Global declaration from July 13 to July 17, 2015 July 27, 2015 First, new drug approval 1. On July 20, 2015, the FDA approved Meridian Bioscience herpes simplex virus type 1 / 2 molecular diagnostic reagent illumigene® HSV 1&2. 2. On July 20, 2015, the EU approved Bristol-Myers Squibb Nivolumab for second-line treatment of advanced metastatic squamous non-small cell lung cancer. 3. On July 21, 2015, the EU approved Amgen PCSK9 inhibitor Evolocumab for primary (heterozygous familial or non-familial) hypercholesterolemia or mixed dyslipidemia or homozygous familial hypercholesterolemia treatment. Evolocumab's PDUFA date is August 27th, and Sanofi Alirocumab's PDUFA date is Friday July 24th. 4. On July 22, 2015, the EU approved Merck PD-1 immunotherapy KEYTRUDA (pembrolizumab) for unresectable or metastatic advanced melanoma. The FDA approved the indication in September 2014. The PDUFA date for non-small cell lung cancer indications was October 2, 2015. 5. On July 24, 2015, the FDA approved the amprolase inhibitor Carfilzomib in combination with lenalidomide for second-line treatment of multiple myeloma. 6. On July 24, 2015, the FDA approved Abbott TECHNIVIE (Ombitasvir/paritaprevir/ritonavir) in combination with ribavirin for the treatment of adult genotype 4 HCV. 7. On July 24, 2015, the FDA approved Bristol-Myers Squibb Dartarevir in combination with sofosbuvir for genotype 3 HCV. 8. On July 24, 2015, the FDA approved Novartis Sonidiegib for the treatment of advanced basal cell carcinoma. 9. On July 24, 2015, the FDA approved Sanofi Alirobumab as scheduled to treat heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease. Second, breakthrough therapy identification 1. On July 21, 2015, the FDA awarded Bristol-Myers Squibb Fostemsavir in combination with ART for the treatment of HIV breakthrough therapy. Third, fast channel 1. On July 23, 2015, Omeros anti-MASP-2 monoclonal antibody OMS-721 atypical hemolytic uremic syndrome indication entered the FDA fast track. Fourth, orphan drugs 1. On July 20, 2015, FDA granted Osmotica Amantadine Sustained-release Tablets for the treatment of levodopa-induced dyskinesia orphan drug in patients with Parkinson's disease. 2. On July 20, 2015, the FDA granted the new antisense drug Mongersen the treatment of Crohn's disease orphan drug. 3. On July 23, 2015, the FDA granted Taiwan Guoding Biotech Android Quinoler the right to treat orphan drugs for hepatocellular carcinoma. 4. On July 23, 2015, the FDA granted Insys medical cannabinol to treat infantile orphan drug. 5. On July 23, 2015, the FDA granted Vanquish oncology PAC-1 the qualification to treat malignant glioma orphan drugs. 6. On July 23, 2015, the FDA granted Ziopharm oncology INXN-2001 the qualification to treat malignant glioma orphan drugs. V. Listing application and review 1. On July 20, 2015, Heron submitted to the FDA for the third time a NHT application of the 5HT-3 receptor antagonist SUSTOL (Grastron controlled release preparation) for the prevention of delayed nausea and vomiting caused by highly vomiting chemotherapy. Heron's predecessor, AP Pharmaceutical, filed an NDA application twice in 2009 and 2012. 2. On July 22, 2015, Catalyst began submitting ampicillin treatment for Lambert-Eaton syndrome rolling NDA, which is expected to be completed in the fourth quarter of this year. The therapy has been approved for breakthrough therapy and orphan drug. 3. On July 23, 2015, Bristol-Myers Squibb reported two new indications for nivolumab in the European Union: 1. Second-line treatment for non-squamous non-small cell lung cancer; 2. First-line treatment of melanoma with Iprimum. 4. On July 23, 2015, EMA accepted the Merck Elbasvir+grazoprevir cocktail treatment for 1,5,4,6 HCV listing applications. Sixth, clinical progress On January 20th, Fibrocell and Intrexon jointly submitted an IND application for genetically modified fibroblast therapy FCX-007 for the treatment of recessive genetic dystrophic bullous epidermolysis. On February 23rd, Biohaven submitted an IND application for BHV-0223 pan-anxiety treatment to the FDA. On March 23rd, Lpath conducted a phase I clinical trial of anti-LPA monoclonal antibody Lpathomab neuropathic pain. 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