Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval

Sanofi Pasteur has announced the completion of the manufacture of TheraCys, an important drug against bladder cancer, and shortages are expected, while the Food and Drug Administration (FDA) on Friday issued draft guidelines to help develop new treatments for non-invasive nonmuscular cancer NMIBC ).
Benjamin Davies, MD, associate professor of urology at the University of Pittsburgh School of Medicine, wrote in Forbes on Thursday, called on the government to step in and posted Sanofi's letter informing doctors of the decision.

Sanofi said production would cease at the Canadian manufacturing facility in mid-2017 and production will not resume.

In 2012, the Canadian facility received a warning letter from the FDA stating that "sterility for all batches of TheraCys, BCG Live (Intravesical) (BCG-IT) manufactured in the building (B) Method Validation in 2000 can not be insured. "

And when the facility closed in 2012, many patients either missed doses or received lower medications in place of BCG, according to another Davies article here.

The same Toronto facility later stated in October 2015 as a result of these molds and other problems Health Canada would allow it to resume production of drugs later in 2015, The FDA.

Sanofi said in his letter this week that no other company would take on the manufacture of the product and "the product will not be relaunched in the United States."

Rejection and draft guidance from the FDA

Separately on Thursday, Spectrum Pharmaceuticals said the FDA had rejected its NMIBC treatment, Apaziquone. "Based on the discussions, the Company is evaluating a new, more modest study that would replace the ongoing Phase 3 program in which enrollments were stopped," the company said in a fil filing.

Telesta Therapeutics also received a full response letter for its FDA NMIBC treatment in February, saying an additional Phase 3 clinical trial would be required.

Following these refusals, the FDA released Friday to 12-page draft guidelines to help pharmaceutical and biotech promoters try to develop drugs and biologics to treat patients with this form of high-risk bladder cancer.

"The alternative is radical cystectomy, the surgical procedure with significant morbidity and mortality," says the FDA.

"The preferred trial design to demonstrate the efficacy of drugs developed to treat NMIBC is a randomized, controlled trial with a survival time without recurrence. (BCG) in situ, with or without papillary using a complete end-of-response rate criterion (and duration) may be appropriate.

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EMA Recommends Nine Drugs for Approval

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced on Friday that I recommend nine drugs for its meeting approval in a This Week of Principles, including four new treatments, three and two generic biosimilars .

Regarding New Medicines, the CHMP Recommends Marketing Authorization for Afstyla (lonoctocog alfa) CSL Behring for the Prevention and Treatment of Hemorrhage in Patients with Haemophilia A, FIASP Novo nodisk (insulin aspart) for Diabetes, Suliqua Sanofi (Glargine / lixisenatide insulin) for the treatment of type 2 diabetes and Vemlidy (tenofovir alaphaenamide) Gilead for chronic hepatitis B.

Three of the four new treatments have been approved by the FDA and US Food and Drug Administration (FDA), including FDA approval Thursday Vemlidy. The US regulator has until last of this my sober decision for the Sanofi Treatment Request After Further Information on the Delivery Device.

In the Biosimilars Front, Lusduna Three New were recommended for approval by the CHMP Merck Sharp and Dohme (Glargine Insulin) for the treatment of diabetes, as well as STEMA Arzneimittel of Movymia not Gedeon Richter Terrosa (Both contain teriparatide) for Treatment of osteoporosis.

None of THESE Treatments Has Been Approved by the US FDA, Merck AGAINST in August A New Drug Application Presented for its biosimilar insulin biosimilar in the US, with Partial Funding Samsung Bioepis.

The CHMP also recommends return generic medications for approval: darunavir Mylan for Treatment HIV-1 Infection by Tadalafil and Mylan for Treatment of Pulmonary Arterial Hypertension. FDA for the First Time American Authorized Generic Darunavir Mylan in 2013, EVEN for Tadalafil, Best Known as in the US Cialis, there is no generic Generic Market.

In addition, EMA recommends extensions of the Indications Novartis Arzerra (ofatumumab), Genzyme Caprelsa (vandetanib) Abbvie Humira (adalimumab), Pfizer's Nimenrix (meningococcal Group A, C, W135 and Y conjugate vaccine) is UCB Pharma Vimpat (lacosamide) .

Complete CHMP also Scientific An evaluation of the Annual Marketing Authorization Renewal Conditional Conditional Treatment of Duchenne Muscular Dystrophy, Duchenne Dystrophy (DMD) from PTC Therapeutics Translarna (ataluren) recommending that you renew the conditional marketing authorization f. In the United States, the FDA sent the Past A decision of February my Refuse AFTER a PTC from the agency SAID the Company's Request for Treatment Was Not Completely Enough.

As part of the CHMP evaluation for Transplanna, the PTC Requester Regulator conducted a randomized, placebo-controlled eighteen-month study with patients in DMD, followed by an 18-month period in which all patients would change to have transplantation. If you expect the Study Results in the primer to be available quarter 2021.

Overall, by 2016, the CHMP has Issued Positive Opinions 73 Medications, Including New Treatments, Biosimilars Generics Y, And 50 Opinions ON THE POSSIBLE EXTENSION OF THERAPEUTIC REGISTRIES.

RAC US Exam Question No 46

Question No 46:

MDUFMA authorized 3rd party establishment inspections. All of the following are true about these inspections EXCEPT:

A. You need to market at least one device in the United States.
B. Participation is mandatory.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
D. Establishments are not required to obtain clearance of a 3rd party in advance.

Answer: B

Health Canada Issues New Medical Device Recall Guide

Health Canada on Thursday issued new guidance on the medical device recalls in detail the responsibilities of sponsors under the Medical Devices Regulations (MDR) in the country, replacing the 2011 Guidelines of the organization.

Specifically, the guide provides advice on keeping medical records distribution, extraction devices instruments, submission to Health Canada recalls and drafting internal procedures for retirement.

The guide has also been rewritten to include support clubs and other language intended to provide clarity and other fund sponsors, including links to definitions, laws and regulations.

For example, in the section on the scope of the document, the agency added an explanation of why the regulatory requirements for reminders apply to different types of businesses:

The requirements to maintain distribution records under [section] 52-56 [Regulation of Medical Devices] and the recovery process in accordance with paragraph 58 (b) of the MDR (Part 1) s' apply to manufacturers, importers and distributors. The information requirements provided for in Articles 64 and 65 manufacturers and importers apply only.

The new guide also focuses more on the process and responsibilities related to the removal of the devices, while the previous version was more technical in nature, focusing on the different sections of the MDR and interpretation.

The new guide also includes additional annexes containing tables and checklists to carry out withdrawals and maintain distribution records.

Finally, the new guide includes detailed instructions for writing retirement procedures and reports of memory sections.

RAC US Exam Question No 45

Question No 45:

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than:

A. 5 calendar days.
B. 15 calendar days
C. 30 calendar days.
D. The next quarterly or annual report.

Answer: C