Novartis has launched a new app that enables patients taking part in ophthalmic clinical trials to self-report data, which could potentially speed up the development of new therapies.
News
NICE backs procedure for benign prostate enlargement
The National Institute for Health and Care Excellence is now endorsing a procedure called Prostate Artery Embolisation (PAE) for NHS use to treat benign prostatic hyperplasia.
Astellas files experimental AML therapy
Astellas has filed its experimental Acute Myeloid Leukemia (AML) therapy gilteritinib with US regulators, seeking approval for its use to treat FLT3 mutation-positive (FLT3mut+) relapsed or refractory forms of the blood cancer.
GSK reports Q1 sales decline
GlaxoSmithKline has booked a 2 percent dip in revenues for the first quarter to £7.2 billion, after results were hit by a “significant currency impact” and lower sales of prescription drugs.
Women with breast cancer risk opting out of tamoxifen therapy
The majority of women at high risk of developing breast cancer decide against prophylactic treatment with tamoxifen, suggest findings of a new study funded by Cancer Research UK and published in Breast Cancer Research and Treatment.
GSK/Innoviva’s Trelegy Ellipta wins expanded nod for COPD
US regulators have approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta to treat a wider population of chronic obstructive pulmonary disease (COPD) patients.
Shire, Takeda move closer to merger deal
Shire’s Board has notified Takeda that it would be “willing to recommend” the latter’s latest merger proposal to shareholders, which is now valued at £46 billion pounds.
Pfizer’s Mylotarg wins EU approval for AML
European regulators have cleared Pfizer’s Mylotarg to treat a certain subset of patients with acute myeloid leukaemia (AML).
FDA advisors back Lilly/Incyte’s rheumatoid arthritis drug
US regulatory advisors are backing approval of the lower dose form of Eli Lilly and Incyte’s once-daily JAK inhibitor baricitinib as treatment for rheumatoid arthritis (RA).
MHRA bans valproate without pregnancy prevention programme
The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines, so that they can no longer be prescribed to females of child-bearing age unless they are on the pregnancy prevention programme.
EU reviewing MSD’s Keytruda/chemo combo
European regulators have kicked off a review of MSD’s Keytruda/pemetrexed combination for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
FDA rejects Pfizer’s Herceptin biosimilar
US regulators have issued a complete response letter regarding Pfizer’s filing for a biosimilar version of Roche’s blockbuster cancer drug Herceptin.
AZ lung cancer combo fails to hit targets
A combination of immunotherapy drugs being tested by AstraZeneca in the third-line setting in patients with lung cancer has failed to slow disease progression or extend survival.
Ministers write letter to Vertex over Orkambi debate
Ministers from the Department of Health have written a letter asking that Vertex bring negotiations with NHS England over access to cystic fibrosis drug Orkambi “to an urgent resolution”.
Fresenius pulls out of $4.3bn Akorn merger
German healthcare firm Fresenius Kabi is walking away from a $4.3-billion merger with US generics group Akorn, claiming that the latter has failed to fulfill several closing conditions.
