Biotech news
Americas
The US Court of Appeals for the Federal Circuit yesterday (August 21) upheld a lower court’s decision that a patent covering rheumatoid arthritis drug Humira (adalimumab) is invalid. 22 August 2014
Americas
PhRMA has voiced concerns about the FDA’s draft guidance on biosimilars, which it suggests if enacted, could have an impact on the safety of biosimilar products. 15 August 2014
Americas
A group of 12 international biotechnology associations has written to the US Patent and Trademark Office (USPTO), raising concerns about the office’s guidelines on determining the patent eligibility of natural products in the aftermath of the Myriad and Mayo cases. 13 August 2014
Americas
South Korean biopharmaceutical company Celltrion has applied for approval from the US Food and Drug Administration (FDA) to market a biosimilar version of Remicade (infliximab), it announced yesterday (August 11). 12 August 2014
Americas
French pharmaceutical company Sanofi and the US-based MannKind Corporation have entered into an exclusive licensing agreement to develop and commercialise MannKind’s Afrezza (insulin human), an inhalable insulin therapy for adults with types 1 and 2 diabetes. 12 August 2014
Americas
The US Food and Drug Administration (FDA) has issued guidance for biological drug makers about what information they should provide the agency to determine when their products’ marketing exclusivity period should begin, known as the “date of first licensure”. 8 August 2014
Biotech
New drugs that target ribonucleic acid (RNA) being developed by Danish biotechnology company Santaris Pharma lie behind the decision by Roche to buy Santaris that was announced yesterday, August 4. 5 August 2014
Americas
Pfizer has entered into a definitive agreement to acquire two vaccines marketed by US biotechnology company Baxter International for $635 million. 31 July 2014
Americas
US officials have accepted an application by Novartis to market a biosimilar of Amgen’s Neupogen (filgrastim) drug, a move thought to be the first of its kind. 29 July 2014
Biotech
German medical device company Occlutech has successfully defeated US-based AGA Medical Corporation after the English High Court declared a patent AGA was trying to assert invalid. 25 July 2014