Search Results for AstraZeneca

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Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

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GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017) By Nick Paul Taylor - Published 10 January 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: AstraZeneca, Bristol-Myers Squibb, Merck, CDSCO, codeine

Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics By Zachary Brennan - Published 18 October 2016

The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: companion diagnostics, IVDs, personalized medicine, Illumina, Genentech, AstraZeneca, BIO

European Regulatory Roundup: AstraZeneca Pulls Cancer Drug After Disagreement With EMA (29 September 2016) By Nick Paul Taylor - Published 29 September 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Crisis management, Drugs, Ethics

Tags: AstraZeneca, Alexion, Strensiq, PCWP

Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics By Zachary Brennan - Published 27 September 2016

Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance.

Categories: News, US, FDA, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: Illumina, Roche, AstraZeneca, next-gen sequencing, infectious disease diagnostics

PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations By Zachary Brennan - Published 22 August 2016

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the user fee program from fiscal years 2018 through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Manufacturing, Quality

Tags: AstraZeneca, PDUFA VI, PDUFA reauthorization, Prescription Drug User Fee Act

Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches By Zachary Brennan - Published 18 August 2016

Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance that aims to improve the way adhesion data is treated for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches.

Categories: News, US, FDA, Clinical, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Perrigo, Mylan, AstraZeneca, ANDAs for topical patches

TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators By Zachary Brennan - Published 29 June 2016

The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Clinical, Crisis management, Drugs

Tags: TransCelerate, Lilly, Pfizer, AstraZeneca, Amgen

FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Research and development

Tags: Viekra Pak, Eli Lilly, AstraZeneca, generic drug draft guidance, generic drug development

Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising By Zachary Brennan - Published 16 February 2016

Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation.

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Drugs, Government affairs

Tags: Manchin, Markey, opioids, Califf, FDA, Valeant, AstraZeneca, Daiichi Sankyo

Swedish Regulators Halt Imports from AstraZeneca’s Indian API Plant By Zachary Brennan - Published 15 December 2015

European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Clinical, Distribution, Drugs, Ethics, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: Medical Products Agency, EMA, AstraZeneca, Indian API manufacturing

Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside? By Zachary Brennan - Published 21 October 2015

In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA, approval, NME, Ostroff, Pfizer, AstraZeneca, Shire

Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin By Michael Mezher - Published 06 July 2015

An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports.

Categories: News, India, Biologics and biotechnology, Distribution, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: Compulsory license, saxagliptin, Lee Pharma, AstraZeneca

House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations By Alexander Gaffney - Published 08 May 2012

Tags: Negotiating, Amgen, Abbott, AstraZeneca, Pfizer, Merck, E&C, Energy and Commerce Committee, PhRMA, House, negotiation, Latest News, Obama, PPACA, information

NIH Launches New Program to Share Drug Compounds By Alexander Gaffney - Published 04 May 2012

Tags: Compounds, Library, Eli Lilly, AstraZeneca, Pfizer, Combine, Translational Science, Thomas Insel, NCATS, NIH, Latest News, pharmaceutical, drug

AstraZeneca CEO Out as New J&J CEO Takes the Helm By Alexander Gaffney - Published 26 April 2012

Tags: CFO, AZ, Lowth, Brennan, Gorsky, Johnson, JNJ, CEO, Weldon, J&J, AstraZeneca, Latest News, head, leadership

AstraZeneca Sues FDA to Halt Generic Seroquel By Alexander Gaffney - Published 14 March 2012

Categories: FDA

Tags: Seroquel, AstraZeneca, Delay, Lawsuit, Injunction, Generic, Citizen Petition, Latest News, Patent

Petitions to Delay Generic Seroquel Denied By Alexander Gaffney - Published 09 March 2012

Categories: FDA, CDER

Tags: Petition, Denial, Antipsychotic, Seroquel XR, Seroquel, AstraZeneca, Denied, Woodcock, RLD, ANDA, Citizen Petition, Latest News