Search Results for Sanofi

Showing 1 – 25  of 29

Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine By Zachary Brennan - Published 19 May 2017

Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds.

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

Tags: Doctors Without Borders, MSF, Zika vaccine, Sanofi

EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars By Zachary Brennan - Published 19 May 2017

The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: CHMP, Sanofi, Celltrion, XBiotech, Spherox

Sanofi, CDC and FDA Work to Avoid Yellow Fever Vaccine Shortage By Michael Mezher - Published 01 May 2017

To head off an impending shortage of YF-VAX, the only US-licensed vaccine for yellow fever, Sanofi Pasteur, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are working to provide travelers with an alternative vaccine.

Categories: News, Africa, Latin America and Caribbean, US, FDA, Biologics and biotechnology

Tags: Yellow Fever, Expanded Access, Sanofi Pasteur, YF-VAX, Stamaril

Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine By Zachary Brennan - Published 24 January 2017

Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi on Tuesday explained the risks of developing such a vaccine.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Government affairs, Manufacturing

Tags: Zika, MSF, Sanofi Pasteur, Zika vaccine

Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval By Zachary Brennan - Published 18 November 2016

Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Government affairs, Quality, Regulatory strategy

Tags: bladder cancer, NMIBC, Sanofi, drug shortage

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

EMA Recommends Nine Drugs for Approval By Zachary Brennan - Published 11 November 2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EMA CHMP, marketing authorisation in EU, Gilead, Sanofi, Novo Nordisk

Updated: EMA Warns of Possible Chemotherapy Shortage in Four Countries Due to Sanofi Manufacturing Snafu By Zachary Brennan - Published 10 June 2016

Fifteen batches of Sanofi’s chemotherapy Taxotere (docetaxel) have been recalled due to a problem in the manufacturing process that could have led to vials being too concentrated, the European Medicines Agency (EMA) said in an updated alert on the possible shortage on Thursday.

Categories: News, Europe, EC, EMA, MHRA, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence

Tags: Sanofi, docetaxel, drug shortage, drug manufacturing

Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA By Zachary Brennan - Published 27 May 2016

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Product withdrawl and retirement

Tags: Sanofi, Mylan, PhRMA, GPhA, biosimilars, BPCIA

Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016) By Nick Paul Taylor - Published 17 May 2016

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

Categories: News, Asia, CDSCO, MHLW, TGA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Postmarket surveillance

Tags: GMP site inspections, India expert committees, Sanofi, packaging

Former FDA and NIH Heads Call for Regulatory Harmonization By Zachary Brennan - Published 11 May 2016

Former US Food and Drug Administration (FDA) commissioner Margaret Hamburg and former National Institutes of Health (NIH) director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EMA, FDA, GHTF, Health Canada, ICH, IMDRF, MHRA, WHO, Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi

Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (10 May 2016) By Nick Paul Taylor - Published 10 May 2016

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

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Crisis management, Drugs, Medical Devices, Regulatory strategy

Tags: Asia Regulatory Roundup, Sanofi, dengue vaccine, vaccine scandal in China

European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016) By Nick Paul Taylor - Published 11 February 2016

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

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Veterinary products

Tags: NICE, Xarelto, Paluent, Sanofi, Amgen, ENVI

Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities By Zachary Brennan - Published 05 February 2016

As part of Health Canada’s transparency push, the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016.

Categories: News, Canada, Health Canada, Audit, Biologics and biotechnology, Compliance, Drugs, Manufacturing, Medical Devices, Quality

Tags: Health Canada, Gilead, Sanofi, Actavis, Baxter, GMP inspections

India Fines GSK, Sanofi for Alleged Anti-Competitive Practices By Michael Mezher - Published 09 June 2015

The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports.

Categories: News, India, Biologics and biotechnology

Tags: Competition Commission of India, CCI, GSK, Sanofi, Meningitis vaccine

Sanofi Bets Nearly a Quarter Billion on Voucher for Faster Drug Approval By Alexander Gaffney, RAC - Published 28 May 2015

An unusual regulatory incentive used to accelerate the review of a small number of drug products has just sold to the French pharmaceutical giant Sanofi for the record-setting sum of $245 million.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Priority Review Voucher, PRV, Rare Pediatric Priority Review Voucher, Sanofi

With New Data in Hand, Could Sanofi and Regeneron Use a Regulatory Shortcut? By Alexander Gaffney, RAC - Published 16 March 2015

A new drug being co-developed by drugmakers Sanofi and Regeneron could, according to new data, dramatically decrease low-density lipoprotein (LDL) cholesterol in patients and lessen cardiac events. But it's a reduction in something else that could be most important for Sanofi and Regeneron: the time it might take the US Food and Drug Administration (FDA) to review the new drug, Praluent.

Categories: News, US, CDER, Biologics and biotechnology, Regulatory strategy, Submission and registration

Tags: Sanofi, Regeneron, Praluent, Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher

First Pediatric Priority Review Voucher Goes up for Sale, Fetching $67M By Alexander Gaffney, RAC - Published 31 July 2014

As far as regulatory incentives go, some are pursued more than others. 

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Pediatric Rare Disease Voucher, Tropical Disease Voucher, Priority Review Voucher, Priority Review, Vimizim, BioMarin, Sanofi, Degeneron

NICE Draft Guidance Rejects Sanofi's Metastatic Colorectal Cancer Treatment Zaltrap By Louise Zornoza, RegLink - Published 21 June 2013

Categories: NICE

Tags: Zaltrap, Sanofi, Latest News, UK, draft guidance

Sanofi Pasteur Recalls Vaccine in UK after Efficacy Concerns Raised By Alexander Gaffney - Published 09 October 2012

Categories: MHRA

Tags: Typhim Vi, Typhoid, Sanofi Pasteur MSD, Vaccine, Recall, Latest News, UK

New MS Drug Receives FDA Approval By Alexander Gaffney - Published 13 September 2012

Categories: FDA

Tags: Aubagio, Genzyme, Multiple Sclerosis, MS, Sanofi, Latest News, REMS

New Colorectal Cancer Therapy Approved by FDA By Alexander Gaffney - Published 03 August 2012

Categories: FDA

Tags: Regeneon, Colorectal Cancer, Zaltrap, Sanofi, Latest News

FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent By Alexander Gaffney - Published 18 May 2012

Categories: FDA

Tags: BMS, Patent Cliff, Plavix, Apotex, Sanofi, Latest News, pharmaceutical, approval, drug

UK: New Prostate Cancer Drug Extends Life, But NICE Against Reimbursement By Louise Zornoza, RegLink - Published 11 May 2012

Categories: Regulatory Update, NICE, Reimbursement

Tags: Costly, Prostate Cancer, Jevtana, Unapproved, Sanofi, CER, UK

Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up By Alexander Gaffney - Published 20 April 2012

Tags: Patient Group, AVE 8112, Michael J. Fox, Parkinson's, MJFF, Sanofi, Latest News, partnership, clinical trial, development