Drugs
FDA and Catalyst Pharmaceuticals have reached an agreement under a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach in an upcoming Phase 3 study evaluating Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome. Catalyst intends to conduct its second Phase 3
Drugs
The latest FDA report on the status of drug postmarketing requirements and commitments shows that industry is struggling to submit annual status reports on time, if submitted at all. As of 9/30/14 there were 639 open NDA/BLA postmarketing requirements, up from 613 on the same date a
Drugs
A Washington Legal Foundation legal backgrounder examines the recent convictions of two Acclarent (Johnson & Johnson subsidiary) executives in U.S. v. Facteau (see story) and the questionable boundaries that currently separate speech from criminal conduct. Authored by Sedgwick attorneys Anthony J. Anscombe and Mary Beth Buckley, the backgrounder notes
Drugs
FDA has sent Regeneron Pharmaceuticals and Sanofi a Complete Response Letter on their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. The letter cites certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le
Drugs
FDA has placed a partial clinical hold on AstraZeneca’s enrollment of new patients with head and neck squamous cell carcinoma in clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. All trials are continuing with existing patients, the company says, adding that the
Drugs
Five organizations that represent consumers, retirees, and patients or that provide medical care globally are expressing concern about the potential for an extension of the monopoly protection for biologics in the Trans-Pacific Partnership (TPP) implementing legislation and/or side letters. A 10/26 letter to President Barak Obama from
Drugs
Adamas Pharmaceuticals has submitted an NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules, indicated for treating levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. The submission is supported by efficacy and safety data from three placebo-controlled trials: EASED, EASE LID and EASE LID 3. The trials
Drugs
Salix Pharmaceuticals is petitioning FDA not to approve an ANDA citing any strength of its Xifaxan (rifaximin) as the reference-listed drug unless it conforms with an extensive series of conditions submitted by Salix. The company says that any ANDA that references either strength or any indication of Xifaxan as
Drugs
Under terms of the Generic Drug User Fee Amendments of 2012, FDA is to prepare a yearly list of regulatory science priorities for generic drugs based on input from industry and other stakeholders. The agency has released this list of priorities for FY 2017: * post-market evaluation of generic drugs,
Drugs
FDA has awarded Engility Holdings a $112 million five-year contract for computational science and bioinformatics services. As part of the contract, the company will provide security, operations and maintenance, and technical support for scientific computing environments and systems. “Engility will help the FDA build fast, reliable and adaptable high
Drugs
The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures (MAPP) for review of investigational NDAs submitted for bioavailability or bioequivalence studies, known as Bio-INDs. The MAPP says the term Bio-IND distinguishes such studies from INDs for investigational new drug products submitted to the
Drugs
Public Responsibility in Medicine and Research (PRIM&R) says it agrees with the need for additional guidance on institutional review boards (IRBs), but has concerns about a guidance with an IRB written procedures checklist issued by FDA and the HHS Office for Human Research Protections. The group cautions that
Drugs
The Biotechnology Innovation Organization (BIO) says in comments on two draft FDA guidances on compounded drug products that it has long supported a prohibition on compounding of commercially available FDA-approved products unless the drugs are medically necessary to address a unique individual patient need not met by the approved
Drugs
The International Society for Pharmaceutical Engineering says a draft FDA guidance on data integrity and compliance with current good manufacturing practice provides greater clarity on many issues surrounding data integrity, but further clarifications are needed. The group says the guidance needs to capture important risk-based principles and should clarify
Drugs
The 7th Circuit Court of Appeals has rejected a plaintiff’s argument that the FDA Amendments Act of 2007 (FDAAA) changed generic drug labeling requirements such that failure-to-warn claims are no longer preempted. Attorney Stephen McConnell (Reed Smith) writes online in the Drug and Device Law blog that
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FDA and the European Union are moving forward with a GMP inspection mutual agreement to recognize each other’s inspectional activities, with such an agreement being finalized in January. The agreement is part of the negotiations under the Transatlantic Trade and Investment Partnership (TTIP). There are still a number of
Drugs
Harvard Medical School professors Aaron Kesselheim and Jerry Avorn say that FDA’s recent approval of eteplirsen (Exondys 51) as a treatment for Duchenne muscular dystrophy provides “a worrisome model for the next generation of molecularly targeted therapies: demonstrate a slight difference in a laboratory test, activate the patient community,
Drugs
In separate amicus briefs, Mylan and the Generic Pharmaceutical Association’s Biosimilars Council have asked the Supreme Court to hear Apotex’ appeal of a lower court decision in its case against Amgen involving provisions of the 2009 Biologics Price Competition and Innovation Act. Apotex has asked the high court to
Drugs
A 10/12-10/16/15 FDA inspection at Interpharm, Modrany, Czech Republic, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) and significant CGMP violations for finished pharmaceuticals, according to a 10/18 Warning Letter. Specific deviations and violations included: * failing to prevent unauthorized
Drugs
Significant violations of current good manufacturing practice regulations for finished pharmaceuticals were found during a 1/21-1/29 FDA inspection at Teva’s drug manufacturing facility in Godollo, Hungary. A 10/13 Warning Letter says that specific violations included: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
Several drug manufacturers are asking FDA for additional information on a draft guidance on clinical trial endpoints for ulcerative colitis. GlaxoSmithKline says the draft lacks guidance for sponsors on the desired definition of clinical response in the context of the proposed use of a modified Mayo score. “While the guidance
Drugs
FDA has approved a class-wide labeling change for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids