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Week in Review
And More Algeta ASA and partner Bayer AG disclosed FDA approval for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, Astellas Pharma IncBioWorld Insight | Monday, May 20, 2013 -
Stimuvax Ekes Out OS Benefit in NSCLC Subgroup
Oncothyreon also reported data from two single-arm Phase II trials of PX-866 in glioblastoma and castration-resistant prostate cancerBy Catherine Shaffer | BioWorld Today | Friday, May 17, 2013 -
Algeta's Xofigo Wins FDA Nod Ahead of Schedule
According to Kay, the only therapy option for advanced prostate cancer patients previously has been chemotherapy...on the strategy for expanding Radium-223 development, importantly further studies in metastatic castrate-resistant prostate cancer (mCRPC), potentially in combination with oral Zytiga/Xtandi and/or in earlier stage patients, but also a possible Phase II trial in metastatic breast cancerBy Catherine Shaffer | BioWorld Today | Thursday, May 16, 2013 -
Tokai Adds $35.5M in Series E, Preps for Phase III CRPC Trials
Development of Tokai Pharmaceuticals Inc.'s triple-acting prostate cancer drug galeterone got a $35.5 million boost, with the Cambridge, Mass.-based biotech closing a Series E round with current investors Apple Tree Partners and Novartis Venture Funds, as well as undisclosed angel investors...Proceeds will go toward expanding the ongoing Phase II ARMOR2 study into patients with castration-resistant prostate cancer (CRPC) and preparing for registrational trialsBy Jennifer Boggs | BioWorld Today | Thursday, May 16, 2013 -
Gradalis' FANG Phase II Peek: Strong Data in Ovarian Cancer
In January, Gradalis raised $24 million in a Series B round, apparently having convinced investors of FANG's difference from Dendreon Corp.'s slow-selling prostate cancer vaccine Provenge (sipuleucel-T), approved in 2010By Randy Osborne | BioWorld Today | Thursday, May 16, 2013 -
American Association for Cancer Research: April 2013
prostate cancer Bone metastases showed a 67% rate of bone scan response and other clinical signs of effect 4/12/13 Onconova Therapeutics Inc. (Newtown, Pa.) Rigosertib A dual pathway inhibitor Solid tumors Phase I data showed tolerability and favorable antitumor activity 4/11/13 Pharmacyclics Inc. (Sunnyvale, Calif.) Ibrutinib Oral agent Chronic lymphocytic leukemia Phase II data showed that 95% of patients experienced a reduction in lymph node size and all showed a reduction in spleenBioWorld Insight | Monday, May 13, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: April 2013
prostate cancer CHMP recommended approval 4/29/13 CARDIOVASCULAR Athersys Inc. (Cleveland) MultiStem An off-the-shelf stem cell product Ischemic stroke UK expanded the ongoing Phase II study to patients who have suffered an ischemic stroke 4/18/13 Gentium SpA (Villa Guardia, Italy) Defibrotide Comprises a complex mixture of the salts of single-stranded oligodeoxyribonucleotides obtained from the mucosa of pigs To prevent hepatic veno-occlusive disease Requested a re-examination of the negativeBioWorld Insight | Monday, May 13, 2013 -
Isis Peers Beyond Kynamro, Seeks $171M for Pipeline
The company said it is seeking to improve utilization of prostate cancer vaccine Provenge (sipuleucel-T) by executing a direct-to-consumer (DTC) campaign that began in March, prompting a trend in improved enrollment that began midway through the first quarterBy Marie Powers | BioWorld Today | Friday, May 10, 2013 -
Other News To Note
Emergent BioSolutions Inc., of Rockville, Md., presented preclinical data on its lead bispecific ADAPTIR modular protein technology molecule, ES414, which is being developed as a potential therapeutic for metastatic castration-resistant prostate cancer (mCRPCBioWorld Today | Monday, May 6, 2013 -
Other News To Note
The product, a small molecule that binds to S100A9, is the subject of a study across 37 countries in 1,245 metastatic castrate-resistant prostate cancer patients who have not yet received chemotherapyBioWorld International | Wednesday, May 1, 2013 -
Other News To Note
Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use recommended approval of Xtandi (enzalutamide) for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapyBioWorld Today | Monday, April 29, 2013 -
Clinic Roundup
The product, a small molecule that binds to S100A9, is the subject of a study across 37 countries in 1,245 metastatic castrate-resistant prostate cancer patients who have not yet received chemotherapyBioWorld Today | Friday, April 26, 2013 -
BIND's Accurin Platform Lands $200M AstraZeneca Partnership
The company has had early success with its lead internal program, BIND-014, a prostate-specific membrane antigen-targeted docetaxel compound, in development for non-small-cell lung cancer, prostate cancer and bladder cancerBy Jennifer Boggs | BioWorld International | Wednesday, April 24, 2013 -
BIND's Accurin Platform Lands $200M AstraZeneca Partnership
The company has had early success with its lead internal program, BIND-014, a prostate-specific membrane antigen-targeted docetaxel compound, in development for non-small-cell lung cancer, prostate cancer and bladder cancerBy Jennifer Boggs | BioWorld Today | Tuesday, April 23, 2013 -
Manufacturing, Marketing And Distribution Agreements Between Biotech And Pharmaceutical Companies: Dec. 1, 2012 - April 18, 2013
prostate cancer Dr. Reddy's launched the product on Dec. 3, which is marketed in North America under the name Trelstar 12/10/12 Galena Biopharma Inc. (Lake Oswego, Ore.) Teva Pharmaceutical Industries Ltd. (Petach Tikva, Israel) ND Partnership to commercialize an investigational breast cancer vaccine, NeuVax (nelipepimut-S), in Israel Teva will take responsibility for regulatory registration in Israel, and support local development and commercializationBioWorld Insight | Monday, April 22, 2013 -
The Rise and Rise of Biotech: Tracking Progress BIO to BIO
Dendreon Corp., for example, secured its long sought-after FDA approval for prostate cancer vaccine Provenge (sipuleucel-T), an event that company president and CEO at that time Mitchell Gold hailed like "the dawn of an entirely new era in medicine" and "the Holy Grail of oncology." (See BioWorld Today, April 20, 2010.) However, this event flattered to deceive with the industry failing to establish much momentum from Dendreon's product successBy Peter Winter | BioWorld Insight | Monday, April 22, 2013 -
Navigating Successful Biotechs: CEOs Need to be Visionaries
The company has started a Phase IIb trial testing RNActive cancer vaccine CV9104 in patients with castration-resistant prostate cancer. (See BioWorld Today, March 28, 2013.) "Considering that we are a relatively small biotech, it is quite a big trial for us involving about 180 chemotherapy-naïve patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer in eight European countries," Hoerr saidBy Peter Winter | BioWorld Today | Friday, April 19, 2013 -
Pharma Clinical & FDA Action Update: March 2013
Prostate cancer Data showed it may be associated with a lower risk of a cardiovascular event or death compared to luteinizing hormone-releasing agonists 3/19/13 H. Lundbeck A/S (Copenhagen, Denmark) and Otsuka Pharmaceutical CoBioWorld Insight | Monday, April 15, 2013 -
Phase I Clinical Trials Update: March 2013
prostate cancer Phase I data showed antitumor activity demonstrated by PSA reductions and soft tissue tumor shrinkageBioWorld Insight | Monday, April 15, 2013 -
Phase II Clinical Trials Update: March 2013
prostate cancer Started a Phase IIb trial 3/28/13 CytRx Corp. (Los Angeles) Tamibarotene Oral retinoid compound Advanced non-small-cell lung cancer Completed enrollment of 140 patients in its Phase IIb study 3/1/13 GTx Inc. (Memphis, Tenn.) GTx-024 Enobosarm Muscle wasting in patients with cancer Phase II data showed there were significant increases in lean body mass and physical function in patients treated with enobosarm 1 mg or 3 mg, in oral daily doses, compared to placebo 3/15/13 MerrimackBioWorld Insight | Monday, April 15, 2013
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