Cedarburg Hauser's DEA Approval Brings Niche Manufacturing Home

28-Feb-2013 - Cedarburg Hauser says US CDMOs are focusing on “niche fields” in order to gain a competitive advantage on foreign competition.

People on the Move: Outsourcing Jobs

28-Feb-2013 - Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry.

Profectus Shifts to US CMO for DNA Vaccine Production

28-Feb-2013 - Profectus BioSciences has signed up San Diego-based CMO Althea Technologies to manufacture DNA vaccines after its deal with Boehringer Ingelheim ended due to currency issues.

BIO, PhRMA Blast FDA Draft Guidance on E-Subs for Trial Site Data

28-Feb-2013 - Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time...

Covance Moves Further into Personalized Medicine with Collaboration

27-Feb-2013 - CRO Covance is teaming up with M2Gen’s cancer-focused database to increase its ability to match more patients in oncology trials based on their tumour profiles. 

South Africa & Lonza Venture Hits Delay on API Facility Construction

27-Feb-2013 - A South African and Lonza joint project says issues in funding, competitiveness and green technologies have delayed construction of its API plant.

Albemarle Expands Manufacturing Capacity in Pennsylvania

27-Feb-2013 - Albemarle is adding new capacity at its manufacturing facility in Pennsylvania with a $30 million expansion.

Hospira Recalls Lots of Five Injections as FDA Re-Inspection Continues

27-Feb-2013 - Hospira has announced it is voluntarily recalling multiple lots of five different injections  because of customer reports of faulty packaging and contamination. 

Distribution Deals: GVKBIO in Taiwan; Sanofi in Austria

26-Feb-2013 - GVK Biosciences says it is looking to target Taiwanese clients following a distribution deal with GGA over its clinical databases.

Outsourcing Acquisitions from Eurofins, Illumina, McKesson

26-Feb-2013 - Eurofins, Illumina and McKesson have gone shopping and are showing off their new purchases – welcome to Outsourcing-Pharma.com’s acquisition round-up.

Icon Beats Q4 Estimates, Prepares for Revenue Uptick in 2013

26-Feb-2013 - Ireland-based CRO Icon unveiled higher than expected revenue and backlog increases in 2012 when compared to 2011, and the company expects even stronger results in 2013.

West: Proprietary Products Propped by Packaging and Manufacturing

25-Feb-2013 - West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.

Dispatches from Informex

Biopharma CMO Market’s Recent Downturn Could be Short-Lived

25-Feb-2013 - Biopharmaceutical CMOs have seen their business slowly shrink as companies seek less volume and smaller batches, but outsourcing is expected to increase over the next three years.

BASF says Bend Accord Targets Different Chemistries than Dow deal

25-Feb-2013 - Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.

Recipharm Says Developing Trust is Key to Taking on Contracts

25-Feb-2013 - Recipharm says taking on a contract started by another CMO is an exercise in building trust and gathering information as rapidly as possible.

News in brief

Lonza wins $7m US NIH stem cell contract

21-Feb-2013 - Lonza has won a second US NIH contract to manufacture stem cells for medical research.

CiToxLAB Beats Preclinical Market Trends

21-Feb-2013 - CiToxLAB says strong revenue growth in 2012 was due to a new global status following its acquisition of Lab Research.

People on the Move: Outsourcing Jobs

21-Feb-2013 - Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry.

Collaboration With Britest Already Paying Off Says Aesica

21-Feb-2013 - UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment. 

ProBioGen in ADCC Enhancement License Deal with Big Pharma

20-Feb-2013 - CMO ProBioGen says its GlymaxX ADCC antibody enhancement technology can be adapted to any biomanufacturing cell line and will attract both Big and Small Pharma.

Dispatches from Informex

Intermediate CMOs Shift Attention to Nucleoside Development

20-Feb-2013 - CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.

Update

Baxter Expands its Cytotoxicity Capabilities - Again

19-Feb-2013 - Baxter says there is a trend towards outsourcing for cytotoxic manufacturing as it begins further expansion of its German plant.

Biocatalysis Becoming Big Business for CMOs

19-Feb-2013 - Biocatalysis is emerging as a hot topic for CMOs in 2013 with AMRI, Almac and DSM all citing drug industry demand as the driver for recent collaborations.

Pfizer to Cut Another Research Unit, Lay Off 100 Employees

19-Feb-2013 - In its second announcement of a closing research unit in little more than a week, Pfizer will axe its peptide therapeutic R&D unit CovX Research in San Diego, CA and...

Dow Signs Up Cambrex for Bioavailability Partnership

19-Feb-2013 - Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.

Takeda Cracks Down on CMO Plant Suspended After Manufacturing Violation

19-Feb-2013 - Takeda says it will help Nihon Pharmaceuticals bring manufacturing operations up to code after Japanese regulators order the CMO to halt production and recall one lot of its vitamin B1...

AMRI to Focus on Large Scale Manufacturing

18-Feb-2013 - AMRI has predicted continuing revenue growth in its contract manufacturing with its API pipeline and once-troubled Burlington site leading the way.

Charles River Sees Flat Quarter, Expectations for 2013 Still High

18-Feb-2013 - CRL (Charles River Laboratories) saw a number of setbacks in the last quarter of 2012 but still expects growth in 2013.

News in brief

Merck & Co Agrees to $300m Research Contract with Lycera

18-Feb-2013 - Merck & Co and Lycera have signed a preclinical research deal that could be worth up to $300m if certain milestones are met.

Quintiles Confirms 'Go Public' Speculation with IPO and Predicts Rosy Future for CROs

18-Feb-2013 - Quintiles painted a rosy picture of the CRO sector in its much anticipated IPO, predicting that biopharma R&D spending will increase and demand for outsourced research will grow. ...

Hospira’s Manufacturing Woes Continue with US Device Plant 483

14-Feb-2013 - Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.

News in brief

SGS Expands Viral Trials: ‘Less Volunteers, Less Cost to Client’

14-Feb-2013 - SGS says the expansion of its Belgian unit will offer a new approach in its clinical trials involving smaller sample sizes.

People on the Move: Outsourcing Jobs

14-Feb-2013 - Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry.

PPD Expands Central Lab Services in Brussels, Singapore

14-Feb-2013 - PPD has expanded its central lab testing services at its Brussels and Singapore labs and will offer additional services in microbiology, peripheral blood mononuclear cell and molecular pathology services.

Outsourcing, Partners Necessary to Make Inroads in China for Small Biotech, Experts Say

13-Feb-2013 - Small biotech companies looking to crack into the increasingly lucrative Chinese pharma market need to outsource or partner with a local company in order to bring their products to market...

Lantheus: 'Supplier Diversification' Strategy After Ben Venue Shutdown

13-Feb-2013 - The US FDA has expedited approval of Jubilant HollisterStier manufacturing sites in further fallout from Ben Venue’s consent decree.

BMS Manufactures for Now as Reckitt Benckiser Enters Latin America

13-Feb-2013 - Bristol-Myers Squibb (B-MS) will continue to make the OTCs it licensed to Reckitt Benckiser for the time being but will hand over manufacturing if the UK drugmaker buys them outright.

Recipharm and PledPharma Tackle Oxidative Stress

12-Feb-2013 - Recipharm has penned a deal to supply the material for trials of a new drug designed to prevent side-effects in chemotherapy patients. 

Reader Poll

Would you invest in a public Quintiles?

12-Feb-2013 - Rumours of a Quintiles IPO will not go away but as yet nothing has been confirmed. 

Beximco starts shipping Formulations to Europe

12-Feb-2013 - Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.

TFS to buy Semcon Caran's EDC business

12-Feb-2013 - Swedish CRO Trial Form Support has announced plans to make its second late-stage, IT focused acquisition in the space of three months.

More CRO Trial Opportunities in Alzheimer’s as FDA Releases Draft Guidance

11-Feb-2013 - More flexible regulations on the path for approving potential Alzheimer's disease treatments represent a huge opportunity, according to the US FDA, CROs and research advocates.

Update

Teva to Sell Californian Plant as Part of Cost-Cutting Initiative

11-Feb-2013 - Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.

Swedish Body Certifies Bend Research for EU GMP Compliance

11-Feb-2013 - Bend Research says collaboration between the Swedish MPA and the US FDA was the reasoning in pursuing GMP from the European body.

Pfizer to Shutter Clinical Research Unit in Singapore

11-Feb-2013 - As part of wider R&D cuts, Pfizer will close its clinical research unit in Singapore later this year and lay off about 30 employees. 

People on the move: Outsourcing jobs

07-Feb-2013 - Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the pharma service industry, including news from Recipharm, Aesica and SMS Oncology.

Lilly drives expansion at Rexam's insulin pen manufacturing plant

07-Feb-2013 - Rexam says that expansion of its French plant is led by Lilly and the growing demand for insulin delivery products.

Uncertainties Abound in Indian Draft Clinical Trial Amendment

07-Feb-2013 - Proposed amendments to Indian clinical trial laws on compensation are confusing and potentially problematic for sponsors and CROs says ACRO.

QPS adds Phase I capacity in the US with MRA buy

07-Feb-2013 - QPS has acquired Florida-based trial site Miami Research Associates (MRA), adding first-in-man capacity to its US services offering.

GVKBIO extends license of biomarker database to FDA

06-Feb-2013 - GVK Bioscience has granted the US FDA further access to its clinical biomarker database following an extension of its license agreement.

FDA approves packaging plant as Almac welcomes US clients

06-Feb-2013 - Almac says that FDA approval of its commercial packaging plant will open doors to fulfill demand from the US market.

M&A motivations differ for CROs and PE investors but deals will continue, says broker

06-Feb-2013 - CROs invest in scope and scale while private-equity groups buy firms they can expand according to Fairmount Partners’ managing director, Neal McCarthy.

GSK, European Parliament Begin Push for Clinical Trial Transparency

06-Feb-2013 - A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to...

Lonza rejigs ops and says more changes are to follow

05-Feb-2013 - Lonza has reorganised its operations into two new divisions – Pharma and Specialty ingredients – and says more changes are on the way.

CMOs, CROs will Report Payments to Doctors Under Final 'Sunshine' Rule

05-Feb-2013 - CMOs and CROs must notify sponsors of payments made to physicians on their behalf under long-awaited US 'Sunshine' rules published last week.

update

Trials published by Pfizer didn't match internal docs say researchers calling for CONSORT revision

05-Feb-2013 - Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal...

Icon to Acquire Clinical Trial Services Division for $52m

05-Feb-2013 - Icon has agreed to purchase the clinical trials services division of Cross Country Healthcare for $52m to primarily expand its staffing, pharmacovigilance and drug safety services.

Bioavailability drives Patheon and Catalent investments

04-Feb-2013 - Patheon says expanding its UK facility is necessary in offering its Solupath services to a European and Asian market.

Solvias buys Confarma for EU pharma quality control capacity

04-Feb-2013 - Solvias has bought quality control services firm Confarma, expanding its analytical offering and adding capacity in several EU markets.