Particulate Matter Found in Cubicin Vial

Cubist Pharmaceuticals announced a voluntary recall of one lot of Cubicin (daptomycin for injection) 500mg in 10mL vials, following a consumer complaint of particulate matter.

Voluntary Recall Issued for Appetite Suppressant

Nature's Universe announced a voluntary recall of all lots of old Thinogenics product due to the presence of an undisclosed ingredient, to the user level.

RECALL: Propofol Injectable Metal Particles Found

The FDA announced a nationwide recall of seven lots of Propofol Injectable Emulsion 1% (Hospira), due to visible metal particles embedded in the glass to the user level.

FDA Approves Short Ragweed Pollen Allergen SL Tab

The FDA announced the approval of Ragwitek (Ambrosia artemisiifolia; Merck), the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis.

Arzerra Gains New Indication

Arzerra Gains New Indication

The FDA has approved a new indication for Arzerra (ofatumumab; GlaxoSmithKline) to use in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

FDA Discourages Laparoscopic Power Morcellation in Hysterectomy, Myomectomy

The FDA is discouraging the use of laparoscopic power morcellation for the removal of the uterus or uterine fibroids in women based on a recent analysis of currently available data.

Foodborne Infections Remain Issue Despite Progress

The Centers for Disease Control and Prevention (CDC) reports that although rates for some foodborne infections are on the decline, others remain stagnant or increased in 2013.

Hidden Ingredient Discovered in Sexual Enhancement Supplement

Hidden Ingredient Discovered in Sexual Enhancement Supplement

The FDA has warned consumers that the sexual enhancement supplement S.W.A.G. contains an undisclosed ingredient and should not be purchased or used.

Volasertib Designated Orphan Drug for Acute Myeloid Leukemia

The FDA has granted Orphan Drug designation to volasertib (Boehringer Ingelheim) for acute myeloid leukemia (AML).

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

AbbVie Launches Veliparib Trial for NSCLC

AbbVie announced the initiation of a Phase 3 trial evaluating the safety and efficacy of veliparib (ABT-888) in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Bloxiverz Inj Available Again for NMBA Reversal

Bloxiverz Inj Available Again for NMBA Reversal

Eclat Pharmaceuticals announced that it has ended shortages of Bloxiverz (neostigmine methylsulfate) injection for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.

BAX 111 Efficacious in Inherited Bleeding Disorder

Baxter announced results from a Phase 3 clinical trial evaluating the safety, efficacy, and pharmacokinetics of BAX 111, a recombinant von Willebrand factor (rVWF) for the treatment of bleeding episodes in patients with von Willebrand disease.

Gilead Releases Data on HCV, Advanced Liver Disease Studies

Gilead Sciences has announced data from a Phase 2 study evaluating once-daily Sovaldi (sofosbuvir) 400mg for the treatment of chronic hepatitis C virus (HCV) infection in patients with advanced liver disease.

New Diabetes Treatment Gets FDA Approval

GlaxoSmithKline announced that the FDA has approved Tanzeum (albiglutide) subcutaneous injection as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Gene Variant Discovered in PCOS

The variant in the gene DENND1A has been identified as a likely stimulant for the overproduction of androgen in women with polycystic ovary syndrome (PCOS).

FDA Approves Timothy Grass Pollen SL Tab

Merck announced that the FDA has approved Grastek (Timothy grass pollen allergen extract) Tablet for Sublingual Use as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.

First Oral Psoriatic Arthritis Drug Launched in Specialty Pharmacies

First Oral Psoriatic Arthritis Drug Launched in Specialty Pharmacies

ReCept announced that it is one of the specialty pharmacies selected to distribute Otezla (apremilast; Celgene), a recently approved drug for adults with active psoriatic arthritis.

Two Phase 2 Trials Report Positive Sofosbuvir Data in HCV

Gilead Sciences announced promising efficacy results of sofosbuvir (SOF) in combination with ledipasvir and GS-5816 from two Phase 2 clinical trials on chronic hepatitis C virus (HCV) infection.

Positive Simeprevir Data in Multiple Phase 2 and 3 Studies

Positive Simeprevir Data in Multiple Phase 2 and 3 Studies

Janssen announced positive new data from the simeprevir clinical program, including data from the Phase 2 COSMOS study, the Phase 3 RESTORE, QUEST-1, QUEST-2, and the PROMISE studies.

Combination HCV Therapy Achieves SVR Rates in Trials

Enanta announced results from the Phase 3 SAPPHIRE-I and SAPPHIRE-II studies for AbbVie's investigational three direct-acting antiviral regimen containing Enanta's ABT-450 for the treatment of hepatitis C virus (HCV) genotype 1(GT1) infection.

NDA for New HIV-1 Single Tablet Combination Therapy

Bristol-Myers Squibb and Gilead announced that it has submitted to the FDA a New Drug Application (NDA) for a fixed-dose combination of atazanavir sulfate and cobicistat (Gilead) for use in conbination with other antiretroviral agents for the treatment of HIV-1 infection.

Emergency Burn Gel to Return to Retail Shelves

Emergency Burn Gel to Return to Retail Shelves

Quest Products has announced that it will now distribute Alocane Emergency Burn Gel (Lidocaine HCl 4%), a topical gel for pain and itch relief.

3D Antiviral Regimen Shows Efficacy in Chronic HCV Study

Enanta announced results from AbbVie's pivotal Phase 3 TURQUOISE-II study of the investigational three direct-acting (3D) antiviral regimen for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis.

Diabetes ID Test for Docs Approved by FDA

Abbott announced that the FDA has given 510(k) clearance for its ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test to aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.

New Fast-Acting Antifungal Cream Launched

New Fast-Acting Antifungal Cream Launched

Valeant announced that Luzu (luliconazole) Cream is now available.

Dangerous Ingredient Found in Weight Loss Products

Dangerous Ingredient Found in Weight Loss Products

The FDA is advising consumers to not buy or use Infinity capsules or Lite Fit USA softgels, products that are marketed and sold for weight loss.

Pacemaker, Defibrillator Use Expanded for HF Use

The FDA has approved the revised labeling for Medtronic's 2 cardiac resynchronization pacemakers (CRT-P) and 8 cardiac resynchronization defibrillators (CRT-D) for use in patients with AV block and less severe heart failure.

New Tumor Imaging Agent Approved for Known HCC

Guerbet announced that the FDA has approved Lipiodol (ethiodized oil) Injection for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma.

Investigational Chronic HCV Agents Effective in Phase 2 Study

Merck announced additional data from the ongoing Phase 2 C-WORTHy study evaluating the efficacy and safety of MK-5172 and MK-8742 in patients with chronic HCV genotype 1 (GT1) infection.

All-Oral HCV Therapy Results Released

All-Oral HCV Therapy Results Released

Bristol-Myers Squibb announced results from its HALLMARK-Dual Phase 3 study of all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV) and asunaprevir (ASV) in patients with genotype 1b hepatitis C virus infection (HCV).

Eloctate Shows Efficacy in Hemophilia A Trial

Biogen Idec and Swedish Orphan Biovitrum announced positive top-line results for the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of Eloctate (recombinant factor VIII Fc fusion protein) in children with severe hemophilia A.

Results Reinforce Ampion Use in OAK

Ampio announced results of the 20 weeks extension of the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK).

Aripiprazole Lauroxil Shows Efficacy in Schizophrenia Trial

Alkermes announced positive results from its Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia.

Paralyzed Patients Move Muscles with Spinal Stimulation

Paralyzed Patients Move Muscles with Spinal Stimulation

A novel therapy that involves electrical stimulation of the spinal cord has resulted in four individuals with paraplegia now being able to voluntarily move previously paralyzed muscles

Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica

Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica

Janssen R&D and Pharmacyclics announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib), based on positive data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL).

Pradaxa Now Approved for Treating DVT/PE

Pradaxa Now Approved for Treating DVT/PE

The FDA has approved Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrent DVT and PE in previously treated patients.

BMS Submits Two NDAs for Hepatitis C Treatment

Bristol-Myers Squibb announced that it has submitted New Drug Applications (NDAs) to the FDA for daclatasvir (DCV) and asunaprevir (ASV) for the treatment of hepatitis C.

Combination Chronic Hep C Therapy Granted Priority Review

The FDA has granted priority review to Gilead's New Drug Application (NDA) for a once-daily fixed-dose combination of ledipasvir (LDV) and sofosbuvir (SOF) for the treatment of chronic hepatitis C genotype 1 infection in adults.

Palbociclib + Letrozole Prolongs PFS in Advanced Breast Cancer Study

Pfizer announced results from the Phase 2 PALOMA-1 study that is investigating the use of palbociclib (PD-0332991) in combination with letrozole in patients with advanced breast cancer.

Aptiom Launched for Partial-Onset Seizures

Aptiom Launched for Partial-Onset Seizures

Sunovion announced that Aptiom (eslicarbazepine acetate) is now available for use as adjunctive treatment of partial-onset seizures.Sunovion announced that Aptiom (eslicarbazepine acetate) is now available for use as adjunctive treatment of partial-onset seizures.

Mental Work Demands Affect Later Cognitive Functioning

Mental Work Demands Affect Later Cognitive Functioning

The mental demands of one's job may have a protective effect on cognitive functioning even after retirement.

Once-Weekly Exenatide Sustains Efficacy for 3 Years

AstraZeneca announced the publication of the 3-year results from DURATION-3, an open-label, randomized clinical trial comparing once-weekly exenatide with once-daily insulin glargine as first injectable therapy.

Amgen Announces Results from Talimogene Laherparepvec Phase 3 Trial

Amgen Announces Results from Talimogene Laherparepvec Phase 3 Trial

Amgen announced top-line results from the primary overall survival (OS) analysis of their Phase 3 trial on talimogene laherparepvec for the treatment of unresected stage IIB, IIIC or IV melanoma.

Primary Endpoint Met in Eye Disorder Study

Santen announced results from its Phase 3 trial evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU).

First-of-Kind Device for Military Wounds Gets FDA Nod

First-of-Kind Device for Military Wounds Gets FDA Nod

The FDA has approved XSTAT (RevMedX), a novel device for military use to control bleeding from certain types of wounds received in battle.

Kalbitor Inj Indication Expanded to Pediatric Patients

Kalbitor Inj Indication Expanded to Pediatric Patients

Dyax announced that the FDA has expanded the indication for Kalbitor (ecallantide) to include patients >12 years old.

CDC: E-Cigarette Poison Center Calls on the Rise

According to the CDC, the number of e-cigarette-related poison center calls has risen significantly from 2010 to 2014.

Updated Action Plan Against Viral Hepatitis Released

Updated Action Plan Against Viral Hepatitis Released

Federal agency partners released an updated version of Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (2011), the first cross-agency action plan to fight viral hepatitis.

FDA Approval Puts Opioid Overdose Reversal in Patients' Hands

FDA Approval Puts Opioid Overdose Reversal in Patients' Hands

The FDA has approved Evzio (naloxone HCl injection; Kaléo Inc.) for the emergency treatment of known or suspected opioid overdose.

Experts Praise Drug Trial for Creating a Realistic Study Population

A German study of a new drug therapy for chronic lymphocytic leukemia (CLL) was lauded for including elderly persons who had other, coexisting health issues. An accompanying editorial noted that the study population more accurately represented patients with CLL.

Undeclared Drugs Found in New You Product

The FDA is warning consumers to avoid using or purchasing the herbal weight loss product New You after a laboratory analysis discovered undeclared sibutramine and phenolphthalein.

FDA Fast Tracks Eravacycline for cIAI and cUTI

The FDA granted Fast Track status to the IV and oral formulations of eravacycline (Tetraphase) for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Alzheimer's Disease Drug to be Discontinued

Alzheimer's Disease Drug to be Discontinued

Forest Laboratories announced its plan to discontinue the sale of Namenda 5mg and 10mg tablets on August 15, 2014.

Low Dose Aspirin Does Not Reduce Pregnancy Loss

Low Dose Aspirin Does Not Reduce Pregnancy Loss

The National Institutes of Health (NIH) reported that daily low dose aspirin therapy did not improve birth rates in most women with prior history of one or more pregnancy losses.

ERY-ASP Designated Orphan Drug for AML

The FDA has granted ERY-ASP (Erytech Pharma) Orphan Drug Designation for the treatment of acute myeloid leukemia (AML).

Heart Failure Trial Shut Down After Primary Endpoint Met

Novartis announced the early closure of its Phase 3 PARADIGM-HF study, indicating that patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril.

Prostate Cancer Trial Launched for Xofigo

Phase 3 trial launched for Xofigo (radium Ra 223 dichloride; Bayer HealthCare) injection in combination with Zytiga (abiraterone acetate; Janssen) and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (mCRPC).

First SL Allergy Immunotherapy Tablet Approved

Greer Laboratories announced that the FDA has approved Oralair sublingual allergy immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.

New Approach Reduces Opioid Painkiller Use After Breast Reconstruction Surgery

A new approach to breast reconstruction surgery aimed at helping patients' bodies get back to normal more quickly cut their postoperative painkiller use in half and reduced hospital stay, a new study found.

Better Long-Term QOL After Esophagectomy and Gastric Pull-Up

Long-term survivors can enjoy a satisfying meal and good quality of life after esophagectomy with gastric pull-up, according to a new study.

Obesity, Not Diet, Can Trigger Colon Cancer

Obesity, Not Diet, Can Trigger Colon Cancer

Changes to the colon that may lead to colorectal cancer appear to be caused by obesity, rather than diet, in mice.

Sentinel-node Biopsy Succeeds in Early Melanoma Spread Detection

Research on a technique for detecting the earliest spread of melanoma has confirmed that the procedure significantly prolongs patients' survival rates compared with traditional watch-and-wait techniques.

NDA Submitted for Combination HIV-1 Therapy

Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA for Prezista (darunavir) with cobicistat (Gilead Sciences) for use in combination with other HIV-1 drugs.

FDA Expands Age Indication for Adacel Tdap Vaccine

Sanofi Pasteur announced that the FDA has approved the use of Adacel Tdap vaccine in children as young as 10 years old.

Darapladib Not Better Than Placebo in Coronary Heart Disease

The novel darapladib demonstrated no advantage over placebo in regards to the study's primary endpoint in patients with chronic coronary heart disease treated with a high level of background care.

Celiac Disease May Be Linked to Increased CAD Risk

Celiac Disease May Be Linked to Increased CAD Risk

Individuals with celiac disease may be at a two-fold increased risk of coronary artery disease compared to the general population.

Biodegradable Biolimus-Eluting Stent Noninferior

Biodegradable Biolimus-Eluting Stent Noninferior

For patients undergoing drug-eluting stent implantation, biodegradable polymer biolimus-eluting stents are noninferior to durable polymer everolimus-eluting stents for death or myocardial infarction, and for target lesion revascularization at two-years.

Young Adult Diet Can Protect Against Artery Plaque 20 Years Later

Young Adult Diet Can Protect Against Artery Plaque 20 Years Later

New research suggests that women who eat a diet high in fresh fruits and vegetables as young adults have a significantly reduced risk of artery plaque build-up in the future.

Evolocumab Significantly Lowers LDL as Statin Add-On

Study results showed evolocumab (Amgen) significantly reduced low-density lipoprotein (LDL) cholesterol as an add-on to statins in all treatment groups.

More Harm than Benefit Halts Aleglitazar Phase 3 Study

Patients treated with aleglitazar showed higher rates of heart failure, kidney events, and gastrointestinal (GI) bleeding with no countering cardio benefits.

Less Patient Discomfort with Visipaque than Isovue in Arteriography

GE Healthcare announced results from a new study that reported less discomfort from patients receiving Visipaque (iodixanol) 320mg I/mL vs. patients receiving Isovue (iopamidol; Bracco) 370mg I/mL during peripheral arteriography.

FDA Clarifies Its Position on Revatio Use in Children

The FDA announced clarifications to its previous recommendation related to prescribing Revatio (sildenafil; Pfizer) for children with pulmonary arterial hypertension (PAH).

Mederma PM Intensive Overnight Scar Cream Launched

Mederma PM Intensive Overnight Scar Cream Launched

Merz Pharmaceuticals announced the launch of Mederma PM Intensive Overnight Scar Cream (dimethicone 2%), a new cream designed to work at night.

Xarelto to be Evaluated in 3 New Thromboembolism Trials

Xarelto to be Evaluated in 3 New Thromboembolism Trials

Janssen R&D announced the addition of three new clinical trials under the EXPLORER global cardiovascular research program for Xarelto (rivaroxaban) to be evaluated for thromboembolic disorders.

FDA Approves OTC Nexium 24HR Caps

FDA Approves OTC Nexium 24HR Caps

The FDA has approved over-the-counter (OTC) Nexium 24HR (esomeprazole; Pfizer Consumer Healthcare) for patients suffering from frequent heartburn.

Nova Dietary Supplements Recalled

Nova Products announced a voluntary recall of African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, XZone Gold, and XZone 1200, products marketed as dietary supplements for sexual enhancement.

FDA Approves New Bleeding Prophylactic for Hemophilia B Patients

The FDA has approved Alprolix injection to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes in patients with Hemophilia B.

Ancient Chinese Medicine May Aid Pancreatic Cancer Treatments

The bark of the Amur cork tree (Phellodendron amurense) has traveled a centuries-long road with the healing arts. Now, it is being put through its paces by science in the fight against pancreatic cancer.

First Adolescent Migraine Prophylactic Approved

First Adolescent Migraine Prophylactic Approved

The FDA has approved Topamax (topiramate; Janssen) for migraine prophylaxis in adolescents aged 12-17 years old. This is the first drug approval for a migraine prophylactic in this age group.

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