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    Supreme Court Weighs Biosimilar Patent Dance

    All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary. Neither side seemed to come away with a decisive win. Sandoz began the arguments on why the additional six months would further delay biosimilars from launching, also explaining why the ...
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    Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance

    Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...
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    Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. J&J, Novartis and Pfizer Comment on TGA Risk Management Proposals Johnson & Johnson, Novartis and Pfizer say they are broadly in favor of the Therapeutic Goods Administration’s (TGA) proposed framework for risk-management plans, but have some specific suggestions as to how it can be improved. TGA released version 3.0 of its guidance on risk management plans for medic...
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    FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition

    The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis. In 2008, FDA approved Sirion Therapeutics' Durezol, a corticosteroid, to treat inflammation and pain associated with ocular surgery. Two years later, Alcon acquired the rights to Durezol from S...
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    EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses

    With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer. EMA EMA’s Pharmacokinetic Working Party (PKWP) and the Modelling and Simulation Working Group (MSWG) are developing a “ Guideline on the Qualification and Reporting of Physiologi...
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    Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

    A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The proposed rule, unveiled in August , would require a complete quality system approach for these safety ...
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    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
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    FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel

    The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label. Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the US from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen). The approval of Erelzi follows a unani...
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    Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan

    Novartis subsidiary Alcon Laboratories has agreed to pay more than $16 million to settle allegations of manufacturing drugs and medical devices in the US and then shipping them to Iran, Syria and Sudan despite US trade embargoes that prohibit such sales. According to the settlement agreement with the US Department of Commerce, Texas-based Alcon Labs and Switzerland-based Alcon Pharmaceuticals sent at least 100 shipments of devices and medical equipment worth more than $8...
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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...
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    EMA Adds Four New Drugs to PRIME Scheme

    The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight. Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated product assessme...
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    European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Novartis Faces MHRA Criticism Over Access to Trial Data Novartis has revealed the Medicines and Healthcare Products Regulatory (MHRA) has criticized its UK operation following an inspection. The criticisms center on the systems Novartis’ UK unit uses to provide health authorities with access to trial data. Specifically, Novartis said MHRA inspectors were critical of t...