• Regulatory NewsRegulatory News

    Sanofi Bets Nearly a Quarter Billion on Voucher for Faster Drug Approval

    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. Background The incentive, known as a Rare Pediatric Disease Priority Review Voucher (Pediatric PRV), is an integral part of a program meant to spur the development of new therapies of rare pediatric diseases. The Pediatric PRV program was established under the Food and Dru...
  • Regulatory NewsRegulatory News

    With New Data in Hand, Could Sanofi and Regeneron Use a Regulatory Shortcut?

    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. Background In July 2014, Sanofi and Regeneron announced they had purchased what...
  • Regulatory NewsRegulatory News

    First Pediatric Priority Review Voucher Goes up for Sale, Fetching $67M

    As far as regulatory incentives go, some are pursued more than others. The US Food and Drug Administration's (FDA) orphan drug exclusivity provisions, for example, have brought about a renaissance of therapies meant to treat patients suffering from rare diseases and conditions. But on the other side of the coin are incentives not often sought out by companies. And perhaps no incentive maintained by FDA is used less than its priority review vouchers. Background: Vouchers...
  • NICE Draft Guidance Rejects Sanofi's Metastatic Colorectal Cancer Treatment Zaltrap

    The UK's National Institute for Health and Care Excellence (NICE) has issued new draft guidance that does not recommend aflibercept (Zaltrap, Sanofi) for treating metastatic colorectal cancer resistant to or progressing after treatment with an oxaliplatin-containing regimen. NICE Chief Executive Sir Andrew Dillon commented that, "Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effectiv...
  • Sanofi Pasteur Recalls Vaccine in UK after Efficacy Concerns Raised

    UK regulators with the Medicines and Healthcare products Regulatory Agency (MHRA) have issued a drug alert to healthcare practitioners warning them of a recall involving Sanofi Pasteur MSD's typhoid vaccine, Typhim Vi. In its 8 October warning, MHRA said while the vaccine remained safe, concerns had been raised about the product's effectiveness against typhoid, and the agency urged all patients who recently traveled abroad and remained "unwell" to seek medical attentio...
  • New MS Drug Receives FDA Approval

    The US Food and Drug Administration (FDA) has given approval to a new once-a-day drug intended to treat relapsing forms of multiple sclerosis (MS), the agency announced on 12 September. Multiple sclerosis affects the connective tissue around the brain and spine, causing the immune system to attack the body's ability to communicate with itself. Though its causes remain unknown, patients are able to keep the disease in a state of remission through various treatment optio...
  • New Colorectal Cancer Therapy Approved by FDA

    The US Food and Drug Administration (FDA) has approved sanofi and Regeneron Pharmaceuticals' Zaltrap (ziv-aflibercept) for the treatment of colorectal cancer in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan). The drug had mixed results in clinical trials, with the two companies revealing in April 2012 that it was ineffective at treating prostate cancer-a target since withdrawn. Sanofi and Regeneron instead decided to focus solely on the drug's col...
  • FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent

    The US Food and Drug Administration (FDA) announced it has approved eleven generic versions of Bristol-Myers Squibb and Sanofi's blockbuster blood-thinner Plavix (clopidogrel bisulfate), marking the latest product to go off the so-called "patent cliff." Many drugs are scheduled to lose their patent protection in the coming two years, marking huge potential losses to the bottom lines of numerous companies. Both Sanofi and BMS said they expect a "rapid, precipitous and mat...
  • UK: New Prostate Cancer Drug Extends Life, But NICE Against Reimbursement

    Despite the recognized life extending benefits of Sanofi's new prostate cancer drug, Jevtana (cabazitaxel), the UK's National Institute for Health and Clinical Excellence (NICE) has recommended against reimbursement by the National Health Service (NHS) because it is not cost effective.  The drug is used in combination with prednisone or prednisolone as a second line treatment for prostate cancer.  In final guidance published 11 May, NICE concluded that while...
  • Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up

    • 20 April 2012
    Following in the footsteps of other successful partnerships between pharmaceutical manufacturers and patient groups, French life sciences company Sanofi is teaming up with the Michael J. Fox Foundation (MJFF) to collaborate on testing a new treatment for Parkinson's disease. The partnership will test a compound known as AVE 8112, a phosphodiesterase type 4 inhibitor, in a phase 1 b clinical trial to assess the drug's safety and tolerability, Sanofi said in a statement. ...
  • Eli Lilly's Lechleiter Replaces Sanofi's Veibacher as PhRMA Chairman

    • 16 April 2012
    The Pharmaceutical Researchers and Manufactuers of America (PhRMA), the powerful trade organization of the pharmaceutical industry, announced at its annual meeting its members have elected John C. Lechleiter, CEO of Eli Lilly and Co., as its next chairman. Lechleiter will replace outgoing Chairman Christopher Veichbacher, CEO of Sanofi, who has served the organization since 2008. The Chairman of the PhRMA Board-along with PhRMA's President, currently John Castellani-has...
  • Lawsuit Against Genzyme Seeks Damages for Fabrazyme Shortages

    • 12 March 2012
    A lawsuit filed by an Idaho woman claims negligence on the part of Genzyme, now a subsidiary of Sanofi, led to persistent drug shortages and consequently the death of her husband. Shortages of Fabrazyme, used to treat Fabry Disease, started in 2009 when viral contamination was discovered at a Genzyme manufacturing facility. Shortages were further exacerbated when additional contamination was found by the US Food and Drug Administration later in 2009, leading to a situati...