AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS).
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.
Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.
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 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.
Despite requiring more API, the price of inhaled insulin Afrezza has dropped below that of injected rapid-acting rivals says MannKind's CEO, reporting a resilient Q3.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
The US Environmental Protection Agency (EPA) has fined Pfizer $190,000 for failing to disclose that it had ammonia and methylamine at its facility in Barceloneta, Puerto Rico.
Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.
Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.
BASF is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.
Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.
Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.
The global excipient certification organization has announced IPEC Association (China) Limited as its fifth member, joining IPEC Europe, IPEC Americas, FECC, and PQG (UK).
A synthetic short cut could make it easier and cheaper to produce nitrile-containing compounds, a group which includes dozens of marketed and pipeline drugs.
Aluminium adjuvants should not be used in trial placebos according to UK scientists who say the differing physical and biological properties of alum salt forms makes some safer than others.
Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."
SRF Limited has unveiled plans for a second chloromethane plant just two months after India imposed anti-dumping tariffs on Chinese and Russian imports.
W.R. Grace has opened a pharma quality control laboratory at its manufacturing facility in Albany, Oregon and predicted higher drug intermediates sales in the second half of the year.
The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
Triazamacrocyclic lipid complexes increase the efficiency of antibody-drug conjugates (ADCs) by delivering the payload right into the heart of a cancer cell, says BioCellChallenge.
API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.
A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.
