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Health Highlights: April 24, 2015

Posted 3 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Warns Supplement Makers About Stimulant The U.S. Food and Drug Administration on Thursday sent warning letters to the makers of eight dietary supplements that state their products contain a potentially dangerous compound that acts like amphetamine. According to The New York Times, the letters notify the...

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Depression, Weapons May Be More Common for Bullied Teens

Posted today in Medical

MONDAY, April 27, 2015 -- Bullied high school students have greater odds for depression and suicidal thoughts than others, and they're also more likely to take weapons to school, according to three new studies. "Teens can be the victim of face-to-face bullying in school, electronic bullying outside of the classroom and dating violence," said Dr. Andrew Adesman, senior investigator of the studies. Each experience is...

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Doctors Say Head Lice Should Not Bar Kids From School

Posted today in Medical

MONDAY, April 27, 2015 -- Outbreaks of head lice in kids can be effectively treated without banning infected children from school, new guidelines from the American Academy of Pediatrics (AAP) say. In fact, the AAP believes that doctors and other health care professionals should educate schools and communities that "no-nit" policies are unfair and should not be implemented. Children found to have head lice or nits...

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HPV Vaccine Produces Early Benefits for Teen Girls: Study

Posted today in Medical

MONDAY, April 27, 2015 -- Girls as young as 14 are receiving important health benefits from the HPV vaccine, which protects against a sexually transmitted virus that causes cervical cancer, a new study reports. Canadian girls who received the vaccine around age 13 experienced a "large and significant reduction" in cases of cervical dysplasia -- an abnormal precancerous lesion caused by human papillomavirus (HPV) --...

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MRI May Help Gauge Stroke Risk in Those With Irregular Heartbeat

Posted today in Medical

MONDAY, April 27, 2015 -- Special MRI scans of the heart can help spot people with atrial fibrillation -- a common heart rhythm disorder -- who are at high risk for stroke, a new study shows. The study also calls into question the mechanism linking atrial fibrillation with higher stroke risk, says a team reporting the findings April 27 in the Journal of the American Heart Association. The irregular heartbeat can...

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FDA Approves Cyramza (Ramucirumab) for Use with FOLFIRI in Second-Line Treatment of Metastatic Colorectal Cancer

Posted 2 days ago in New Drug Approvals

INDIANAPOLIS, April 24, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has received its fourth U.S. Food and Drug Administration (FDA) approval for Cyramza (ramucirumab). Cyramza (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with...

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Medicure Announces Approval of Expanded Dosing Time For Aggrastat

Posted 3 days ago in New Drug Approvals

WINNIPEG, April 23, 2015 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, is pleased to announce that the United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen. The dosing change and label modification was requested by the...

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FDA Approves New Formulation of Minocin (minocycline) for Injection

Posted 6 days ago in New Drug Approvals

PARSIPPANY, N.J.--(BUSINESS WIRE)--Apr. 20, 2015-- The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a new formulation of Minocin (minocycline) for Injection. The FDA has also granted Qualified Infectious Disease Product (QIDP) designation for the new formulation of Minocin for Injection under the...

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Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the FDA for Malignant Gliomas

Posted 9 days ago in New Drug Applications

CALGARY, April 17, 2015 /PRNewswire/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for its lead product candidate, Reolysin, for the treatment of malignant glioma. The...

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FDA Approves Glatopa (glatiramer acetate) as the First Generic Competitor to Copaxone

Posted 10 days ago in New Drug Approvals

Holzkirchen, Germany, April 16, 2015 - Sandoz, a Novartis company, today announced the US approval of Glatopa, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy. "Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," said Peter Goldschmidt,...

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FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor

Posted 11 days ago in New Drug Applications

PARSIPPANY, N.J.--(BUSINESS WIRE)--Apr. 15, 2015-- The Medicines Company (NASDAQ:MDCO) announced today that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 9 - 2 with one abstention to recommend approval of the investigational intravenous antiplatelet agent cangrelor as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of...

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Repros Announces November 30, 2015 PDUFA Goal Date for Enclomiphene Citrate NDA

Posted 11 days ago in New Drug Applications

THE WOODLANDS, Texas, April 15, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. (Nasdaq:RPRX) today announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015, for substantive review of the Company's New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal®. In addition, the FDA has...

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FDA Approves Corlanor (ivabradine) to Treat Heart Failure

Posted 11 days ago in New Drug Approvals

April 15, 2015 -- The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure. Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat...

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ARCA Biopharma Receives FDA Fast Track Designation for Gencaro

Posted 13 days ago in New Drug Applications

Westminster, CO, April 13, 2015 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Gencaro for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure...

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Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD

Posted 13 days ago in New Drug Applications

Québec City, Canada, April 13, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”) today announced plans to conduct a new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (“AGHD”), as well as a dedicated thorough QT study to evaluate the effect of...

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

Posted 3 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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FDA Issues Final Guidance on the Evaluation and Labeling of Abuse-Deterrent Opioids

Posted 3 weeks ago in Pharma Industry News

April 1, 2015 -- The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop...

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Monthly News Roundup - March 2015

Posted 3 weeks ago in Pharma Industry News

FDA Approves First Biosimilar Product Zarxio On Friday, March 6th the U.S. Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz), the first U.S. approved biosimilar. Zarxio, the biosimilar for Amgen’s filgrastim (Neupogen), is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments. Biological products are generally derived from a...

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Federal Judge Enters Consent Decree Against Specialty Compounding LLC

Posted 6 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...

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Monthly News Roundup - February 2015

Posted 8 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...

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MediciNova Announces Positive Interim Safety Data From Clinical Trial of MN-166 (ibudilast) in ALS

Posted 5 days ago in Clinical Trials

LA JOLLA, Calif., April 21, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that Dr. Benjamin Rix Brooks, principal investigator, presented interim safety data from the ongoing clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) today at the...

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Onconova Therapeutics, Inc. Submits Pivotal Clinical Trial Protocol for IV Rigosertib in Higher-Risk Myelodysplastic Syndromes to FDA and EMA

Posted 6 days ago in Clinical Trials

NEWTOWN, Pa., April 20, 2015 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that the Company has submitted a protocol for a global pivotal study of IV rigosertib in patients with higher-risk myelodysplastic syndromes (HR-MDS) for whom prior treatment with approved...

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ARIAD Presents Updated Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer

Posted 9 days ago in Clinical Trials

GENEVA & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 17, 2015-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor, brigatinib (AP26113), in patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The new results include an analysis of safety and efficacy for...

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OncoMed Presents Demcizumab Data From Phase 1b Clinical Trial in Non-Small Cell Lung Cancer Patients at the European Lung Cancer Conference

Posted 10 days ago in Clinical Trials

REDWOOD CITY, Calif. and GENEVA, April 16, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED) presented new data from the Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) in patients with first-line advanced non-small cell lung cancer (NSCLC) at the European Lung Cancer Conference. Demcizumab is a first-in-class monoclonal antibody targeting DLL4 with anti-cancer stem cell,...

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Phase III Trial of the Merck and NewLink Genetics Investigational Ebola Vaccine Initiated in Sierra Leone

Posted 12 days ago in Clinical Trials

KENILWORTH, N.J. & AMES, Iowa - April 14, 2015 -- (BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ: NLNK), confirmed today that the third, late-stage, clinical trial of their Ebola vaccine candidate rVSV-ZEBOV-GP (V920) has been initiated in Sierra Leone. The vaccine candidate was originally developed by the Public Health Agency of...

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