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EMA and FDA aligned on marketing authorisations: report

EU, US19-08-2019Sarah Morgan

The US and Europe have reached the same conclusion in more than 90% of marketing authorisation decisions for new medicines, according to a report from the European Medicines Agency.

Pharma bodies sign NDAs with UK govt over no-deal Brexit plans

UK16-08-2019Saman Javed

Several pharma bodies have signed non-disclosure agreements which prevent them from disclosing the UK government’s plans for a no-deal Brexit.

Fed Circuit majority ‘problematically’ adds new rule in Actavis suit: chief judge


The US Court of Appeals for the Federal Circuit yesterday, August 15, blocked Actavis’s attempt to market a generic version of Nalpropion Pharmaceuticals’ weight-loss drug Contrave.

Sanofi victorious at Fed Circ in prostate cancer drug dispute

15-08-2019Sarah Morgan

Sanofi secured a win at the US Court of Appeals for the Federal Circuit yesterday, August 14, after the appeals court concluded a lower court lacked authority to invalidate claims of a patent covering a prostate cancer drug.

NHS to receive £8m from Aspen over anti-competitive practices

UK15-08-2019Sarah Morgan

Drugmaker Aspen has offered to pay the UK’s National Health System £8 million to resolve competition concerns.

Jazz Pharma buys clinical-stage biotech company

Ireland14-08-2019Sarah Morgan

Ireland-based Jazz Pharma has acquired Virginia-based Cavion in a deal that values the clinical-stage biotech company at up to $312.5 million.

Eli Lilly unit accuses Alzheimer's institute of ‘malicious’ patent prosecution

US14-08-2019Sarah Morgan

Avid Radiopharmaceuticals, a subsidiary of Eli Lilly, has taken the Alzheimer's Institute of America to court over its “malicious” prosecution of a patent infringement case.

Allergan says rivals using trade secrets disclosed by USITC order

US13-08-2019Saman Javed

Allergan has filed a motion asking for its “trade secrets” to be removed from evidence in a dispute over its wrinkle treatment, Botox.

Sandoz to appeal against Amgen biosimilar ruling

US13-08-2019Sarah Morgan

Sandoz has confirmed that it plans to appeal against a decision that upheld the validity of two of Amgen’s patents for its arthritis treatment Enbrel, effectively blocking the launch of Sandoz’s biosimilar version.

Fed Circ affirms Eli Lilly victories over cancer drugs

US13-08-2019Sarah Morgan

The US Court of Appeals for the Federal Circuit last week affirmed two findings that Dr Reddy’s and Hospira had infringed Eli Lilly’s cancer drug Alimta.

Showing 1 to 10 of 2608 results