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

Health Highlights: Aug 28, 2015

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Bread Recalled Due to Possible Glass Fragments The risk of glass fragments from a broken light bulb has led to the recall of bread in 11 states. The recall is for Sara Lee, Kroger, Bimbo, Nature's Harvest, Great Value and L'Oven Fresh brand breads sold in Alabama, Florida, Georgia, Kentucky, Mississippi, North...

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Impulsive, Agitated Behaviors May Be Warning Signs for Suicide

Posted today in Medical

SATURDAY, Aug. 29, 2015 -- Risky behaviors such as reckless driving or sudden promiscuity, or nervous behaviors such as agitation, hand-wringing or pacing, can be signs that suicide risk may be high in depressed people, researchers report. Other warning signs may include doing things on impulse with little thought about the consequences. Depressed people with any of these symptoms are at least 50 percent more likely...

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Hate Hangovers? Then Don't Drink Too Much

Posted yesterday in Medical

FRIDAY, Aug. 28, 2015 -- Since people first started drinking alcohol, the search has been on for a way to go heavy on the pour but light on the hangover. Unfortunately, two new drinking surveys suggest that search is probably futile. One poll, conducted in Canada, concluded that if you drink to excess, you're going to have a hangover -- no ifs, ands, or buts. A second poll, conducted in the Netherlands, suggested...

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FDA Warns of Joint Pain Tied to Common Type 2 Diabetes Drugs

Posted yesterday in Medical

FRIDAY, Aug. 28, 2015 -- Use of a class of widely prescribed medications for type 2 diabetes is tied to severe joint pain in some patients, the U.S. Food and Drug Administration warned on Friday. The drugs -- sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta) and alogliptin (Nesina) -- come from a newer class of medications called DPP-4 inhibitors. The drugs can be taken alone or used in...

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As Tropical Storm Erika Eyes Southeastern U.S., Residents Need to Prepare

Posted yesterday in Medical

FRIDAY, Aug. 28, 2015 -- With tropical storm Erika motoring toward the southeastern United States, hurricane season is clearly under way and people who live in the paths of these dangerous storms need to be prepared. On Friday, Florida Gov. Rick Scotta declared a state of emergency, as Erika is expected to hit that state by Monday. The soaker of a storm has already left 12 dead as it crosses the Caribbean. To be...

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FDA Approves Repatha (evolocumab) to Treat Certain Patients with High Cholesterol

Posted 2 days ago in New Drug Approvals

August 27, 2015 -- The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult...

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FDA Approves Synjardy (empagliflozin/metformin hydrochloride) for Type 2 Diabetes

Posted 2 days ago in New Drug Approvals

RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 27, 2015 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), for the treatment of adults with type 2 diabetes (T2D). Synjardy is the third product containing empagliflozin to be approved by the FDA,...

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Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)

Posted 5 days ago in New Drug Applications

THOUSAND OAKS, Calif., Aug. 25, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent...

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FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura

Posted 5 days ago in New Drug Approvals

August 24, 2015 -- The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the...

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Alkermes Provides Update on FDA Review of Aristada for the Treatment of Schizophrenia

Posted 8 days ago in New Drug Applications

DUBLIN, August 21, 2015 -- Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has advised Alkermes that it will not be able to complete its review of the New Drug Application (NDA) for Aristada (aripiprazole lauroxil) for the treatment of schizophrenia by the Prescription Drug User Fee Act (PDUFA) action date of Aug. 22, 2015. The FDA indicated that this delay was expected...

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FDA Approves Addyi (flibanserin) for Hypoactive Sexual Desire Disorder in Premenopausal Women

Posted 11 days ago in New Drug Approvals

August 18, 2015 - The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. “Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said...

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InSite Vision Announces FDA Acceptance of NDA Filing for BromSite (0.075% bromfenac)

Posted 12 days ago in New Drug Applications

ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 17, 2015-- InSite Vision Incorporated (OTCBB: INSV), a company developing ophthalmic products for unmet eye care needs, today announced that the U.S. Food and Drug Administration (FDA), in a Day-74 letter, has accepted for review InSite’s New Drug Application (NDA) for BromSite™ (0.075% bromfenac). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of...

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FDA Approves Expanded Label for Procysbi to Treat Children Aged 2-6 Years With Nephropathic Cystinosis

Posted 12 days ago in New Drug Approvals

NOVATO, Calif., Aug. 17, 2015 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (NASDAQ:RPTP) today announced that the U.S. Food and Drug Administration (FDA) approved the expanded use of Procysbi (cysteamine bitartrate) delayed-release capsules to treat children two to six years of age with nephropathic cystinosis. The approved supplement was based on efficacy and safety data from an ongoing long-term extension study...

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Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease

Posted 2 weeks ago in New Drug Applications

JERUSALEM--(BUSINESS WIRE)--Aug. 12, 2015-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the...

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Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain

Posted 3 weeks ago in New Drug Applications

CANTON, Mass., Aug. 7, 2015 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone extended-release capsules) on...

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Monthly News Update: July 2015

Posted 4 weeks ago in Pharma Industry News

Praluent: First Approval in New PCSK9 Inhibitor Class Sanofi and Regeneron’s Praluent (alirocumab), the first in a potential blockbuster class of cholesterol-reducing agents known as PCSK9 inhibitors, was FDA-approved on July 24, 2015. Praluent use is approved in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as a...

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FDA Warns Consumers Who Purchase Diazepam Online of Potentially Serious Counterfeiting Issue

Posted 7 weeks ago in Pharma Industry News

July 6, 2015 -- The FDA is warning consumers who purchase Diazepam, an anti-anxiety medication, on the internet of the potential risk that this drug may be counterfeit. The World Health Organization (WHO) has reported 700 adverse events from patients in Central Africa taking mislabeled Diazepam that was actually the anti-psychotic drug, Haloperidol. The patients who mistakenly took Haloperidol suffered acute...

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FDA Takes Action Against Unapproved Prescription Ear Drop Products

Posted 8 weeks ago in Pharma Industry News

July 1, 2015 -- The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not...

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Monthly News Roundup - June 2015

Posted 8 weeks ago in Pharma Industry News

FDA Approves Antiplatelet Agent Kengreal The U.S. Food and Drug Administration has approved The Medicines Company’s Kengreal (cangrelor), an intravenous blood thinner (P2Y12 platelet inhibitor) used in patients undergoing Percutaneous Coronary Intervention (PCI) to reduce the risk of thrombotic events, like heart attack or stent thrombosis, during the procedure. PCI is more commonly known as a coronary (heart)...

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FDA Panel to Discuss Safety of Contraceptive Device Essure

Posted 9 weeks ago in Pharma Industry News

The U.S. Food and Drug Administration on Wednesday announced that it would hold a public meeting to discuss the safety of the contraceptive device Essure. Essure -- a small metal coil placed via catheter into the fallopian tubes -- is the only permanent birth control device approved for use in the United States. The device received approval in 2002, but over the years the FDA has been alerted to thousands of...

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Novo Nordisk to Initiate Phase 3a Development of Oral Semaglutide, a Once-Daily Oral GLP-1 Analogue

Posted 4 days ago in Clinical Trials

Bagsværd, Denmark, 26 August 2015 - Novo Nordisk today announced the decision to initiate a phase 3a programme with oral semaglutide; a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. The decision follows the encouraging results of the proof-of-concept phase 2 trial announced on 20 February 2015 and the subsequent consultations with regulatory authorities. Novo Nordisk intends to...

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GSK Announces NEJM Publication of Phase 3b/4 Study of Ambrisentan and Tadalafil as First-Line Combination Treatment in Patients with Pulmonary Arterial Hypertension

Posted 4 days ago in Clinical Trials

London, UK -- 26 August 2015 -- GSK today announced publication of the AMBITION study, the first outcomes study to compare the safety and efficacy of investigational first-line combination therapy of Volibris® (ambrisentan) and Adcirca® (tadalafil) to first-line monotherapy of either treatment alone in treatment-naïve patients with pulmonary arterial hypertension (PAH). The AMBITION study was a randomised,...

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Syndax Enters Clinical Trial Collaboration In Cancer Immunotherapy Combining Entinostat and Atezolizumab

Posted 4 days ago in Clinical Trials

WALTHAM, Mass., August 26, 2015 – Syndax Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing entinostat as a combination therapy in multiple cancer indications, announced today that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the safety, tolerability and preliminary efficacy of Syndax’s entinostat, an oral small...

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Corium Initiates Phase 1 Clinical Trial of Corplex Donepezil Transdermal System for the Treatment of Alzheimer's Disease

Posted 5 days ago in Clinical Trials

MENLO PARK, Calif., Aug. 25, 2015 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the commencement of dosing in a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of Corplex™ Donepezil Transdermal System for...

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AstraZeneca and Peregrine Pharmaceuticals to Collaborate on Immuno-Oncology Combination Clinical Trial

Posted 6 days ago in Clinical Trials

Monday, 24 August 2015 -- AstraZeneca today announced that it has entered into a clinical trial collaboration with Peregrine Pharmaceuticals, Inc. to evaluate the safety and efficacy of Peregrine’s investigational phosphatidylserine (PS)-signalling pathway inhibitor, bavituximab, in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase...

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