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Breaking News on Contract Research, Manufacturing & Clinical Trials

Japanese companies acquire CMO KBI Biopharma

26-Feb-2015 - Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research...

News in brief

Bayer manufactures for biologics start-up in CoLaborator project

26-Feb-2015 - Bayer has announced a strategic alliance to manufacture a preclinical candidate for small biotech Aronora.

Sagent shifts production in-house after US FDA concerns about CMO Emcure

25-Feb-2015 - Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.

Catalent wants to raise $630m through follow on offering

24-Feb-2015 - Catalent wants to raise $629.3m (EUR550m) through a follow-on offering that will see Blackstone sell 17.6m shares.

Syringe reuse not clever: WHO advocates use of "smart" syringes to stop disease spread

23-Feb-2015 - ‘Smart’ syringes that can’t be reused should be the drug and vaccine delivery technology of choice for healthcare programmes according to the WHO, which says needle reuse is spreading deadly...

Facility already supplying Granules' JV partner Ajinomoto Omnichem with validation batches

Granules predicts US and EMA approval for new API plant in two years

23-Feb-2015 - An API and intermediates plant set up by Granules India and Ajinomoto Omnichem is a step closer to opening after an offical inauguration ceremony last week. 

Rebooting HAL part of Indian plans to boost API capacity and cut relaince on China

19-Feb-2015 - The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.

Lonza enters licensing agreement to help produce arGEN-X antibodies

19-Feb-2015 - Swiss CMO Lonza and clinical-stage biopharma company arGEN-X have entered into a multi-product commercial license agreement for making arGEN-X’s therapeutic antibodies. 

Novasep signs €4.7m biomanufacturing deal with biotech

18-Feb-2015 - Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.

Fresenius Kabi sells cancer compounding biz to NewCo Pharma

17-Feb-2015 - Fresenius Kabi has sold its cancer drug pharmacy network CFL GmbH to NewCo Pharma GmbH five years after spending €42m to buy compounding capacity in Germany.

More US FDA draft guidance for compounders

16-Feb-2015 - The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.

PE-backed Laurus Labs sets up US drug ingredients business

16-Feb-2015 - Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.

survey

Ever wanted to buy catalysts on your iPhone? Now you can thanks to Johnson Matthey

16-Feb-2015 - Quick question for chemists: Have you ever wanted to research chemical reactions and buy catalysts on your mobile phone? 

Enteris plans to beat established API CMOs on lead times

16-Feb-2015 - Enteris Biopharma says it can compete with established API CMOs by offering shorter lead times and greater flexibility.

AMRI looks to close API facility in Wales as part of network realignment

12-Feb-2015 - AMRI has announced plans to close an API development and manufacturing plant in Wales, UK, after efforts to establish it as a conduit between the US and Europe were deemed...

Ex-Unigene execs who run Enteris add API contracting service to delivery tech licensing business

12-Feb-2015 - Enteris BioPharma has broadened its business beyond drug delivery tech licensing and launched a contract API manufacturing service.

Penn is mightily pleased with safety record

10-Feb-2015 - Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.

Unilife upping device production as market opportunity offsets flat sales

10-Feb-2015 - Unilife Corporation has ramped up production of delivery devices as pharmas looks to differentiate injectable therapies from the competition.

Juno Therapeutics adds new biomanufacturing facility in Washington, will continue using CMOs

10-Feb-2015 - Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.

Cambrex: ‘Either we invest now or turn away API business”

09-Feb-2015 - Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.

Provenge in a dish not yet sold: Valeant ups Dendreon offer after competing bids

06-Feb-2015 - Bankrupt cell therapy firm Dendreon has attracted more suitors according to stalking horse bidder Valeant, which upped its offer for the Provenge (sipuleucel-T) developer to $400m this week.

Dispatches from InformEx

What helps an outsourcing partnership? Be up front about the bad news

06-Feb-2015 - When it comes to forging solid relationships between CMOs (contract manufacturing organizations) and drug developers, one thing is clear: deviations will occur.

Dispatches from InformEx

Post-IPO Catalent turns to internal investments to meet new demands

05-Feb-2015 - With its stock up about 35% since its IPO , Catalent is continuing to invest internally to meet the growing demands of its clients.

Water Street targets generic injectables sector with CMO buy

05-Feb-2015 - Water Street Healthcare Partners has bought US generic injectables contractor Custopharm.

Think you’re on track for 2018 EU serialisation? No you’re not

04-Feb-2015 - Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.

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