By Kurt R. Karst – Now that the dust from 2015 has settled, we’re able to take a look at and evaluate the year that was in orphan drug designations and approvals. Our annual review has become quite popular. We often see the numbers we provide …
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Prescription Drugs and Biologics
- Orphan Drug Approvals Dipped in 2015, While Designations and Designation Requests Continue Upward TrendFebruary 9th, 2016
- HP&M’s Karla Palmer to Speak at FDLI’s Drug Quality and Security in 2016 ConferenceFebruary 9th, 2016
In November 2013, the Drug Quality and Security Act (“DQSA”) was signed into law in an effort to increase the quality of the United States drug supply. The law contains two separate acts: the Compounding Quality Act (Title I), and the Drug Supply Chain Security …
- Eisai Says That the Recently Enacted IRTNMTA Should Result in a Longer PTE for FYCOMPA PatentFebruary 8th, 2016
By Kurt R. Karst – The ink from President Obama’s signature on Public Law No. 114-89, the “Improving Regulatory Transparency for New Medical Therapies Act” (or “IRTNMTA”), was hardly dry when the company that led the charge to change the law, Eisai Inc. (“Eisai”), asked the …
- FDA’s Orange Book Preface Gets a Facelift: What’s New?February 3rd, 2016
By Kurt R. Karst – Those folks who have been following this blog for several years have a good sense about the depths of this blogger’s passion for the Orange Book. There’s the license plate (“ORNGBUK”), the trip to the summit of Mt. Kilimanjaro with the …
- Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation DismissedJanuary 27th, 2016
By Kurt R. Karst – Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or challenging FDA’s denial of New Chemical Entity (“NCE”) exclusivity for VASCEPA (icosapent ethyl) Capsules (NDA …
- FTC Releases Latest Staff Report on Drug Patent Settlement Agreements; Post-Actavis Trends Seem to Be FormingJanuary 19th, 2016
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2014) – Agreements Filed with the Federal Trade Commission under the Medicare …
- CDER Launches Clinical Outcomes Assessment Compendium, Seeks Input on Future ExpansionsJanuary 13th, 2016
By James E. Valentine – On January 13, 2015, CDER’s Clinical Outcome Assessments Staff (formerly Study Endpoints and Labeling Development (SEALD)) announced the launch of Stage 1, or the pilot stage, of its Clinical Outcomes Assessment (COA) Compendium. A COA measures patients’ symptoms, overall mental state, or …
- Briefing in Appeal Over Colchicine 505(b)(2) Approval Wraps Up; Oral Argument and a Decision are Patiently AwaitedJanuary 11th, 2016
By Kurt R. Karst – A few months have passed since the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia Circuit after …
- FDA Issues Proposal on Prescription and OTC Fixed-Combination and Co-Packaged ProductsDecember 30th, 2015
By Riëtte van Laack – On December 23, 2015, FDA issued a proposed rule amending the regulations for prescription and over-the-counter (OTC) fixed-combination products, co-packaged drugs, and combinations of active ingredients under consideration for inclusion in an OTC monograph. The 20-page proposal is intended to harmonize …
- New Life for the Pediatric Priority Review Voucher ProgramDecember 29th, 2015
By Alexander J. Varond – On December 18, Congress extended the rare pediatric disease priority review voucher (pediatric PRV) program out to September 30, 2016. The extension was granted as part of Congress’s budget deal. Although modest, it has been welcomed by industry. Many hope, however, …
- Any Given Patient for Any Given Indication: AbbVie Petitions FDA on Interchangeable BiosimilarsDecember 28th, 2015
By Kurt R. Karst – The once nascent biosimilars industry took off in 2015 with the first biosimilar approval (ZARXIO [filgrastim-sndz], which FDA licensed on March 6, 2015 under BLA 125553), myriad court decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) (see …
- Legislators Want GAO Studies on Non-Biologic Complex Drugs & FDA Inspections, and Want a Raft of Documents as Questions are Raised About ANDA Review EfficiencyDecember 22nd, 2015
By Kurt R. Karst – Congress has been busy in the lead-up to the holiday! In addition to the recently-enacted 2016 Consolidated Appropriations Act, which saddles FDA will meeting myriad requests and new requirements, a host of lawmakers from the U.S. House or Representatives recently sent …
- Pacira Settles and Heralds Changes to How FDA Will Regulate Off-Label Promotion in the New YearDecember 15th, 2015
By David C. Gibbons & Jeffrey N. Wasserstein – Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) announced today that it had reached agreement with FDA to settle its First Amendment challenge regarding the promotion of its drug, EXPAREL. As we discussed in a previous post, Pacira …
- “C” Will Always Follow “P”, Except When the BPCIA is the “BCPIA”, Says District Court in NEULASTA DecisionDecember 14th, 2015
By Kurt R. Karst – Last week, the folks over at the Big Molecule Watch Blog broke the news that the U.S. District Court for Southern District of Florida (Judge James I. Cohn) ruled on a Motion for Preliminary Injunction (supplemented) filed by Amgen, Inc. and …
- Nearing its Sunset, Pediatric Voucher Program Gains MomentumDecember 13th, 2015
By Alexander J. Varond – On December 8, 2015, FDA approved two new therapies: Vonvendi (BLA 125577) for von Willebrand disease and Kanuma (NADA 141-453) for lysosomal acid lipase (LAL) deficiency. These approvals bring the number of new molecular entities and new therapeutic biological products approved this …