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Diagnostics Rapidly Evolving, Ideal Companions in Drug R&D
Kadcyla is marketed by Roche AG unit Genentech Inc., of South San FranciscoBy Peter Winter | BioWorld Insight | Monday, May 13, 2013 -
Phase I Clinical Trials Update: April 2013
San Francisco) CK-2127107 Molecule activator of the fast skeletal muscle troponin complex Conditions associated with neuromuscular dysfunction, muscular weakness and/or muscle fatigue Started a Phase I trial 4/2/13 Immunomic Therapeutics Inc. (Lancaster, Pa.) JRC-LAMP-vax Immunothera-peutic vaccine Red cedar allergy Phase I data showed it met all of its primary safety endpoints 4/25/13 Lipocine Inc. (Salt Lake City) LPCN 1111 Next-generation oral testosterone replacement product TestosteroneBioWorld Insight | Monday, May 13, 2013 -
Phase III Clinical Trials Update: April 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Rigel Pharmaceuticals Inc. (South San Francisco) and AstraZeneca plc (London) Fostamatinib Oral spleen tyrosine kinase inhibitor Rheumatoid arthritis Missed the X-ray endpoint of modified Total Sharp score, but hit statistical significance in ACR20 scoring, although the Phase III still fell short of those achieved by Pfizer Inc.'s approved Xeljanz 4/8/13 CANCER Array BioPharma Inc. (Boulder, Colo.) ARRY-520 A selective KSPBioWorld Insight | Monday, May 13, 2013 -
Other News To Note
Curis earned a $4 million milestone payment from Genentech Inc., of South San Francisco (a unit of Roche AG), as a result of the Australian approvalBioWorld Today | Monday, May 13, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: April 2013
once-daily Multiple sclerosis Was approved in Argentina in a 14 mg formulation for patients with relapsing forms 4/9/13 CANCER Celgene Corp. (Summit, N.J.) Revlimid Lenalidomide Transfusion-dependent anemia CHMP adopted a positive opinion for Revlimid 4/29/13 Curis Inc. (Lexington, Mass.) Erivedge Vismodegib Symptomatic metastatic basal cell carcinoma CHMP recommended conditional approval 4/29/13 Medivation Inc. (San Francisco) and Astellas Pharma Inc. (Tokyo) Xtandi Enzalutamide MetastaticBioWorld Insight | Monday, May 13, 2013 -
FDA Submissions, Approvals & Other Actions: April 2013
San Francisco) and GlaxoSmithKline plc (London) Breo Fluticasone furoate (FF)/vilanterol (VI), the combination corticosteroid and long-acting beta2 agonist Chronic obstructive pulmonary disease FDA committee recommended approval 4/18/13 Tris Pharma Inc. (Monmouth Junction, N.J.) Karbinal ER Carbinoxamine maleate extended-release oral suspension Seasonal and perennial allergic rhinitis FDA approved it 4/4/13 MISCELLANEOUS Enlivex Therapeutics Ltd. (Jerusalem) ApoCell A treatment based on inducingBioWorld Insight | Monday, May 13, 2013 -
Other News To Note
Jennerex Biotherapeutics Inc., of San Francisco, said the FDA granted orphan drug status for Pexa-Vec (JX-594, pexastimogene devacirepvec) for the treatment of hepatocellular carcinoma (HCCBioWorld Today | Friday, May 10, 2013 -
Earnings Roundup
Exelixis Inc. , of South San Francisco, reported net revenues for the quarter ended March 31, 2013, were $9.7 million, compared to $18.5 million for the comparable period in 2012...Onyx Pharmaceuticals Inc. , of South San Francisco, reported a doubling of its total revenues to $145.5 million in its financial results for the first quarter 2013, as compared to total revenue of $72 million for the comparable period in 2012BioWorld Today | Thursday, May 9, 2013 -
Clinic Roundup
Portola Pharmaceuticals Inc., of South San Francisco, Calif., reported safety and efficacy data from a Phase II proof-of-concept study of PRT4445 of Eliquis (apixaban) in healthy volunteersBioWorld Today | Thursday, May 9, 2013 -
AiCuris Wins Breakthrough Alliance Annual Deal Award
SAN FRANCISCO – When AiCuris GmbH, of Wuppertal, Germany, analyzed the market for human cytomegalovirus (HCMV) therapies, it found a market with high medical need, neglected by big pharma, featuring a variety of disease manifestations...Rubsamen-Schaeff accepted the award on behalf of AiCuris at an award banquet recently at the Palace Hotel in San FranciscoBy Catherine Shaffer | BioWorld International | Wednesday, May 8, 2013 -
Other News To Note
VistaGen Therapeutics Inc., of South San Francisco, said its human pluripotent stem cell-derived cardiomyocytes were used by collaboration partner Duke University to grow three-dimensional (3D) human heart muscleBioWorld Today | Wednesday, May 8, 2013 -
Latest Astellas, Drais Spinout, Tacurion Launches with $15M
Portola Pharmaceuticals Inc., of South San Francisco, set the price range for its proposed initial public offering (IPO), aiming to sell 6.9 million shares priced between $13 and $16 eachBy Catherine Shaffer | BioWorld Today | Wednesday, May 8, 2013 -
Week in Review
And More Check out BioWorld Today's coverage of Allicense 2013 held in San Francisco last weekBioWorld Insight | Monday, May 6, 2013 -
Other Financings Of Public Biotechnology Companies: April 2013
LLC acted as exclusive placement agent 4/19/13 Ohr Pharmaceutical Inc. (New York) Exercise of Series B warrants N/A $5.05 Ohr raised about $5.05M from institutional and accredited shareholders through the exercise of Series B warrants 4/23/13 OxiGene Inc. (South San Francisco) Private placement of zero coupon convertible preferred stock Convertible into 1.38S $5 OxiGene raised $5M through the placement...StemCells issued SVB a warrant to purchase 293,531 shares of common stock at $1.7034 per shareBioWorld Insight | Monday, May 6, 2013 -
Re-verb: Conjugates Lure BMS to Ambrx Deal Number Three
San Francisco, in December 2012 inked a potential $500 million deal with Summit, N.J.-based Celgene CorpBy Randy Osborne | BioWorld Today | Monday, May 6, 2013 -
Public Financing Of Biotechnology: April 2013
Sunrise Securities Corp. $25 Ambit Biosciences Inc. (San Diego; AMBI)2 2/20/13 4.645S $13-$15 12.9 Citigroup Leerink Swann (co-lead) BMO Capital Markets Baird $65.03 Audeo Oncology Inc. (San Francisco; AURX)3 7/6/12 3.25S $14-$16 10.8 Leerink Swann Oppenheimer & Co. (co-lead) $49 Epizyme Inc. (Cambridge, Mass.; EPZM) 4/26/13 N/A N/A N/A Citigroup Cowen and Co. (co-lead) Leerink Swann (co-lead) JMP Securities Wedbush PacGrow Life Sci. $69 GlobeImmune Inc. (Louisville, Colo.; GBIM) 7/2/12BioWorld Insight | Monday, May 6, 2013 -
Bench Press: BioWorld Looks at Translational Medicine
Early Bird Gene Mutation Linked to Migraine A group of scientists from the University of California at Los Angeles and the University of California at San Francisco discovered a gene mutation that is linked to both familial advanced phase sleep syndrome, in which individuals go to bed and wake up very early, and migraineBioWorld Today | Monday, May 6, 2013 -
Venture Capital And Other Investments In Private Biotechnology Companies: April 2013
San Francisco $10 Cleave raised $10M in an extension of its Series A round from New Enterprise Associates, bringing its Series A total to $54M 4/10/13 Cydan LLC Cambridge, Mass. $16 Cydan received $16M from investors led by New Enterprise Associates and Pfizer Venture InvestmentsBioWorld Insight | Monday, May 6, 2013 -
Biocom Helps SoCal Grow Its Biotech Sector
A report from real estate firm Jones Lang LaSalle in March lists San Diego as the number two biotechnology cluster in the U.S. Like any list, the ranking is debatable, especially by people in the San Francisco Bay Area who came in thirdBy Brian Orelli | BioWorld Insight | Monday, May 6, 2013 -
Other News To Note
Hyperion Therapeutics Inc., of South San Francisco, said the FDA notified the firm that Ravicti (glycerol phenylbutyrate) qualified for orphan drug exclusivity, giving the product exclusivity on the market for seven years from the date of approval on Feb. 1BioWorld Today | Friday, May 3, 2013
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