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FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. [More]
FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label. [More]
Helsinn's Akynzeo for CINV prevention receives EC approval

Helsinn's Akynzeo for CINV prevention receives EC approval

Helsinn, the Swiss Group focused on building quality cancer care, announces today that on 27th May 2015, the European Commission (EC) approved Akynzeo® (netupitant-palonosetron) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in the European Union. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
New TB-Profiler tool to find appropriate drugs for TB patients may improve likelihood of cure

New TB-Profiler tool to find appropriate drugs for TB patients may improve likelihood of cure

Finding out what drugs can be used to treat a patient with tuberculosis (TB) can be sped up by days or weeks, thanks to a new free online tool. The new TB-Profiler tool, developed by a team of scientists led by Dr Taane Clark at the London School of Hygiene & Tropical Medicine, analyses and interprets genome sequence data to predict resistance to 11 drugs used for the treatment of TB. [More]
STA, Helsinn announce approval of AKYNZEO for prevention of chemotherapy-induced CINV

STA, Helsinn announce approval of AKYNZEO for prevention of chemotherapy-induced CINV

Australian biopharmaceutical company Specialised Therapeutics Australia and Helsinn, a Swiss group focused on building quality cancer care, announce that the Therapeutic Goods Administration has approved AKYNZEO for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. [More]
Boehringer Ingelheim's OFEV (nintedanib) capsules receive FDA approval for IPF treatment

Boehringer Ingelheim's OFEV (nintedanib) capsules receive FDA approval for IPF treatment

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved OFEV (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). [More]
LSTM experts use integrated model to assess effects of new diagnostic algorithms for TB

LSTM experts use integrated model to assess effects of new diagnostic algorithms for TB

Experts at LSTM have used a novel modelling approach to project the effects of new diagnostic methods and algorithms for the diagnosis of tuberculosis (TB) recently endorsed by the World Health Organization, looking at the patient, health system and population perspective in Tanzania. [More]
Eating food just before taking TB drug could reduce effectiveness of medicine

Eating food just before taking TB drug could reduce effectiveness of medicine

The timing of food intake in the early phase of TB treatment could have a negative impact on the effectiveness of TB treatment. [More]
First step toward new drugs that can transcend antibiotic resistance issues

First step toward new drugs that can transcend antibiotic resistance issues

Scientists in the United States and India have successfully modified the precursor to one of the drugs used to treat tuberculosis, an important first step toward new drugs that can transcend antibiotic resistance issues that experts consider a serious threat to global health. [More]
New data on Gilotrif and investigational compounds to be presented at 50th ASCO annual meeting

New data on Gilotrif and investigational compounds to be presented at 50th ASCO annual meeting

Boehringer Ingelheim today announced that new data will be presented from 7 abstracts for Gilotrif (afatinib) and investigational compounds, including nintedanib and BI 836845, from its oncology pipeline at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, on May 30 – June 3, 2014. [More]
Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Otsuka Pharmaceutical Co., Ltd. today announced that the European Commission has granted a marketing authorization for Deltyba (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. [More]
Xpert MTB/RIF test quickly detects TB and resistance to rifampicin

Xpert MTB/RIF test quickly detects TB and resistance to rifampicin

A second systematic review of a diagnostic test for tuberculosis (TB) endorsed by the World Health Organisation (WHO), has confirmed the accuracy of the test. The updated review assessing the accuracy of Xpert MTB/RIF includes new studies published since the original Cochrane Review was published in January last year. [More]
Gilead Sciences gets marketing authorization from European Commission for Sovaldi 400 mg tablets

Gilead Sciences gets marketing authorization from European Commission for Sovaldi 400 mg tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Sovaldi (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C infection in adults, in combination with other antiviral agents (ribavirin and pegylated interferon alpha (peg-IFN)). [More]
Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir. [More]
Groundbreaking study reveals novel approach to treat, eliminate MRSA infection

Groundbreaking study reveals novel approach to treat, eliminate MRSA infection

Recent work from University Distinguished Professor of Biology Kim Lewis promises to overcome one of the leading public health threats of our time. In a groundbreaking study published Wednesday in the journal Nature, Lewis' team presents a novel approach to treat and eliminate methicillin resistant staphylococcus aureus, or MRSA, a potent bacterium whose resistance to antibiotics has kept it one step ahead of researchers. [More]
TB Alliance, Svizera Europe partner to create, enable access to new medicines for childhood TB

TB Alliance, Svizera Europe partner to create, enable access to new medicines for childhood TB

In an effort to develop and deliver treatments for children with tuberculosis—answering a critical need in public health today—TB Alliance, a not-for-profit organization with the mission to develop better, faster-acting, and affordable drugs for TB, has entered into a collaboration with Svizera Europe, one of the leading global supply and distribution companies for TB treatments. [More]
Holistic approach to understand and treat TB

Holistic approach to understand and treat TB

For years, physicians around the world have watched as strain after strain of the deadly bacteria Mycobacterium tuberculosis evolves resistance to drugs. [More]
Vitamin C kills drug-resistant TB bacteria in lab

Vitamin C kills drug-resistant TB bacteria in lab

In a striking, unexpected discovery, researchers at Albert Einstein College of Medicine of Yeshiva University have determined that vitamin C kills drug-resistant tuberculosis bacteria in laboratory culture. [More]
Multidrug-resistant tuberculosis (MDR-TB): an interview with Dr. Jennifer Cohn, Médecins Sans Frontières

Multidrug-resistant tuberculosis (MDR-TB): an interview with Dr. Jennifer Cohn, Médecins Sans Frontières

MDR-TB is tuberculosis, a mycobacterial infection, that has developed resistance to two important and powerful first-line anti-TB drugs, INH and rifampin. [More]
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