News

The US Food and Drug Administration is warning that type II diabetes drugs belonging to the popular SGLT2 inhibitor class could cause a serious condition where blood ketone levels become dangerously high.

Vertex’ cystic fibrosis therapy Orkambi is in the spotlight again with the publication of two trials confirming the drug’s benefit in the New England Journal of Medicine.

US regulators have issued a green light for the use of Pernix Therapeutics’ Treximet for the treatment of acute migraine in children aged 12 years and above.

First data from a mid-stage trial assessing Amgen’s fully human monoclonal antibody AMG 334 show the drug to be effective in preventing migraine, one of the world’s top 10 most debilitating conditions affecting more than 10% of the population. 

UK allergy group Circassia has announced plans to raise £275 million from a share sale to fund its purchase of two asthma-focused companies, Aerocrine and Prosonix, to create “a world-class allergy and asthma specialty pharma business”.

Pharma has to take a closer interest in the competing demands a commissioner has to deal with, an independent commissioning expert has urged. 

A UK government-commissioned review of antimicrobial resistance is calling on big pharma to help fund a $2-billion innovation pot to drive the search for new antibiotics.

Bristol-Myers Squibb/AbbVie’s experimental monoclonal antibody elotuzumab has turned in impressive interim Phase III data showing increased progression-free survival in patients with relapsed/refractory multiple myeloma.

Eli Lilly is hooking up with non-profit medical research group Sanford-Burnham to discover and develop new immunological therapies for a variety of conditions.

A mid-stage trial of Roche’s MPDL3280A has shown that, compared to the chemotherapy docetaxel, the experimental immunotherapy doubled the likelihood of survival in patients with non-small lung cancer expressing the highest levels of PD-L1.

AstraZeneca is fuelling its drive for personalised medicine with a duo of deals expanding its work across diabetes, cardiovascular disease and asthma fields.

Advisors to the US Food and Drug Administration are supporting the approval of Vertex’ cystic fibrosis combination Orkambi, which targets the most common form of the illness.

Takeda and Orexigen have pulled the plug on a post-marketing study assessing the cardiovascular effects of their obesity pill Contrave, not because of superior efficacy or safety issues but because of premature data disclosure.

Sanofi has decided to take up its option to license and develop an experimental immunotherapy owned by Selecta Biosciences for the treatment of Coeliac disease.

Takeda has killed off a late stage programme assessing the potential of alisertib in lymphoma after interim analysis failed to show any benefit in progression-free survival.