Drug Pipeline

Second-generation antipsychotics are the mainstay of treatment in schizophrenia.

Every 5 years, Congress is called on to reauthorize a series of user fees that support FDA oversight of drugs and medical products. The Prescription Drug User Fee Act (PDUFA) and similar measures authorizing fees to fund a number of FDA regulatory programs have become increasingly vital for maintaining the agency's ability to maintain an efficient approval process for new therapies.

The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.

Uncontrolled diabetes may result in hearing loss in women, much like it affects vision or kidney function, according to the results of a new study.

FDA has notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis, Merck) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these drugs when they are used together.

The use of proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), according to a recent FDA Drug Safety Communication.

Vorapaxar added to standard of care reduced the risk of cardiovascular events and stroke compared to standard of care alone, according to Merck, who announced top-line results of its TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study earlier this month. However, results also demonstrated that the drug was associated with a significant increase in bleeding, including intracranial hemorrhage (ICH).

The antiplatelet arm of The Secondary Prevention of Small Subcortical Stroke (SPS3) study was halted in July 2011 due to reasons of safety and futility, according to principal investigator Oscar R. Benavente, MD, FRCP (C), professor of neurology at Canada's University of British Columbia in Vancouver, British Columbia.

Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate

A new weight-loss medication got an overwhelming endorsement on Wednesday from FDA?s Endocrinologic and Metabolic Drugs Advisory Committee. The committee voted 20-2 in favor of approving phentermine/topiramate (Qnexa, Vivus).

A recent study challenges the conventional assumption about how Clostridium difficile infection spreads in hospitals, finding that almost three-quarters of the new cases aren?t transmitted by patients in the same ward.

No significant difference was found in treating patients experiencing clinically diagnosed uncomplicated acute rhinosinusitis with antibiotic amoxicillin compared with patients who received placebo, according to a study in the February 15 issue of JAMA.

There are no beneficial effects of supplementation with relatively low doses of B vitamins and/or omega-3 fatty acids on cancer outcomes in individuals with prior cardiovascular disease, according to a study published online February 13 in the Archives of Internal Medicine.

Zinc used in conjunction with antibiotics significantly reduced mortality in children ages 6 months to 59 months with severe pneumonia when compared with antibiotics alone, according to the findings of a recent study done in Uganda.

Medco Health Solutions and its Accredo Health Group specialty pharmacy have launched a program for employers to better manage specialty-drug costs within major medical coverage.

FDA has granted priority review to pertuzumab (Genentech, a member of the Roche Group) in combination with trastuzumbab (Herceptin, Genentech) and docetaxel chemotherapy for certain breast-cancer patients.

Men with ED also were more likely to have had open-angle glaucoma than those without ED, according to a study published in the February 12 online issue of Opthalmology.

Anti-infective drug shortages pose significant problems for clinicians and are a rapidly evolving public-health emergency that may require government oversight, according to an article published online January 19 in Clinical Infectious Diseases.

Uncontrolled diabetes may result in hearing loss in women, much like it affects vision or kidney function, according to the results of a new study.

Physicians should prescribe oral metformin as a first-line therapy for most patients with type 2 diabetes, as well as for those whose blood sugar cannot be controlled with diet, exercise, and weight loss, according to new guidelines from the American College of Physicians.

FDA declined approval of the diabetes drug dapagliflozin (Bristol-Myers Squibb and AstraZeneca), based on the recommendations of one of its advisory committees.

FDA has approved linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, a new tablet that provides a single-tablet treatment option, taken twice-daily, for adult patients who need to control their blood sugar.

FDA approved axitinib (Inlyta, Pfizer) to treat patients with an advanced kidney cancer called renal cell carcinoma who have not responded to another drug for this type of cancer.

An FDA advisory panel recommended against using denosumab (Xgeva, Amgen) to delay or prevent the spread of castration-resistant prostate cancer at risk for bone metastases.

Nursing home residents with dementia who use average doses of selective serotonin reuptake inhibitors (SSRIs) are three times more likely to have a fall resulting in injury compared with those who don’t use SSRIs, according a study published online January 18 in the British Journal of Clinical Pharmacology