Search Results for Novartis

Showing 1 – 25  of 37

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

Supreme Court Weighs Biosimilar Patent Dance By Zachary Brennan - Published 26 April 2017

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.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: Supreme Court, biosimilars, Novartis, Sandoz

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017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GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.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: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 February 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition By Michael Mezher - Published 14 February 2017

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.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Durezol, Difluprednate Ophthalmic Emulsion, Alcon, Novartis, Citizen Petition, Bioequivalence

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

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.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations By Zachary Brennan - Published 26 January 2017

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.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: Pfizer, Novartis, Celgene, GLP for nonclinical lab studies, FDA proposed rules

Four Pharma Companies Lead in Regulatory, Legal Compliance By Zachary Brennan - Published 14 November 2016

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 Bill & Melinda Gates Foundation’s Access to Medicines Index.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, WHO, Biologics and biotechnology, Drugs

Tags: pharmacovigilance, pharmaceutical regulatory compliance, Gilead, Sanofi, Takeda, Pfizer, Novartis, Takeda, Gates Foundation, pharma regulations

FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel By Zachary Brennan - Published 30 August 2016

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.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Due Diligence

Tags: biosimilar, Enbrel, Amgen, Novartis, Sandoz

Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan By Zachary Brennan - Published 29 August 2016

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.

Categories: News, Africa, Middle East, Distribution, Due Diligence, Government affairs, Medical Devices

Tags: Alcon Labs, Novartis, Iran, Syria, Sudan

Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

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.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

EMA Adds Four New Drugs to PRIME Scheme By Michael Mezher - Published 27 July 2016

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.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: PRIME scheme, PRIority MEdicines, Novartis, Merck, Adaptimmune, DNATrix, CTL019, Ebola Vaccine, NY-ESO-1c259T, DNX-2401

European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016) By Nick Paul Taylor - Published 21 July 2016

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

Categories: News, Europe, EC, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs

Tags: European Regulatory Roundup, Novartis, adverse events

Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar By Zachary Brennan - Published 13 July 2016

For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s Enbrel (etanercept).

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Submission and registration

Tags: Sandoz, Novartis, Enbrel, Humira, biosimilars

FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster By Zachary Brennan - Published 11 July 2016

Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.”

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Submission and registration

Tags: biosimilar, Enbrel, Amgen, Sandoz, Novartis

EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug By Zachary Brennan - Published 11 May 2016

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals.

Categories: News, Europe, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis

Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants By Zachary Brennan - Published 07 April 2016

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate.

Categories: News, US, CDER, Audit, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: regulatory training, regulatory affairs, Novartis, FDA regulatory training

EU High Court Upholds Orphan Exclusivity Ruling By Michael Mezher - Published 23 March 2016

Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Submission and registration

Tags: Glivec, Gleevec, Tasigna, Teva, Novartis, Market exclusivity

FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs By Michael Mezher - Published 16 March 2016

The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells.

Categories: News, CBER, Biologics and biotechnology, Clinical, Manufacturing, Research and development

Tags: CAR T-cells, chimeric antigen receptors, CD19, Recombinant DNA Advisory Committee, Cancer, Oncology, Juno, Kite, Novartis, B-cell lymphoma, Investigational new drug application, IND

India’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment By Zachary Brennan - Published 21 January 2016

India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss.

Categories: News, India, CDSCO, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Avastin, Roche, Novartis, Lucentis, Genentech, CDSCO

After Being Sued for Patent Infringement, Cipla Offers to License Novartis Drug By Michael Mezher - Published 29 April 2015

In the midst of arguments before a prominent court in India, generic drug maker Cipla has offered to pay a "reasonable" royalty to Swiss multinational Novartis, The Economic Times reports.

Categories: News, India, Drugs, Government affairs

Tags: Patents, Intellectual property, Trademark, Delhi High Court, Cipla, Novartis

In Major Decision, India Rejects Patent on Gilead's Hepatitis C Drug Sovaldi By Michael Mezher - Published 15 January 2015

Gilead Sciences has been denied a patent for its blockbuster drug Sovaldi (sofosbuvir) in India. India’s patent office rejected the application for the drug due to a lack of evidence that “minor changes in the molecule” substantially improved the drug.

Categories: News, India, Drugs

Tags: Gilead, Sovaldi, Indian Patent Office, Patent, Sofosbuvir, Glivec, Gleevec, Novartis

NICE: Novartis' Jakavi not Cost-Effective for Treating Myelofibrosis By Louise Zornoza, RegLink - Published 26 June 2013

Categories: NICE

Tags: HTA, Novartis, CER, cost, UK, EU

Novartis Hammered by US Attorneys for Second Time in Four Days as Further Allegations Emerge By Alexander Gaffney, RF News Editor - Published 29 April 2013

Categories: DOJ

Tags: Kickbacks, Novartis

Novartis' and Forrest's Cystic Fibrosis Drugs Green Lighted by NICE By Louise Zornoza, RegLink - Published 28 March 2013

Categories: NICE

Tags: Novartis, UK