-Advaxis, Inc., a clinical stage biotechnology company developing cancer immunotherapies, today announced the commencement of Part B of the KEYNOTE-046 clinical trial evaluating Advaxis Lm immunotherapy candidate, ADXS-PSA, in combination with KEYTRUDA in patients with previously treated, metastatic castration-resistant prostate cancer.
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved ZINPLAVA? Injection 25 mg/mL. Merck anticipates making ZINPLAVA available in first quarter 2017.. For generations, Merck has been steadfast in its commitment to fighting infectious diseases and that commitment co
-Retrophin, Inc. today announced that additional data from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis will be presented at the late-breaking High-Impact Clinical Trials oral session at the American Society of Nephrology Kidney Week 2016. ASN Kidney Week 2016 is being held November 15-20 in Chicago.
Saniona, a leading biotech company in the field of ion channels, today announces that it has reached the first research milestone for identifying new drug candidates for the treatment of Parkinson`s disease, which is supported by the The Michael J. Fox Foundation for Parkinson`s Research. In February 2016, Saniona announced that The Michael J. Fox
By a News Reporter-Staff News Editor at Drug Week AbbVie, a global biopharmaceutical company, announced Health Canada has issued a Notice of Compliance with Conditions for VENCLEXTA?. Under NOC/c policy, AbbVie will provide Health Canada with data from additional studies to confirm the clinical benefit of VENCLEXTA. It worked fine until I relap
Alkermes plc (NASDAQ:ALKS) today announced positive topline results from FORWARD-5, the third phase 3 efficacy study to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate r
PRINCETON, N.J. and LUND, Sweden, Oct. 21, 2016/ PRNewswire/ Braeburn Pharmaceuticals and Camurus announce the presentation of new data from three clinical studies on CAM2038, an investigational long-acting injectable medication with flexible dosing, at a joint annual meeting of the International Society of Addiction Medicine and the Canadian Soc
Dermira, Inc., a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, presented data from its DRM01 Phase 2 b clinical trial at the 35 th Anniversary Fall Clinical Dermatology Conference in Las Vegas.. Positive topline r
DGAP-News: Newron Pharmaceuticals S.p.A./ Schlagwort: Zulassungsantrag Newron Pharmaceuticals S.p.A.: U.S. FDA: Newon's neu eingereichter NDA-Zulassungsantrag fr Xadago (R) ist vollstndige Antwort der Klasse 2 auf Complete Response Letter; PDUFA-Datum: 21. Mrz 2017 21.10. 2016/ 07:03 Fr den Inhalt der Mitteilung ist der Emittent verantwortl
By a News Reporter-Staff News Editor at Drug Week Pulmatrix, Inc., a pharmaceutical company developing innovative inhaled drugs, announced that the company has appointed Matthew L. Sherman, M.D., Executive Vice President and Chief Medical Officer of Acceleron Pharma, Inc., a clinical stage biopharmaceutical company as a new member to its Board of
Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced that the U.S. Food and Drug Administration has approved the use of its PreciseType HEA test to screen blood donors for Sickle Cell Trait. The PreciseType HEA test is the only FDA- approved molecular assay designed to provide clinicians and blood banks with th
TOKYO and NEW YORK, Oct. 21, 2016/ PRNewswire/ Astellas Pharma Inc. and Pfizer Inc. today announced the U.S. Food and Drug Administration approved a supplemental New Drug Application to update the U.S. product labeling for XTANDI capsules to include new clinical data versus bicalutamide from the TERRAIN study. The updated label includes data t
Research and Markets has announced the addition of the "Herceptin Biosimilar Clinical Trial Insight" clinical trials to their offering. The Herceptin Biosimilar Clinical Trial Insight report gives comprehensive clinical insight on 37 biosimilar version of Herceptin drug in clinical pipeline. Currently 3 biosimilar version of Herceptin are...
WASHINGTON, Oct. 21 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. A Notice by the Food and Drug Administration on 10/17/2016. FDA has determined that EXONDYS 51, manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher.
As more fully discussed in Item 8.01 below, on October 18, 2016, Lannett Company, Inc. received a notice from the U.S. Food and Drug Administration that the FDA will seek to withdraw approval of the Company's Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets. As a result of receiving the FDA notice, the Com
Release date- 20102016- MorphoSys AG announced today that it has received a milestone payment from Novartis in connection with the initiation of a phase 1 clinical trial with a novel HuCAL antibody. 'This is the 13th therapeutic antibody based on MorphoSys's technologies that Novartis is evaluating in clinical trials, thus making our collaboration
NANOBIOTIX, a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today announced that its Asia-Pacific partner, PharmaEngine, has dosed its first patient in a new Phase I/II trial in patients with head and neck cancers patient receiving radiotherapy plus chemotherapy, this October.
Investors of Pfizer Inc. failed to boost the sentiments after the company disclosed that its sNDA for prostate cancer drug XTANDI was granted approval by the FDA. Pfizer's Medivation interim chief medical officer, Mohammad Hirmand, commented, "We are pleased with the FDA's decision to update the XTANDI label with these data from the first and large
-RadioMedix Inc. is excited to announce the completion of the Phase I/II clinical trial of AminoMedix proprietary formulation used for kidney radioprotection during PRRT. Due to the lack of an FDA approved compound to protect kidneys during PRRT, currently different solutions of amino acids are being used, off-labeled, in the clinics. The current o
Retrophin, Inc. today announced that additional data from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis will be presented at the late-breaking High-Impact Clinical Trials oral session at the American Society of Nephrology Kidney Week 2016. Pharmacokinetics of Sparsentan in Healthy Subjects: In Vitro.
The cobas MPX test enables donor screening laboratories to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread of Human Immunodeficiency Virus Groups 1 and 2, Hepatitis B Virus, and Hepatitis C Virus through transfused blood products. "This approval.
Studies from Hyogo Cancer Center Reveal New Findings on Lung Cancer. By a News Reporter-Staff News Editor at Genomics& Genetics Weekly Researchers detail new data in Oncology- Lung Cancer. According to news reporting originating from Akashi, Japan, by NewsRx correspondents, research stated, "The epidermal growth factor receptor tyrosine kinase ha
ZUBSOLV was originally approved by the FDA on July 3, 2013 in two dosages of 5.7 mg/1. 4 mg and 1.4 mg/0. 36 mg sublingual tablet strengths. Since then, Orexo has received FDA approval of 4 additional dosage strengths advancing the offering available to the market. "The FDA approval of the 0.7 mg/0. 18 mg dose constitutes yet another important mil
Release date- 19102016- RARITAN, N.J- Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced today that the U.S. Food and Drug Administration has approved VERMOXTM CHEWABLE for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides and Tr
Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration accepted a supplemental Biologics License Application, which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy. The FDA granted the...