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.
26-Feb-2015 - A new California bill introduced earlier this week would, for the first time, require pharma companies to unveil a number of unique operational costs as a way to better understand drug pricing.
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.
24-Feb-2015 - In order to close Novartis’ $16bn purchase of GlaxoSmithKline’s portfolio of cancer treatments , the FTC (Federal Trade Commission) is requiring Novartis to divest all assets related to its potential BRAF and MEK inhibitor drugs to settle anticompetitive charge.
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.
19-Feb-2015 - The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
19-Feb-2015 - The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.
18-Feb-2015 - SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.
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.
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.
09-Feb-2015 - Pfizer visited three troubled facilities in Hospira’s manufacturing network before entering a $17bn definitive merger agreement, the company says.
05-Feb-2015 - Margaret Hamburg will retire from her role as Commissioner of the US FDA after nearly six years.
05-Feb-2015 - [View the story "Nice work if you can get it: Excipient firms on the Côte d'Azur" on Storify]
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.
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