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Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations.

17 Jan 2013

Protein Sciences receives FDA approval for Flublok vaccine

The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

16 Jan 2013

Tamoxifen can counteract some pathologic features in mouse model of DMD

A new study has found that tamoxifen, a well-known breast cancer drug, can counteract some pathologic features in a mouse model of Duchenne muscular dystrophy (DMD). At present, no treatment is known to produce long-term improvement of the symptoms in boys with DMD, a debilitating muscular disorder that is characterized by progressive muscle wasting, respiratory and cardiac impairments, paralysis, and premature death.

16 Jan 2013

Blocking cholesterol biosynthesis pathway in cancer cells appears to improve ability of common drugs

Shutting down a specific pathway in cancer cells appears to improve the ability of common drugs to wipe those cells out, according to new research from scientists at Fox Chase Cancer Center, published in the January issue of Cancer Discovery.

16 Jan 2013

WHO recommends switching to injectable polio vaccine

"[T]his month the World Health Organization (WHO) in Geneva, Switzerland, proposed a shift in [polio] vaccination strategy from oral vaccines to injected ones that may have to be administered in clinics," Nature reports, adding, "The change is needed to mop up the last remaining pockets of polio, but experts say that it poses challenges in [rural areas], which have poor access to health care."

16 Jan 2013

Thermo Scientific QMS Everolimus Assay Kit receives CE Mark for liver transplant application

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its Thermo Scientific QMS Everolimus Assay Kit has been CE marked for sale in the European Union for a third application, namely liver transplants.

From Thermo Fisher Scientific Inc. 16 Jan 2013

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

Today Biogen Idec and Elan Corporation, plc announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels.

16 Jan 2013

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

16 Jan 2013

Janssen receives EC approval for PREZISTA 800mg tablet to treat HIV

Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day.

16 Jan 2013

Zimbabwe continues to face medicine shortages, stock-outs, PlusNews reports

"Chronic shortages of generic and antiretroviral drugs, stock-outs, high medication costs, and long distances to clinics are some of the hurdles people face in their quest to access essential medicines in Zimbabwe," PlusNews reports.

16 Jan 2013

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

16 Jan 2013

CHOP to study antibiotic delivery to children after hospitalization for serious bacterial infection

The Children's Hospital of Philadelphia (CHOP) was awarded nearly $2M in research funding from the Patient-Centered Outcomes Research Institute (PCORI) to study antibiotic delivery to children returning home after hospitalization for a severe bacterial infection.

16 Jan 2013

Experimental vaccine elicits antibodies that can protect against Ebola virus infection

Researchers at the National Institutes of Health (NIH) and Oregon Health & Science University (OHSU) have found that an experimental vaccine elicits antibodies that can protect nonhuman primates from Ebola virus infection.

16 Jan 2013

Patients with Parkinson's develop artistic talents after dopamine-inducing therapy

Parkinson's experts across the world have been reporting a remarkable phenomenon - many patients treated with drugs to increase the activity of dopamine in the brain as a therapy for motor symptoms such as tremors and muscle rigidity are developing new creative talents, including painting, sculpting, writing, and more.

16 Jan 2013

Pfizer’s Quillivant XR now available in the U.S. for treatment of ADHD

Pfizer Inc. today announced that Quillivant XR (methylphenidate hydrochloride) CII for extended-release oral suspension is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD).

16 Jan 2013

Diospyrin inactivates a drug target for tuberculosis in new way

A compound from the South African toothbrush tree inactivates a drug target for tuberculosis in a previously unseen way.

16 Jan 2013

Over-expression of NEK2 in cancer cells significantly enhances drug resistance

Increased NEK2 gene expression linked to increased drug resistance, faster cancer growth, and poorer patient outcome - The finding may improved diagnostic and prognostic tools for cancer care and could lead to improved cancer therapies

16 Jan 2013

Children with chronic medical conditions more likely to use alternative medicine

Children who regularly see specialists for chronic medical conditions are also using complementary medicine at a high rate, demonstrates recently published research from the University of Alberta and the University of Ottawa.

15 Jan 2013

Multidisciplinary team work on proactive approach to flu vaccine design

An internationally recognized expert in viruses, Robert W. Finberg, MD, the Richard M. Haidack Professor of Medicine and chair and professor of medicine at the University of Massachusetts Medical School, is lead investigator on a $12 million project to develop new ways of predicting how the influenza virus changes and evolves in response to anti-viral drugs and the human immune system. This approach has promise for becoming a pivotal tool in creating a more effective vaccine against the virus.

11 Jan 2013

Additional insights into workings of ALVAC vaccine against HIV

Four years ago, a potential HIV vaccine showed promise against the virus that causes AIDS, but it fell short of providing the broad protection necessary to stem the spread of disease.

11 Jan 2013

Pharmaceutical News

Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Protein Sciences receives FDA approval for Flublok vaccine

Tamoxifen can counteract some pathologic features in mouse model of DMD

Blocking cholesterol biosynthesis pathway in cancer cells appears to improve ability of common drugs

WHO recommends switching to injectable polio vaccine

Thermo Scientific QMS Everolimus Assay Kit receives CE Mark for liver transplant application

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

Janssen receives EC approval for PREZISTA 800mg tablet to treat HIV

Zimbabwe continues to face medicine shortages, stock-outs, PlusNews reports

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

CHOP to study antibiotic delivery to children after hospitalization for serious bacterial infection

Experimental vaccine elicits antibodies that can protect against Ebola virus infection

Patients with Parkinson's develop artistic talents after dopamine-inducing therapy

Pfizer’s Quillivant XR now available in the U.S. for treatment of ADHD

Diospyrin inactivates a drug target for tuberculosis in new way

Over-expression of NEK2 in cancer cells significantly enhances drug resistance

Children with chronic medical conditions more likely to use alternative medicine

Multidisciplinary team work on proactive approach to flu vaccine design

Additional insights into workings of ALVAC vaccine against HIV

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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