The Promise of Biosimilars

Posted by Hugo LeRoux on Posted on

What is the role of biosimilars in the biologics market? How do they effect patients, providers…etc? What is their impact on innovation? As discussed in our previous post “Biosimilars Approval: Opportunities and Challenges,” Biosimilars are drug products that are “highly similar” to an FDA-approved biological product. As the contemporary cousin of the generic drug, biosimilars
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Biosimilars Approval: Opportunities and Challenges

Posted by Hugo LeRoux on Posted on

What are biosimilars and what makes them different from generic medicines? Biosimilars (also called follow-on biologics) are biologics medicines that are “highly similar” to an FDA-approved biological product, known as a reference product. Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted
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FDA Panel Recommends Approval Of Actavis’ Ceftazidime-Avibactam

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On December 5th, the Anti-Infective Drugs Advisory Committee (AIDAC) discussed new drug application (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc. (a subsidiary of Actavis), for the proposed indications of: Complicated Intra-abdominal Infections (cIAI), Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options.
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FDA panel supports approval of new “abuse-deterrent” opioid oral tablets

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On May 5, 2016, a joint panel of the Anesthetic and Analgesic Drug Products (AADPAC) and the Drug Safety and Risk Management Advisory Committees (DSaRM) supported approval of Apadaz, an opioid drug sponsored by KemPharm Inc. Apadaz is an immediate-release (IR) benzhydrocodone HCI/acetaminophen oral tablet indicated for short-term (maximum of 14 days) handling of acute pain.
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FDA Panel does not Support approval of Eteplirsen

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On April 25, 2016, the Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNSDAC) voted against the market approval of the Eteplirsen drug. Developed by Sarepta Therapeutics, Eteplirsen is currently under New Drug Application (NDA) review for the treatment of Duchenne muscular dystrophy (DMD) in patients with mutations that can benefit from exon 51 skipping.
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FDA Panel Supports Approval of Lesinurad (Zurampic) for Gout

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In October, the Arthritis Advisory Committee (AAC) voted 10 to 4 in favor of approval of lesinurad (Zurampic, AstraZeneca) 200 mg once daily for the treatment of gout-associated hyperuricemia, in combination with a xanthine oxidase inhibitor (XOI). Furthermore, the committee voted unanimously that the company presented substantial evidence in favor of the drug’s efficacy. However, a split vote resulted when the
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FREE WEBINAR – FTC Advertising Claims Enforcement; Hosted by Kelley Drye & Warren

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Innovative Science Solutions invites you to join us for an upcoming, FREE webinar, hosted by Innovative Science Solutions, LLC and Kelley Drye & Warren, LLP: Preparing For The Worst: A Step By Step Guide to Understanding How the FTC Advertising Claims Enforcement Process Works on Tuesday, November 17th from 2-3pm EST.
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FDA Advisory Panel Makes Recommendations for Future of Essure

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Last week, the Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices Advisory Committee made several recommendations regarding Bayer HealthCare’s permanent female sterilization device, Essure:
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FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER

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On September 11th, in a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA), panelists voted unanimously to support the approval of Xtampza ER™ (oxycodone extended-release capsules) for the management of pain severe enough to require daily,
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FDA Panel Suggests that Necitumumab Has Benefit for Lung Cancer

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On Friday, July 9th, the Oncologic Drugs Advisory Committee (ODAC), suggested that necitumumab (Lilly), a monoclonal antibody, shows promise in the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin.
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