Markets & Regulations

The US Patent and Trademark Office and case law have created confusion around IP

Sequenom case leaves pharma confused over patent law

By Fiona BARRY

US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

PDS staff adjusting a capsule machine. Photo courtesy of NIH

NIH’s PDS suspends manufacturing operations

By Zachary Brennan

The National Institutes of Health’s (NIH) Pharmaceutical Development Section (PDS), which manufactures products for clinical trials, has suspended operations due to the discovery of serious manufacturing problems and contamination by US FDA inspectors.

Celltrion manufactures a biosimilar to Janssen's Remicade

Celltrion presents data at US conference

By Gareth Macdonald

Celltrion’s Remsima campaign rolled into the US this week with another presentation of data showing that the Remicade (Infliximab) biosimilar is equivalent to the reference drug.

NJ Assembly committee approves biosimilar substitution bill

NJ Assembly committee approves biosimilar substitution bill

By Zachary Brennan

Under the bill first proposed in 2014, which won unanimous approval last week from a New Jersey Assembly committee, pharmacists would have to notify prescribers within five days of dispensing an interchangeable biosimilar.

European group criticizes proposed WHO, FDA biosimilar naming schemes

European group criticizes proposed WHO, FDA biosimilar naming schemes

By Zachary Brennan

The EBG (European Biosimilars Group), a part of the EGA (European Generic Medicines Association), says that more complex systems for naming biosimilars increases the likelihood that physicians and pharmacists will leave something out and disrupt the tracking...

US CMS releases new info around biosimilar pricing, uptake

US CMS releases new info around biosimilar pricing, uptake

By Zachary Brennan

With the release of four different documents around the pricing and use of biosimilars this week, the US CMS (Centers for Medicare and Medicaid Services) is making clear it will fully encourage states to call on prescribers to use cost-effective biosimilars...

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