15-Oct-2015 - API suppliers should be allowed to make process improvements without having to seek re-approval says consultant Girish Malhotra, who argues that the current rules create inefficiency and waste.
14-Oct-2015 - Clients are turning their backs on low-cost economies like India and returning to Infa Group, the Italian API maker says.
07-Oct-2015 - The US Government is becoming increasingly critical of industry attempts to ward off competition through ‘product-hopping,’ an IP lawyer says.
06-Oct-2015 - The NHS has rejected Napp Pharmaceuticals’ accusation it lacks biosimilar guidance, citing a recently published policy document.
06-Oct-2015 - The US FDA has issued a product safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility.
05-Oct-2015 - The MHRA has signed a Memorandum of Understanding (MOU) with Indian regulators to help ensure the quality of drugs in the UK.
02-Oct-2015 - Over 40 new jobs will be created at Pfizer’s manufacturing sites in Cork, Ireland, including at a bulk Lipitor facility once earmarked for closure.
02-Oct-2015 - A second Sandoz biosimilar has been accepted for review by US FDA setting the stage for another potential legal battle with Amgen.
30-Sep-2015 - The FDA will begin destroying drugs which are refused entry to the US instead of returning them to their sender.
30-Sep-2015 - Teva has acquired Gecko Health Innovations, adding an inhaler app it says can help patients manage asthma and COPD.
29-Sep-2015 - A UK supplier of metal catalysts to the drug industry has been fined after an explosion at its site in Widnes left an employee with minor injuries.
28-Sep-2015 - The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.
25-Sep-2015 - Air pollution increases the likelihood that people genetically predisposed to Alzheimer’s will develop the disease according to Mexican researchers.
23-Sep-2015 - India may classify vitamin supplements as drugs rather than foods if the manufacturers of such products claim they can treat or prevent disease.
23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.
23-Sep-2015 - Drugmakers need more certainty and reliabilty around their supply chain in light of increased regulatory vigilance says Mylan, itself carrying out remediation across several Indian facilities.
22-Sep-2015 - UK scientists have applied to the country’s fertility regulator for permission to use CRISPR and other genome editing techniques on human embryos.
22-Sep-2015 - Sandoz has reiterated its call for US FDA guidance on biosimilar interchangeability arguing that the lack of clarity makes it hard to gauge what impact switching rules will have on pricing.
21-Sep-2015 - South African Police shut down three counterfeit drug making plants last weekend in an INTERPOL-co-ordinated operation that seized 150 tonnes of fake medicines.
21-Sep-2015 - A Massachusetts-based police department has published contact and salary details of Big Pharma CEOs in an effort to force industry to help manage opiate addiction.
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