News & Updates

Difelikefalin reduces itch in haemodialysis patients

15 Nov 2019 by

The novel agent difelikefalin significantly reduced itch intensity and improved itch-related quality of life among patients on haemodialysis in the phase III KALM-1 study.

Difelikefalin reduces itch in haemodialysis patients

15 Nov 2019

Original New Drug Application Approvals by US FDA (01 - 15 November 2019)

15 Nov 2019

New drug applications approved by US FDA as of 01 - 15 November 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (01 - 15 November 2019)

15 Nov 2019

Golimumab shows sustained efficacy for ankylosing spondylitis

14 Nov 2019 by

The efficacy of the monoclonal anti-TNF* antibody golimumab was maintained in patients with active ankylosing spondylitis (AS) through 1 year, according to the updated results of the GO-ALIVE** study.

Golimumab shows sustained efficacy for ankylosing spondylitis

14 Nov 2019

Ceritinib ups hyperglycaemia risk

14 Nov 2019

Ceritinib use appears to carry a significant risk of developing hyperglycaemia, a new Japan study has found.

Ceritinib ups hyperglycaemia risk

14 Nov 2019

Rivaroxaban monotherapy safe, effective in AF, stable CAD patients

14 Nov 2019

In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.

Rivaroxaban monotherapy safe, effective in AF, stable CAD patients

14 Nov 2019

Aclidinium bromide safe for COPD patients regardless of exacerbation history

12 Nov 2019 by

The LAMA* aclidinium bromide was similarly effective in reducing exacerbation rate without raising the risk of MACE** or all-cause mortality regardless of recent history of exacerbations in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD), according to a subgroup analysis of the phase IV ASCENT-COPD*** trial presented at the CHEST 2019 Annual Meeting.

Aclidinium bromide safe for COPD patients regardless of exacerbation history

12 Nov 2019

Elderly myocardial infarction patients benefit from 2 years of statins

12 Nov 2019

The use of statins is beneficial in elderly patients after their first myocardial infarction (MI) episode, particularly if medication is sustained for at least 2 years, a recent study has shown.

Elderly myocardial infarction patients benefit from 2 years of statins

12 Nov 2019

Omega-3, vitamin D no help for kidney function: Time to shift attention

12 Nov 2019 by

Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.

Omega-3, vitamin D no help for kidney function: Time to shift attention

12 Nov 2019

Asian ERBB2+ breast cancer patients respond well to neoadjuvant pertuzumab-trastuzumab-docetaxel

12 Nov 2019 by

The addition of pertuzumab to a trastuzumab-docetaxel regimen in the neoadjuvant setting improved total pathological complete response (tpCR) rates in Asian women with early or locally advanced ERBB2-positive breast cancer, according to the phase III PEONY trial from China.

Asian ERBB2+ breast cancer patients respond well to neoadjuvant pertuzumab-trastuzumab-docetaxel

12 Nov 2019

Endocrine therapy negatively affects QoL in postmenopausal breast cancer patients

12 Nov 2019

Quality of life (QoL) in breast cancer patients worsens 2 years following diagnosis with different courses by treatment received, a study has found. Specifically, endocrine therapy exerts a major detrimental impact on QoL as opposed to chemotherapy having a transient negative effect in postmenopausal patients.

Endocrine therapy negatively affects QoL in postmenopausal breast cancer patients

12 Nov 2019

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Difelikefalin reduces itch in haemodialysis patients

Difelikefalin reduces itch in haemodialysis patients

Original New Drug Application Approvals by US FDA (01 - 15 November 2019)

Original New Drug Application Approvals by US FDA (01 - 15 November 2019)

Golimumab shows sustained efficacy for ankylosing spondylitis

Golimumab shows sustained efficacy for ankylosing spondylitis

Ceritinib ups hyperglycaemia risk

Ceritinib ups hyperglycaemia risk

Rivaroxaban monotherapy safe, effective in AF, stable CAD patients

Rivaroxaban monotherapy safe, effective in AF, stable CAD patients

Aclidinium bromide safe for COPD patients regardless of exacerbation history

Aclidinium bromide safe for COPD patients regardless of exacerbation history

Elderly myocardial infarction patients benefit from 2 years of statins

Elderly myocardial infarction patients benefit from 2 years of statins

Omega-3, vitamin D no help for kidney function: Time to shift attention

Omega-3, vitamin D no help for kidney function: Time to shift attention

Asian ERBB2+ breast cancer patients respond well to neoadjuvant pertuzumab-trastuzumab-docetaxel

Asian ERBB2+ breast cancer patients respond well to neoadjuvant pertuzumab-trastuzumab-docetaxel

Endocrine therapy negatively affects QoL in postmenopausal breast cancer patients

Endocrine therapy negatively affects QoL in postmenopausal breast cancer patients