Publication of a US FDA enforcement report detailing a recall by Ranbaxy in January saw the beleaguered Indian drugmakers’ share price fall 3% last week.
In a sign of further consolidation, CRO INC Research has acquired CRO MEK Consulting and will absorb its more than 40 employees based in the Middle East and north Africa.
Drug excipient makers in India and those serving the market have a dedicated IPEC chapter after the delayed fifth branch of the industry group was finally formally incorporated at the end of January.
Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.
Boehringer Ingelheim says it will pump a further €330m ($453m) into a German manufacturing facility critised by the US FDA in its rejection of the drug empagliflozin.
Susan Thornton PhD, president and CEO of Celerion, broke down the company’s recent moves to partner with Seoul National University Hospital in an Outsourcing-Pharma.com exclusive.
Columbia Laboratories has reported strong annual results despite a fourth quarter affected by Actavis taking the manufacture of vaginal gel Crinone in-house and the “lumpiness” of Merck Serono.
The Alliance for a Stronger FDA has expressed disappointment that President Obama’s FY 15 budget request for FDA falls short of what the agency needs to fulfill its responsibilities.
Addiction doctors have petitioned the US FDA to prevent Zohydro ER, the first single-entity hydrocodone painkiller, hitting the market this month citing its potential for abuse. Its maker, Zogenix, has been tight-lipped on whether the drug’s formulation...
Harlan is looking to take advantage of a dearth of new products in pharma clients’ pipelines with an early drug development partnership with France’s Bertin Pharma.
Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.
Clinical research group Venn Life Sciences has acquired the rights to LabSkin (pictured), a human skin substitute that behaves like the real thing, from dermatology CRO Evocutis.
Jubilant HollisterStier says the Warning Letter in place at its Montreal, Canada facility did not affect manufacturing or business as - twelve months later – the US FDA upgrades the site to ‘acceptable.’
The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site.
The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
Scientists developing vaccines for potentially deadly diseases like influenza, SARS and HIV struggle to find a CRO with the right capabilities according to contractor TNO Triskelion.
Criminal access to APIs must be cut off in a way that does not infringe generics companies’ right to buy chemicals, a top US prosecutor told In-Pharmatechnologist.com.
Plans to give customs officers the power to seize and destroy suspected fake medicines as they move through the EU have been welcomed by industry group EFPIA.
Despite investor concerns about growth in R&D dollars for big pharma, CROs (contract research organizations) will benefit from the continued outsourcing, according to Citi analysts.
European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a Canadian firm testing the abuse potential of medicines.
With a drive towards personalised medicine, Big Pharma is acting like mini-biotech firms in its approach to R&D, says Horizon Discovery who is launching a £25m ($42m) IPO.
National prioritization, investments in healthcare infrastructure and building better epidemiological and cost databases could bring more innovative medicines to middle-income countries, according to an independent study conducted by Charles River Associates.
As part of an effort to ease the transition between clinical and commercial launch for blister products, Almac has added new blistering technology at its US commercial packaging facility in Audubon, PA.
Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.
Tokyo, Japan-based JCR Pharmaceuticals has asked UK firm Plasticell to help develop differentiation protocols for its range of candidate stem cell-based therapies.
Cellceutix has selected Dr. Reddy’s Custom Pharmaceutical Services (CPS) for the formulation of its defensin mimetic drug Brilacidin for use in ophthalmic and otitis infections.
Pharma industry employees and wholesalers with access to narcotic APIs would be subject to background checks and drug testing under new proposals being considered in the US.
With a growing demand for comparative effectiveness data and questions on quality research persisting, Quintiles teamed with the National Pharmaceutical Council to develop and test a checklist to evaluate the quality and usefulness of observational research...
FMC has hired Connell Brothers (CBC) to distribute its drug excipients in Japan, citing the move as a key step to building its business in the country.
A history of recreational drug use normally stops someone taking part in a trial, but growing US FDA pressure for data on a drug’s abuse potential has prompted CROs to start recruiting users says INC Research.
In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.
The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
CRO Pharmaceutical Product Development (PPD) and the Charité – Universitätsmedizin hospital in Berlin are collaborating to increase the volume of clinical trials conducted in Germany.
Parexel says a service which manages regulatory activities for already approved drugs fills a gap in the market for pharmaceutical companies feeling the pressure to be efficient.
Development of a new quality "super office" was motivated by a desire to simplify oversight and is not a response to the recent spate of problems at overseas suppliers, says the US FDA.
