GSK’s Dovato is approved by the US FDA for the treatment of individuals with HIV with no previous antiretroviral therapy, in a first for a two-drug, fixed-dose, complete regimen.
Cure Pharma expands its DEA license to include authorization to manufacture both cannabis plant extracts and CBD within the scope of its patent portfolio.
Noramco partners with Nemus to produce an analogue of cannabidiol that possesses greater bioavailability, that could be used to treat diseases of the retina.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
Lonza and Emerald Health enter an agreement for the large-scale manufacturing of a synthetic derivative of CBD and its oral drug product for the treatment of MS and other CNS diseases.
The approval of the farm bill has intensified interest in CBD but Nexien BioPharma CEO warns pharma-grade products are needed for patients with serious conditions.
Novo Nordisk Pharmatech selected DKSH to distribute its pharmaceutical grade compounds to the company’s growing customer base in the Asia-Pacific region.
Roquette has purchased a majority stake in excipient manufacturer Crest Cellose, in an aim to increase its footprint in India’s generic pharmaceutical market.
If approved by President Trump, the five-year farm bill – which removes hemp from the federal controlled substance list – could help advance cannabinoid R&D, says Nexien Biopharma.
GW Pharma has told investors its capacity is “more than sufficient” to meet launch requirements in Europe next year, where the firm’s CBD medicine Epidiolex is under review.
SPI Pharma has launched Mannogem XL mannitol for the production of various forms of tablets, which the firm says enhances productivity compared to compendial mannitol.
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
Ajinomoto’s amino acid technologies division announced a 10% price increase across all of its markets due to rising costs of manufacturing and transportation.
The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.
Nanoform specialises in producing APIs in a nanoparticle size range, which the company claims can significantly improve bioavailability and potentially change the fate of an asset in the clinic.
CMO-focused marketing and PR agency, ramarketing, has signed a lease on offices in the rapidly growing pharma and biotech hub of Cambridge, Massachusetts.
Novo Nordisk announced a distribution agreement that will see quats delivered by Signet to the healthcare industry in India, as well as Bangladesh and Sri Lanka.
The Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
The European Commission says it will not intervene in an eviction dispute between a farmer cultivating a “record crop” of goji berry extract for the pharmaceutical industry, and the Romanian government.
Pfizer has revealed it will invest $5bn to support operations in the US, with the first step being the construction of a 400,000-square-foot production facility, costing $465m.
The US Patent and Trademark Office (USPTO) has granted two patents related to VistaGen Therapeutics’ lead asset AV-101, an oral candidate designed to treat CNS diseases and disorders.
Fermion Oy has completed construction of its manufacturing plant in Hanko, Finland, where it will make highly potent ingredients for ‘main markets’ and a growing client base in India, says president.
The US FDA has announced that over 236,000 bottles of statins will be voluntarily recalled by Dr. Reddy’s Laboratories, after issues were found with impurities.
Researchers from Harvard University have developed an insulin formulation using two ionic liquids they say could lead to the development of a pill for diabetics.
UK-based GW Pharmaceuticals has been given marketing approval by the US FDA for its product, Epidiolex, to be used for the treatment of two severe forms of epilepsy – Lennox-Gastaut syndrome and Dravet syndrome.
A growing client base in the US and healthy demand for highly potent active pharmaceutical ingredients (HPAPIs) are driving expansion at the UK-based CDMO Sterling Pharma Solutions.
DSP has released its generic Atorvastatin drug product within the EU with additional markets to be added later this year the firm looks to become a full-service generics company.
Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.
