FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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Antibody drug conjugates market to be worth $15bn by 2030
Antibody drug conjugates are presently recognised as a potent class of targeted anticancer therapies which will result in growth in the market.
Unique hydrogel strategy aids the delivery of drugs
Scientists have developed a hydrogel-based carrier that can deliver siRNAs directly to where they are needed.
Amgen patent claims invalidated by US district court
A US district court has invalidated Amgen's patent claims for antibodies targeting PCSK9.
Health union leaders warn of medicine shortages in event of no-deal Brexit
A statement from 11 health union leaders highlights the possibility of severe drug shortages if the UK leaves the EU without a deal.
Farxiga has been granted Fast Track status by the FDA
Fast Track designation has been granted to Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
Breztri Aerosphere Phase III trial meets primary endpoints
A clinical trial to study a chronic obstructive pulmonary disease treatment has found that the drug is effective and safe.
China to relax generic drug import laws
The government in China has stated that small quantities of generic medicines that are legal in foreign countries will no longer be classed as “fake drugs”.
17 Spanish infants develop ‘werewolf syndrome’ after drug mislabelling
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
NICE to work with GW Pharma on cannabidiol evaluation
NICE and GW Pharma will work together to address the issues highlighted in its evaluation of cannabidiol for treating two types of epilepsy.
Licence extension submission accepted for kidney disease treatment by EMA
The licence extension submission for Invokana and Vokanamet has been accepted by the EMA.
Significant number of drugs on the market not yet fully approved
A large number of drug manufacturers are failing to complete the FDA's Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
J&J ordered to pay $572m to Oklahoma over opioid crisis
The pharmaceutical company is planning to appeal the decision to pay the state for damages relating to the US opioid crisis.
Drug makers file complaint for regulations to lower Canadian drug prices
Five pharma companies have filed a complaint in Canadian court over new rules intended to lower the price of drugs in the country.
HRT shortage in UK expected to continue until next year
Around half of HRT products have been reported as out of stock in UK pharmacies due to supply issues in China, leading to a shortage.
