04-Mar-2015 - The US Food and Drug Administration (FDA) has ordered makers of testosterone therapies to change their labelling and conduct clinical trials to investigate heart attack and stroke risk.
03-Mar-2015 - A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.
03-Mar-2015 - The US FDA is requiring manufacturers to place label warnings on all multi-dose diabetes pens as patients continue to share the devices.
02-Mar-2015 - Med Prep Consulting execs committed fraud and violated the Federal Food, Drug and Cosmetic Act (FDCA) according to the US DoJ, which has accused the New Jersey compounder of knowingly selling drugs produced in unsanitary conditions.
27-Feb-2015 - The German Institute for Quality and Efficiency in Health Care (IQWiG) says the EMA’s proposal to establish a publicly accessible database of clinical trial data does not do enough to make the data transparent.
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.
Pfizer has entered into a definitive merger agreement to buy Hospira for $17bn.
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