Time for big pharma to step up before the drug price debate rises again

18 December 2017 - In today’s social and political climate, public opinion and public action can galvanise and turn on an ...

Read more →

FDA accepts biologics license application for fremanezumab with priority review for prevention of migraine and grants fast track designation for cluster headache development program

18 December 2017 - Teva anticipates launching anti-CGRP product in the U.S. for the prevention of migraine in 2018. ...

Read more →

US FDA accepts regulatory submission for Tagrisso in first-line EGFR-mutated non-small cell lung cancer

18 December 2017 - Tagrisso granted priority review. ...

Read more →

Looking north: can a single-payer health system work in the U.S.?

18 December 2017 - For Dr. Peter Cram, an American internist who spent most of his career practicing in Iowa ...

Read more →

Humana in talks to buy Kindred Healthcare with equity firms

18 December 2017 - U.S. health insurer Humana is in advanced talks to acquire acute care provider Kindred Healthcare in ...

Read more →

Novel cancer drug gets stymied by Medicare rigid billing system

16 December 2017 - Annual code updates take ‘too long’ for patients, doctors. ...

Read more →

WTX101 granted fast track designation by the U.S. FDA for the treatment of Wilson disease

14 December 2017 - Wilson Therapeutics today announced that the U.S. FDA has granted WTX101 fast track designation for the treatment ...

Read more →

US FDA grants fast track designation to Renova Therapeutics’ RT-100 AC6 gene transfer for the treatment of heart failure

14 December 2107 - FLOURISH Phase 3 clinical trial in patients with heart failure and reduced ejection fraction to begin ...

Read more →

FDA targets insulin for increased competition to lower prices

16 December 2017 - Prices of the diabetes medicine have risen 270%. ...

Read more →

An open-source consensus-based approach to value assessment

15 December 2017 - Value Assessment? Yes, But How? ...

Read more →

Statement from FDA Commissioner on new FDA efforts to support more efficient development of targeted therapies

15 December 2017 - In recent years, the medical community has experienced a shift in the way health care is ...

Read more →

Strong demand for health insurance as deadline looms

13 December 2017 - More than one million people signed up last week for health insurance under the Affordable Care ...

Read more →

Institute for Clinical and Economic Review to assess elagolix for management of endometriosis

14 December 2017 - Open input now being accepted until 8 January 2018. ...

Read more →

Amicus Therapeutics submits new drug application to U.S. FDA for migalastat for treatment of Fabry Disease

14 December 2017 - Amicus Therapeutics submitted a new drug application to the U.S. FDA to request approval of the ...

Read more →

New steps to facilitate beneficial medical device innovation

14 December 2017 - In recent days, the FDA has committed to several new policies that will modernise the agency’s approach ...

Read more →