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A German court on Wednesday dismissed a suit from Novartis AG (NYSE:NVS; SIX:NOVN) seeking to block the assessment of the pharma's Type II diabetes drugs in the dipeptidyl peptidase-4 (DPP-4) inhibitor (gliptin) class. …
Published on 5/15/2013
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Alvine Pharmaceuticals Inc. (San Carlos, Calif.) granted AbbVie Inc. (NYSE:ABBV) an exclusive option to acquire the company or its ALV003, which is in Phase II testing to treat celiac disease, under undisclosed terms. …
Published on 5/14/2013
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FDA approved an sNDA from Astellas Pharma Inc. (Tokyo:4503) on Tuesday to expand the label for Tarceva erlotinib and also approved the cobas EGFR Mutation Test from partner Roche (SIX:ROG; OTCQX:RHHBY) as a companion …
Published on 5/14/2013
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Seattle Genetics Inc. (NASDAQ:SGEN) said FDA accepted for review an sBLA to expand the label of Adcetris brentuximab vedotin to include retreatment and an extended duration of treatment beyond 16 cycles in relapsed …
Published on 5/14/2013
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AbbVie Inc. (NYSE:ABBV) disclosed in an SEC filing that SVP and CSO John Leonard will retire in the "next few months." AbbVie said Leonard will be involved in the transition process for naming his successor. Leonard was…
Published on 5/13/2013
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Cempra Inc. (NASDAQ:CEMP) granted Toyama Chemical Co. Ltd. exclusive rights to develop and commercialize solithromycin in Japan. The fluoroketolide/macrolide antibiotic is in Phase III testing to treat moderate to …
Published on 5/13/2013
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Biogen Idec Inc. (NASDAQ:BIIB) said FDA accepted for review a BLA for Eloctate rFVIIIFc to treat hemophilia A. The company submitted the application in March; a standard review would place the PDUFA date in March 2014, …
Published on 5/13/2013
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FDA accepted and granted Priority Review to an NDA from the Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) for simeprevir to treat HCV genotype 1 infection in adult patients with compensated …
Published on 5/13/2013
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Vectura Group plc (LSE:VEC) partnered with Tianjin KingYork Group Co. Ltd. and private equity investor Zendex Bio Strategy to form a JV -- Tianjin Kinnovata Pharmaceutical Co. Ltd. -- to develop and commercialize …
Published on 5/13/2013
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Shares of generics company Actavis Inc. (NYSE:ACT) and specialty pharma Warner Chilcott plc (NASDAQ:WCRX) jumped on Friday after the companies disclosed before market close they are in "early stage" discussions to merge…
Published on 5/10/2013
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Shares of Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics Inc. (NASDAQ:PTIE) slid on Friday after partner Pfizer Inc. (NYSE:PFE) disclosed in an SEC filing that if it "elect[s] to continue development" of Remoxy …
Published on 5/10/2013
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FDA denied a 2012 Citizen Petition from Endo Health Solutions Inc. (NASDAQ:ENDP) asking the agency to determine that the original formulation of the company's pain drug Opana ER oxymorphone had been withdrawn due to …
Published on 5/10/2013
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FDA approved a regulatory application from Novartis AG (NYSE:NVS; SIX:NOVN) to expand the label for Ilaris canakinumab to include treatment of systemic juvenile idiopathic arthritis. The news sent shares of Regeneron …
Published on 5/10/2013
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FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet on July 18 to discuss a resubmitted NDA from Merck & Co. Inc. (NYSE:MRK) for sugammadex for the reversal of neuromuscular blockade induced by …
Published on 5/9/2013
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Intas Pharmaceuticals Ltd. (Ahmedabad, India) launched Mabtas rituximab in India to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL) alone or in combination with chemotherapy. The product is a …
Published on 5/9/2013
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Salix Pharmaceuticals Inc. (NASDAQ:SLXP) disclosed in its post-market 1Q13 earnings that it submitted an appeal to FDA for a July 2012 complete response letter for an sNDA for subcutaneous Relistor methylnaltrexone to …
Published on 5/9/2013
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Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said Anna Protopapas, EVP and global business development head at the pharma's Takeda Pharmaceutical International Inc. subsidiary, will also become president of Takeda's …
Published on 5/9/2013
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Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) jumped $0.96 (22%) to $5.31 on Wednesday after granting Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) exclusive, U.S. rights to Adasuve loxapine, which FDA approved in …
Published on 5/8/2013
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Merck & Co. Inc. (NYSE:MRK) said FDA accepted for review a BLA for Ragweed Allergy Immunotherapy Tablet (AIT) in adults with ragweed-induced allergic rhinitis. The pharma submitted the BLA in March and said it expects a…
Published on 5/8/2013
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Oncobiologics Inc. (Cranbury, N.J.) and Zhejiang Huahai Pharmaceutical Co. Ltd. (Shanghai:600521) partnered to co-develop and commercialize four biosimilars. The biologics are autoimmune drug Humira adalimumab; …
Published on 5/8/2013
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Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) will acquire infectious disease company Inviragen Inc. (Fort Collins. Colo.) for $35 million in cash up front, plus up to $215 million in milestones. Inviragen's DENVax, a …
Published on 5/8/2013
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Astellas Pharma Inc. (Tokyo:4503) and Drais Pharmaceuticals Inc. (Bridgewater, N.J.) partnered to form a virtual company -- Tacurion Pharma Inc. -- to develop and commercialize Astellas' ASP7035 for nocturia. Tacurion …
Published on 5/7/2013
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Arena Pharmaceuticals Inc. (NASDAQ:ARNA) gained $0.82 (11%) to $8.34 on Tuesday after the U.S. Drug Enforcement Agency issued a final rule establishing twice-daily obesity drug Belviq lorcaserin as a class IV controlled…
Published on 5/7/2013
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GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA extended the PDUFA date by three months for an NDA for trametinib to treat patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an …
Published on 5/6/2013
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Ambrx Inc. (La Jolla, Calif.) partnered with Bristol-Myers Squibb Co. (NYSE:BMY) to discover and develop antibody-drug conjugates (ADCs) for undisclosed cancer indications. Ambrx will receive $15 million up front and …
Published on 5/3/2013