Drugs
Brothers Malvinder Mohan Singh and Shivinder Mohan Singh, the former majority owners of Ranbaxy Laboratories, say they will fight a three-person Singapore arbitration panel’s 2-1 ruling that they must pay about $386 million in damages to Daiichi Sankyo in response to a Daiichi complaint that the two
FDA Policy/General
Federal Register Notice: FDA is making available grant funds to support FDA’s Office of Orphan Products Development Natural History Grants Program. The program’s goal is to support studies that advance rare disease medical product development through characterizing the natural history of rare diseases/conditions, identifying genotypic and phenotypic
FDA Policy/General
Federal Register Notice: FDA has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Such tests systems are used in diagnosing and treating carbohydrate
FDA Policy/General
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 6/1 entitled “Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.” The objective of the workshop is to discuss quantitative and qualitative approaches for verifying
Drugs
Harvard Medical School professor Eric Campbell says that the “financial rewards companies reap” from engaging in behaviors that result in payments to settle civil and criminal cases “far outstrip any penalties they pay.” Campbell is quoted in a Fair Warning online story on a Public Citizen report detailing major drug
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Market Claims in Direct-to-Consumer Prescription Drug Print Ads has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. Its purpose is to assist sponsors in all phases of development of direct-acting antiviral drugs for treating chronic hepatitis C. It revises the draft
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Special Protocol Assessment. It provides information about the procedures and general policies adopted by CDER and CBER for special protocol assessment. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA aims to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public
Drugs
FDA has granted priority review to Eli Lilly for a BLA for olaratumab to be used in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery. Olaratumab is a human IgG1 monoclonal antibody, according to the company,
Devices
FDA says B. Braun is recalling 1,033 units of its Dialog+ Hemodialysis Systems manufactured between 4/1/13 and 7/3/13, and distributed between 6/25/13 and 10/7/15. The company says the recall is due to cracks in conductivity sensors that may allow air to
Drugs
FDA has granted fast track status to Axsome Therapeutics for AXS-02 for treating knee osteoarthritis pain associated with bone marrow lesions. There is currently no product approved specifically for this indication, according to the company. AXS-02 is a potent osteoclast inhibitor being developed as an oral, targeted, non-
Biologics
FDA has accepted for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The agency has set a user fee target action date
Devices
FDA has approved a Boston Scientific PMA for two catheters that can be used with its Rhythmia Mapping System — the IntellaNav XP and the IntellaNav MiFi XP navigation-enabled ablation catheters — which are intended to treat Type I atrial flutter. “These are the first magnetically-tracked catheters that Boston Scientific
Drugs
Angiochem says FDA has scheduled a 6/16 end-of-Phase 2 meeting to discuss clinical study results for the company’s ANG1005 for treating Leptomeningeal Carcinomatosis in patients with breast cancer and brain metastases. The company says the parties will determine the adequacy of current studies, and the safety
FDA Policy/General
FDA says it has submitted to the Office of Management and Budget its data-gathering research proposal to investigate through direct-to-consumer print ads for prescription drugs the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. The submission contains comments
Drugs
Attorneys Frederick Ball and Carolyn Alenci (Duane Morris) say that a recent FDA draft guidance on data integrity and subsequent Warning Letter to Sri Krishna Pharmaceuticals indicate that “FDA is anticipating long-term measures to be part of a corrective action plan that includes enhancing procedures, systems, and ‘human resources.
Drugs
The HHS Office of Inspector General (OIG) finalized 4/18 a guidance explaining how it will base its decision to exclude drug or medical device companies or their personnel from federal healthcare programs due to False Claims Act suits or investigations. The guidance says a decision to exclude is based
FDA Policy/General
Federal Register Notice: FDA has determined that several drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Drugs
A study by the Centers for Disease Control and Pew Charitable Trusts that involved researchers across the country says that only about 70% of antibiotic prescriptions in the U.S. in 2010-2011 were appropriate, supporting the need for establishing a goal for outpatient antibiotic stewardship. The story was published
FDA Policy/General
FDA associate deputy commissioner for medical products and tobacco Rachel Sherman and commissioner Robert Califf say there are several principles that must be kept in mind as interoperability and connectivity are used to build a national system for evidence generation. Writing in an FDA Voice blog post, they list the
Drugs
Reps. Gerry Connolly (D-VA) and Morgan Griffith (R-VA) have introduced the Curb Opioid Misuse by Advancing Technology (COMBAT) act that they say would encourage drug manufacturers to engage in studies demonstrating abuse-deterrent effectiveness and to increase diversity in abuse-deterrent technologies by providing for extended periods of