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Americas
A Brazilian antitrust watchdog is fining German pharmaceutical company Merck $1.8 million for an alleged conspiracy to stop medicine distributors from working with generic drug makers. 14 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
New Jersey-based pharmaceutical company Merck has sued generic drug maker Fresenius for infringing patents relating to its anti-fungal injection Cancidas (caspofungin acetate). 11 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
Americas
The US Court of Appeals for the Federal Circuit has affirmed a district court’s decision that pharmaceutical company Tyco’s patents directed to sleep aid drug temazepam were not infringed. 7 August 2014
Americas
US District Court for the Northern District of California judge Lucy Koh has dismissed Japanese pharmaceutical company Takeda’s patent infringement case against generic maker Mylan concerning acid reflux drug Dexilant (dexlansoprazole). 6 August 2014
Biotechnology
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
US-based injections maker Akorn has agreed to sell its rights to develop, manufacture and market generic tuberculosis injection rifampin to Watson Laboratories to settle charges by the US Federal Trade Commission (FTC) that its proposed acquisition of pharmaceutical company VersaPharm was likely to be anticompetitive. 5 August 2014