SMC - August 2016 decisions

8 August 2016 - Treatments for blood cancer, skin cancer and high cholesterol among six new medicines accepted for routine use ...

Read more →

Decision relating to enoxaparin sodium and plerixafor

8 August 2016 - PHARMAC is pleased to announce the approval of an agreement with Sanofi-Aventis New Zealand Limited (Sanofi) for ...

Read more →

Decision relating to idarucizumab and dabigatran

8 August 2016 - PHARMAC is pleased to announce the approval of an agreement with Boehringer Ingelheim NZ Limited for the ...

Read more →

The FDA approves first generic version of widely used influenza drug Tamiflu

On August 3, 2016, the U.S. FDA approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication ...

Read more →

Brivaracetam in epilepsy: additional clinical benefits not seen as before

4 August 2016 - The new indirect comparison is methodologically better but there is still no evidence of an additional ...

Read more →

ITM´s subsidiary ITG receives drug approval for EndolucinBeta

4 August 2016 - ITM Isotopen Technologien München AG today announced that the EMA has granted marketing authorization for EndolucinBeta of ...

Read more →

Agreement for supply of influenza vaccine approved by PHARMAC

5 August 2016 - PHARMAC is pleased to announce the approval of an agreement with BGP Products Pty Ltd (trading as ...

Read more →

NICE issues draft guidance on the use of lesinurad

3 August 2016 - NICE has issued draft guidance on the use of lesinurad (Zurampic) for the treatment of patients ...

Read more →

NICE draft guidance recommends new drug for people with ankylosing spondylitis

4 August 2016 - New draft guidance from NICE means thousands of people with back condition ankylosing spondylitis will soon have ...

Read more →

NICE issues draft guidance on the use of Otezla (apremilast)

3 August 2016 - NICE has issued draft guidance on the use of apremilast for the treatment of patients with moderate ...

Read more →

Merck’s Keytruda (pembrolizumab) approved by the European Commission for patients with advanced non-small cell lung cancer whose tumors express PD-L1

3 August 2016 - Approval based on trial results demonstrating superior overall survival compared to chemotherapy in previously-treated patients. ...

Read more →

Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA breakthrough therapy designation as first-line treatment for HR+/HER2- advanced breast cancer

3 August 2016 - Designation underscores the continuing unmet need of the HR+/HER2- advanced breast cancer population and the potential of ...

Read more →

Ramucirumab in gastric cancer: no sign of an additional clinical benefit

1 August 2016 - Former orphan drug undergoes regular early benefit assessment; submitted studies unsuitable for assessment. ...

Read more →

Nivolumab in advanced lung cancer: evidence for significant additional benefits

1 August 2016 - Advantages in overall survival and side effects. ...

Read more →

Nivolumab in renal cell carcinoma: indication of additional clinical benefits

1 August 2016 - Benefits in overall survival, morbidity and side effects. ...

Read more →