Shire has submitted a New Drug Application in the US seeking permission to market its experimental drug lifitegrast for dry eye disease in adults.
News
Taiho submits colorectal cancer drug in Europe
Taiho Pharma has submitted an application in Europe for its investigational oral colorectal cancer therapy TAS-102.
Two more NHS Foundation Trusts for England
Monitor has awarded coveted Foundation Trust status to Nottingham Healthcare and Kent Community Health NHS Trusts, giving more than two and half million people across England a louder voice in running local healthcare services.
GP leaders call for cash to protect care continuity
GP leaders in the UK are calling on the incoming government for extra funds to ensure that continuity of care is not interrupted in the bid to increase access to general practice.
Novartis’ wet AMD drug hits PhII targets
Mid-stage data assessing Novartis’ eye drug RTH258 indicates that it could be an effective option for treating wet age-related macular degeneration, with the added bonus of less frequent dosing than Regeneron/Bayer’s Eylea (aflibercept).
Three new drugs put forward for EU approval
Novartis’ lung cancer treatment Zykadia (ceritinib), Otsuka’s kidney disease drug Jinarc (tolvaptan) and Amgen’s neutropenia therapy Ristempa (pegfilgrastim) have taken a giant step closer to entering the European market after regulatory advisors endorsed their approval.
UCB turns in 7% sales growth for 2014
UCB has booked a 7% rise in sales to 3.3 billion euros for 2014, as generic competition to anti-epileptic Keppra (levetiracetam) and a dip in royalty income/fees was more than compensated for by strong performances across core medicines.
US priority review for B-MS’ Opdivo in lung cancer
The US Food and Drug Administration has agreed to review Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) as a treatment for advanced squamous non-small cell lung cancer (NSCLC) after prior therapy.
AMR review head O’Neill calls for $2 billion innovation fund
The head of the UK’s government review into antimicrobial resistance has told PharmaTimes that an innovation fund of around $2 billion is needed to speed development of new drugs.
Earlier start for new GSK chairman Hampton
Sir Philip Hampton will take over from Sir Christopher Gent as chairman of GlaxoSmithKline on May 7, nearly four months earlier than expected.
Japan hits Novartis with 15-day ban over side effect reports
Acting on a previous threat, the Japanese government has suspended Novartis’ pharmaceuticals operations in the country for breaching adverse effects reporting rules.
Bayer books record sales for 2014
Bayer has achieved record sales for 2014, posting a 5.2% rise to 42.2 billion euros, in line with the company’s forecasts.
Boehringer puts BACE inhibitor trial on hold
Boehringer Ingelheim has temporarily placed on hold a Phase I clinical trial assessing its experimental BACE inhibitor BI 1181181 in Alzheimer’s disease, to further investigate potential side effects.
EMA will review Amgen/Onyx’ myeloma drug
The European Medicines Agency has accepted Amgen/Onyx’ Marketing Authorisation Application for Kyprolis (carfilzomib) as a treatment for multiple myeloma.
FDA gives green light to Sanofi Lantus follow-up Toujeo
Sanofi has been boosted by the news that the US Food and Drug Administration has approved Toujeo, the follow-up to its diabetes blockbuster Lantus.
