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. Although none of the findings of the inspections have been listed on Health Canada’s inspection tracker , and specific details on the...

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. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...

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...

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...

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...

The UK's National Institute for Health and Care Excellence (NICE) has issued new draft guidance that does not recommend aflibercept (Zaltrap, Sanofi) for treating metastatic colorectal cancer resistant to or progressing after treatment with an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...

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...

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...

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...

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...

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...

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. ...