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Breaking News on Contract Research, Manufacturing & Clinical Trials

French connection: Vaccine biomanufacturing service providers Accinov and Biodextris merge

05-Dec-2016 - Accinov has teamed up with Canadian clinical research organisation (CRO) Biodextris to provide a transatlantic biomanufacturing ‘plug and play’ service for biopharmaceuticals—with a particular expertise in vaccines.

Spain's Idifarma adds capsule filling to service offerings

01-Dec-2016 - Idifarma has invested over €300,000 in its facility in Spain in order to offer its customers automated capsule filling for commercial batches.

Vetter data processing center completes certification

30-Nov-2016 - Vetter's new data processing center at its headquarters in Ravensburg, Germany has met all criteria required to meet the European DIN EN 50600 standard.

WuXi AppTec inks new manufacturing services agreement with Lion Biotechnologies

29-Nov-2016 - Lion Biotechnologies has expanded its ‘favorable’ existing relationship with WuXi AppTec to manufacture its autologous cell therapy products.

How CMOs can fight back against the counterfeit drug market

29-Nov-2016 - Fighting counterfeit medications is a “team sport,” and contract manufacturing organizations (CMOs) play a “pivotal role,” says Applied DNA Sciences.

Cellectar secures 'extended partnership' to support clinical trial needs

29-Nov-2016 - Cellectar Biosciences has announced a partnership with the Centre for Probe Development and Commercialization (CPDC) to establish manufacturing capacity ahead of the company’s NCI-supported Ph II trial of CLR 131.

update

Patheon buys Roche's Xeloda API plant and signs supply deal

29-Nov-2016 - Patheon has bought a US API facility from Roche in a deal that will also see the CMO supply the Swiss firm with drug ingredients.

Compounding issues: gov’t watchdog releases drug compounding report

28-Nov-2016 - The FDA is still in “the early stages” of overseeing 503B outsourcing facilities, but efforts continue as concerns surround the oversight of drug compounders, according to a recent report by...

Ideal Cures adds new manufacturing facility at 'tax holiday' location

28-Nov-2016 - Ideal Cures has added a fourth manufacturing location at Sikkim in India to meet the demand of its local customers and to expand its global customer base.

Catalent adding OTC capsule maker Accucaps to global softgel network

28-Nov-2016 - Catalent will add two Canadian manufacturing facilities to its softgel network through the acquisition of Accucaps.

US FDA finalises contract manufacturing quality agreement guidance

24-Nov-2016 - A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.

Almac expands capabilities to meet pediatric formulations demand

23-Nov-2016 - The acquisition of a stick sachet packaging line from Merz expands Almac Group’s MHRA/FDA-approved UK commercial packaging facility to meet the growing demand for specialist packing solutions.

Swallowing Stars: MIT spin-out invents gastric device which solves problem of daily dosing

22-Nov-2016 - Lyndra Inc. has developed a star shaped gastric device which claims to solve the problem of delivering drugs with short half-lives.

Both small and large CMOs to benefit from pharma capacity and agility demands

21-Nov-2016 - Larger CMOs are likely to be better for commercial manufacturing but small players offer niche services and agility for lower volumes, say Symbiosis and Idifarma.

Two-thirds of pharmaceutical manufacturing is outsourced, ISR Reports

17-Nov-2016 - Only one-third of manufacturing is currently conducted in-house, from development stages to after commercial launch, according a recent report.

Almac announces £27m global expansion

11-Nov-2016 - The Almac Group is planning to expand its operations in Europe and North America with an investment totaling £27m across three sites.

Slovakian CDMO Saneca ups capabilities after controlled release contract win

10-Nov-2016 - Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.

Trump presidency unlikely to ‘materially’ impact CROs

09-Nov-2016 - Analysts suggest a Trump presidency won’t have a material impact on contract research organizations – though a shake-up in trade policy could complicate the larger, global pharmaceutical industry.

New serialization platform allows CMOs to use data 'in a smarter way'

08-Nov-2016 - Adents and Microsoft have introduced a new platform that allows contract manufacturing organizations (CMOs) to leverage data generated during the serialization process.

Biologics manufacturing services boost for Charles River Labs in Q3

04-Nov-2016 - Biologics manufacturing and testing activities helped Charles River Laboratories grow in Q3 and will drive further gains say analysts.

Catalent breaks ground on WI expansion to support commercial biomanufacturing

02-Nov-2016 - The $34m expansion at its Madison, Wisconsin site will support Phase III and commercial biologics production, says Catalent.

Recipharm invests €1.2m in Italian small-scale API capabilities

02-Nov-2016 - Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.

IDT Biologika to provide live virus filling and finishing services to BARDA

25-Oct-2016 - IDT Biologika has been awarded a five-year contract to provide live virus filling and finishing services in a deal worth up to $50m.

Almac discovers novel immune response mechanism

19-Oct-2016 - Almac Group’s Diagnostics business will engage with pharma to validate the link between its immune response assay and checkpoint inhibitor based therapy.

News in brief

CordenPharma completes API process bay for category 4 compounds

19-Oct-2016 - This week CordenPharma announced the completion of its new highly potent API process bay for category 4 compounds.

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