"Chitosan Nanofiber for Anionic Protein Drug Delivery, Method of Preparing the Same, and Pharmaceutical Preparation for Transmucosal Administration Comprising the Chitosan Nanofiber" in Patent Application Approval Process. By a News Reporter-Staff News Editor at Biotech Week A patent application by the inventors YOO, Hyuk Sang; CHOI, Ji Suk; KIM,
By a News Reporter-Staff News Editor at Biotech Week A patent application by the inventors Levy, Ruth; Eyal, Eli; Goren, Tamar; Oren, Sheila; Sayag, Naim; Weiss, Yonatan; Ben-Ami, Miri, filed on November 27, 2013, was made available online on September 4, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondent
By a News Reporter-Staff News Editor at Biotech Week A patent application by the inventor SESHA, RAMESH, filed on May 13, 2014, was made available online on September 4, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application is assigned to Gruenenthal Gmbh. EP 693,475 and is currentl
SHENYANG, China, Sept. 1 6, 2014/ PRNewswire/ 3 SBio Inc., a leading biotechnology company based in China focusing on researching, developing, manufacturing and marketing biopharmaceutical products, announced today that it has entered into an exclusive license agreement with JenKem Technology Co., Ltd for the development, manufacturing and market
By a News Reporter-Staff News Editor at Biotech Week ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in neurological and related central nervous system disorders, announced that the U.S. Food and Drug Administration has granted...
By a News Reporter-Staff News Editor at Biotech Week Actavis plc announced that the U.S. Food and Drug Administration has accepted for filing Actavis' New Drug Application for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome. Actavis' NDA for.
By a News Reporter-Staff News Editor at Biotech Week Ascendia Pharmaceuticals, a start-up specialty pharmaceutical company in the business of providing formulation technologies and product development services for poorly soluble molecules, announced that the company has successfully applied its nano-emulsion technology platform to a novel...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled, "Threshold of Regulation for Substances Used in Food-Contact Articles" has been..
Alios BioPharma will be presenting data at several scientific meetings. Meeting: IDWeek 2014 to be held in Philadelphia, PA from October 8- 12. Meeting: AASLD The Liver Meeting to be held in Boston, MA from November 7- 11.
Alnylam Pharmaceuticals, Inc. reported that it is broadening its pipeline with ALN-AGT, a subcutaneously administered RNAi therapeutic targeting angiotensinogen for the treatment of hypertensive disorders of pregnancy, including preeclampsia, one of the most common complications of pregnancy. According to a company release, in a poster presented at
By a News Reporter-Staff News Editor at Biotech Week Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced that management will present a company overview at the Morgan Stanley Global Healthcare Conference on Wednesday, September 10, 2014 at 10:20 a.m. ET at the Grand Hyatt in New York City. The company's demonstrated comm
Amarin reported that the Office of New Drugs within the U.S. Food and Drug Administration has denied Amarin's appeal of FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment agreement. Amarin continues to believe that reinstatement of this SPA agreement and approval of an indication based on the ANCHOR clinical trial results is
Dublin- Research and Markets has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry- 2014" report to their offering. This research presents Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry- a comprehensive coverage of the generic drugs market in the United States. Strategies for s
Release date- 16092014- Berlin,- Bayer HealthCare and Orion Corporation, a pharmaceutical company based in Espoo, Finland, have begun to enroll patients in a Phase III trial with ODM-201, an investigational novel oral androgen receptor inhibitor in clinical development for the treatment of patients with prostate cancer. The study, called ARAMIS, ev
Biogen Idec and AbbVie released the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA, dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis compared to AVONEX. According to a media release, these results are b
By a News Reporter-Staff News Editor at Biotech Week Clearside Biomedical, Inc., announced the closing of a $16 million Series B financing. The financing included new investor RusnanoMedInvest and existing investors Hatteras Venture Partners, Santen Pharmaceuticals Co. Ltd., Mountain Group Capital and Georgia Research Alliance Venture Fund.
By a News Reporter-Staff News Editor at Biotech Week Researchers at the University of California, San Diego School of Medicine, in partnership with the California Institute for Regenerative Medicine and Celgene Corporation, a New Jersey- based biopharmaceutical company, have launched a phase 1 human clinical trial to assess the safety and efficac
The American cardiologist Dr Dean Ornish believes that copying the takeaway-culture and push-button lifestyles of the West has resulted in the sharp rise in lifestyle diseases in India. Here's a prescription for finding the right way.Dr Dean Ornish, 61, the founder and president of the non-profit Preventive Medicine Research Institute and Clinical.
Jeanne M. Novak, President and CEO of Boulder, Colorado- based CBR International Corp., a full-service biopharmaceutical product, clinical, medical device and regulatory development and compliance group, has been invited by Dr. Working side-by-side with Mapp Biopharmaceutical, Inc., Kentucky Bioprocessing, Emory University Hospital, ELWA Hospital,
This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications and related submissions for which the applicant is seeking approval of a new strength of the drug product. The draft guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA.
Release date- 16092014- AstraZeneca today announced that the US Food and Drug Administration approved MOVANTIK tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, in adult patients with chronic, non-cancer pain. Briggs Morrison, Executive Vice...
In January, the U.S. Food and Drug Administration issued a "safety announcement," to say it was "investigating the risk of stroke, heart attack, and death in men taking FDA- approved testosterone products." The agency said patients should not stop taking prescribed products without talking to a health-care professional, but also said, those "profes
By a News Reporter-Staff News Editor at Biotech Week GE Healthcare announced the FDA approval of SenoClaire*, GE's new breast tomosynthesis solution designed with a three-dimensional imaging technology. Daniel Kopans, Senior Radiologist, Breast Imaging Division Department of Radiology, Massachusetts General Hospital. Murray Rebner MD, FACR, Profe
Release date- 16092014- NEW DELHI- Gilead Sciences, Inc. today announced that the company has signed non-exclusive licensing agreements with seven India- based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies- Cadila Healthcare Ltd., Cipla Ltd., He
Dublin- Research and Markets has announced the addition of the "Global Gene Therapy Market Outlook 2018" report to their offering. Gene therapy is the treatment of a disease by replacing, altering, or supplementing a gene that is absent or abnormal and whose absence or abnormality is causing the disease. Unlike other regions globally, the United St