The United States Food and Drug Administration (FDA) has announced it will consider products outside the nanoscale, up to 1,000 nanometres (nm), to involve nanotechnology and so be potentially liable for “particular examination.”
A new cell therapy development centre has opened at Guy’s Hospital in London today in the latest stage of a Government-backed effort to establish the UK as a global hub.
Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline.
The US National Institutes of Health (NIH) has launched a 3D Print Exchange which will turn data submitted by the public into files for printing 3D models.
Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant
Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.
Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.
Recipharm AB has not ruled out battling with Catalent and Patheon in the softgels market and confirmed that acquisitions were the key driver for its decision to go public.
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.
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.
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.
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.
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.
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.
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).
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.
Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
As part of a wave of good news for the beleaguered Hospira, the company said it will inject $120m into its McPherson, Kansas, facility, which will result in 150 new jobs over the next five years.
As the number of drug approvals declined between 2012 and 2013 by more than 30%, the value of new therapeutic agent approvals seems to indicate a stronger year than initially thought.
Eli Lilly is maintaining greater in-house control as manufacturing processes become more complex, whilst MSD is leveraging external over-capacity to fulfil its needs, the firms told Outsourcing-Pharma.com during a recent visit to Ireland.
California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...
Manufacturing powerhouse Roche is doubling down on its small molecule manufacturing with investments of $134.6m in two facilities in Basel, Switzerland.
Both Fresenius Kabi and Abbott have extended their operations further in the Latin American market with new acquisitions that signal growth in the region.
Horizon, which supplies genomics research services, has bought cell-screening business CombinatoRx from Zalicus for £4.74m ($8m) and plans more acquisitions.
China-based Wuxi announced 11% growth in its net revenues when compared to last year, which was boosted by manufacturing services the most of all service offerings.
Experiments on semiconductors reveal a new way to study and control crystallisation. The discovery has relevance to pharmaceutical manufacturing as many drugs are made from small molecules that must crystallise in just the right way to have the proper...
Wuxi PharmaTech has completed an expansion of its materials characterization testing facility in St. Paul, Minnesota, as well as its work on a new biologics biosafety testing facility in Suzhou, China.
Atop the list of concerns among political onlookers in what is shaping up to be a fierce attempt by Pfizer to acquire AstraZeneca: Jobs -- where will they be slashed and how many will lose out?
WuXi PharmaTech has announced its manufacturing business, Syn-The-All (STA) Pharmaceuticals Co., Ltd., has broken ground on an R&D and manufacturing site in China.
Onyx Scientific, a UK contract development and manufacturing organisation (CDMO) has completed an API (active pharmaceutical ingredient) production deal for Neuronascent, a US company developing neurological therapies.
Teva will close eleven of its manufacturing plants and is considering shutting another 16 as part of a campaign to cut annual spending by $2bn (€1.4bn).
Boehringer Ingelheim says the Saudi Arabian market is a huge drive for big pharma as it teams with local firms to manufacture secondary packaging for 26 products.
Pfizer will keep a “substantial” level of manufacturing in the UK if it takes over AstraZeneca, said the CEO in a letter to the country’s Prime Minister.
Sun Pharma says the closure of a Michigan plant employing 179 staff is necessary in order to consolidate its US manufacturing network, and not related to its Ranbaxy acquisition.
