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Use of antidepressants in late pregnancy may be associated with increased risk of PPHN

An analysis of approximately 3.8 million pregnancies finds that use of antidepressants late in pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN), according to a study in the June 2 issue of JAMA. However, the absolute risk was small and the risk increase appears more modest than suggested in previous studies.

3 Jun 2015

Researchers explore association between SSRI exposure in late pregnancy and risk of PPHN

Use of antidepressants late in pregnancy has been controversial since the FDA issued a Public Health Advisory in 2006 warning that the use of antidepressants in late pregnancy may increase risk of persistent pulmonary hypertension of the newborn (PPHN), a condition that typically occurs in term or near-term infants and presents within hours of birth with severe respiratory failure requiring intubation and mechanical ventilation.

2 Jun 2015

ASCO 2015: AMGEN presents new data evaluating less-frequent dosing of kyprolis for multiple myeloma patients

Amgen today announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis®

2 Jun 2015

ASCO 2015: AMGEN presents new data evaluating less-frequent dosing of kyprolis for multiple myeloma patients

Amgen today announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis®

2 Jun 2015

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Novartis today announced new data from two Phase II studies of Zykadia (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist (trametinib) in certain patients with non-small cell lung cancer.

2 Jun 2015

Genesis Rehab Services forms groundbreaking partnership with Zhejiang Bang-Er Medical Group

Genesis Rehab Services, a division of Genesis HealthCare, one of the nation's largest providers of post-acute care, today announced a groundbreaking partnership with Zhejiang Bang-Er Medical Group, an orthopedic hospital system in China.

2 Jun 2015

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Novartis is highlighting data from an ongoing Phase II clinical study of CTL019, an investigational chimeric antigen receptor (CAR) T cell therapy, that indicate its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma.

2 Jun 2015

Enzalutamide Phase 2 study for AR positive triple-negative breast cancer meets primary endpoint

Astellas Pharma Inc. announced that data from a Phase 2 study evaluating the investigational use of enzalutamide as a single agent for the treatment of advanced androgen receptor (AR) positive, triple-negative breast cancer (TNBC) were presented during an oral abstracts session at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

2 Jun 2015

Vaccines - a needle-free future? An interview with Thomas Johnston and Dr. Kees Leenhouts, Mucosis

Scientists recognize that 90% of pathogens actually enter the body through the mucosa and secondly, we have evolved a mucosal defense system that can be used to defend against disease...

1 Jun 2015

Contaminant particles emitted by vehicles have negative repercussions in children with respiratory illnesses

Particles of less than 2.5 microns emitted by vehicles have negative repercussions for bronchiolitis, pneumonia, asthma and bronchitis in children.

1 Jun 2015

Actavis acquires Auden Mckenzie

Actavis plc today announced that it has completed its acquisition of Auden Mckenzie Holdings Limited, a dynamic and fast growing company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the UK.

1 Jun 2015

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.

1 Jun 2015

Pharmacyclics's Phase III RESONATE™ trial shows adherence to 420mg dose of IMBRUVICA improves outcomes in CLL patients

Pharmacyclics LLC today highlighted results from a sub-analysis of the Phase III RESONATE™ (PCYC-1112) trial, which found that previously-treated patients with chronic lymphocytic leukemia (CLL) who adhered to the recommended 420 mg dose of IMBRUVICA® (ibrutinib) experienced improved progression-free survival (PFS; the primary endpoint) as assessed by an Independent Review Committee (IRC), compared to patients who took lower doses or missed doses, regardless of high-risk genetic factors.

1 Jun 2015

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent.

1 Jun 2015

Combination of Mekinist and Tafinlar drugs improves outcome in patients with metastatic melanoma

Novartis today announced data from the Phase III COMBI-d study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) compared to Tafinlar monotherapy alone.

1 Jun 2015

Process of aging could be delayed in human cell lines

Can the process of aging be delayed or even reversed? Research led by specially appointed Professor Jun-Ichi Hayashi from the University of Tsukuba in Japan has shown that, in human cell lines at least, it can. They also found that the regulation of two genes involved with the production of glycine, the smallest and simplest amino acid, is partly responsible for some of the characteristics of aging.

1 Jun 2015

$Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma$

Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma

Amgen today announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis® (carfilzomib) for Injection administered once-weekly with dexamethasone versus the current U.S. Food and Drug Administration (FDA) approved twice-weekly administration schedule in patients with relapsed and refractory multiple myeloma who have received prior treatment with bortezomib and an immunomodulatory agent (IMiD).

1 Jun 2015

Phase III HELIOS trial results show ibrutinib combination therapy improves outcomes in CLL/SLL patients

Today, Pharmacyclics LLC announced the results of the Phase III HELIOS trial (CLL3001), which found that patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received ibrutinib (IMBRUVICA) in combination with bendamustine and rituximab (BR) experienced an 80% reduction in the risk of progression or death compared to patients receiving placebo in combination with BR.

1 Jun 2015

Novartis to highlight strength of its expanded oncology portfolio at ASCO 2015

Novartis will highlight the strength of its expanded oncology portfolio in 21 medicines and 11 investigational compounds across more than 185 data presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, May 29-June 2, and the Congress of the European Hematology Association (EHA), June 11-14.

1 Jun 2015

Pharmacyclics initiates ibrutinib-MEDI4736 combination multi-center study for R/R DLBCL or FL

Pharmacyclics, Inc. today announced the initiation of PCYC-1136-CA, a multi-center study that will investigate the use of ibrutinib (IMBRUVICA®) in combination with MEDI4736, an investigational anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca.

1 Jun 2015

Respiratory News and Research

Use of antidepressants in late pregnancy may be associated with increased risk of PPHN

Researchers explore association between SSRI exposure in late pregnancy and risk of PPHN

ASCO 2015: AMGEN presents new data evaluating less-frequent dosing of kyprolis for multiple myeloma patients

ASCO 2015: AMGEN presents new data evaluating less-frequent dosing of kyprolis for multiple myeloma patients

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Genesis Rehab Services forms groundbreaking partnership with Zhejiang Bang-Er Medical Group

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Enzalutamide Phase 2 study for AR positive triple-negative breast cancer meets primary endpoint

Vaccines - a needle-free future? An interview with Thomas Johnston and Dr. Kees Leenhouts, Mucosis

Contaminant particles emitted by vehicles have negative repercussions in children with respiratory illnesses

Actavis acquires Auden Mckenzie

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

Pharmacyclics's Phase III RESONATE™ trial shows adherence to 420mg dose of IMBRUVICA improves outcomes in CLL patients

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Combination of Mekinist and Tafinlar drugs improves outcome in patients with metastatic melanoma

Process of aging could be delayed in human cell lines

Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma

Phase III HELIOS trial results show ibrutinib combination therapy improves outcomes in CLL/SLL patients

Novartis to highlight strength of its expanded oncology portfolio at ASCO 2015

Pharmacyclics initiates ibrutinib-MEDI4736 combination multi-center study for R/R DLBCL or FL

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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