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Janssen gets positive CHMP opinion for IMBRUVICA (ibrutinib) to treat patients with previously untreated CLL

Janssen gets positive CHMP opinion for IMBRUVICA (ibrutinib) to treat patients with previously untreated CLL

Janssen-Cilag International NV today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a Positive Opinion, recommending broadening the existing marketing authorisation for ibrutinib as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). [More]
AstraZeneca reports new Phase I extended follow-up data on osimertinib in NSCLC patients at ELCC 2016

AstraZeneca reports new Phase I extended follow-up data on osimertinib in NSCLC patients at ELCC 2016

AstraZeneca today reported new Phase I extended follow-up data on osimertinib in both first- and second-line treatment of patients with non-small cell lung cancer (NSCLC), at the European Lung Cancer Conference (ELCC) 2016. Late-breaker presentations reinforced the efficacy and safety profile for osimertinib previously seen in the AURA clinical trials programme. [More]
RedHill Biopharma initiates phase II study of BEKINDA for irritable bowel syndrome

RedHill Biopharma initiates phase II study of BEKINDA for irritable bowel syndrome

RedHill Biopharma Ltd. (NASDAQ; RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced that it has initiated a randomized, double-blind, 2-arm parallel group Phase II clinical study in the U.S. evaluating the safety and efficacy of BEKINDA™ 12 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). [More]
Shigella dysenteriae pathogen probably originated in Europe, genetic study reveals

Shigella dysenteriae pathogen probably originated in Europe, genetic study reveals

The largest genetic study on the bacterium responsible for epidemic dysentery has revealed that the Shigella dysenteriae pathogen, which remains a real scourge in Africa and Asia, probably originated in Europe. [More]
Cobimetinib with vemurafenib may have added benefit in melanoma with BRAF V600 mutation

Cobimetinib with vemurafenib may have added benefit in melanoma with BRAF V600 mutation

Cobimetinib (trade name: Cotellic) has been approved since November 2015 in combination with vemurafenib for the treatment of adults with advanced, i.e. metastatic or unresectable, melanoma with a BRAF V600 mutation. [More]
Researchers describe antibiotic resistance as either selfish or co-operative

Researchers describe antibiotic resistance as either selfish or co-operative

Trace concentrations of antibiotic, such as those found in sewage outfalls, are enough to enable bacteria to keep antibiotic resistance, new research from the University of York has found. The concentrations are much lower than previously anticipated, and help to explain why antibiotic resistance is so persistent in the environment. [More]
New FDA approval expands use of AstraZeneca's Faslodex for women with HR+, HER2- metastatic breast cancer

New FDA approval expands use of AstraZeneca's Faslodex for women with HR+, HER2- metastatic breast cancer

AstraZeneca today announced that the US Food and Drug Administration has approved a new indication in the US, expanding the use of Faslodex (fulvestrant) to include use in combination with Ibrance (palbociclib). [More]
Study assesses health problems related to food hypersensitivity

Study assesses health problems related to food hypersensitivity

A study by researchers at the University of Southampton and Southampton General Hospital, is the first to assess the prevalence of two different types of food hypersensitivity and the risk factors associated with them. [More]
ViiV Healthcare presents positive results from LATTE-2 study at CROI

ViiV Healthcare presents positive results from LATTE-2 study at CROI

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive results from the LATTE-2 study at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. Headline results were announced in November 2015. [More]
Amgen announces availability of Kyprolis (carfilzomib) in the UK for treatment of relapsed multiple myeloma

Amgen announces availability of Kyprolis (carfilzomib) in the UK for treatment of relapsed multiple myeloma

Amgen today announced that Kyprolis in combination with lenalidomide and dexamethasone is now available in the UK for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. [More]
AstraZeneca’s TAGRISSO (osimertinib) approved in EU for metastatic EGFR T790M mutation-positive NSCLC

AstraZeneca’s TAGRISSO (osimertinib) approved in EU for metastatic EGFR T790M mutation-positive NSCLC

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). [More]
NICE recommends Xofigo (radium-223 dichloride) for prostate cancer patients after treatment with docetaxel

NICE recommends Xofigo (radium-223 dichloride) for prostate cancer patients after treatment with docetaxel

The National Institute for Health and Care Excellence has issued its final guidance recommending Xofigo for use on the NHS in England and Wales as an option for treating adult men, with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, who have received previous docetaxel therapy. [More]
Increased breastfeeding could save over 800000 children’s lives annually

Increased breastfeeding could save over 800000 children’s lives annually

Just 1 in 5 children in high-income countries are breastfed to 12 months, whilst only 1 in 3 children in low and middle-income countries are exclusively breastfed for the first 6 months. [More]
UNICEF launches US $2.8 billion appeal to meet the needs of children in crisis

UNICEF launches US $2.8 billion appeal to meet the needs of children in crisis

In the Pacific Islands, many children don’t have enough safe water to drink and their education has been interrupted as result of the severe, ongoing El Niño. [More]
Selexipag reduces clinical events in PAH patients

Selexipag reduces clinical events in PAH patients

Selexipag, alone or in combination with other classes of pulmonary arterial hypertension medication, reduced the composite rate of disease complications and deaths among patients in a phase III trial. [More]
Early promise for cannabis extract treatment in epilepsy

Early promise for cannabis extract treatment in epilepsy

A preliminary, open-label study suggests that cannabidiol may be a useful adjunctive treatment in adults and children with intractable epilepsy. [More]
Stem cell therapy not significantly better than conventional treatment for Crohn's disease

Stem cell therapy not significantly better than conventional treatment for Crohn's disease

A clinical trial to test the effectiveness of a stem cell therapy among adults with difficult to treat Crohn's disease has found it is not significantly better than conventional treatment in producing sustained disease remission after one year. [More]
Post-progression afatinib exposure boosts NSCLC outcomes

Post-progression afatinib exposure boosts NSCLC outcomes

Continued exposure to afatinib plus paclitaxel can benefit non-small-cell lung cancer patients who developed resistance to erlotinib or gefitinib and progressed after initially responding to afatinib monotherapy, suggest phase III trial results. [More]
Potential for chemotherapy-free standard of care in advanced mantle cell lymphoma

Potential for chemotherapy-free standard of care in advanced mantle cell lymphoma

The combination of ibrutinib and rituximab shows activity in patients with relapsed or refractory mantle cell lymphoma, suggests research published in The Lancet Oncology. [More]
Second-line bosutinib offers ‘durable’ response for chronic phase CML patients

Second-line bosutinib offers ‘durable’ response for chronic phase CML patients

Four-year results for an ongoing study of second-line bosutinib indicate that the tyrosine kinase inhibitor offers long-term efficacy with manageable side effects for patients with chronic phase chronic myeloid leukaemia. [More]
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