27-Feb-2015 - Novartis’s Japanese unit has been ordered to temporarily halt production of drugs by Japan’s health Ministry as punishment for delayed reporting of side effects.
25-Feb-2015 - Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.
24-Feb-2015 - A register of clinical investigators can help eliminate bias according to Big Pharma Group Transcelerate, which has teamed with DrugDev to develop such a database.
23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
20-Feb-2015 - Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
18-Feb-2015 - Sanofi has partnered with Dutch biotechnology spin-out Lead Pharma to discover autoimmune drugs that target ROR gamma t hormone receptors.
16-Feb-2015 - The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.
12-Feb-2015 - The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.
11-Feb-2015 - The US FDA has rescinded Breakthrough Therapy designation of a second HCV treatment, but Bristol-Myers Squibb says submission timelines for daclatasvir will not be affected.
10-Feb-2015 - The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
10-Feb-2015 - Stripping Merck & Co.'s hep C pill of breakthrough status shows the US FDA is monitoring market developments in real-time warns one industry analyst.
10-Feb-2015 - Though it’s difficult to quantify, industry experts told investors at the BIO CEO conference in New York on Monday that the US FDA-industry interactions are improving though there’s still some inconsistency between FDA leadership, division directors and reviewers.
05-Feb-2015 - Pfizer has entered into a definitive merger agreement to buy Hospira for $17bn.
05-Feb-2015 - Margaret Hamburg will retire from her role as Commissioner of the US FDA after nearly six years.
04-Feb-2015 - The anti-abortion group that blames Merck & Co for the recent US measles outbreak says it would not judge parents who have children vaccinated with MMR II for the good of society.
04-Feb-2015 - Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.
04-Feb-2015 - Bangalore, India-based Apotex and Verna, India-based Micro Labs both received warning letters last month from the US FDA detailing data integrity questions linked to their quality systems.
03-Feb-2015 - The Japanese health ministry has warned Novartis it plans to suspend its business in Japan, a move the company says will bring “manageable” costs.
03-Feb-2015 - The US Food and Drug Administration (FDA) is requesting a budget of $4.9bn for fiscal year (FY) 2016 – a 9% increase over the enacted budget for FY 2015.
02-Feb-2015 - Researchers claiming Tamiflu cuts flu symptom duration and hospitalisations analysed less than half as many studies as were included in the 2014 Cochrane Collaboration review.
02-Feb-2015 - The US CDC has recommended that doctors give people Tamiflu (oseltamivir) after detecting that this year's vaccines a less effective than in previous years.
02-Feb-2015 - Executives’ attitudes are shifting when it comes to supporting the idea that the FDA should evaluate drugs based on both clinical and economic effectiveness, a new PriceWaterhouseCoopers Health Research Institute survey found.
02-Feb-2015 - The drug industry may soon be the sole focus for the US FDA if a Bill proposing a new Food Safety Administration (FDA) is passed.
Pfizer has entered into a definitive merger agreement to buy Hospira for $17bn.
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