News

J&J’s Stelara shows PhIII promise for Crohn’s

Johnson & Johnson’s psoriasis biologic Stelara has shown efficacy in inducing a clinical response and remission in patients with Crohn’s disease, providing the drugmaker with crucial evidence to support expanding the drug’s label.

US ‘breakthrough’ status for Pfizer’s leukaemia drug

Pfizer’s investigational antibody-drug conjugate inotuzumab ozogamicin has been awarded ‘breakthrough’ status in the US for the treatment of acute lymphoblastic leukaemia, potentially putting the drug on a faster development and review pathway.

NICE supports NHS use of Lundbeck’s Brintellix

The National Institute for Health and Care Excellence has published draft guidelines supporting National Health Service use of Lundbeck’s Brintellix for treating major depressive episodes.

Shire’s dry eye drug hit with US rejection

Shire’s bid to secure US approval for its experimental dry eye disease therapy lifitegrast has hit a bump in the road after regulators issued a complete response letter outlining some additional requests regarding the application following a priority review.

US OKs first antidote to Boehringer’s bloodthinner Pradaxa

The US Food and Drug Administration has stamped its seal of approval on Boehringer Ingelheim’s Praxbind, marking the the first time a specific antidote to a novel oral anticoagulant – in this case Pradaxa – has been cleared for the US market.

Researchers develop blood test to match cancer patients with treatment

In a potential breakthrough for cancer treatment, scientists funded by Cancer Research UK have designed a blood test that could not only match up patients to the most suitable therapy but also track the tumour’s progress to assess whether treatment is effective.

Setback for AZ diabetes combo

AstraZeneca’s combination of two of its main type 2 diabetes treatments, Forxiga and Onglyza, has had its application turned down by the FDA.

NICE OK for BMS’ hepatitis C drug Daklinza

Bristol-Myers Squibb has welcomed a decision by the National Institute for Health and Care Excellence to recommend Daklinza in England and Wales as a treatment option for adult patients with chronic hepatitis C virus infection.

NICE unconvinced of Duchenne drug benefit

Cost regulators for health technologies funded by the National Health Service in England and Wales have rejected a novel treatment for the genetic condition Duchenne Muscular Dsytrophy, seeking more data from the firm to confirm its benefit and justify its high cost.

BMS, Five Prime sign $1.74bn deal for antibody programme

Bristol-Myers Squibb and Five Prime Therapeutics have sealed a £1.74-billion worldwide license and collaboration deal to develop and commercialise the latter’s colony stimulating factor 1 receptor antibody programme.