Two billion cartridges of inhaled insulin drug Afrezza will be manufactured annually by Mannkind, the firm says as it awaits final approval next month.
The European Medicines Agency (EMA) has abandoned plans to stop researchers downloading clinical trial data but the European Ombudsman says she is unaware if other limits on transparency remain.
Phase II and III research is expected to see the biggest upturn in terms of outsourcing from large and medium-sized pharma, according to a survey from the Life Sciences Strategy Group.
Following its merger with RPS, as well as a number of other acquisitive moves, CRO PRA will now be known as PRA Health Sciences and will look to continue to establish itself as a top 5 CRO in the world.
A European expert has cast doubt on a claim by Indian regulator CDSCO that it can assess and confirm the quality of an API supplier’s manufacturing operations in writing in just 30 days.
Local talent is not satisfying the “tremendous” demand for top-level pharma employees in Asia and recruiters are searching internationally for candidates, a pharmaceutical head-hunter has said.
Teva could halve its manufacturing network as part of its $2bn-a-year efficiency programme says CFO Eyal Desheh, with most cuts hitting its core generics business.
As manufacturers will have to identify illegitimate product for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might...
Sounding upbeat on Covance’s recent gains in its early stage clinical business, CFO Alison Cornell expressed a conservative amount of optimism that growth will continue.
The EMA is being criticised on two fronts with some suggesting its trial data publication plans will drive away drug R&D while others argue the agency is backtracking in a way that will hinder public health research.
Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.
The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.
When it comes to pharma acquisitions size does matter, according to analyst Ross Muken who says the momentary lapse in megamergers means business as usual for CROs.
The US Food and Drug Administration (FDA) has launched openFDA, a programme allowing web developers and researchers to access “massive” datasets on adverse effects and to use them to build their own applications.
The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).
Supply chain security consortium Rx-360 has shifted its focus to China where it is forming a working group to further ensure compliance in a country that has had some difficulties with spurious drugs in the past.
Transparency campaigners have called on the EMA (European Medicines Agency) to rethink regulations set to be approved on Thursday that they say will severely limit clinical trial openness.
Merck & Co. says the $3.85bn (€2.8bn) acquisition of Idenix will springboard its oral hepatitis C programme but according to an analyst is unlikely to threaten Gilead’s $1,000 pill Sovaldi.
Bureaucracy is the biggest problem in accessing the Brazilian clinical research market, according to local CRO Techtrials, who says its expansion into the US was a far easier procedure.
Malvern Instruments will buy GE Healthcare’s MicroCal business in a deal that adds protein analysis and formulation development tech to its expanding drug industry offering.
German CMO Rentschler Biotechnologie GmbH is adding a 2,000 L single-use bioreactor to its facility in Laupheim, Germany, which it expects to be fully operational by the end of the first quarter of 2015.
ScinoPharm Taiwan on Monday signed a manufacturing and clinical supply contract with TaiGen Biotechnology to provide the API for Burixafor, a potential stem cell treatment.
Clinical trial patients who share their experiences on social media may “unblind” clinical trials, Pfizer’s head of Clinical Innovation for Worldwide R&D has said.
A single-dose of an investigational MRSA drug could be equivalent to a ten-day course of antibiotics due to the application of PK-PD principles in its design and optimization, The Medicines Company says.
Fans heading to the World Cup in Brazil should consider getting vaccinated against yellow fever according to Public Health England (PHC), which says manufacturing problems at Sanofi Pasteur MSD will not restrict access.
J&J says it collaborated with Novartis and GSK to install wind turbines in Cork, Ireland to substantially reduce electricity costs at its local manufacturing plants.
Aprecia Pharmaceuticals has selected inVentiv Health to sell and market its three-dimensional printing technology to create fast-melt pharmaceutical treatments.
European regulatory authorities have reinstated the Good Manufacturing Practice (GMP) certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, which was suspended in January.
As big pharma and biotech companies increasingly take R&D centers offline, the companies are also looking to reduce the number of outsourcing partnerships, Jim Foster, CEO of Charles River Laboratories, said recently.
Johnson Matthey has completed restructuring its API unit and plans to pursue more generics industry business, after non-branded drug launches drove fine chemicals growth in fiscal 2014.
The Puerto Rico Industrial Development Company (PRIDCO) says Actavis’ investment at two facilities is evidence of continued pharma growth, despite a number of recent closures on the island.
Capsugel has installed a commercial-scale dryer in its recently acquired Bend Research R&D facility, citing a rise in demand for non-GMP spray dried dispersion (SDD) services.
Outsourcing is still a significant part of Janssen’s strategy, the firm says despite suffering shortages due to manufacturing and quality problems at now defunct CMO Ben Venue.
Bristol-Myers Squibb (B-MS) announced a five-year extension to its drug discovery and development collaboration in the subcontinent with Syngene International, India's largest CRO.
The Active Pharmaceutical Ingredients Committee (APIC) has unveiled a new guidance document for API distributors that seeks to provide step-by-step instructions on how to meet WHO and European Union guidelines on the distribution of APIs.
Provence Technologies, a French chemical developer, has acquired the active pharmaceutical ingredient (API) maker Synprosis, a specialist in synthesising long-chain peptides.
Clondalkin Pharma & Healthcare has been fined £12,000 for safety failings after a worker was injured by unguarded machinery at the contract packaging and printing firm’s facility in Cambridgeshire, UK.
As WuXi talks of a surge in its outsourced manufacturing services, the company has begun offering high-potency active pharmaceutical ingredients (HPAPIs).
A UK software maker has launched an iPad tool it says ends the need for CROs (clinical research organisations) to hire trained neuropsychologists to measure drugs’ effects on the brain.
Microscopic worms exposed to the diabetes medication metformin live longer because the drug makes them produce more free radicals according to a new study that has implications for human health and advocates of “anti-aging” antioxidants.
As biotech funding saw one of the strongest quarters since 2004, Covance CEO Joe Herring predicts that the CRO industry is poised see an even higher percentage of biopharma R&D to be outsourced.
The Form 483 from the US FDA cited Chicago-based Morton Grove Pharmaceuticals, which was acquired by Wockhardt in October 2007, for 12 different observations.
European pharmaceutical manufacturing jobs are at risk according to a group representing generic firms which says price caps in EU member states are hurting drugmakers.
CMO (contract manufacturing organization) AMRI has agreed to acquire Oso Biopharmaceuticals Manufacturing for $110m in cash and thereby expand to late-stage and commercial product manufacturing.
The Life Sciences Strategy Group has launched a new website for biopharma outsourcing professionals, which includes a star-based user ratings program for CROs that’s similar to Yelp’s ratings system of restaurants.
A few months after announcing its arrival in South Korea, Celerion and the Korean Drug Development Fund (KDDF) have agreed to collaborate to provide drug development expertise and support for the emerging industry.
