MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.
Novartis will close an OTC plant in Puerto Rico by 2019 and transfer manufacturing and packaging actives to sites in the US and facilities operated by Eli Lilly and Virbac.
Sanofi has selected Boehringer-Ingelheim to manufacture monoclonal antibodies in an agreement that extends to the French drugmaker's partner Regeneron.
CMO consolidation is resurrecting the ‘all-under-one-roof’ manufacturing model, but will firms fall into the same inefficiency pitfalls that drove pharma to outsource in the first place?
A Fresenius Kabi plant in New York has been upgraded, and up to five new products could receive FDA approval, almost three years after receiving a warning letter.
Critical solvents used by the pharmaceutical manufacturers have been excluded from the EPA's final ruling on waste disposal, in a move welcomed by a US industry group.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
2015 is the year that AMRI loses its royalties for discovering the API of Allegra and the company is now looking to its string of recent acquisitions and new contract revenue to offset the loss.
Fareva has added extra micronization capacity citing growing demand and the opportunity to work with customers earlier in the development process as the driver for the investment.
Shire says its $5.2bn (€4.4bn) acquisition of NPS Pharmaceuticals is a calculated risk, coming just days before the US FDA decides whther to approve the hormone replacement therapy Natpara.
Almost two years since it was first rejected, Impax Pharmaceuticals said late last week that the US FDA has approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease.
AMRI has paid $60m for two Aptuit facilities including an aseptic manufacturing site in Glasgow, UK which the firm says will boost its presence in Europe.
Cancer and infectious disease immunotherapy developer Argos Therapeutics is collaborating with Saint-Gobain’s Performance Plastics division, to design, integrate and scale production of a range of disposables for use in the manufacturing of Argos’ lead...
Injectable-heavy drug pipelines and increased biotech funding are driving up US demand for sterile manufacturing, according to UK-based Symbiosis, which is looking to help fill the gap left by several high-profile exits from the space.
Sartorius AG has announced plans to sell its industrial weighing and control tech business, Intec, as part of a long-term strategy to focus on bioprocessing and laboratory equipment.
Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of the castration-resistant prostate cancer drug Xofigo (radium Ra 223 dichloride).
An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.
GE Healthcare has pledged its support and technology to a national £55m ($86m) Cell Therapy manufacturing centre in Stevenage, UK, set to launch in 2017.
Asian API makers are turning to ‘out-of-the-box’ Manufacturing Execution Systems (MES) to help manage documentation and control quality, according to IT solutions Werum.
German contract development and manufacturing organisation (CDMO) Vetter has built a facility for pre-clinical and clinical syringe filling in Chicago.
Analyst firm N+1Singer has endorsed stem cell manufacturer Reneuron based on its “off-the-shelf” therapy pipeline and a new facility that will reduce the need to outsource.
Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.
Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.
Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.
Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.
Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.
The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
Mylan will manufacture and distribute Gilead's antiretroviral HIV drugs, following a tech transfer, in order to increase access in developing countries.
Aurobindo Pharma has recalled one lot of Gabapentin for the treatment of epilepsy and postherpetic neuralgia (pain after shingles), after it was found to contain empty capsules.
Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies.
The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.
The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.
