Breaking News on Global Pharmaceutical Technology & Manufacturing


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The self-regulation society? Consultant challenges manufacturing status quo

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.

European API makers must invest to compete with India, says Infa Group

14-Oct-2015 - Clients are turning their backs on low-cost economies like India and returning to Infa Group, the Italian API maker says.

US FTC: 'Product-hopping' illegally impedes generic entry

07-Oct-2015 - The US Government is becoming increasingly critical of industry attempts to ward off competition through ‘product-hopping,’ an IP lawyer says.


NHS rejects suggestion a lack of guidance has slowed biosimilar uptake

06-Oct-2015 - The NHS has rejected Napp Pharmaceuticals’ accusation it lacks biosimilar guidance, citing a recently published policy document.

US FDA issues alert for sterile products made by Californian compounder

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.


UK and India sign agreement to help ensure drug quality

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.

Pfizer hiring 40 at its Lipitor and Viagra API plants in Ireland

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.

Round 2 Amgen? US FDA accepts Sandoz's Enbrel biosimilar for review

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.

US FDA rule: banned drugs will be destroyed

30-Sep-2015 - The FDA will begin destroying drugs which are refused entry to the US instead of returning them to their sender.

Teva adds an 'appy medium to its respiratory portfolio with Gecko buy

30-Sep-2015 - Teva has acquired Gecko Health Innovations, adding an inhaler app it says can help patients manage asthma and COPD.

Catalloy fined after explosion at metal catalysts plant

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.

US FDA withdraws approval for Sun migraine drug over concerns about Halol plant

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.

Car fumes increase Alzheimer's risk in people genetically predisposed, study

25-Sep-2015 - Air pollution increases the likelihood that people genetically predisposed to Alzheimer’s will develop the disease according to Mexican researchers.

India mulls reclassifying vitamins as drugs if they come with health claims

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.

EC, EU and WHO share 'need to know' private drug data

23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.

A reliable supply chain has never been more important, says Mylan CEO

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.


UK asks to use CRISPR on human embryos

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.

Lack of regulatory clarity dominates US biosimilar debate post Zarxio

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.

SA police shut down three counterfeit drug making faciltiies in INTERPOL swoop

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.

Police Facebook campaign calls on high-paid Pharma CEOs to tackle opioid abuse

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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