Ascension Orthopedics, a developer of PyroCarbon orthopedic devices, has received FDA approval to market the Titan modular total shoulder system. According to the company, the Titan modular total shoulder system offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty.
Sept. 05Can-Fite BioPharma Ltd. has obtained US Food and Drug Administration approval for the Phase III clinical trial of its CF101 anti-inflammatory drug for the treatment of dry-eye syndrome. Can-Fite added, however, that to register the drug for use, two Phase III trials, with 500 patients altogether, will be needed.
CSL Behring announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 18 months to 24 months. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature for up to 24
Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration.
SUMMARY: The Food and Drug Administration is publishing a list of premarket approval applications that have been approved. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm.
GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta belimumab as a potential treatment for systemic lupus erythematosus.
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA belimumab as a Potential Treatment for Systemic Lupus Erythematosus. Human Genome Sciences, Inc. and GlaxoSmithKline PLC announced that the U.S. Food and Drug Administration has granted a priority review designation to BENLYSTA as a potential treatme
Sept. 03The pharmaceutical company that manufactures Botox will pay Indiana a civil settlement of nearly $636,000 as part of a broader payout of $600 million nationally to resolve claims of improper marketing. Allergan Inc. is paying the civil and criminal penalties to resolve claims that it illegally marketed Botox for unapproved medical uses.
Item 7.01 Regulation FD Disclosure. On September 2, 2010, Orexigen Therapeutics, Inc. issued a press release announcing that they entered into a Collaboration Agreement with Takeda Pharmaceutical Company Limited on September 1, 2010, to develop and commercialize Contrave in the United States, Canada and Mexico.
www.OTCtipReporter.com Reports Critical NEWS ALERTS Green Globe International, Inc., Orexigen Therapeutics, Inc., Cardiome Pharma Corp., Car Charging Group, Inc. Sign-Up for our FREE Stock Alerts AND AWARD WINNING NEWSLETTER at HYPERLINK "http://www.OTCtipReporter.com/" www.OTCtipReporter.com -
www.OTCtipReporter.com Reports Critical NEWS ALERTS Green Globe International, Inc., Orexigen Therapeutics, Inc., Cardiome Pharma Corp., Car Charging Group, Inc. Sign-Up for our FREE Stock Alerts AND AWARD WINNING NEWSLETTER at HYPERLINK "http://www.OTCtipReporter.com/" www.OTCtipReporter.com -
Susan G. Komen for the Cure and the Ovarian Cancer National Alliance today urged the U.S. Food and Drug Administration to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for some patients and warning of a chilling effect on new drug development if app
Actavis, a US-based manufacturing and marketing unit of generics firm Actavis Group, has received approval from the US Food and Drug Administration, or FDA, to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder, or ADHD. Actavis intends to market Atomoxetine HCl in 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 10
Agensys, an affiliate of Tokyo-based Astellas Pharma, a pharmaceutical company, has initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate, or ADC, that is being developed for the treatment of metastatic renal cancer.
AUSTIN, Texas, Sept. 2 Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the TITAN Modular Total Shoulder System.
CARY, N.C., Sept. 2 Cetero Research, the leading early-stage contract research organization, is launching a series of scientific seminars, "An Accelerated Path to Proof-of-Concept in Drug Development," designed to help pharmaceutical and biotechnology researchers learn the latest innovations in Phase I and IIa clinical trial designs.
Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, announces that all five products in its novel line of XTRASORB HCS Dressings have received Healthcare Common Procedural Coding System codes.
September 2, 2010 Unilife Corp. said that its Unitract Tuberculin Syringe has received 510 market clearance from the U.S. Food and Drug Administration. The Unitract range is designed to allow operators to control the speed of passive needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place.
The Indiana Attorney General issued the following news release: Through whistleblower lawsuits that exposed alleged Medicaid fraud, the pharmaceutical company that manufactures Botox will pay Indiana a civil settlement of nearly $636,000, Attorney General Greg Zoeller announced today.
ST. LOUIS, Sept. 2 K-V Pharmaceutical Company announced today that it has received notification from the New York Stock Exchange stating that the Company has reestablished compliance with the NYSE's minimum share price requirements for continued listing on an accelerated basis.
Sept. 02After two stinging legal setbacks this summer over its drug patents, Eli Lilly and Co. has found the third time is a charm. A federal appeals court on Wednesday upheld a pair of key patents on the Indianapolis company's osteoporosis drug Evista, meaning that generic drug maker Teva Pharmaceuticals will not be able to sell a copy of the bl
SHENZHEN, China, Sept. 2 In a new peer-reviewed article published by the Journal of Translational Medicine, scientists from Beike Biotechnology, China's leading stem cell research and regenerative medicine company, and Medistem, Inc., reported positive safety data in 114 patients who were treated by doctors at Nanshan Affiliated Hospital of Guangdo
Item 1.01 Entry into a Material Definitive Agreement. Collaboration Agreement with Takeda Pharmaceutical Company Limited. On September 1, 2010, Orexigen Therapeutics, Inc. entered into a collaboration agreement with Takeda Pharmaceutical Company Limited to develop and commercialize Contrave, the Company's investigational drug for the treatment of
SAN DIEGO and OSAKA, Japan, Sept. 2 Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited, today announced that they have entered into an exclusive partnership to develop and commercialize Contrave, Orexigen's investigational drug for the treatment of obesity, in the United States, Canada and Mexico.
