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

Health Highlights: Feb. 5, 2016

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Nearly 13 Million People Sign Up for Obamacare in 2016 About 12.7 million Americans are signed up for Obamacare in 2016, the White House says. That number includes people who signed up for individual private coverage or renewed their insurance for this year, Health and Human Services Secretary Sylvia Burwell said...

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Vacation Weight Gain Can Lead to 'Creeping Obesity,' Study Finds

Posted today in Medical

SUNDAY, Feb. 7, 2016 -- Along with souvenirs, there's a good chance you'll return from your vacation with some extra weight, new research suggests. The study looked at 122 American adults, aged 18 to 65, who went on vacations ranging from one to three weeks between March and August. Sixty-one percent gained weight while on vacation, with an average gain of 0.7 pounds, and that weight tended to stay on after they...

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Super Bowl Safety: Protect Kids From Toppling TVs

Posted yesterday in Medical

SATURDAY, Feb. 6, 2016 -- As families gather to watch the Super Bowl on Sunday, they should protect children from television tip-overs, experts say. More than 17,000 children are treated in U.S. emergency departments each year for injuries from a toppling TV, according to a study published in the journal Pediatrics. That works out to about one child every 30 minutes, with kids younger than 5 years at greatest risk,...

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Surviving Spouse Still Influenced By the Other

Posted 2 days ago in Medical

FRIDAY, Feb. 5, 2016 -- The influence of a husband or wife on their spouse's quality of life remains strong even after death, a new study says. Couples who have been married a long time develop a high level of interdependence, and one partner's quality of life at death continues to influence the survivor, the University of Arizona researchers said. "If your partner has higher quality of life before they pass away,...

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Record Heat, Drought May Explain Zika Outbreak in Brazil: Research

Posted 2 days ago in Medical

FRIDAY, Feb. 5, 2016 -- There may be a link between the recent hot and dry winter and spring in Brazil and the outbreak of the Zika virus, preliminary research suggests. "The extreme temperature and drought are due to a combination of the El Nino phenomenon and the climate changes of recent years," researcher Shlomit Paz, from the department of geography and environmental studies at the University of Haifa in...

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Monthly News Roundup - January 2016

Posted 6 days ago in Pharma Industry News

Merck’s Once-Daily Zepatier for Hepatitis C Wins Approval Hepatitis C virus (HCV) affects over 3 millions Americans, and may lead to liver impairment, cirrhosis or even liver failure. In January, the U.S. Food and Drug Administration (FDA) approved the oral treatment Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 (the most common) and ...

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Dr. Reddy’s Laboratories Ltd. Receives FDA Approval for Zembrace SymTouch (sumatriptan succinate) Injection for the Acute Treatment of Migraines

Posted 9 days ago in New Drug Approvals

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy's Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that the U.S. Food and Drug Administration (FDA) has approved Zembrace™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing tre...

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Synergy Pharmaceuticals Files NDA for Plecanatide in Chronic Idiopathic Constipation

Posted 9 days ago in New Drug Applications

NEW YORK, January 29, 2016 -- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the company has filed with the U.S. Food and Drug Administration (FDA) its first new drug application (NDA) for plecanatide in chronic idiopathic constipation (CIC). “The submission of the plecanatide NDA for CIC marks a major milestone for Synergy as we move the product candidate another step closer to potential approval e...

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FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4

Posted 9 days ago in New Drug Approvals

January 28, 2016 -- The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of...

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FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine

Posted 9 days ago in New Drug Approvals

ALISO VIEJO, Calif., January 28, 2016 -- Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. Onzetra Xsail is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered...

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FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma

Posted 9 days ago in New Drug Approvals

January 28, 2016 -- The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. “Halaven is the first drug a...

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FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

Posted 10 days ago in New Drug Approvals

DEERFIELD, Ill., Jan. 27, 2016 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc., (Takeda) (TSE: 4502) today announced that the United States (U.S.) Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor (PPI)...

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Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis

Posted 12 days ago in New Drug Applications

LAVAL, Quebec, Jan. 25, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with...

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Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA

Posted 12 days ago in New Drug Applications

Lexington, Mass. – January 25, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced it has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on Oct...

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FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501

Posted 13 days ago in New Drug Applications

THOUSAND OAKS, Calif., Jan. 25, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). "If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory ...

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Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis

Posted 2 weeks ago in New Drug Applications

INDIANAPOLIS, Jan. 19, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA). As a result, Incyte will receive a milestone payment of...

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Federal Judge Enters Consent Decree Against Downing Labs

Posted 3 weeks ago in Pharma Industry News

January 11, 2016 -- On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield. According to the complaint filed with the consent decree, Downing Labs (formerly known as NuVision P...

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FDA Approves Integra Omnigraft Dermal Regeneration Matrix to Treat Diabetic Foot Ulcers

Posted 4 weeks ago in Pharma Industry News

January 7, 2016 -- The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound. An estimated 29 million people...

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US Marshals Seize Dietary Supplements Containing Kratom

Posted 4 weeks ago in Pharma Industry News

January 6, 2016 -- The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000. “We have identified kratom as a bot...

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Monthly News Roundup - December 2015

Posted 5 weeks ago in Pharma Industry News

Bridion Approval Launches New Drug Class Neuromuscular blocking drugs cause temporary muscle paralysis and are used to prevent movement during surgery, facilitate endotracheal intubation, and in ICU mechanical ventilation. This month, the FDA approved Merck’s Bridion (sugammadex), a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. In P...

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Results from Phase 3 Trial of Defibrotide for the Treatment of Severe Veno-Occlusive Disease and Multi-Organ Failure Published Online

Posted 6 days ago in Clinical Trials

DUBLIN, Feb. 1, 2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that data from the phase 3 pivotal study of defibrotide were published online in BLOOD, the Journal of the American Society of Hematology (ASH). The data demonstrated that defibrotide use in patients with hepatic veno-occlusive (VOD), also known as sinusoidal obstruction syndrome (SOS), with multi-organ failure (MOF)...

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Profectus BioSciences Initiates Ebola Vaccine Phase 1 Clinical Trial

Posted 2 weeks ago in Clinical Trials

BALTIMORE, Jan. 19, 2016 /PRNewswire/ -- Profectus BioSciences, Inc., a clinical-stage vaccine company developing novel vaccines for the prevention and treatment of infectious diseases and the treatment of cancer, announced today the initiation of a Phase 1 clinical study of Profectus' VesiculoVax™-vectored Ebola virus vaccine. The vaccine is a version of the company's patented VSV vector that has been engineered f...

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Eleven Biotherapeutics Reports Phase 3 Data on Isunakinra (EBI-005) in Allergic Conjunctivitis

Posted 3 weeks ago in Clinical Trials

CAMBRIDGE, Mass., January 15, 2016 --(BUSINESS WIRE)-- Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced top-line results from the Phase 3 clinical trial of its lead drug candidate, isunakinra (EBI-005), for the treatment of severe allergic conjunctivitis. In this trial, there were no...

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Geron Announces Initiation of Janssen Phase 2/3 Clinical Trial of Imetelstat in Myelodysplastic Syndromes

Posted 3 weeks ago in Clinical Trials

MENLO PARK, Calif., Jan. 14, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced the dosing of the first patient in a Phase 2/3 clinical trial to evaluate imetelstat in patients with myelodysplastic syndromes (MDS). This clinical trial, also referred to as the IMergeTM study, is being conducted by Janssen Research & Development, LLC, and is the second study to be initiated under the terms of...

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Karyopharm Initiates Clinical Trial of Oral Selinexor in Advanced Liposarcoma

Posted 3 weeks ago in Clinical Trials

NEWTON, Mass., Jan. 14, 2016 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, announced today the initiation of Selinexor in Advanced Liposarcoma ("SEAL"), a new Phase 2/3 clinical trial with oral selinexor, the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE™) compound that inhibits exportin 1 (XPO1). SEAL is a multi-center, r...

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