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.
Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.
A new method for determining the crystal structures of organic salts – which make up 40% of all APIs – could “greatly speed up” the drug development process, say researchers.
Cambrex has completed construction and validation of a new $3.2m, 11,000 square foot analytical laboratory at the former PharmaCore facility in High Point, NC.
Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.
Ferring Pharmaceuticals is buying Rebiotix and says its lead candidate has the potential to be the first human microbiome product approved anywhere in the world.
The active ingredient for Nichi-Iko’s diabetic neuropathy drug will be the first of a number of APIs to be supplied from Eisai’s facility in Vizag, India.
Novartis will sell its stake in a consumer healthcare joint venture to partner GSK and plans to invest the $13bn into its core pharmaceutical businesses.
The race to buy Pfizer’s OTC business – including Advil painkillers and Centrum vitamins – may have collapsed after both GlaxoSmithKline and Reckitt Benckiser officially walked away from the auction within days of each other.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
The Danish drugmaker says it will take responsibility for commercial manufacturing after acquiring Parkinson’s disease candidate foliglurax in a deal worth up to €905m ($1.1bn).
CDMO Ardena has purchased active pharmaceutical ingredient and nanomedicine maker ChemConnection, as part of an acquisition strategy focused on development services.
Partnering with CMOs makes sense for emerging biotechs, says Ardelyx exec James Kanter, who relies on networking and clear communication guidelines to manage third-party relationships.
Indena says industry’s recognition of the high quality of Italian-made ingredients has driven investments in an HPAPI kilolab and a multi-purpose pilot plant near Milan.
Axim says its proprietary methods to extract and microencapsulate cannabinoid molecules make purer active pharmaceutical ingredients than traditional methods.
Reckitt Benckiser Group says it will be disciplined in its M&A strategy but remains silent on speculation it is buying Pfizer’s consumer healthcare business.
The US State Patent and Trademark Office has granted Teewinot Life Science Corporation its second patent this year covering biosynthetic cannabinoid production methods.
AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.
