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

Health Highlights: May 27, 2015

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: White House Puts Hold on Type of Gene Engineering Genetic engineering that makes DNA changes that are passed along to future generations should be put on hold until more is known about possible consequences, the Obama administration says. Altering DNA that is passed from parents to children is called germline...

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Global Trial Finds HIV Drugs Should Be Taken Right After Diagnosis

Posted today in Medical

WEDNESDAY, May 27, 2015 -- People with HIV should start taking medications to battle the virus that causes AIDS as soon as they're diagnosed, a new international study finds. Scientists involved in the trial were so impressed by the health benefits of early use of HIV drugs that they shut the study down early so they could offer the medications to all participants. The findings could alter World Health Organization...

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FDA Approves Xifaxan (rifaximin) for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea)

Posted today in New Drug Approvals

LAVAL, Quebec, May 27, 2015 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and...

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Vegan Diet Might Ease Diabetic Nerve Pain

Posted today in Medical

WEDNESDAY, May 27, 2015 -- A vegan diet might help people with diabetes-related nerve damage shed weight and find some pain relief, a small pilot study suggests. Vegan diets are free of all animal products, including eggs and dairy. Instead, people get their protein, fat and all other nutrients from foods such as beans, nuts, whole grains, vegetables, fruit and plant-based oils. In the new study, researchers...

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Mediterranean Diet Tied to Lower Odds of Uterine Cancer

Posted today in Medical

WEDNESDAY, May 27, 2015 -- Adhering to a Mediterranean diet may significantly reduce a woman's risk of uterine cancer, a new study suggests. "Our research shows the impact a healthy, balanced diet could have on a woman's risk of developing womb [uterine] cancer. This adds more weight to our understanding of how our everyday choices, like what we eat and how active we are, affect our risk of cancer," study author...

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Chronic Gambling Linked to Depression, Impulsivity

Posted today in Medical

WEDNESDAY, May 27, 2015 -- Young men who are chronic gamblers probably suffer from depression, a new study suggests. The Canadian researchers also found boys with impulsive behaviors in childhood were more likely to gamble later in life. "Gambling problems may be more a personal problem similar to an addiction: Once acquired, they are difficult to get rid of," wrote study leader Frederic Dussault, from the...

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FDA Approves Viberzi (eluxadoline) for Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults

Posted today in New Drug Approvals

DUBLIN, May 27, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) announced today that Viberzi (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist. "The...

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FDA Approves Two Therapies to Treat Irritable Bowel Syndrome with Diarrhea (IBS-D)

Posted today in Pharma Industry News

May 27, 2015 -- The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or...

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ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia

Posted yesterday in New Drug Applications

REDWOOD CITY, Calif., May 26, 2015 (GLOBE NEWSWIRE) -- ZS Pharma, Inc. (Nasdaq:ZSPH), a biopharmaceutical company focused on the development and commercialization of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for ZS-9 (sodium zirconium...

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FDA Approves Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for COPD

Posted yesterday in New Drug Approvals

RIDGEFIELD, Conn., May 26, 2015 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray. It has been approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema....

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Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel XR

Posted 6 days ago in New Drug Applications

MONMOUTH JUNCTION, N.J., May 21, 2015; - Tris Pharma, Inc. ("Tris") announced that U.S. Food and Drug Administration ("FDA") has accepted for review its New Drug Application ("NDA") for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October, 2015. Dyanavel XR was developed using Tris’ innovative technology,...

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FDA Approves Invega Trinza (paliperidone palmitate) Four-Times-A-Year Treatment for Schizophrenia

Posted 8 days ago in New Drug Approvals

TITUSVILLE, N.J., May 19, 2015 – There’s a new treatment option for schizophrenia – Invega Trinza (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available. Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved under priority review the New...

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FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients

Posted 12 days ago in New Drug Approvals

MORRISTOWN, NJ – May 15, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.1 Treximet is the first approved combination prescription...

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FDA Advisory Panel Voted 12 to 1 to Recommend Approval of Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis F508del Mutation

Posted 2 weeks ago in New Drug Applications

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 12 to 1 to recommend that the FDA approve Orkambi (lumacaftor/ivacaftor) for use in people with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation in the CFTR gene. Advisory committees...

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AcelRx Pharmaceuticals Provides Zalviso Regulatory Update

Posted 3 weeks ago in New Drug Applications

REDWOOD CITY, Calif., May 4, 2015 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today provided a regulatory update on Zalviso and reported financial results for the three months ended March 31, 2015. Zalviso Regulatory Update On April 21, 2015,...

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Monthly News Roundup - April 2015

Posted 3 weeks ago in Pharma Industry News

FDA Approves First-Time Generic for BMS’s Abilify Abilify (aripiprazole) is a blockbuster atypical antipsychotic drug used to treat the mental illnesses schizophrenia and bipolar disorder. On April 28th, the U.S. Food and Drug Administration (FDA) okayed the first generic versions of Abilify, which will save millions of dollars for patients and healthcare systems. Alembic Pharmaceuticals, Hetero Labs, Teva...

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FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics

Posted 3 weeks ago in Pharma Industry News

April 30, 2015 -- The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. “Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings,...

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Amgen Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) for High Cholesterol

Posted 4 weeks ago in New Drug Applications

THOUSAND OAKS, Calif., April 29, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) will review data supporting the Company's Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol at a meeting on June 10, 2015. Repatha is an investigational fully...

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FDA Approves First Generic Abilify (aripiprazole) to Treat Mental Illnesses

Posted 4 weeks ago in Pharma Industry News

April 28, 2015 -- The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths...

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Ferring Pharmaceuticals Receives FDA Approval for Growth Hormone Name Change, Acquires Zomacton [somatropin (rDNA origin)]

Posted 8 weeks ago in Pharma Industry News

PARSIPPANY, N.J., March 31, 2015 – Ferring Pharmaceuticals Inc. today announced U.S. Food and Drug Administration (FDA) approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as Zomacton [somatropin (rDNA origin)] for injection, and its needle-free delivery system to be marketed in the U.S. as ZOMA-Jet™. Ferring purchased the U.S. rights to Zomacton,...

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Pivotal Study Results Showed Talimogene Laherparepvec Improved Durable Response Rates in Patients With Metastatic Melanoma

Posted yesterday in Clinical Trials

THOUSAND OAKS, Calif., May 26, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the publication of primary results from the Phase 3 OPTiM study in the Journal of Clinical Oncology (JCO). The data published in JCO, which were previously presented at the Annual Meetings of the American Society of Clinical Oncology (ASCO) in 2013 and 2014, demonstrated a significantly higher durable response rate (DRR) in...

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Amgen to Terminate Participation in Co-Development and Commercialization of Brodalumab

Posted 5 days ago in Clinical Trials

THOUSAND OAKS, Calif., May 22, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (LON:AZN, STO:AZN and NYSE:AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial...

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Cardiorentis Completes Enrollment in Pivotal Phase III Clinical Trial of Ularitide for Acute Heart Failure

Posted 5 days ago in Clinical Trials

ZUG, Switzerland – May 22, 2015 – Cardiorentis AG, a privately held biopharmaceutical company, today announced that it has completed enrollment in TRUE-AHF, its pivotal Phase III clinical trial for the treatment of acute heart failure (AHF). The TRUE-AHF Phase III trial was initiated in August 2012. Led by principal investigator Milton Packer, M.D., University Texas, Southwestern Medical Center in Dallas,...

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Intellipharmaceutics Intends to Accelerate its Rexista Oxycodone XR Development Program on the Basis of Positive Feedback from the FDA

Posted 6 days ago in Clinical Trials

TORONTO, May 21, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") provided the Company with...

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Sanofi And Regeneron Announce Positive Topline Results From Phase 3 Studies With Sarilumab In Rheumatoid Arthritis

Posted 6 days ago in Clinical Trials

Paris and Tarrytown, New York - May 21, 2015 - Sanofi and Regeneron Pharmaceuticals, Inc. announced today that a Phase 3 study of sarilumab, an investigational, fully-human IL6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks, and physical function at 12 weeks compared to placebo. The study, called SARIL-RA-TARGET,...

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