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 FDA to conduct research relating to health...
May 04 Analysts are speculating on Biogen Inc.' s next move after the Cambridge drug maker said yesterday that it would spin off its hemophilia franchise so it can focus on developing drugs for neurodegenerative diseases, such as multiple sclerosis and Alzheimer's disease. Potential buyers of its core neuro franchise "won't be put off by concerns
Dublin- Research and Markets has announced the addition of the "Cognitive Impairment- Pipeline Review, H1 2016" drug pipelines to their offering. The report provides comprehensive information on the therapeutics under development for Cognitive Impairment, complete with analysis by stage of development, drug target, mechanism of action, route of...
Research and Markets has announced the addition of the "Cognitive Impairment- Pipeline Review, H1 2016" drug pipelines to their offering. AbbVie Inc. Addex Therapeutics Ltd AgeneBio Inc. Amarantus Bioscience Holdings, Inc. Astellas Pharma Inc. AstraZeneca Plc Eli Lilly and Company Ensol Biosciences Inc. F. Hoffmann-La Roche Ltd. FORUM Pharmaceutica
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The 1984 amendments include what is now section 505 of
DUBLIN- BioMarin Pharmaceutical Inc. expects to submit EU and U.S. Marketing Application for Cerliponase alfa, intended for the treatment of children with CLN2 disease, a form of Batten disease, by mid-2016. In just another two months, Corcept Therapeutics Inc. will be reporting results from a phase 1/ 2 trial of mifepristone in combination with an
Dublin- Research and Markets has announced the addition of the "Glaucoma- Pipeline Review, H1 2016" drug pipelines to their offering. -Kukje Pharmaceutical Industry Co., Ltd.. -Sun Pharma Advanced Research Company Ltd..
May 03 PORTLAND, Maine Maine is in line to recover $7.7 million from a national settlement with drugmaker Wyeth and its parent company, Pfizer, over allegations that the company did not properly calculate drug discounts to state Medicaid programs. Maine Attorney General Janet Mills said in a release Tuesday that a proposed settlement between th
May 03 The generic drug industry is under pressure, but Mylan NV CEO Heather Bresch said the company is positioned to deal with lower prices and investor concerns about slowing growth. Mylan shares are down about 40 percent from a high last summer when it was fighting off an unwanted acquisition bid from Teva Pharmaceutical Industries while attem
May 03 Generic drug giant Mylan reported that first-quarter profits skidded 75 percent to $13.9 million from $56.6 million a year earlier on higher expenses. "We are off to a great start in 2016," CEO Heather Bresch said in a statement, reaffirming the company's full-year adjusted earnings guidance of $4.85 to $5.15 per share. Mylan announced in
By a News Reporter-Staff News Editor at Biotech Week Mystic Pharmaceuticals, Inc., a privately held, life science technology company, announced it has received a patent from the United States Patent Office for its "Dose Dispensing Containers". "Nose to brain delivery is emerging as a viable means of non-invasive delivery of certain classes of dr
-Ohr Pharmaceutical, Inc., an ophthalmology research and development company, today announced that David M. Brown, MD, Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research at the Blanton Eye Institute, Houston Methodist Hospital, and partner at Retina Consultants of Houston, has been appointed to serve as the c
By a News Reporter-Staff News Editor at Biotech Week From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Baroni, Sergio; Bellinvia, Salvatore; Viti, Francesca, filed on December 15, 2014, was published online on April 19, 2016. The patent's assignee for patent number 9314434 is Nogra Pharma Limited. News editors ob
By a News Reporter-Staff News Editor at Biotech Week From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Robeson, Lloyd Mahlon; Rothrock, Ginger Denison, filed on December 17, 2014, was published online on April 19, 2016. The patent's assignee for patent number 9314548 is Liquidia Technologies, Inc.. News editors o
By a News Reporter-Staff News Editor at Biotech Week NOVEN PHARMACEUTICALS, INC. has been issued patent number 9314470, according to news reporting originating out of Alexandria, Virginia, by NewsRx editors. The patent's inventors are Patel, Prashant; Nguyen, Viet; Liao, Jun. This patent was filed on December 27, 2013 and was published online on
Researchers Submit Patent Application, "Polymeric Hydrogel Pharmaceutical Compositions with On-Demand Release of a Drug in Response to a Electrical Stimulus", for Approval. By a News Reporter-Staff News Editor at Biotech Week From Washington, D.C., NewsRx journalists report that a patent application by the inventors PILLAY, Viness; INDERMUN, Suna
MARTIN Shkreli, the notorious former pharma chief executive, could be about to face fresh charges. Shkreli, who infamously hiked the price of a drug by 5,000 per cent last year sparking a public outcry, now could face additional charges of securities fraud, federal prosecutor Winston Paes said at a hearing in New York. The future charges would rela
By a News Reporter-Staff News Editor at Biotech Week Biologics, Inc. is pleased to announce the company has been selected by AbbVie Inc. to be a specialty pharmacy provider for VenclextaTM. Approved by the U.S. Food and Drug Administration on April 11, 2016, Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia wi
"At Alnylam, we continue to advance a broad pipeline of investigational RNAi therapeutics- including 10 programs in clinical development and 2 programs in Phase 3- across a broad range of disease indications. A major milestone in the first quarter was completion of enrollment in our APOLLO Phase 3 trial for patisiran, and we're on track to view res
AMAG Pharmaceuticals, Inc., a specialty pharmaceutical company with a diverse portfolio of products in the areas of maternal health, anemia management and cancer supportive care, today reported unaudited consolidated financial results for the first quarter ended March 31, 2016. Prior to the commercial availability of this new Makena formulation,.
Amicus Therapeutics, a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced financial results for the first quarter ended March 31, 2016. John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, At Amicus we have a clear vision to build a leading global biotechnolo
Presentation Speaker will be Edward D. Kim, M.D., Professor, The University of Tennessee Graduate School of Medicine. SAN DIEGO, May 03, 2016 Apricus Biosciences, Inc., a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced it will host a Vitaros and erectile dysfunction key opinion leader even
Array BioPharma Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, today reported results for its fiscal year third quarter ending March 31, 2016 and provided an update on the progress of its key clinical development programs. "We have a number of near-term..
By a News Reporter-Staff News Editor at Cancer Weekly Avella Specialty Pharmacy announced that it has been selected by pharmaceutical manufacturer AbbVie to dispense Venclexta, the first therapy in its class to win FDA approval. Venclexta is an oral, once-daily drug indicated for use in chronic lymphocytic leukemia patients who lack a portion of
Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders, received from the U.S. Food and Drug Administration Fast Track designation for AXS-02 for the treatment of the pain of knee osteoarthritis associated with bone marrow lesions. We are pleased t