US regulators have approved the first generic versions of Abilify (aripiprazole), sold in the US by Bristol-Myers Squibb, for the treatment of schizophrenia and bipolar disorder.
News
FDA will Biogen/AbbVie’s once-monthly MS shot
US regulators have agreed to review Biogen and AbbVie’s application to market Zinbryta (daclizumab; high yield process) for relapsing-remitting forms of multiple sclerosis.
Currency effects hit Pfizer’s 2015 forecasts
Pfizer has lowered its 2015 sales and earnings forecasts as it became the latest international pharma to be hit by the weakening Euro.
GSK’s shingle jab 97.2% effective
GlaxoSmithKline has unveiled full data from a Phase III trial of its shingle vaccine HZ/su, showing a high level of protection across all age groups studied.
Merck’s DPP-4 inhibitor Januvia hits heart safety target
There was good news this week for Merck & Co’s blockbuster diabetes drug Januvia and indeed the whole class of DPP-4 inhibitors, after long-term clinical data backed the drug’s heart safety.
US fast-track for Genzyme’s Fabry disease therapy
Sanofi group Genzyme will be celebrating news that US regulators have awarded fast-track designation to its investigational treatment for the rare genetic disorder Fabry disease, which affects around 10,000 people around the globe.
FDA advisors question Amgen’s T-Vec study
Amgen’s cancer immunotherapy T-Vec will not be granted accelerated approval by US regulators for melanoma because of trial data concerns and the increasing availability of other new therapies for the disease, official reports indicate.
First HIV home test goes on sale in the UK
The self-proclaimed most accurate HIV home-testing kit in the World has been launched across the UK, in the hope of reducing the number of undiagnosed cases in circulation.
Mylan throws out Teva bid
As expected, Mylan’s board has unanimously and vehemently rejected Teva’s takeover offer of around $40 billion, slamming the proposal for “grossly undervaluing” the firm.
Novartis’ Arzerra shows benefit in relapsed CLL
Late-stage data for Novartis cancer drug Arzerra shows that it could provide a progression-free survival benefit in patients with relapsed chronic lymphocytic leukaemia.
Perrigo spurns second offer from Mylan
The Perrigo-Mylan-Teva takeover saga has taken another turn after Perrigo again spurned Mylan’s advances, rejecting a second bid from the generics giant.
Eleven medicines leap closer to approval in Europe
Advisors to the European Medicines Agency have recommended the approval of eleven new medicines in the region, including a new treatment for skin cancer and the first therapy for the rare condition non-24-hour sleep-wake disorder.
Fourth US approval for Lilly’s Cyramza
Lilly’s Cyramza has picked up its fourth US approval in just over a year, this time for the treatment of advanced colorectal cancer, significantly extending its patient reach.
US priority review for AbbVie’s HCV genotype 4 therapy
AbbVie’s chronic hepatitis C therapy for adult patients with genotype 4 forms of the disease has been assigned a priority review by the US Food and Drug Administration, signalling a much shorter review time.
AZ seals immuno-oncology deals as Q1 sales, earnings, slip
AstraZeneca has further singled out immuno-oncology as a central vein of its future business with three separate deals seeking to develop new therapies in the field.
