AB Science SA, a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors, today announced encouraging follow-up results from a phase 2 study with its investigational drug, masitinib, in patients with nonresectable, metastatic colorectal cancer after progression to first-line treatment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development. All comments should be identified with the OMB control number 0910- NEW and tit
All comments should be identified with the OMB control number 0910-0389. Also include the FDA docket number found in brackets in the heading of this document. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. The section authorizes FDA to
Aldeyra Therapeutics, Inc., a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that an Investigational New Drug application to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis, was submitted to the United States Food and Drug...
On December 18, 2014, Aldeyra Therapeutics, Inc. issued a press release announcing that it has submitted an Investigational New Drug application to the United States Food and Drug Administration to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis. A copy of the press release is attached hereto as Exhibit 9
Alkermes reported the initiation of a phase 1 clinical study of extended dosing intervals of aripiprazole lauroxil, the company's investigational, novel, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. "Building upon our longstanding expertise with multiple long- acting atypical antipsychotics available today,...
Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system and various types of cancer, will present at Biotech Showcase 2015 on Monday January 12, 2015 at 2:00pm PST. The investor and partnering conference will take place at th
Release date- 17122014- Berlin,- Bayer HealthCare today announced that it has filed a Biologics License Application to the U.S. Food and Drug Administration seeking approval for BAY 81-8973, a recombinant Factor VIII compound, for the treatment of hemophilia A in adults and children. The submission follows Bayer's recent application to the European
BioCryst Pharmaceuticals, Inc., today announced that it has dosed the first patient in OPuS-2, a blinded, randomized, placebo-controlled clinical trial of orally-administered BCX4161 in patients with hereditary angioedema. Marc Riedl, M.D., M.S., Associate Clinical Professor at the University of California-San Diego School of Medicine, Clinical D
Biothera announced today that it has joined AstraZeneca, Astex Pharmaceuticals, Eli Lilly and Company, MedImmune and Verastem as the latest pharmaceutical partner in Cancer Research UK's Combinations Alliance. Today s announcement marks the signing of a Memorandum of Understanding between Biothera and Cancer Research UK that provides the framewo
Additionally, clinical safety laboratory measurements were normal across all tablet strengths after single or repeat dosing. "Successful completion of this Phase 1 trial of the tablet formulation of Oral CR845 represents a key milestone for Cara as we look to expand the clinical development of CR845 beyond the treatment of acute pain in a hospital
Celator Pharmaceuticals, Inc., a biopharmaceutical company transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced that the application of European patent number 2,222,278 was allowed by the European Patent Office. This patent provides protection until November 2028.
Coronado Biosciences, Inc. reports the closing on December 17, 2014 of the initial public offering of CB Pharma Acquisition Corp.. Copies of the prospectus relating to the offering may be obtained by contacting EarlyBirdCapital, Inc., the sole book-running manager for the offering, at EarlyBirdCapital, Inc., Attention: Prospectus Department, 366
Shown to be superior to nicotine replacement therapy in study of 1,310 patients funded by the Health Research Council of New Zealand. Extab Corporation, a privately-held, pharmaceutical company focused on advancing Tabex?, a smoking cessation drug containing the active substance cytisine, announces that positive data from a Phase 3 clinical trial
Curis, Inc., an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive/ HER2-negative breast cancer or
Curis, Inc., an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive/ HER2-negative breast cancer or..
REHOVOT, Israel, December 18, 2014/ PRNewswire/. D-Pharm Ltd. reported today, December 18th, 2014, that its Phase 2 clinical study of THR-18 successfully achieved its primary endpoint in acute ischemic stroke patients treated with tissue plasminogen activator. THR-18 demonstrated statistically significant reductions in the incidence of intracrani
DGAP-News: co.don Aktiengesellschaft/ Key word: Study results co.don Aktiengesellschaft: Analysis of data from Phase II clinical trial confirms the effectiveness and safety profile of the pharmaceutical product co.don condrosphere (R) in the dosages examined 18.12. 2014/ 09:33- Pre
Extab Corporation, a privately-held, pharmaceutical company focused on advancing Tabex?, a smoking cessation drug containing the active substance cytisine, announces that positive data from a Phase 3 clinical trial of cytisine as a smoking cessation aid were published in the December 18 edition of The New England Journal of Medicine in an article
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today reported initial data from the first 12 subjects administered PROHEMA in the Company's ongoing Phase 2 PUMA study and announced that the study's independent Data Monitoring Committee suppor
Dec. 18 CHAPEL HILL Pharmaceutical company Pozen said Wednesday that two versions of an experimental drug were denied approval for the second time by the Food and Drug Administration. John Plachetka, CEO of the Chapel Hill- based company, said in a conference call that the FDA cited the same reason as the first time, which was a deficiency in a
Pugliese added, "Even in this fast-paced industry-as devices evolve at breakneck speed-HITLAB has deep evaluation and validation expertise needed to maintain efficient, effective, and FDA- compliant clinical trials using smart devices and smart phone applications. Smart Consulting Group, an industry consultant SME on FDA regulatory compliance issue
Dec. 18 Apira Science, which makes a laser helmet system to grow hair, has received FDA marketing clearance for sales to women. Apira, based in Boca Raton, received FDA clearance for sales to men in 2012. Clearance by the FDA doesn't mean a product works, only that it's not harmful. The iGrow system, which retails for $695, is sold online at igro
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/ 0.5%, the therapeutic equivalent to the reference listed drug, Cosopt Ophthalmic Solution, 2%/ 0.5%, of Oak Pharmaceutica
Marina Biotech, Inc., a leading nucleic acid-based drug discovery and development company focused on rare diseases, and MiNA Therapeutics Limited, the pioneer in RNA activation therapeutics, announced today that they have entered into a license agreement regarding the development and commercialization of small activating RNA based therapeutics...