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Illinois-based drug company Hospira has sued the FDA, challenging its recent decision to approve generic versions of Precedex (dexmedetomidine hydrochloride). 20 August 2014
Americas
Actavis-owned pharmaceutical company Forest, along with US-based Adamas Pharmaceuticals, has sued Indian generic drug maker Lupin for infringing seven patents directed to its Alzheimer’s drug Namenda XR (memantine hydrochloride), a once daily version of Namenda. 19 August 2014
Americas
The US Court of Appeals for the Federal Circuit has affirmed a lower court’s ruling that an Apotex patent covering a method of making a drug is unenforceable due to inequitable conduct by the company’s founder and chairman Bernard Sherman. 18 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PhRMA has voiced concerns about the FDA’s draft guidance on biosimilars, which it suggests if enacted, could have an impact on the safety of biosimilar products. 15 August 2014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
The US Court of Appeals for the Federal Circuit has refused to grant an en banc review of its ruling that cloned animals made by methods that produced Dolly the sheep cannot be patented, according to Law360. 14 August 2014
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