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 The leading web portal for pharmacy resources, news, education and careers December 19, 2014
Pharmacy Choice - News - Pharmaceutical Development - December 19, 2014

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 250     Next >>     Go To Page:

12/18/14 - AB Science: report of positive clinical study data in metastatic colorectal cancer
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.
12/18/14 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry,...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development.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
12/18/14 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track...
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
12/18/14 - Aldeyra Therapeutics Submits FDA IND Filing for Noninfectious Anterior Uveitis
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...
12/18/14 - ALDEYRA THERAPEUTICS, INC. FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits
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
12/18/14 - Alkermes Commences Clinical Study of Aripiprazole Lauroxil [Health & Beauty Close - Up]
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,...
12/18/14 - Anavex to Present at Biotech Showcase 2015 in San Francisco
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
12/18/14 - Bayer Submits Application for U.S. FDA Approval for Recombinant Factor VIII Product (BAY 81-8973) for the Treatment of Hemophilia A in Adults and Children
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
12/18/14 - BioCryst Initiates OPuS-2: A Clinical Trial of BCX4161 in Patients With Hereditary Angioedema
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
12/18/14 - Biothera Participates in Cancer Research UK Combinations Alliance
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
12/18/14 - Cara Announces Positive Top-Line Data from Phase 1b Trial of IV CR845; Provectus To Sponsor American Association Of Physicians Of Indian Origin
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
12/18/14 - Celator Pharmaceuticals Receives European Patent Allowance on Nanoparticle Delivery Technology
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.
12/18/14 - Coronado Biosciences Announces Closing of Initial Public Offering of CB Pharma Acquisition Corp.
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
12/18/14 - CORRECTING and REPLACING Extab Corporation Announces Positive Data from Phase 3 Clinical Study of Cytisine as a Smoking Cessation Aid Published in The New England Journal of Medicine
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
12/18/14 - Curis Announces Dosing of First Patient in Phase 1 Trial of CUDC-907 in Patients With Advanced/ Relapsed Solid Tumors
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
12/18/14 - Curis Reports Dosing of First Patient in Phase 1 Trial of CUDC-907 in Patients with Advanced/Relapsed Solid Tumors
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..
12/18/14 - D-Pharm Achieves Primary End-point in Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated With tPA
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
12/18/14 - DGAP-News: 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
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
12/18/14 - Extab Corporation Announces Positive Data from Phase 3 Clinical Study of Cytisine as a Smoking Cessation Aid Published in The New England Journal of Medicine
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
12/18/14 - Fate Therapeutics Announces Interim Data From Ongoing Phase 2 PUMA Study
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
12/18/14 - FDA continues delay in Chapel Hill drug approval [The Herald-Sun, Durham, N.C.]
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
12/18/14 - HITLAB Finalizes GCP Audit for FDA Smart Device & App Compliance [Professional Services Close - Up]
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
12/18/14 - iGrow hair growth helmet cleared for women [Sun Sentinel]
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
12/18/14 - Lannett Receives FDA Approval for Dorzolamide HCL with Timolol
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
12/18/14 - Marina Biotech and MiNA Therapeutics Announce License Agreement for the Development of saRNA-Based Therapeutics
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...
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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