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Health Highlights: May 25, 2012
Posted 3 days ago in Daily MedNews
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Children Swallowing Tiny Detergent Packets Hundreds of American children have swallowed miniature laundry detergent packets after confusing them with candy. Poison control centers say nearly 250 cases have been reported so far this year, with children suffering symptoms such as nausea and...
Read More...HRT Update: Therapy May Reduce Fractures, Boost Some Risks
Posted today in Daily MedNews.
MONDAY, May 28 -- Updated evidence on hormone replacement therapy for menopausal women presents good news for those at risk of osteoporosis, but a mixed bag of results regarding breast cancer and other chronic diseases. While estrogen-only and estrogen-plus-progestin formulations reduce the risk of fractures, both increase the odds for stroke and other conditions including gallbladder disease,...
Read More...Doubt Cast on Usefulness of 'Sensory' Therapies for Autism
Posted today in Daily MedNews.
MONDAY, May 28 -- Sensory therapies using brushes, swings and other play equipment are increasingly used by occupational therapists to treat children with developmental issues such as autism, but a large pediatricians organization says there isn't much evidence that such therapies actually work. Still, the group isn't completely discounting the potential of sensory therapies -- it's a ripe area...
Read More...Health Tip: Don't Spread Germs
Posted today in Daily MedNews.
-- Your mother's plea to cover your mouth when you cough was sound medical advice, says the U.S. Centers for Disease Control and Prevention. The agency suggests how to prevent the spread of germs: When you sneeze or cough, use a tissue to cover your nose and mouth. Always throw your used tissue in the trash. Sneeze or cough into your elbow (not your hand) if you don't have a tissue. Frequently...
Read More...Health Tip: Keep Off the Weight You've Lost
Posted today in Daily MedNews.
-- Maintaining weight loss can be more difficult than losing it in the first place. The American Council on Exercise suggests how to help maintain weight loss: Weigh yourself every week. Move as much as possible, walking frequently, watching less TV and even fidgeting while you're seated. Stock your kitchen with plenty of nutritious treats. Place your gym bag near the door, and keep any home...
Read More...PDUFA Passes the Senate, Awaits Debate on House Floor
Posted 3 days ago in Pharma Industry News.
From BioWorld Today (May 25, 2012) WASHINGTON, May 25, 2012 (BIOWORLD TODAY) - Biopharma has cause to celebrate as PDUFA V rolled through the Senate Thursday with little in the way of fireworks. The FDA Innovation and Safety Act (FDASIA), S. 3187, passed the Senate 96-1 after a full day of debate on various amendments. "By reauthorizing PDUFA, members of both sides of the aisle have taken an...
Read More...Senate Passes FDA Safety And Innovation Act
Posted 3 days ago in Pharma Industry News.
Bill Makes Some Improvements to Medical Device Oversight But Important Patient Safety Protections Still Missing WASHINGTON, May 24, 2012 /PRNewswire-USNewswire/ -- The Senate approved the Food and Drug Administration Safety and Innovation Act today. While the legislation includes some improvements over current law, it leaves significant flaws with the FDA's current medical device oversight system...
Read More...MDLinx Survey: Ninety Percent of US Oncologists Report Crucial Cancer Drug Shortage
Posted 5 days ago in Pharma Industry News.
Physicians express concern about safety of emergency overseas drugs approved by FDA WASHINGTON--(BUSINESS WIRE)--May 23, 2012 - In an MDLinx (www.mdlinx.com) survey conducted of 200 U.S. oncologists this month, 90.5 percent reported experiencing shortages of key cancer drugs in their practices. MDLinx, a web property of M3 USA (http://usa.m3.com) is the nation's leading specialty physician...
Read More...U.S. Marshals Seize Unapproved New Drug From Crescendo Therapeutics LLC
Posted 5 days ago in Pharma Industry News.
California firm previously warned not to market HybriSil topical corticosteroid U.S. Marshals, acting at the request of the Food and Drug Administration, have seized HybriSil (methylprednisolone acetate 1% percent in silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, LLC, of Vista, Calif. The seizure, which took place under a warrant issued by the U.S. District Court...
Read More...FDA-Led Research Team Discovers An Autoimmune Mechanism for Serious Drug-Induced Adverse Reactions
Posted 5 days ago in Pharma Industry News.
A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. In an article available online today in the journal AIDS1 2, the team found that in certain at-risk patients, the anti-HIV drug Ziagen (abacavir) causes the immune system to “see” a patient’s own healthy...
Read More...FDA Approves Levemir for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
Posted 6 days ago in New Drug Approvals.
PRINCETON, N.J., May 22, 2012 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for use in children ages two to five years with type 1 diabetes. With the expansion of its pediatric indication, Levemir is now available for type 1 diabetes patients...
Read More...Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
Posted 1 weeks ago in New Drug Approvals.
BETHLEHEM, Pa., May 18, 2012 /PRNewswire/ -- Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pertzye, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Pertzye is a unique pancreatic enzyme product...
Read More...Stiefel Receives US FDA Approval of Fabior Foam, 0.1%
Posted 2 weeks ago in New Drug Approvals.
RESEARCH TRIANGLE PARK, N.C., May 11, 2012 /PRNewswire/ -- Stiefel, a GSK company, today announced that the US Food and Drug Administration has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older. "Stiefel is dedicated to meeting the needs of...
Read More...FDA Advisory Committee Supports Approval of Gilead's Once-Daily Quad Single Tablet Regimen for HIV
Posted 2 weeks ago in New Drug Applications.
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 11, 2012 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1...
Read More...Lorcaserin Receives Positive Vote From FDA Advisory Committee
Posted 2 weeks ago in New Drug Applications.
SAN DIEGO and WOODCLIFF LAKE, N.J., May 10, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a...
Read More...FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
Posted 2 weeks ago in New Drug Applications.
NEW YORK--(BUSINESS WIRE)--May 9, 2012 - Pfizer Inc. announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The Committee's recommendation will be considered by the FDA in its...
Read More...Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy
Posted 2 weeks ago in New Drug Applications.
Osaka, Japan, May 9, 2012 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that the U.S. subsidiary Shionogi Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ospemifene oral tablets 60 mg for the treatment of vulvar and vaginal atrophy (VVA) due to...
Read More...Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo
Posted 3 weeks ago in New Drug Applications.
SAN MATEO, Calif., May 7, 2012 -- Talon Therapeutics Inc. today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) seeking accelerated approval of Marqibo(R) has been given a three-month Prescription Drug User Fee Act (PDUFA) date extension to August 12, 2012. On March 21, 2012, the Oncologic Drugs Advisory Committee...
Read More...MEDA Announces Dymista Approved by the FDA
Posted 3 weeks ago in New Drug Approvals.
Göteborg, Sweden--(BUSINESS WIRE)--May 2, 2012 -- The U.S. Food and Drug Administration (FDA) has approved Dymista, a new patented product for treatment of seasonal allergic rhinitis (SAR). In several clinical studies, Dymista has consistently showed a rapid and more complete symptom relief than standard treatment. "Allergic rhinitis is an increasing problem. Many patients have severe...
Read More...FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease
Posted 3 weeks ago in New Drug Approvals.
May 1, 2012 -- The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder. Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials (lipids) to collect in the spleen, liver, kidneys,...
Read More...Heart disease and stroke deaths drop significantly for people with diabetes
Posted 3 days ago in Clinical Trials.
Heart disease and stroke deaths drop significantly for people with diabetes Healthier lifestyles, better disease management are helping people live longer ATLANTA, May 22, 2012 /PRNewswire-USNewswire/ -- Death rates for people with diabetes dropped substantially from 1997 to 2006, especially deaths related to heart disease and stroke, according to researchers at the Centers for Disease Control...
Read More...Apofore Founder Publishes Studies Identifying Apolipoprotein A-IV as New Potential Target for Type 2 Diabetes Therapeutics
Posted 3 days ago in Clinical Trials.
PNAS report suggests Apolipoprotein A-IV plays important role in regulating glucose homeostasis CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 22, 2012 - Apofore Corporation today announced that its scientific founder at the University of Cincinnati, Patrick Tso, PhD, Professor in the Department of Pathology and Laboratory Medicine, has published new data demonstrating that the naturally occurring...
Read More...New Phase 3 Data for Tradjenta (Linagliptin) Tablets in Black Or African American Patients With Type 2 Diabetes Showed Significant Improvement in Blood Sugar
Posted 4 days ago in Clinical Trials.
First published trial of a dipeptidyl peptidase-4 (DPP-4) inhibitor specifically conducted in black or African American patients with type 2 diabetes RIDGEFIELD, Conn. and INDIANAPOLIS, May 24, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced Phase 3 study results for linagliptin 5 mg once-daily, which showed significant...
Read More...Kancera´s ROR inhibitors are active against Fludarabine resistant leukemia
Posted 4 days ago in Clinical Trials.
Kancera’s inhibitors of ROR1 show an effect on leukemia cells from patients for whom standard therapy is not currently working. Kancera’s partner and co-founder Professor Håkan Mellstedt and his research group at the Karolinska University Hospital conducted the studies. Chronic Lymphatic Leukemia, CLL is the most common form of leukemia among adults in U.S. and Europe. One...
Read More...MediciNova Reports Results of a Phase 2b Clinical Trial of MN-221 in Asthma Exacerbations
Posted 4 days ago in Clinical Trials.
Company Intends to Move Forward With End-of-Phase 2 Meeting With FDA and Phase 3 Clinical Development Management to Host Conference Call to Discuss Results Today, May 23rd at 5:00pm (EDT) SAN DIEGO, May 23, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Trading Symbol: MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code...
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