Morphotek announces agreement for development of antibodies to treat prostate cancer http://www.news- medical.net/ ?id=34203 Morphotek, Inc., a subsidiary of Eisai Co., Ltd., has announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development of therapeutic antibodies to a cancer-associated protein identified by NCI researchers.
Bio-identical hormone replacement therapies targeted by FDA http://www.news- medical.net/ ?id=34192 The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency.
FDA says claims about benefits of bio-identical hormone replacement therapy are false and misleading http://www.news- medical.net/ ?id=34169 Health officials in the United States have issued a warning regarding so-called "bio-identical" hormone therapy (BHRT).
Analysis defines impact of Medicare Part D http://www.news- medical.net/ ?id=34117 The most thorough study to date of the impact of the Medicare Prescription Drug Benefit (Part D) found that this benefit led to a 13.1 percent decrease in out-of-pocket expenses for patients and a 5.9 percent increase in prescription use.
NicOx extends ophthalmology agreement with Pfizer http://www.news- medical.net/ ?id=34134 NicOx S.A. has announced it has signed an extension of its March 2006 collaboration agreement, which grants Pfizer Inc the exclusive right to apply its proprietary nitric oxide-donating technology to drug discovery research in the field of ophthalmology.
FDA approves Cialis (tadalafil) for U.S http://www.news- medical.net/ ?id=34116 Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Cialis (tadalafil) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED).
New meningitis vaccine a potential new weapon against the deadly disease http://www.news- medical.net/ ?id=34168 In a joint venture British and Canadian researchers have found that a new type of meningitis vaccine offers immunity to infants as young as six months from the deadly disease.
Magen BioSciences licenses dermatology compounds from Lilly http://www.news- medical.net/ ?id=34073 Magen BioSciences, Inc., a privately held specialty pharmaceutical company focused on developing pharmaceuticals to treat diseases of the skin, announced today that it had acquired the rights to a series of novel pre-clinical compounds from Eli Lilly and Company.
FDA warnings appeared to effectively increase perception of risks involved with antidepressant treatment http://www.news- medical.net/ ?id=34064 U.S. Food and Drug Administration warnings regarding the risk of suicidal thoughts and behaviors in children and adolescents taking antidepressants appear to have had modest and targeted effects on the intended populations, according to a report in the January issue of Archives of General Psychiatry.
Baxter to develop recombinant Factor IX proteins to treat hemophilia B http://www.news- medical.net/ ?id=34048 Baxter International Inc. has announced that it has initiated pre-clinical programs to develop recombinant Factor IX proteins to treat hemophilia B.
Daiichi Sankyo, Lilly submit NDA for investigational antiplatelet drug, Prasugrelin U.S. http://www.news- medical.net/ ?id=33999 Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA).
Takeda submits NDA for Alogliptin (SYR-322) in the U.S. http://www.news- medical.net/ ?id=34022 Takeda Pharmaceutical Company Limited (Takeda) has announced that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes.
Experts say far too much is spent on needless indigestion drugs http://www.news- medical.net/ ?id=34030 According to two experts in Britain the National Health Service (NHS) is needlessly spending at least 100m pounds per year on indigestion drugs.
Prescription drug ads on television minimize risk information http://www.news- medical.net/ ?id=33976 Prescription drug ads on television first hit the airwaves just over a decade ago, but a new University of Georgia study finds that most of them still do not present a fair balance of information, especially when it comes to the risk of side effects.
Watson Pharmaceuticals launches generic Biaxin http://www.news- medical.net/ ?id=33985 Watson Pharmaceuticals, Inc. has announced it has launched Clarithromycin Extended-Release Tablets, USP in the 500 mg strength.
Big pharma spends almost twice as much on marketing drugs than on research and development http://www.news- medical.net/ ?id=33951 The pharmaceutical industry spends almost twice as much on the marketing and promotion of drugs than on research and development, according to a new analysis in this week's PLoS Medicine.
Sanofi Pasteur enters agreement eith Crucell for next-generation biologicals against rabies http://www.news- medical.net/ ?id=33974 Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has signed an exclusive collaboration and commercialization agreement with Crucell N.V. for Crucell's rabies monoclonal antibodies (MAbs), next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.
FDA reviews new data on risks of erythropoiesis- stimulating agents http://www.news- medical.net/ ?id=33954 The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis- stimulating agents, or ESAs.
New flu vaccine protects against all strains including bird flu http://www.news- medical.net/ ?id=33993 A new flu vaccine which protects against all strains of influenza has had promising results in trials.
Avoiding overuse, misuse, and underuse of medications http://www.news- medical.net/ ?id=33910 Adverse drug events are more common in older adults because they are prescribed more drugs and are effected differently by these drugs than their younger counterparts.
Barr receives approval for generic KYTRIL tablets http://www.news- medical.net/ ?id=33884 Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s KYTRIL (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base).
Watson receives FDA approval for generic DuoNeb http://www.news- medical.net/ ?id=33928 Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.).
AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms http://www.news- medical.net/ ?id=33883 AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.
Perrigo receives FDA OK for OTC Cetirizine Hydrochloride tablets http://www.news- medical.net/ ?id=33862 Perrigo Company has announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.
Ensuring heart safety of non-heart drugs http://www.news- medical.net/ ?id=33846 Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyteria n Hospital/Weill Cornell Medical Center in New York City .
Mylan announces FDA approval for Cetirizine Hydrochloride tablets http://www.news- medical.net/ ?id=33857 Mylan Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.
FDA approves Voluven for blood loss post surgery http://www.news- medical.net/ ?id=33789 The U.S. Food and Drug Administration has approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.
Novavax's new bird flu vaccine could bolster the arsenal against a pandemic http://www.news- medical.net/ ?id=33767 The drug company Novavax has announced that it's experimental avian flu vaccine has proved to be both safe and effective in Phase I/IIa trials in humans.
More warnings about anti smoking drug Champix http://www.news- medical.net/ ?id=33761 The European drugs regulator, the European Medicines Agency (EMEA) is calling for warnings to be placed on the the anti smoking drug Champix (varenicline) .
Authorities in the U.S. say hold back on children's Hib vaccine http://www.news- medical.net/ ?id=33757 Health authorities in U.S. are advising doctors to defer giving booster shots of a childhood vaccine following suspicions that production equipment may not have been properly sterilized.
Anthrax vaccine will add to America's arsenal against bioterrorism http://www.news- medical.net/ ?id=33697 A company, based in Rockville , Maryland in the USA , with the help of government funding, has used the human genome to develop a vaccine that may give protection from anthrax.
FDA warns vaginal contraceptive offers no protection against AIDS http://www.news- medical.net/ ?id=33695 The U.S. Food and Drug Administration has decreed that the over-the-counter vaginal contraceptive and spermicidal product Nonoxynol-9, or N9, must carry a warning about its use.
Thyroid cancer drug given expanded approval by FDA http://www.news- medical.net/ ?id=33692 The U.S. Food and Drug Administration (FDA) has given expanded approval for a drug used to treat thyroid cancer.
New scheme to revolutionise system of prescribing medicines http://www.news- medical.net/ ?id=33666 Patients could be saved millions of trips to their GP under a new scheme that has the potential to revolutionise the system of prescribing medicines.
Eli Lilly and BioMS Medical announce licensing and development agreement http://www.news- medical.net/ ?id=33644 Eli Lilly and Company and BioMS Medical Corp. have announced that the two companies have entered into a licensing and development agreement granting Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis (MS) compound, MBP8298.
Oral diabetes medication - new guidelines http://www.news- medical.net/ ?id=33654 A pair of plain-language guides that outline the latest scientific evidence on the effectiveness and safety of oral medications for adults with type 2 diabetes are now available from HHS' Agency for Healthcare Research and Quality.
NCPA applauds pharmacy tricare provisions in the congressional passage of the defense authorization bill http://www.news- medical.net/ ?id=33616 The National Community Pharmacists Association (NCPA) thanks Congress for including key pharmacy provisions in the Defense Authorization Act Conference Report for fiscal year 2008 it passed last week.
New principle for developing vaccines http://www.news- medical.net/ ?id=33548 Infections with a certain type of bacteria (group B streptococcus) can lead to severe, sometimes life-threatening, infections in newborn infants.
BioMarin Pharmaceutical announces FDA approval for Kuvan http://www.news- medical.net/ ?id=33524 BioMarin Pharmaceutical Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). |
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