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Pharma Offers Insights on Partnering: Focused Is Better
You've got to be a little out of the box to adjust for the risk in bringing on the molecule," Golumbeski said, highlighting Celgene's "build to buy" collaboration with San Francisco-based Quanticel Pharmaceuticals Inc. (See BioWorld Today, Nov. 7, 2011.) While some pharmas worry about being able to recoup their investment after the drug is approved, Golumbeski said Celgene doesn't even do formal pricing and reimbursement studies before signing deals because of the changing timesBy Brian Orelli | BioWorld Today | Friday, March 1, 2013 -
Other News To Note
Aciex Therapeutics Inc., of Boston, said it entered a research agreement with Portola Pharmaceuticals Inc., of South San Francisco, providing Aciex with exclusive rights to develop Portola's small-molecule dual SYK/JAK inhibitors for ophthalmic indications...Titan Pharmaceuticals Inc., of South San Francisco, said the FDA's Psychopharmacologic Drugs Advisory Committee is scheduled to review the firm's new drug application (NDA) for Probuphine for the maintenance treatment of adults with opioidBioWorld Today | Thursday, February 28, 2013 -
Clinic Roundup
KaloBios Pharmaceuticals Inc., of South San Francisco, said data from its Phase I/II study of KB002 (precursor chimeric anti-GM-CSF monoclonal antibody to KB003) in persistent asthma demonstrated preliminary safety, tolerability and signs of activity and support continued development of Humaneered antibody KB003BioWorld Today | Thursday, February 28, 2013 -
Financings Roundup
Hyperion Therapeutics Inc., of South San Francisco, said it is offering up to $50 million of shares of common stock, though the number of shares and share price have not yet been disclosedBioWorld Today | Thursday, February 28, 2013 -
Other News To Note
Cubist Pharmaceuticals Inc., of Lexington, Mass., and Adynxx Inc., of San Francisco, said that they have entered into an option agreement providing Cubist the exclusive right to acquire privately held Adynxx following the data readout of its Phase II trial for lead product candidate, AYX1, as a potential treatment for the reduction of acute pain and prevention of persistent and chronic pain following surgery...Jennerex Inc., of San Francisco, and Lee's Pharmaceutical Holdings, of Hong KongBioWorld Today | Tuesday, February 26, 2013 -
Clinic Roundup
Adynxx Inc., of San Francisco, said the first patient was dosed in a Phase II study of AYX1 , its lead candidate to prevent post-surgical pain...Genentech Inc., of South San Francisco, a member of the Roche Group, and Novartis AG, of Basel, Switzerland, said results from a Phase III trial, ASTERIA II, demonstrated that omalizumab met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria, who remained symptomatic despite treatment with approved H1 antihistamine dosesBioWorld Today | Tuesday, February 26, 2013 -
Biotechnology Company Deals With Other Biotechnology Companies: Dec. 1, 2012 - Feb. 21, 2013
SCT also will have an option to develop and commercialize selected products resulting from the research 12/4/12 Sutro Biopharma Inc. (South San Francisco) Celgene Corp. (Summit, N.J.) $500 $500M deal includes two undisclosed targets against which antibody conjugates and bispecific antibodies will be deployed, plus the manufacturing of a Celgene-owned antibody The deal brings a "substantial" up-front amount and includes milestone payments for Sutro as the companies will design and developBioWorld Insight | Monday, February 25, 2013 -
Breast-Case Scenario: Kadcyla Price Set at Premium to Others
and Sutro Biopharma Inc., of San Francisco, are trying new approaches to refine ADCs. (See BioWorld Insight, Aug. 6, 2012.) "A number of the items that were noted in the boxed warnings do mirror what you have seen for Herceptin," Junius saidBy Randy Osborne | BioWorld Today | Monday, February 25, 2013 -
Other News To Note
Exelixis Inc., of South San Francisco, partnered with Swedish Orphan Biovitrum AB (Sobi), of Stockholm, Sweden, to distribute and commercialize Cometriq (cabozantinib) for metastatic medullary thyroid cancer in the European Union and potentially other countries...Shimojani LLC, of San Francisco, licensed an invention from Nigata University that it said has potential to substantially reduce the risk of hemorrhage in acute ischemic stroke patients, including those who receive tissue plasminogenBioWorld Today | Monday, February 25, 2013 -
Earnings Roundup
Exelixis Inc., of South San Francisco, reported a net loss of $52.2million, or ($0.28) per share, for the fourth quarter 2012 compared to an income of $46.3 million, or $0.35 per share, for the comparable period in 2011...Onyx Pharmaceuticals Inc., of South San Francisco, reported a net loss of $162.9 million, or $2.50 per diluted share, for the full year 2012 and $24 million, or $0.36 per diluted share, for the fourth quarter 2012BioWorld Today | Monday, February 25, 2013 -
Appointments and Advancements
MyoKardia Inc., of South San Francisco, named Jonathan C. Fox chief medical officer...Sutro Biopharma Inc., of San Francisco, appointed Edward C. Albini chief financial officerBioWorld Today | Friday, February 22, 2013 -
Clinic Roundup
Onyx Pharmaceuticals Inc., of South San Francisco, said Leukemia published results from the Phase II study known as PX-171-005, testing Kyprolis (carfilzomib) in patients with relapsed and refractory multiple myeloma and varying degrees of renal insufficiencyBioWorld Today | Thursday, February 21, 2013 -
Phase I Clinical Trials Update: January 2013
San Francisco) AV-101 An oral prodrug candidate Chronic neuropathic pain Completed its final Phase I study 1/24/13 Zogenix Inc. (San Diego) Relday A once-monthly subcutaneous formulation of risperidone Schizophrenia Phase I data showed that adverse events were generally mild to moderate and consistent with other risperidone products 1/4/13 DIABETES Biodel Inc. (Danbury, Conn.) BIOD-238 and BIOD-250 Ultra-rapid-acting insulin analogue-based formulations Type I diabetes Phase I data from a trialBioWorld Insight | Tuesday, February 19, 2013 -
Phase II Clinical Trials Update: January 2013
Ltd. (Osaka, Japan) OCA Obeticholic acid Nonalcoholic steatohepatitis Began a Phase II trial 1/9/13 Tobira Therapeutics Inc. (South San Francisco) Cenicriviroc An oral, once-daily CCR5/CCR2 inhibitor HIV Phase IIb data showed it met the primary objective 1/8/13 INFLAMMATORY Receptos Inc. (San Diego) RPC1063 Selective sphingosine1 phosphate 1 receptor modulator Moderately to severely active ulcerative colitis Dosed the first patient in a Phase II study 1/7/13 XOMA Corp. (Berkeley, CalifBioWorld Insight | Tuesday, February 19, 2013 -
Phase III Clinical Trials Update: January 2013
San Francisco) and Genentech Inc. (South San Francisco) Zelboraf Vemurafenib...BRAF inhibitor Malignant melanoma First patient was dosed in a pivotal Phase III trial 1/18/13 Morphotek Inc. (Exton, Pa.) Farletuzumab Ovarian cancer drug Ovarian cancer Phase III trial of farletuzumab with carboplatin and taxane did not meet its primary endpoint of progression-free survival 1/14/13 Onyx Pharmaceuticals Inc. (South San Francisco) and Bayer AG (Leverkusen, Germany) Nexavar Sorafenib Locally advanced orBioWorld Insight | Tuesday, February 19, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: January 2013
San Francisco) and GlaxoSmithKline plc (London) UMEC-VI A combination of GSK573719 (umelidinium bromide) and vilanterol Chronic obstructive pulmonary disease Submitted an MAA in the European Union 1/10/13 MISCELLANEOUS Keryx Pharmaceuticals Inc. (New York) Ferric citrate Ferric citrate Hyperphos-phatemia in chronic kidney disease Filed an NDA in Japan 1/8/13 Santhera Pharmaceuticals Inc. (Liestal, Switzerland) Raxone Idebenone Blindness The CHMP turned down the drug by a narrow majority 1/22/13BioWorld Insight | Tuesday, February 19, 2013 -
FDA Submissions, Approvals & Other Actions: January 2013
San Francisco) Avastin Bevacizumab Metastatic colorectal cancer FDA granted approval for patients receiving Avastin plus an irinotecan or oxaliplatin containing chemotherapy to continue to receive Avastin plus a different chemotherapy after their cancer worsens 1/25/13 Icon Bioscience Inc. (Sunnyvale, Calif.) Melphalan Intraocular injection formulated using the Verisome delivery technology Retinoblastoma Was granted orphan designation by the FDA 1/4/13 Telik Inc. (Palo Alto, Calif.) TelintraBioWorld Insight | Tuesday, February 19, 2013 -
Jennerex's Pexa-Vec Attacks Tumors Through 3 Mechanisms
Pexa-Vec (JX-594), developed by San Francisco-based Jennerex Inc., is a triple cancer killerBy Brian Orelli | BioWorld Insight | Tuesday, February 19, 2013 -
Other News To Note
JDRF, of New York, and the California Institute for Regenerative Medicine, of San Francisco, each will contribute $3 million to develop a stem cell therapy at ViaCyte Inc., of San DiegoBioWorld Today | Thursday, February 14, 2013 -
Swiss Start-up Piqur Develops Dual PI3K-mTOR Inhibitors
Paris-based Sanofi SA is also in the clinic with a dual inhibitor, SAR245409 (XL765), which it in-licensed from Exelexis Inc., of South San FranciscoBy Cormac Sheridan | BioWorld International | Wednesday, February 13, 2013
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