which specializes in milling, micronization and powder size classification.  

AMRI's business risk profile 'weak,' says S&P

27-Jul-2015 - A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO...

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