"Fast Track designation underscores the importance that the FDA places on developing new treatments for life-threatening disorders, such as MPS IIIA, and reinforces our mandate of accelerating the development of ABO-102 to market," stated Timothy J. Miller, Ph.D., President and CEO of Abeona Therapeutics. This designation is in addition to ABO-102
Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative.
-Achaogen, Inc., a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant gram-negative infections, today announced multiple data presentations from its plazomicin program at the Infectious Diseases Society of America IDWeek 2016, being held in New Orleans, LA, from October 26 to 30, 2016.
Aclaris Therapeutics, Inc., a clinical-stage specialty pharmaceutical company, will release its third quarter financial results before the market opens on Thursday, November 3, 2016.. The conference will be webcast live over the Internet and can be accessed by logging on to the Investors section of the Aclaris Therapeutics website, www.acla
Actinium Pharmaceuticals, Inc., a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company has initiated the European Medicines Agency Scientific Advice process for Iomab-B. The Scientific Advice process allows Actinium to dialogue with regulators..
Aduro Biotech, Inc. (NASDAQ:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that trials with investigational agents based on its LADD (Listeria-based immunotherapy construct) platform have been placed on partial clinical h
-Advaxis, Inc., a clinical stage biotechnology company developing cancer immunotherapies, today announced topline results from the early closure of stage 2 of the Phase 2 GOG-0265 trial, conducted by the Gynecologic Oncology Group and supported by the Cancer Therapy Evaluation Program of the National Cancer Institute. GOG-0265 is a single-arm, open
Advaxis, Inc.(NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced topline results from the early closure of stage 2 of the Phase 2 GOG-0265 trial, conducted by the Gynecologic Oncology Group (GOG, now part of NRG Oncology) and supported by the Cancer Therapy Evaluation Program (CTEP) of the Nati
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. Section 1701 of the Public Health Service Act authorizes the FDA to conduct research relating to healt
Agilent Technologies Inc. announced that its Dako PD-L1 IHC 22 C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer with KEYTRUDA . The FDA also announced on October 24 that KEYTRUDA is now approved for the
Release date- 24102016- CARPINTERIA, Calif-Agilent Technologies Inc. today announced that its Dako PD-L1 IHC 22 C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer with KEYTRUDA. The FDA also announced on Oc
Allergan plc, a leading global pharmaceutical company, today announced the successful completion of Allergan's tender offer to purchase all outstanding shares of Vitae Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on innovative development programs for dermatologic conditions. As previously announced, Allergan offered.
ANI Pharmaceuticals, Inc. today announced the launch of Benztropine Mesylate Tablets USP 0.5 mg, 1 mg and 2 mg. Arthur S. Przybyl, ANI's President and CEO stated, "Benztropine is the tenth new commercial product introduction for ANI in 2016. ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company developing, manufacturing, and
Array BioPharma Inc. will report financial results for the first quarter of fiscal 2017 and hold a conference call to discuss those results on Tuesday, November 1, 2016. Ron Squarer, Chief Executive Officer, will lead the call. About Array BioPharma Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and...
At a recent pharmaceutical industry conference, the founder and director of biotech start-up Asymmetrex, James L. Sherley, asked a panel of noted investors, who were reviewing promising new pharmaceutical and biopharmaceutical companies for investment, "What are the stem cell medicine companies on your radar screen for investment?" The silence was
BUFFALO, New York and HONG KONG, Oct. 25, 2016/ PRNewswire/ Athenex Pharmaceutical Division and Beijing Sciecure Pharmaceutical Co., Ltd., a specialty pharmaceutical company, today announced a binding agreement to launch and market 5 pharmaceutical products, all injectable, in the North America territory. Sciecure, a mid-sized company with many o
Atrin Pharmaceuticals, Inc. today announced the appointment of Gerhard J. Sperl, Ph.D., as Vice President, Chemistry, Manufacturing and Controls. He is very excited about returning to the oncology field, "said Oren Gilad, Ph.D., Atrin Pharmaceuticals President and Chief Executive Officer. Dr. Sperl was most recently the Senior Director, Manufactu
Release date- 22102016- Incentives intended to stimulate the development of more treatments for rare diseases are being exploited to boost the profits of pharmaceutical companies, new research led by Bangor University shows. The study, carried out by experts from Bangor University and the University of Liverpool, and published in PLOS ONE, examined
LONDON- Beximco Pharmaceuticals Ltd on Tuesday said the US Food& Drug Administration has approved the firm's Sotalol Hydrochloride product, a generic version of the cardiovascular drug Betapace. The approval will let Beximco, a Bangladesh- based generic drugs and active pharmaceutical ingredients firm, produce Sotalol tablets in two different stren
Beximco Pharmaceuticals Ltd received the approval of US Food and Drug Administration for Sotalol Hydrochloride, a generic version of the cardiovascular drug Betapace, following submission of an Abbreviated New Drug Application in June, 2014.. This is the second product from Beximco Pharma to be approved by the US FDA after Carvedilol, a prescriptio
"Enbrel Biosimilars Clinical Trial Insight" report by PNS Pharma gives comprehensive clinical insight on 36 biosimilar version of Enbrel drug in clinical pipeline. Currently 5 biosimilar version of Enbrel are commercially available in Iran, Mexico, India, UK and Australia. The patent on Enbrel was originally set to expire on October 23, 2012, but,
"Humira Biosimilars Clinical Trial Insight" report by PNS Pharma gives comprehensive clinical insight on 33 biosimilars version of Humira drug in clinical pipeline. More than 10 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. The patent protection assigned to Humira will expire in 2016 f
Over the past two decades, big pharmaceutical companies increased their focus on biologics. Several companies recorded a revenue growth of more than 10 percent from biologics during the last 5 years, and in 2015, biologics dominated the list of the top 10 drugs by revenue. "Big pharma that are keen to stay ahead of the curve have harnessed the r
-Bioblast Pharma Ltd., a clinical-stage, orphan disease-focused biotechnology company, today announced results of a double-blind, placebo-controlled pharmacokinetic study of intravenous trehalose 90 mg/mL in healthy volunteers. The primary objective of the study was to establish safety and tolerability of escalating doses of trehalose.
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) announced the addition of BUNAVAIL(buprenorphine and naloxone) buccal film (CIII) as a preferred drug to the Texas Medicaid formulary from its previous non-formulary status. Suboxone film will share preferred status with BUNAVAIL. The formulary change goes into effect on January1, 2017. T