The Charles Stark Draper Laboratory Inc. has inked a three year partnership with Pfizer to create personalised versions of Draper’s Microphysiological Systems (MPS), for cheaper and more effective preclinical testing.
The US FDA has criticized Pocono Coated Products' (PCP) efforts to bring its transdermal patch plant in Cherryville, North Carolina into compliance with cGMP standards.
Newly identified impurities in sugar excipients pose a risk to patients and could explain why some drugs fail safety tests according to scientists from the Netherlands.
The Slovakian Government has granted Saneca Pharma €1.5m ($1.6m) to invest in ‘green’ API manufacturing and anti-abuse technologies for its opiate-based drugs.
Swedish Orphan Biovitrum AB (Sobi) and Horizon Pharma plc have teamed up for a 5-year deal to distribute urea cycle disorder drugs Ravicti and Ammonaps in Europe and the Middle East.
Fareva Group has set up an aerosol manufacturing facility at its site in Richmond, Virginia as part of a $40m (€37m) investment in its drug, OTC medicine and beauty care business.
Breckenridge Pharmaceutical has entered into a multi-product marketing agreement with development and manufacturing partner Gland Pharma Limited for seven injectable products.
AstraZeneca has partnered with Bicycle Therapeutics in a potential $1bn deal to develop a new class of small molecules which have antibody-like properties.
Celgene has made a second investment in a machine learning and simulation platform for applications across drug discovery, clinical development, and commercialization.
Accinov has teamed up with Canadian clinical research organisation (CRO) Biodextris to provide a transatlantic biomanufacturing ‘plug and play’ service for biopharmaceuticals—with a particular expertise in vaccines.
Arrowhead Pharmaceuticals Inc. has also laid off its Chief scientific officer David Lewis - as part of the 34 staff cull - after several trials using delivery vehicle Ex1 were stopped by the firm.
Party drug MDMA has been claimed to be effective in helping treat Post-traumatic stress disorder (PTSD) patients, with the FDA approval for a Ph III trial to go ahead in the US.
The acquisition of a stick sachet packaging line from Merz expands Almac Group’s MHRA/FDA-approved UK commercial packaging facility to meet the growing demand for specialist packing solutions.
Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.
An increase in resources dedicated to pediatric drug development is proving promising in the industry, according to a new analysis completed by the Tufts Center for the Study of Drug Development.
Envigo has launched an integrated program of in vitro technologies that help predict the likelihood of compounds causing drug induced livery injury (DILI) as part of its new De-Risking Program.
The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.
The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.
Thermo Fisher Scientific has provided Rutgers’ researchers with hot-melt extrusion tech to support development of continuous manufacturing for drug production.
Pfizer has earmarked two sites in the UK for closure, including an ex-Hospira aseptic plant in London it says would need ‘significant investment’ to remain open.
Adents and Microsoft have introduced a new platform that allows contract manufacturing organizations (CMOs) to leverage data generated during the serialization process.
Increasing demand for reduced particle loads in pharmaceutical containers has driven Datwyler to build a CHF 100m plant making elastomer components for injectable drug delivery systems.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.
Lovelace Biomedical launched this week as a not-for-profit preclinical contract research organization (CRO) with a business model that will let it “put science first.”
Thermo Fisher Scientific has revealed a preemptive pharmacogenomic risk factor screening tool to help increase drug development outcome efficiency and reduce adverse drug reactions.
Biotrial looks to run 50 clinical trials per year at its new US-based facility as it says group activities are up – with the exception of Ph I activities in France.
French regulators have recommended that drugs containing APIs made at Nandu Chemicals Industries’ site in Hubli, India be recalled after uncovering “serious” problems during an inspection in August.
