Biosimilars Approval: Opportunities and Challenges

Posted by on June 14, 2018

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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Managing Relationships: Identifying and Engaging Thought Leaders in Pharma and Biotech

Posted by on March 29, 2018

Who are Key Opinion Leaders and why they are important? Key Opinion Leaders (KOLs) are physicians and scientific experts that have an independent voice or strong impact earned from an established reputation in their field. These thought leaders are extremely useful to pharmaceutical, medical device and biotech companies, as they can play an important role
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Demand for Experts When the Stakes are High – The Added Value of KOLs

Posted by on March 26, 2018

A Key Opinion Leader (KOL) is an individual who has achieved such a significant social or professional status in a certain community, such as doctors, researchers, lawyers, celebrities, etc., that their recommendations can impact the decision-making process of their peers. The benefits of engaging KOLs is apparent in almost every industry but has been particularly
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FDA Advisory Committee Gives Amgen Green Light on New Indication for Blincyto®

Posted by on March 14, 2018

On March 7th, 2018 the Oncologic Drugs Advisory Committee (ODAC) gathered to discuss supplemental biologic license application (sBLA) 125557/S-013, for Blincyto ® (blinatumomab) injection for intravenous use via Amgen, Inc.  The panel discussed the proposed indication for the treatment of minimal residue disease-positive B-cell precursor acute lymphoblastic leukemia (MRD+ ALL).  Amgen’s blinatumomab was awarded breakthrough therapy
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FDA Advisory Committee Supports New Ulcerative Colitis Indication for Xeljanz (Tofacitinib)

Posted by on March 13, 2018

On March 8th, 2018 the FDA Gastrointestinal Drugs Advisory Committee (GDAC) discussed the supplemental new drug application (sNDA) 203214 supplement 18, for XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., for the treatment of adults with moderate to severely active ulcerative colitis (UC) who have had inadequate response, loss of response,
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FDA Advisory Committee Denies Charleston Laboratories’ Hydexor

Posted by on February 20, 2018

On February 14th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) reviewed new drug application (NDA) 209257 for Charleston Laboratories’ novel pain drug, Hydexor. Hydexor is a fixed-dose combination oral tablet containing hydrocodone, acetaminophen, and promethazine for the treatment
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FDA Panel Denies Aradigm the Opportunity to Market Inhaled Antibiotic Treatment for Non-Cystic Fibrosis Bronchiectasis Patients

Posted by on January 29, 2018

The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp. The panel discussed the proposed indication of treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa. Aradigm has since received a complete response letter
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FDA Panel Rejects Philip Morris’ Claim that iQOS Device is Safer than Continuing to Smoke Cigarettes

Posted by on January 26, 2018

The Tobacco Products Scientific Advisory Committee met on January 24th and 25th, 2018 to discuss the modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for iQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks. These modified-risk applications are different from
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FDA Panel Denies Clarus and Lipocine a Run at the First Oral Testosterone Replacement Therapy

Posted by on January 16, 2018

The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations: Jatenzo (Clarus Therapeutics) and Tlando (Lipocine). Both formulations are the first proposed oral testosterone replacement therapy for males with conditions associated with a deficiency or absence of testosterone, such as congenital/acquired primary hypogonadism
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FDA Panel Conducts Safety Review of Gadolinium Retention in the Brain from Gadolinium Based Contrast Agents

Posted by on November 27, 2017

On September 8th, the Medical Imaging Drugs Advisory Committee (MIDAC) discussed the potential risk of systemic gadolinium retention, especially in the brain, in patients receiving gadolinium-based contrast agents (GBCAs) used for magnetic resonance imaging (MRI) diagnostic procedures. This was a multi-sponsor meeting, which included Bayer Healthcare, Bracco Diagnostics, GE Healthcare, and Guerbet. The meeting began
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