Biosimilars (PDF file)
EMA draft guidance updating and clarifying 2006 guidance on the non-clinical and clinical requirements for developing biosimilars (see BioCentury Extra, Monday, June 10).
Cardiovascular disease (PDF files)
Pharmaceutical Research and Manufacturers of America (PhRMA) report and an overview of products in development for heart disease and stroke.
Combination treatments (PDF file)
FDA final guidance on the co-development of two or more new investigational drugs (see BioCentury Extra, Friday, June 14).
GAIN (PDF file)
FDA proposed rule listing pathogens that would be eligible for drug development incentives under the Generating Antibiotic Incentives Now (GAIN) Act (see BioCentury Extra, Tuesday, June 11).
EMA notice of a Nov. 26 workshop to discuss parallel scientific advice of drug development with health-technology assessment bodies.
Draft document from the China Securities Regulatory Commission (CSRC) proposing a stringent set of regulatory requirements for IPOs, including updated guidelines on the pricing and placement of shares and stronger information disclosure requirements (see BioCentury Extra, Monday, June 10).
Orphan Drugs (PDF file)
FDA final rule that clarifies language in Orphan Drug regulations, including when a compound may be eligible for Orphan Drug designation for a subset of patients with a non-rare disease (see BioCentury Extra, Wednesday, June 12).
Patents (PDF files)
— U.S. Supreme Court decision in Association for Molecular Pathology, et al. v. U.S. PTO, et al. ruling unanimously that isolated DNA cannot be patented but cDNA can be patented (see BioCentury, June 17).
— U.S. Patent and Trademark Office preliminary guidance to patent examiners instructing them to reject product claims "drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not" (see BioCentury Extra, Friday, June 14).
Pharmacovigilance (PDF files)
EMA draft modules on good pharmacovigilance practices: Module VI on managing and reporting adverse events; and Module XVI on risk minimization measures to prevent or reduce adverse reactions.
— Iluvien: The U.K.'s NICE draft guidance recommending use of Iluvien fluocinolone acetonide intravitreal implant for a subset of patients with chronic diabetic macular edema (DME); from Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA) (see BioCentury Extra, Thursday, June 13).
— Jetrea: The U.K.'s NICE draft guidance recommending use of Jetrea ocriplasmin to treat vitreomacular traction in a subset of patients without an epiretinal membrane and who have severe symptoms; from ThromboGenics N.V. (Euronext:THR) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, June 11).
— Revolade: The U.K.'s NICE final appraisal determination (FAD) recommending use of Revolade eltrombopag to treat chronic idiopathic thrombocytopenia purpura (ITP) in adults who have had a splenectomy and whose condition is refractory to other treatments or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated; from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)