AstraZeneca’s global biologics R&D arm MedImmune has picked up a fast track designation in the US for its investigational treatment for patients hospitalised with Type A strain influenza, which could help accelerate its development pathway.
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AbbVie snaps up rights to Boehringer psoriasis drug for $595m
AbbVie and Boehringer Ingelheim have formed a global alliance focused on the development and commercialisation of BI 655066, a biologic therapy in Phase III development for psoriasis.
EU launches novel medicines accelerator
European regulators have rolled out a new scheme striving to accelerate the approval of promising new medicines through a programme of enhanced support for companies working on drugs targeting unmet medical needs.
Merck moves to expand Keytruda label for NSCLC
US regulators are reviewing Merck & Co’s application to include new data on its immunotherapy Keytruda that could expand its use within the non-small cell lung cancer (NSCLC) patient population.
Three new drugs cleared for use on NHS Scotland
Three new medicines have been issued a green light by cost regulators for use on NHS Scotland, offering new treatment options to patients for breast cancer, prostate cancer and heart failure.
US green light for novel, long-acting haemophilia B drug
The US Food and Drug Administration has approved CSL Behring’s Idelvion, paving the way for patients with Haemophilia B to access treatment with the first and only factor IX therapy that offers up to 14-day dosing to protect against or reduce bleeds.
Long-term data back safety of GSK’s asthma biologic
GlaxoSmithKline has unveiled new safety and efficacy data for its asthma biologic Nucala, showing that the drug’s risk/benefit profile was maintained over an extended 52-week period.
XBiotech ready to file its true ‘human’ monoclonal antibody
European regulators have agreed to review an investigational treatment for advanced colorectal cancer being developed by XBiotech, which said it now expects to submit a marketing authorisation application shortly.
Novartis’ Cosentyx beats J&J’s Stelara on skin clearance in psoriasis
Novartis’ Cosentyx has again come out on top in a study comparing its efficacy in psoriasis to that of Johnson & Johnson’s Stelara.
FDA clears J&J/AbbVie’s Imbruvica for first-line CLL
US regulators have expanded the use of Johnson & Johnson group Janssen and AbbVie’s cancer drug Imbruvica to include its first-line use in chronic lymphocytic leukaemia (CLL), offering patients the first chemotherapy-free option at this stage of their treatment pathway.
Groundbreaking’ discovery sees scientists uncover cancer’s weak spot
Scientists are reporting a breakthrough in cancer research that could lead to the development of highly targeted immunotherapies that enable the body to fight the disease without harming healthy tissues.
Merck, Pfizer and Verstem to assess ovarian cancer combo
Merck, Pfizer and Verastem have sealed a deal to assess the potential of combining their drugs to treat ovarian cancer.
FDA expands use of AZ’ breast cancer drug Faslodex
US regulators have expanded the scope of AstraZeneca’s breast cancer drug Faslodex to include the drug’s use in combination with Pfizer’s Ibrance.
GSK’s Benlysta slows organ damage in lupus patients, study finds
A long-term analysis of GlaxoSmithKline’s Benlysta has shown low rates of organ damage progression in patients with moderate-to-severe systemic lupus erythematosus (SLE) taking the drug for five years, regardless of their level of damage at the start of the trial.
BMA warns of growing crisis in general practice
The British Medical Association is warning that the current crisis in general practice – driven by soaring demand, recruitment/retention issues and funding difficulties – looks set to worsen with potentially thousands of doctors in England considering leaving the profession.
