More Flu-Related Deaths Seen in Super Bowl Team Cities

More Flu-Related Deaths Seen in Super Bowl Team Cities

Areas with teams playing in the Super Bowl are more likely to see an increase in influenza-related deaths, particularly in years when the dominant influenza strain is more virulent or when the event occurs closer to the peak of influenza season, according to researchers at Tulane University.

Government Initiative Aims for Personalized Medicine

The White House has released new information about the Precision Medicine Initiative, a research program to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies for individualized patient care.

Super Bowl Sunday Could Mean Super Calories

Super Bowl Sunday Could Mean Super Calories

Super Bowl Sunday is reported to be the second biggest food day for Americans after Thanksgiving, with the average American consuming as much as 2,400 calories during the game.

Evotaz Approved for HIV-1 Infection

Evotaz Approved for HIV-1 Infection

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Evotaz (atazanavir and cobicistat) in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Prezcobix Tabs Approved for HIV-1

Prezcobix Tabs Approved for HIV-1

Janssen announced that the Food and Drug Administration (FDA) has approved Prezcobix (darunavir, cobicistat) tablets for the treatment of HIV-1 infection in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.

Nutrition Plays Key Role in Mental Health, Argues Study

Nutrition Plays Key Role in Mental Health, Argues Study

A new international collaboration published in The Lancet Psychiatry is encouraging the fields of psychiatry and public health to recognize the relationships between diet quality, potential nutritional deficiencies, and mental health.

Single Access Heart Pump OK'd for Right Heart Support

Abiomed announced that the Food and Drug Administration (FDA) has approved the Impella Right Percutaneous System under a Humanitarian Device Exemption (HDE).

Eye-Tracking Tool Promising for Concussion, Brain Injury Diagnosis

Eye-Tracking Tool Promising for Concussion, Brain Injury Diagnosis

Researchers at NYU Langone Medical Center have developed a unique diagnostic tool for concussion or brain injury that can be utilized in the emergency room, and potentially on the sidelines at sporting events.

ADHD Linked to Earlier Substance Abuse, HIV-Risk Behaviors

A history of attention deficit hyperactivity disorder (ADHD) in adults is significantly associated with younger ages of initiation for illicit substance use and a greater risk of engagement in recent HIV-risk behaviors such as injection drug use and needle sharing, suggests a new article in the journal Addictive Behaviors.

Imbruvica Gains New Lymphoma Indication

Imbruvica Gains New Lymphoma Indication

The Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) for patients with Waldenström's macroglobulinemia (WM).

Novel Cervical Retractor Device Gets FDA Clearance

Bioceptive announced it has received clearance from the Food and Drug Administration (FDA) for its suction cervical retractor for use in various gynecological procedures.

Neutrolin Catherter Lock Solution Designated QIDP Status

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to Neutrolin Catheter Lock Solution for oncology, hemodialysis, and intensive care unit patients, where catheter-related blood stream infections and clotting can be life threatening.

First Dermal Filler Approved for Lip Enhancement, Perioral Lines

First Dermal Filler Approved for Lip Enhancement, Perioral Lines

Galderma announced the launch of Restylane Silk, the first dermal filler approved for lip augmentation and correction of perioral rhytids in patients over 21 years old.

Probiotic + Protein Combo Promising for Peanut Allergy in Children

Probiotic + Protein Combo Promising for Peanut Allergy in Children

A new oral therapy that combines a probiotic and peanut protein appears to be a successful immunotherapy for peanut allergy, based on a study conducted by researchers at Murdoch Childrens Research Institute at the Royal Children's Hospital in Australia.

Phase 3 Trial of Epilepsy Drug for Cognitive Impairment To Be Initiated

The Alzheimer's Drug Discovery Foundation has awarded a $900,000 grant to AgeneBio to support the initiation of a Phase 3 clinical trial with AGB101 for the treatment of amnestic mild cognitive impairment (aMCI).

Kyprolis sNDA Submitted for Relapsed Multiple Myeloma

Amgen announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

New Norditropin FlexPro Strength Approved

Novo Nordisk announced that the Food and Drug Administration (FDA) has approved a new 30mg/3.0mL strength of Norditropin (somatropin [rDNA origin] injection) FlexPro pen.

Pulmozyme with eRapid Nebulizer Use Approved for CF

The Food and Drug Administration (FDA) has approved PARI's eRapid Nebulizer System (eRapid), the first electronic nebulizer to deliver Pulmozyme (dornase alfa [recombinant human DNase]; Genentech) for the treatment of cystic fibrosis.

New MRSA/SA Dx Test Uses Single Nasal Swab

Roche announced that the FDA has granted clearance for the cobas MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens.

First Apps Approved for Sharing Glucose Monitoring Data

First Apps Approved for Sharing Glucose Monitoring Data

The Food and Drug Administration (FDA) has granted marketing of the Dexcom Share system, the first set of mobile medical applications (apps) that allow patients with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.

New Inhalers for Asthma, COPD Launched

New Inhalers for Asthma, COPD Launched

GlaxoSmithKline announced the launch of Arnuity Ellipta (fluticasone furoate inhalation powder) and Incruse Ellipta (umeclidinium bromide inhalation powder).

Abuse-Deterrent Hysingla ER Tabs Launched

Abuse-Deterrent Hysingla ER Tabs Launched

Purdue announced the launch of Hysingla ER (hydrocodone bitartrate) extended-release tablets.

New Triferic Replaces Iron Losses, Maintains Hemoglobin in Hemodialysis Patients

Rockwell Medical announced that the FDA has approved Triferic (soluble ferric pyrophosphate) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease.

Priority Review for Hypercholesterolemia Drug Praluent

The Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.

FDA Approves Second Meningitis B Vaccine

FDA Approves Second Meningitis B Vaccine

Novartis announced that the Food and Drug Administration (FDA) has granted accelerated approval of Bexsero (meningococcal group B vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningitis B in patients aged 10 to 25 years.

New Fixed-Dose Combo Tabs for Hypertension Approved

Symplmed announced that the Food and Drug Administration (FDA) has approved Prestalia (perindopril arginine and amlodipine) tablets for the treatment of hypertension in patients whose blood pressure is uncontrolled on monotherapy.

Natpara Injection Approved for Hypocalcemia

The Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone; NPS Pharmaceuticals) for injection as adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.

New CDC Report on Influenza, Plus a Quiz for Clinicians

The Centers for Disease Control and Prevention (CDC) has issued a new surveillance report for the week ending January 17, 2015 on influenza-related mortality, hospitalizations, and outpatient illness, as well as the geographic spread.

Labeling Update for Xarelto

Labeling Update for Xarelto

The Food and Drug Administration (FDA) announced that it has approved an update to the prescribing information for Xarelto (rivaroxaban; Janssen).

Human Hair Found in Sodium Chloride Injection

Hospira announced a voluntary recall of one lot of 0.9% Sodium Chloride Injection due to particulate matter sealed in the bag at the additive port area. The particulate matter was identified as a human hair.

Disney-Related Measles Outbreak Spreads to Six States

Disney-Related Measles Outbreak Spreads to Six States

Over 50 people across six states were reported to have measles from January 1 to 16, 2015.

Cresemba Approval Supported by FDA Advisory Committee

Astellas announced that the Anti-infective Drugs Advisory Committee of the Food and Drug Administration (FDA) has recommended the approval of Cresemba (isavuconazonium) for the treatment of invasive aspergillosis and mucormycosis.

CDC: Reduce Opioid Exposure Among Reproductive-Aged Women

A new study shows the need for more interventions to reduce opioid prescriptions among women of reproductive potential, especially when safer alternatives are available or when opioid use is unnecessary.

Health Tracker Included in New Maternity Clothing Line

Health Tracker Included in New Maternity Clothing Line

An undergraduate student at Cornell University has designed a collection of maternity wear that can also wirelessly monitor the mother's health using conductive silver fibers in the clothing fabric.

Counterfeit ED Drug Found in U.S. Mail

Counterfeit ED Drug Found in U.S. Mail

The Food and Drug Administration (FDA) is warning healthcare professionals and consumers that counterfeit versions of Cialis (tadalafil; Eli Lilly) 20mg tablets were discovered in the mail in transit to a U.S. consumer.

Supplement Found to Contain Undeclared Sildenafil

Supplement Found to Contain Undeclared Sildenafil

The Food and Drug Administration (FDA) is advising consumers to not buy or use Happy Passengers, a product promoted and sold for sexual enhancement.

Cosentyx for Plaque Psoriasis Approved

Cosentyx for Plaque Psoriasis Approved

Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

FDA: Avoid Bone Grafts with Recombinant Proteins in Patients Under 18

The Food and Drug Administration (FDA) is recommending against the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients under 18 years old.

New Spiriva Inhalation Formulation Now Available

New Spiriva Inhalation Formulation Now Available

Boehringer Ingelheim announced that Spiriva Respimat (tiotropium bromide) Inhalation Spray is now available.

Hepatitis C Infection Treatment Will Be Discontinued

The Food and Drug Administration (FDA) is informing that Victrelis (boceprevir; Merck) 200mg capsules will be discontinued.

New Glucose Monitor Features Enhanced Tracking, Positive Reinforcement

New Glucose Monitor Features Enhanced Tracking, Positive Reinforcement

LifeScan announced the launch of OneTouch Verio System, a new blood glucose monitoring system that helps patients with diabetes understand their test results better.

All Healthcare Providers Should Be Immunized, ACP Urges

A newly approved policy recommendation by the American College of Physicians (ACP) urges all healthcare providers to be properly immunized.

Hypoglycemia Education Needed for Diabetes Patients

In a recent survey of 1,000 adults living with type 1 or type 2 diabetes, 62 percent expressed concern about experiencing hypoglycemia but only 42 percent were unable to define hypoglycemia correctly.

Phoxillum Approved for Electrolyte Imbalances in CRRT

Phoxillum Approved for Electrolyte Imbalances in CRRT

Baxter announced that the Food and Drug Administration (FDA) has approved Phoxillum Renal Replacement Solutions (BK4/2.5 and B2K4/0) for use in continuous renal replacement therapy (CRRT) to replace plasma volume removed by ultrafiltration, correct electrolyte and acid-base imbalances, and for use in drug poisoning when CRRT is used to remove dialyzable substances.

Three-Month Paliperidone Palmitate NDA Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate (Janssen R&D) to treat schizophrenia in adults.

Deflazacort Designated Fast Track Status for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has granted Fast Track designation to deflazacort (Marathon Pharmaceuticals) for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Acute Myeloid Leukemia Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track status to CPX-351 (cytarabine:daunorubicin; Celator Pharmaceuticals) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

Insulin Nasal Spray May Improve Memory in Alzheimer's Dementia

Insulin Nasal Spray May Improve Memory in Alzheimer's Dementia

Researchers from the Forest Baptist Medical Center found that a man-made form of an insulin nasal spray may improve working memory and other mental capabilities in adults with mild cognitive impairment and Alzheimer's dementia.

FDA Wants to Know How Drugs Affect Driving

The U.S. Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Center for Drug Evaluation and Research (CDER) have issued a draft guidance document on evaluating drug effects on the ability to operate a motor vehicle to assist pharmaceutical sponsors.

Phase 2/3 Study Data Announced for Vectibix in Colorectal Cancer

Amgen announced new data from its PEAK and PRIME studies that support Vectibix (panitumumab), in combination with FOLFOX, as first-line therapy in patients with wild-type RAS metastatic colorectal cancer (mCRC)

Treximet sNDA Accepted by FDA for Adolescent Migraine

Treximet sNDA Accepted by FDA for Adolescent Migraine

Pernix announced that the sNDA for Treximet (sumatriptan/naproxen sodium) for use in adolescents aged 12-17 years for the acute treatment of migraine with or without aura has been accepted by the FDA.

Folic Acid Important for NTD Prevention, Says CDC

Folic Acid Important for NTD Prevention, Says CDC

New research by the Centers for Disease Control and Prevention (CDC) supports the protective effect of folic acid supplementation against recurrent neural tube defects (NTD).

CDC: Early Estimates on the Effectiveness of This Year's Flu Vaccine

A new report by the Centers for Disease Control and Prevention (CDC) suggests that the 2014-15 influenza vaccine has low effectiveness against circulating influenza A (H3N2) viruses, but vaccination is still recommended.

Pharmacological Strategies for Obesity, Weight Loss: New Guideline Issued

Pharmacological Strategies for Obesity, Weight Loss: New Guideline Issued

The Endocrine Society has issued a Clinical Practice Guideline (CPG) on pharmacological strategies for managing obesity and promoting weight loss.

FDA: Simulated IV Saline Products Distributed to Healthcare Facilities

FDA: Simulated IV Saline Products Distributed to Healthcare Facilities

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur simulated intravenous (IV) saline products being administered to patients. These products are not sterile and are intended for training purposes only.

Brilinta Reduced Major CV Events in PEGASUS-TIMI 54 Study

Brilinta Reduced Major CV Events in PEGASUS-TIMI 54 Study

AstraZeneca announced that Brilinta (ticagrelor) met the primary endpoint in the PEGASUS-TIMI 54 study.

Overactive Bladder Drug May Possibly Promote Weight Loss

Brown adipose tissue was successfully activated and energy expenditure increased in 12 lean adult men treated with mirabegron in a new study.

Deaths from Heroin, Cocaine Up in 2013, Rx Opioids Steady

The White House Office of National Drug Control Policy (ONDCP) announced that mortality rates due to fatal overdoses from heroin and cocaine increased in 2013, while deaths related to prescription opioids remained stable compared to 2012.

Xarelto Shows Consistent Results in Post-Marketing Studies

Xarelto Shows Consistent Results in Post-Marketing Studies

Results from an ongoing 5-year post-marketing study evaluating the safety of Xarelto (rivaroxaban; Janssen) show that rates and patterns of major bleeding in clinical practice are overall consistent with those seen in Phase 3 clinical trials used to approve the medicine.

Oral HIV Vaccine Undergoing Testing

Oral HIV Vaccine Undergoing Testing

A new oral vaccine to prevent HIV infection that does not contain the HIV virus is currently being tested in clinical trials at the University of Rochester Medical Center.

First-of-Its-Kind Device to Treat Obesity Gets FDA Approval

First-of-Its-Kind Device to Treat Obesity Gets FDA Approval

The Food and Drug Administration (FDA) has approved EnteroMedics' VBLOC vagal blocking therapy, delivered via the Maestro System, which is the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.

Some Abilify Formulations to Discontinue in 2015

The Food and Drug Administration (FDA) has informed that certain Abilify (aripiprazole; Otsuka) formulations will be discontinued before the end of 2015.

Sparsentan Gains Orphan Drug Designation for Rare Nephropathy

The Food and Drug Administration (FDA) has granted orphan drug designation for Retrophin's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).

Largest Capacity Insulin Pump Gets FDA Clearance

Largest Capacity Insulin Pump Gets FDA Clearance

Tandem Diabetes Care announced that the Food and Drug Administration (FDA) has cleared t:flex Insulin Pump, the largest capacity insulin pump currently available.

Tarina Fe 1/20 Oral Contraceptive Now Available

Tarina Fe 1/20 Oral Contraceptive Now Available

Afaxys announced the availability of Tarina Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, 1mg/20mcg/75mg) for the prevention of pregnancy in women who choose to use oral contraceptives as a method of contraception.

New Enteral Suspension OK'd for Parkinson's Disease

New Enteral Suspension OK'd for Parkinson's Disease

AbbVie announced that the Food and Drug Administration (FDA) has approved Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease.

For Headaches, Clinicians Increasingly Ignoring Evidence-Based Guidelines

Clinicians are increasingly ordering advanced diagnostic imaging and referring patients to other physicians for the management of headache, despite recommendations in evidence-based guidelines against these practices.

FDA Releases Statement on Use of Pain Meds During Pregnancy

FDA Releases Statement on Use of Pain Meds During Pregnancy

The Food and Drug Administration (FDA) has issued a statement regarding the benefits and potential risks associated with the use of prescription and over-the-counter (OTC) pain medications during pregnancy in response to recent reports questioning their safety when used during pregnancy.

New Tx Approved for VTE, Stroke Risk Reduction

Daiichi Sankyo announced that the FDA has approved Savaysa (edoxaban) tablets to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF), and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral coagulant.

Avocado Diet Shows Added LDL-C Lowering Benefit

Avocado Diet Shows Added LDL-C Lowering Benefit

New research in the Journal of the American Heart Association suggests that inclusion of one avocado per day as part of a moderate-fat diet may help to improve specific blood lipid markers compared to an energy-matched moderate-fat diet without avocado or a low-fat diet with avocado.

Novel Antibiotic Debio 1450 Designated Fast Track Status

Debiopharm announced that the Food and Drug Administration (FDA) has granted Fast Track designation for Debio 1450, an antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Positive Results for Elagolix in Endometriosis Study

AbbVie announced positive results from one of two ongoing Phase 3 trials for elagolix in premenopausal women with endometriosis.

FDA Approves Rytary for Parkinson's Disease

Impax announced that the FDA has approved Rytary (carbidopa/levodopa) extended-release capsules for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

FDA: Availability of Antivirals for 2014-15 Flu Season

The Food and Drug Administration (FDA) is reporting no current shortage of antivirals for the 2014-2015 influenza season.

Intelliport System Cleared to Improve IV Bolus Management

Intelliport System Cleared to Improve IV Bolus Management

BD announced that the Food and Drug Administration (FDA) has cleared the BD Intelliport Medication Management System, a management system for manual IV bolus injections.

Cutaneous T-Cell Lymphoma Tx Designated Fast Track

Soligenix announced that the FDA has granted a Fast Track designation for SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.

Rapid Influenza A/B Test Granted CLIA Waiver for Greater Access

Rapid Influenza A/B Test Granted CLIA Waiver for Greater Access

The Food and Drug Administration (FDA) has granted the first CLIA waiver for Alere i Influenza A & B test, a nucleic acid-based test, for use in expanded healthcare settings.

Natroba Now Approved for Younger Children with Head Lice

Natroba Now Approved for Younger Children with Head Lice

ParaPRO announced that the Food and Drug Administration (FDA) has approved an expanded age range for Natroba (spinosad) Topical Suspension, to include children 6 months of age and older who have pediculosis capitis (head lice).

Alcohol Poisoning Deaths at Nearly 2,200 Per Year

About six individuals die per day due to alcohol poisoning, with the majority of the approximately 2,220 deaths per year involving adults ages 35-64, reports a new study by the Centers for Disease Control and Prevention (CDC).

Early Glucose Control in T1DM Linked to Longer Life

Early control of blood glucose in patients with type 1 diabetes is linked to a longer life than those without early control, recent research has shown.

Positive Safety, Tolerability Data for ALKS 5461 in MDD Study

Alkermes announced positive results for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).

"Imaginary Meal" Pill Leads to Weight Loss, Blood Sugar Reduction in Study

"Imaginary Meal" Pill Leads to Weight Loss, Blood Sugar Reduction in Study

Researchers at the Salk Institute for Biological Studies have developed a compound that targets the farnesoid X receptor (FXR) in the intestines and may help to reduce diet-induced weight gain, body-wide inflammation, and hepatic glucose production while enhancing thermogenesis and browning of white adipose tissue (WAT).

Naropin 2% Launched in New Freeflex Containers

Naropin 2% Launched in New Freeflex Containers

Fresenius Kabi announced that the Food and Drug Administration (FDA) has approved the launch of Naropin (ropivacaine HCl) injection in the company's Freeflex delivery system.

BioBag Now Available for Biosurgical Wound Debridement

BioBag Now Available for Biosurgical Wound Debridement

BioMonde announced the launch of BioBag, a biosurgical medical device for wound debridement.

First Dermal Filler for Acne Scar Treatment Approved

First Dermal Filler for Acne Scar Treatment Approved

Suneva Medical announced that the Food and Drug Administration (FDA) has approved Bellafill for the treatment of acne scars in patients over age 21.

What the Results of a 12-Year Study Tell Us About Measles-Containing Vaccines

What the Results of a 12-Year Study Tell Us About Measles-Containing Vaccines

A 12-year study of measles-containing vaccines has found no new safety concerns regarding adverse events associated with the measles-mumps-rubella-varicella (MMRV) vaccine compared with the separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine.

New QNASL Spray Strength Now Available for Pediatric Use

New QNASL Spray Strength Now Available for Pediatric Use

Teva announced the launch of QNASL (beclomethasone dipropionate) Nasal Aerosol in a new 40mcg strength.

Gadavist Injection Gains Expanded Age Range

Gadavist Injection Gains Expanded Age Range

Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with MRI in pediatric patients <2 years old, including term neonates.

Galderma Launches OTC Acne Regimen

Galderma Launches OTC Acne Regimen

Galderma announced the launch of Benzac Acne Solutions, their first over-the-counter (OTC) acne regimen.

Antiviral Drug Recalled Due to Contamination

Valeant announced a voluntary recall of one lot of Virazole (ribavirin powder for solution) due to microbial contamination.

New NSAID Inj Approved for Pain Management

New NSAID Inj Approved for Pain Management

Hospira announced it has received approval from the Food and Drug Administration (FDA) for Dyloject (diclofenac sodium) Injection for the management of mild to moderate pain in adults, and for moderate to severe pain alone or in combination with opioid analgesics.

Menopausal Symptoms Tied to Hip Fracture Risk

A new study shows that women who experience menopausal symptoms (eg, severe hot flashes, night sweats) tend to have lower bone mineral density and higher rates of hip fractures vs. women who do not have menopausal symptoms.

Spectrum Submits NDA for Propylene Glycol-Free Melphalan

Spectrum Submits NDA for Propylene Glycol-Free Melphalan

Spectrum announced the submission of an NDA for Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

FDA Expands Kalydeco Use in Cystic Fibrosis

FDA Expands Kalydeco Use in Cystic Fibrosis

Vertex announced that the FDA has approved the use of Kalydeco (ivacaftor) in patients with cystic fibrosis (CF) ages 6 years and older who have the R117H mutation in the CFTR gene.

NDA Submitted for Buprenorphine Buccal Film for Pain

Endo and BioDelivery Sciences announced the submission of an NDA for buprenorphine HCl buccal film to the FDA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Safinamide NDA Resubmitted for Parkinson's Disease

Newron announced the resubmission of its NDA for safinamide to the FDA.

Is There a Pharmacotherapy Effective for Cannabis Dependence?

Is There a Pharmacotherapy Effective for Cannabis Dependence?

In a study published in The Cochrane Library, researchers sought to assess the safety and efficacy of various pharmacotherapies in the treatment of cannabis dependence.

Short- vs. Longer-Duration Corticosteroid Tx for COPD Exacerbations

Short- vs. Longer-Duration Corticosteroid Tx for COPD Exacerbations

Currently, COPD guidelines recommend that patients with acute exacerbations be treated with systemic corticosteroids for 7-14 days, however, an updated review suggests that corticosteroid treatment of a shorter duration may be as effective as conventional longer-duration therapy.

Subpotent, Impure Lots of Mitoxantrone Prompt Recall

Hospira announced a voluntary recall of 10 lots of Mitoxantrone after confirmation of subpotency and elevated impurity levels.

Emergency Use Authorized for Ebola Virus Dx Test

Roche announced that the FDA has granted an Emergency Use Authorization (EUA) for the LightMix Ebola Zaire rRT-PCR Test for use in patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as those traveling from West Africa.

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