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FDA approves Ampio’s IND for Optina for treatment of diabetic macular edema

Ampio Pharmaceuticals, Inc. announced today that the FDA has accepted the Company's IND for Optina™ for the treatment of diabetic macular edema (DME). Ampio plans to commence enrollment in a clinical trial in the first quarter of 2013. The FDA granted Optina™ 505(b)(2) status in July, 2012. Drugs designated under this pathway can be approved on a single trial.

22 Jan 2013

Mitsubishi Tanabe Pharma in-licenses CETP inhibitor to Dezima Pharma

Dezima Pharma ('Dezima'), the biotechnology company developing innovative drugs in the field of dyslipidemia, announced today the in-licensing of a cholesteryl ester transfer protein (CETP) inhibitor DEZ-001 (formerly TA-8995) from Mitsubishi Tanabe Pharma Corporation (MTPC). Terms of the deal were not disclosed.

22 Jan 2013

Kaiser Permanente study examines increasing prevalence of undervaccination

In a new study published today in JAMA Pediatrics (formerly Archives of Pediatrics and Adolescent Medicine), Kaiser Permanente researchers found that 49 percent of children ages 2-24 months did not receive all recommended vaccinations or did not get vaccinated according to the Advisory Committee on Immunization Practices schedule.

22 Jan 2013

Regular aspirin use appears to be associated with increased risk of neovascular AMD

Regular aspirin use appears to be associated with an increased risk of neovascular age-related macular degeneration (AMD), which is a leading cause of blindness in older people, and it appears to be independent of a history of cardiovascular disease and smoking, according to a report published Online First by JAMA Internal Medicine, a JAMA Network publication.

22 Jan 2013

Current smokers with HIV more likely to get bacterial pneumonia

Bacterial pneumonia is one of the commonest and most serious infections occurring in people infected with HIV. A metanalysis of cohort and case control studies published in BioMed Central's open access journal BMC Medicine finds that current smokers with HIV were at double the risk of bacterial pneumonia than non-smoking counterparts, but that when people stopped smoking their risk was reduced.

21 Jan 2013

Study shows first empirical evidence of exposure to conflict-of-interest policies

Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who trained in residency programs without such policies, according to a new study by researchers from the Perelman School of Medicine at the University of Pennsylvania.

19 Jan 2013

Stage IV cancer cells even more susceptible to grape seed extract than stage II

When the going gets tough, grape seed extract gets going: A University of Colorado Cancer Center study recently published in the journal Cancer Letters shows that the more advanced are colorectal cancer cells, the more GSE inhibits their growth and survival. On the other end of the disease spectrum, GSE leaves healthy cells alone entirely.

19 Jan 2013

G-CON completes delivery and installation of POD system in PaxVax's GMP production facility

G-CON today announced the completed delivery and installation of the ground-breaking POD system in PaxVax's licensed GMP production facility based in San Diego, California where PaxVax manufactures innovative and socially responsible oral vaccines against infectious diseases.

19 Jan 2013

Ban on thiomersal in vaccines would harm global immunization efforts

"Government representatives are meeting in Geneva this week to decide whether to introduce a global ban on mercury that could include thiomersal, a mercury-based preservative that has been used in some vaccine manufacturing since the 1930s to prevent bacterial or fungal contamination of multidose vials of vaccine," Seth Berkley, a medical epidemiologist and chief executive of the GAVI Alliance, writes in a New York Times opinion piece.

19 Jan 2013

EMA adopts positive opinion for Pfizer’s bosutinib conditional approval in the EU

Pfizer Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion regarding the conditional marketing authorization of bosutinib in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

19 Jan 2013

New method may help predict response to chemotherapy for bowel cancer

Scientists at the Royal College of Surgeons in Ireland (RCSI) and Beaumont Hospital have developed a new method of predicting which patients with bowel (colorectal) cancer will respond effectively to chemotherapy. The results of this study are published in the current issue of the prestigious Cancer Research journal.

19 Jan 2013

FDA approves Allergan’s BOTOX to treat overactive bladder

Allergan, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved BOTOX (onabotulinumtoxinA) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication.

19 Jan 2013

Rite Aid obtains more than 400,000 additional seasonal flu shots

In response to the nationwide flu epidemic and customer demand, Rite Aid Corporation announced today it has obtained more than 400,000 additional seasonal flu shots, which began arriving in stores earlier this week.

19 Jan 2013

New math model may help predict colon cancer resistance to chemotherapy

Scientists may be able to better predict which patients with colorectal cancer will respond to chemotherapy using a new mathematical model that measures the amount of stress required for a cancer cell to die without harming healthy tissue. The results of this study are published in Cancer Research, a journal of the American Association for Cancer Research.

19 Jan 2013

SPARC protein acts much like ibuprofen to heal tissues inflamed by tumors

Cancer researchers are increasingly aware that in addition to genetic mutations in a cancer itself, characteristics of the surrounding tissue can promote or suppress tumor growth. One of these important tissue characteristics is inflammation - most cancers prosper in and attach to inflamed tissue and so many cancers have developed ways to create it.

19 Jan 2013

Survey finds shortage of TB medicines in U.S.; Consequences similar to lack of access in developing countries, advocate says

"More than 80 percent of health departments in the United States that treat tuberculosis [TB] resistant to standard treatment have trouble obtaining the drugs they need to cure the disease, according to a national survey released on Thursday," Reuters reports.

18 Jan 2013

Researchers identify signaling pathway used by malarial parasites to destroy host cells

One of the most insidious ways that parasitic diseases such as malaria and toxoplasmosis wreak their havoc is by hijacking their host's natural cellular processes, turning self against self.

18 Jan 2013

Allergan receives FDA approval for Botox to treat overactive bladder

The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.

18 Jan 2013

Medications often prescribed for PAH could affect heart health of treated patients

A research team with the Faculty of Medicine & Dentistry at the University of Alberta reported findings that significantly improve understanding of how widely used drugs in Pulmonary Arterial Hypertension (PAH) affect the heart health of treated patients.

18 Jan 2013

$ADT increases risk of fracture incidence after treatment completion in men with prostate cancer$

ADT increases risk of fracture incidence after treatment completion in men with prostate cancer

In what is believed to be the first study to describe the impact on men with a 'high' risk of bone fracture who are receiving long-term androgen deprivation therapy (ADT) for prostate cancer, new research from The Cancer Institute of New Jersey shows this population to have a higher fracture incidence following treatment completion.

18 Jan 2013

Pharmaceutical News

FDA approves Ampio’s IND for Optina for treatment of diabetic macular edema

Mitsubishi Tanabe Pharma in-licenses CETP inhibitor to Dezima Pharma

Kaiser Permanente study examines increasing prevalence of undervaccination

Regular aspirin use appears to be associated with increased risk of neovascular AMD

Current smokers with HIV more likely to get bacterial pneumonia

Study shows first empirical evidence of exposure to conflict-of-interest policies

Stage IV cancer cells even more susceptible to grape seed extract than stage II

G-CON completes delivery and installation of POD system in PaxVax's GMP production facility

Ban on thiomersal in vaccines would harm global immunization efforts

EMA adopts positive opinion for Pfizer’s bosutinib conditional approval in the EU

New method may help predict response to chemotherapy for bowel cancer

FDA approves Allergan’s BOTOX to treat overactive bladder

Rite Aid obtains more than 400,000 additional seasonal flu shots

New math model may help predict colon cancer resistance to chemotherapy

SPARC protein acts much like ibuprofen to heal tissues inflamed by tumors

Survey finds shortage of TB medicines in U.S.; Consequences similar to lack of access in developing countries, advocate says

Researchers identify signaling pathway used by malarial parasites to destroy host cells

Allergan receives FDA approval for Botox to treat overactive bladder

Medications often prescribed for PAH could affect heart health of treated patients

ADT increases risk of fracture incidence after treatment completion in men with prostate cancer

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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