News

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.

Oxford University and Oxford University Hospitals NHS Trust have brought UK analytics group Genomics plc onboard a research project focused on the translation of whole genome sequencing into clinical practice.

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.

Certain patients in the UK struggling to keep their cholesterol levels in check now have the option of treatment with Sanofi’s PCSK9 inhibitor Praluent following its launch across the country.

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 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.

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.

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.

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.

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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.

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

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.

Patient safety across health and social care services in England has been highlighted by the Care Quality Commission as its “greatest concern” in its annual inspection report.

US regulators have turned down Pfizer’s request to sell its rheumatoid arthritis drug Xeljanz as a treatment for chronic plaque psoriasis.