AquaBounty Technologies, Inc. AquaBounty Technologies, Inc., a biotechnology company focused on enhancing productivity in the aquaculture market, announces progress on its pending New Animal Drug Application for AquAdvantage Salmon from the U.S. Food and Drug Administration.
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.
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.
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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.
09/02/10 Daxor Corporation, a medical instrumentation and biotechnology company, today announced that the Board of Directors has voted to declare a dividend of $0.25 per share. This is the second dividend the Company has declared for 2010. These payments are in keeping with the declaration of Company management in 2008 to pay dividends when fund
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
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.
SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that the United States Food and Drug Administration has received the Company's 510 submission seeking marketing clearance in the U.S. for SQI's IgX PLEX Celiac Assay and automated SQiDworks Diagnostics Platform.
Unilife, a US-based medical device company, has announced that its Unitract Tuberculin, or TB, syringe has received 510k market clearance from the US Food and Drug Administration, or FDA. According to the company, the Unitract TB syringe is a variant of the Unitract 1ml insulin syringe for which Unilife secured FDA clearance earlier in 2010.
FDA panel recommends approval of new emergency contraceptive pill. Ulipristal acetate pill already available in 22 European countries. American women might have another option in emergency contraception if the Food and Drug Administration follows the recommendation of its reproductive health panel in approving ulipristal acetate.
DES PLAINES, Ill., Sept. 1 Abbott announced today it has received approval from the U.S. Food and Drug Administration to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus in a patient's blood.
MORRISTOWN, N.J., Sept. 1 /PRNewswire/ Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder. Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.
SANTA MONICA, Calif., Sept. 1 Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate that is being developed for the treatment of metastatic renal cancer.
