Medication Guide App

Pharmaceutical News and Articles

Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Get news by email or subscribe to our news feeds.

Health Highlights: March 26, 2015

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Kelly Osbourne Will 'One Day"'Have Same Surgery as Angelina Jolie Celebrity Kelly Osbourne has the same cancer-promoting gene mutation as Angelina Jolie and says she plans to one day have the same surgery the actress recently underwent to reduce her risk of ovarian cancer. Jolie has a high genetic risk for...

Read more...

Kidneys From Dead Older Donors May Help Seniors, Study Finds

Posted today in Medical

THURSDAY, March 26, 2015 -- Older people who need a kidney transplant are better off receiving an available organ from an older deceased donor rather than waiting for one from a younger donor, a new study shows. While kidneys from older donors can't provide younger patients with a lifetime of kidney function, they are suitable for older people because of their shorter life expectancy, the researchers...

Read more...

Terminally Ill Can Do Without Statins, Study Finds

Posted today in Medical

THURSDAY, March 26, 2015 -- Halting the use of cholesterol-lowering statins in terminally ill patients may improve their quality of life, a new study indicates. These findings suggest that care for terminally ill patients can be improved by taking them off medication primarily meant to prevent other health problems, the study authors said. "For patients with shorter life expectancy, greater concern about pill...

Read more...

Hope to Live to 100? Check Your Genes

Posted today in Medical

THURSDAY, March 26, 2015 -- Healthy eating and exercise might help most people live to a respectable old age, but making it to 95 or 100 might require help from your DNA, a new study finds. "Genetic makeup explains an increasingly greater portion of the variation in how old people live to be," especially for people approaching or exceeding the one-century mark, study co-author Dr. Thomas Perls, of Boston...

Read more...

CDC Launches New Round of Graphic Anti-Smoking Ads

Posted today in Medical

THURSDAY, March 26, 2015 -- U.S. health officials on Thursday released a new round of graphic anti-smoking ads featuring former smokers living with the ravages of tobacco. The new ads highlight the benefits of quitting for the families of smokers and the importance of giving up cigarettes completely, according to the U.S. Centers for Disease Control and Prevention. "Bottom line, these ads will save lives and they...

Read more...

Sanofi Pasteur Announces FDA Approval of Quadracel DTaP-IPV Vaccine for Children 4 through 6 Years of Age

Posted yesterday in New Drug Approvals

SWIFTWATER, Pa., March 25, 2015 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi , announced today that the U.S. Food and Drug Administration (FDA) has approved use of Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of...

Read more...

FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular Edema

Posted yesterday in New Drug Approvals

March 25, 2015 -- The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema. Diabetic retinopathy (DR) is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2)...

Read more...

FDA Approves Anthrasil, [Anthrax Immune Globulin Intravenous (Human)], for Inhalation Anthrax

Posted yesterday in New Drug Approvals

March 25, 2015 -- The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs. Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. It is...

Read more...

Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide)

Posted 7 days ago in New Drug Applications

PARIS, March 19, 2015 /PRNewswire/ -- Sanofi announced today top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. ELIXA full results will be presented...

Read more...

FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations

Posted 8 days ago in New Drug Approvals

BOSTON, Mar 18, 2015 --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Kalydeco® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H). Prior...

Read more...

FDA Approves Cholbam (cholic acid) for Rare Bile Acid Synthesis Disorders

Posted 9 days ago in New Drug Approvals

March 17, 2015 -- Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with these rare, genetic, metabolic conditions exhibit manifestations of liver disease,...

Read more...

Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha (Evolocumab)

Posted 11 days ago in New Drug Applications

THOUSAND OAKS, Calif., March 15, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced one-year data from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase 2 (OSLER-1) and Phase 3 (OSLER-2) open-label extension studies of Repatha™ (evolocumab), a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication. These data were presented today at a...

Read more...

Sanofi and Regeneron Announce 18-Month Results of ODYSSEY LONG TERM Trial With Praluent (Alirocumab)

Posted 11 days ago in New Drug Applications

Paris and Tarrytown, New York - March 15, 2015 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that 18-month (78-week) results of a Phase 3 trial of Praluent (alirocumab), an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density...

Read more...

New Detailed Data From Phase 3 Study Show Amgen's Repatha (Evolocumab) In Combination With Statins Reduced LDL-C By 67-76 Percent Compared To Placebo

Posted 12 days ago in New Drug Applications

THOUSAND OAKS, Calif., March 14, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 YUKAWA-2 study evaluating Repatha™ (evolocumab), a novel investigational cholesterol-lowering medication, in Japanese patients with high cardiovascular risk and high cholesterol. Data from the study showed subcutaneous Repatha 140 mg every two weeks or 420 mg monthly, compared to placebo, in...

Read more...

Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection

Posted 13 days ago in New Drug Applications

KENILWORTH, N.J., March 13, 2015 --(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for...

Read more...

Federal Judge Enters Consent Decree Against Specialty Compounding LLC

Posted 2 weeks ago in Pharma Industry News

March 11, 2015 -- U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that...

Read more...

Monthly News Roundup - February 2015

Posted 3 weeks ago in Pharma Industry News

Sanofi Receives FDA Approval for Basal Insulin Toujeo The U.S. Food and Drug Administration has approved Sanofi’s Toujeo (insulin glargine [rDNA origin], a once-daily long-acting basal insulin for adults with type 1 or type 2 diabetes. In the clinical trials evaluating Toujeo, all of the primary study endpoints were met by demonstrating similar blood sugar control with Toujeo as compared to Lantus. The most...

Read more...

Lupin Receives FDA Approval for Generic Lumigan Ophthalmic Solution 0.03%

Posted 4 weeks ago in Pharma Industry News

Mumbai, India and Baltimore, Maryland -- February 23, 2015: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Bimatoprost Ophthalmic Solution, 0.03% from the United States Food and Drugs Administration (FDA) to market a generic version of Allergan Inc.'s Lumigan Ophthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc. (LPI), the company's U.S. subsidiary would commence...

Read more...

FDA Approves VenaSeal Closure System to Permanently Treat Varicose Veins

Posted 4 weeks ago in Pharma Industry News

February 20, 2015 -- The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow...

Read more...

FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome

Posted 5 weeks ago in Pharma Industry News

The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt...

Read more...

Tenth Cohort Completed in Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin, No Adverse Events Reported

Posted 2 days ago in Clinical Trials

BEVERLY, MA–(Marketwired – Mar 24, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the tenth cohort in the Company’s Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard’s Dana-Farber Cancer...

Read more...

Acura Pharmaceuticals Reports Successful Topline Results From Nexafed Extended-Release Clinical Study

Posted 3 days ago in Clinical Trials

PALATINE, IL, March 23, 2015 -- Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), today announced preliminary topline results from a pilot clinical study which demonstrated bioequivalence of one formulation of Nexafed (pseudoephedrine HCl) extended-release tablets to Sudafed® 12-Hour Tablets. Nexafed extended-release tablets utilize Acura's IMPEDE 2.0 enhanced methamphetamine-resistant technology. Acura intends to...

Read more...

Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab

Posted 3 days ago in Clinical Trials

Monday, March 23, 2015 -Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) announced today that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to lift the partial...

Read more...

Boehringer Ingelheim’s Investigational Biologic Cleared Skin Better than Ustekinumab in Head-to-Head Phase II Psoriasis Study

Posted 6 days ago in Clinical Trials

SAN FRANCISCO, Calif., March 20, 2015 – For the first time, Boehringer Ingelheim announced Phase II data from its investigational compound BI 655066*. Nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (described as PASI 90) after 12 weeks of treatment with BI 655066 compared to ustekinumab (77.1% versus 40% of patients). The study (NCT02054481)...

Read more...

Biogen Idec Presents Positive Interim Results From Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab

Posted 6 days ago in Clinical Trials

CAMBRIDGE, Mass., Friday, March 20, 2015 – Today Biogen Idec (NASDAQ:BIIB) announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab (BIIB037), in which aducanumab demonstrated an acceptable safety profile and positive results on radiologic and clinical measurements in patients with prodromal or mild Alzheimer’s disease (AD). These data are being presented today at the 12th...

Read more...
Hide
(web3)