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New insulin pill shows promise as novel form of therapy for diabetes

An insulin pill being developed by researchers at UC Santa Barbara may in the near future give another blood sugar management option to those who suffer from diabetes. The novel drug delivery technology may also apply to a wide spectrum of other therapies.

19 Nov 2015

IQWiG finds no added benefit for insulin degludec/liraglutide in adults with type 2 diabetes

The fixed combination of the two drugs insulin degludec and liraglutide (trade name: Xultophy) has been approved since June 2015 also in adults with type 2 diabetes mellitus when oral antidiabetics (OADs) combined with a GLP-1 receptor agonist do not provide adequate glycaemic control. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this fixed combination offers an added benefit over the appropriate comparator therapy (ACT).

19 Nov 2015

FDA approves Narcan nasal spray to prevent or reverse effects of opioid overdose

Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

18 Nov 2015

Gamma interferon may have potential to prevent Ebola infection

The recent Ebola outbreak in West Africa has claimed more than 11,300 lives and starkly revealed the lack of effective options for treating or preventing the disease. Progress has been made on developing vaccines, but there is still a need for antiviral therapies to protect health care workers and local populations in the event of future outbreaks.

18 Nov 2015

Scientists identify mechanism that may help prostate cancer cells escape effects of cancer drugs

Advanced prostate cancer is a disease notoriously resistant to treatment. New research by scientists at Fred Hutchinson Cancer Research Center and the University of California, San Francisco sheds light on a new mode of drug resistance to emerging therapies in metastatic prostate cancer.

18 Nov 2015

PTI explains strength and BCS-based biowaivers

Pharmaceutical Training International (PTI), the leading supplier of online and public event-based training courses for the pharma, biotech and medical device sectors, is launching a series of easy-access and cost–effective webinar e-courses to guide pharma professionals through the industry challenges they face.

From Pharmaceutical Training International 18 Nov 2015

Race/ethnicity disparities, hospital factors affect analgesic use at US EDs

Minority patients are less likely to receive analgesic medications for abdominal pain at US emergency departments (EDs), suggests a nationwide study in the December issue of Medical Care.

18 Nov 2015

Driving while affected by medications as dangerous as driving under the influence of illegal drugs

Warning labels on medications about the dangers of driving are not enough to stop people getting behind the wheel with most driving while affected by drugs, according to Queensland University of Technology road safety researcher Dr Tanya Smyth.

18 Nov 2015

URI researcher developing novel vaccine delivery system to improve nicotine vaccine effectiveness

Xinyuan Chen, an assistant professor of biomedical and pharmaceutical sciences, joined URI's College of Pharmacy after seven years at Massachusetts General Hospital in Boston, bringing with him a $1.08 million career development grant from the National Institute of Drug Abuse and a $432,000 grant from the National Institute of Allergy and Infectious Disease.

18 Nov 2015

UCLA researchers find new way to reduce ascites with minimal side effects

Women who have ovarian cancer often develop a condition called ascites, which is a buildup of fluids in the abdomen. The most common treatment for ascites is puncturing the abdomen and manually draining the fluid, which is painful and risky and must be repeated every few weeks.

18 Nov 2015

Giving antibiotics early can reduce risk of severe lower respiratory tract illness in children

Respiratory infections are common in preschoolers, but while most children recover fairly easily from the typical coughs and congestion, a significant number develop illnesses severe enough to interfere with breathing and warrant trips to urgent care clinics or emergency rooms.

18 Nov 2015

Mylan announces U.S. launch of generic AXERT tablets

Mylan N.V. today announced the U.S. launch of Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT.

17 Nov 2015

RNA-based drugs provide many advantages over CRISPR/Cas9 gene editing system

In just the past few years, researchers have found a way to use a naturally occurring bacterial system known as CRISPR/Cas9 to inactivate or correct specific genes in any organism. CRISPR/Cas9 gene editing activity runs continuously, though, leading to risk of additional editing at unwanted sites. Now, researchers at University of California, San Diego School of Medicine, Ludwig Cancer Research and Isis Pharmaceuticals demonstrate a commercially feasible way to use RNA to turn the CRISPR-Cas9 system on and off as desired -- permanently editing a gene, but only temporarily activating CRISPR-Cas9.

17 Nov 2015

AstraZeneca announces FDA approval of TAGRISSO (AZD9291) for treatment of lung cancer patients

AstraZeneca today announced that the US Food and Drug Administration has approved TAGRISSO (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

17 Nov 2015

Nearly 50% of Medicaid patients infected with hepatitis C denied coverage for life-saving antiviral drugs

Nearly 50 percent of Medicaid patients infected with chronic hepatitis C whose doctors had prescribed newer, life-saving antiviral drugs were denied coverage to the therapies because they weren't considered "a medical necessity" or because the patients tested positive for alcohol/drugs, among other reasons, according to new Penn Medicine research.

17 Nov 2015

Drug prevents onset of cognitive and cellular effects in mouse model of Alzheimer’s disease

In a novel animal study design that mimicked human clinical trials, researchers at University of California, San Diego School of Medicine report that long-term treatment using a small molecule drug that reduces activity of the brain's stress circuitry significantly reduces Alzheimer's disease (AD) neuropathology and prevents onset of cognitive impairment in a mouse model of the neurodegenerative condition.

17 Nov 2015

IASLC commends FDA's decision to grant accelerated approval for new lung cancer therapy

The International Association for the Study of Lung Cancer commends the U.S. Food and Drug Administration's (FDA) decision to grant accelerated approval for osimertinib (Tagrisso), an oral medication for advanced non-small cell lung cancer (NSCLC) patients with a specific epidermal growth factor receptor (EGFR) mutation (T790M) and following progression after previous EGFR inhibitor therapies.

17 Nov 2015

FDA grants accelerated approval for Darzalex to treat patients with multiple myeloma

Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

17 Nov 2015

Ranibizumab may become reasonable treatment alternative for patients with proliferative diabetic retinopathy

Among patients with proliferative diabetic retinopathy, treatment with an injection in the eye of the drug ranibizumab resulted in visual acuity that was not worse than panretinal photocoagulation at 2 years, according to a study appearing in JAMA.

15 Nov 2015

Adynovate approved for patients with Hemophilia A

The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.

15 Nov 2015

Pharmaceutical News

New insulin pill shows promise as novel form of therapy for diabetes

IQWiG finds no added benefit for insulin degludec/liraglutide in adults with type 2 diabetes

FDA approves Narcan nasal spray to prevent or reverse effects of opioid overdose

Gamma interferon may have potential to prevent Ebola infection

Scientists identify mechanism that may help prostate cancer cells escape effects of cancer drugs

PTI explains strength and BCS-based biowaivers

Race/ethnicity disparities, hospital factors affect analgesic use at US EDs

Driving while affected by medications as dangerous as driving under the influence of illegal drugs

URI researcher developing novel vaccine delivery system to improve nicotine vaccine effectiveness

UCLA researchers find new way to reduce ascites with minimal side effects

Giving antibiotics early can reduce risk of severe lower respiratory tract illness in children

Mylan announces U.S. launch of generic AXERT tablets

RNA-based drugs provide many advantages over CRISPR/Cas9 gene editing system

AstraZeneca announces FDA approval of TAGRISSO (AZD9291) for treatment of lung cancer patients

Nearly 50% of Medicaid patients infected with hepatitis C denied coverage for life-saving antiviral drugs

Drug prevents onset of cognitive and cellular effects in mouse model of Alzheimer’s disease

IASLC commends FDA's decision to grant accelerated approval for new lung cancer therapy

FDA grants accelerated approval for Darzalex to treat patients with multiple myeloma

Ranibizumab may become reasonable treatment alternative for patients with proliferative diabetic retinopathy

Adynovate approved for patients with Hemophilia A

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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