Mylan generic of lung cancer drug Alimta approved
Mylan NV's generic version Eli Lilly and Co’s lung cancer drug, Alimta, has been given tentative approval by the FDA.
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Multiple myeloma treatment receives Orphan Drug Designation
Orphan Drug Designation has been granted to the CT053 anti-BCMA CAR-T programme for multiple myeloma treatment.
Biologics and generics reported to save NHS £700m
An NHS-wide plan to use more generic and biologic products has reportedly saved the healthcare provider £700 million since 2016.
Rova-T programme discontinued following poor trial results
A Phase III trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer demonstrated no survival benefit.
Study shows the potential to deliver immunotherapy directly to brain tumours
New nano-immunotherapy has traversed the blood-brain barrier in mice, inducing an immune response in brain tissue surrounding tumours.
Drugs with ingredients from threatened species not covered by Chinese insurance
The Chinese government has announced that medicines containing ingredients from threatened species such as pangolins will no longer be eligible for insurance coverage.
Small molecules dominate FDA drug approvals this month
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
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.
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”.
