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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-81/
- Published: 2016-06-12T12:00:00.000Z
- Updated: 2026-09-14T21:09:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135923

**Paradigm Spine** has agreed to pay the U.S. government $585,000 to resolve allegations under the False Claims Act that it caused health care providers to submit false claims to Medicare and other federal health care programs by marketing the company’s coflex-F device for unapproved uses, according to U.S. Attorney for the District of Maryland **Rod J. Rosenstein.** According to the settlement agreement, from 2011 to 2013, Paradigm Spine allegedly marketed coflex-F for surgical uses that were not approved by the FDA and from 2012 to 2015, the company allegedly provided health care providers with improper guidance on how to claim reimbursement for coflex. Paradigm denies the allegations.The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act by Chris Coyle, a former Paradigm Spine sales representative

**TapImmune, Inc.** says it has exercised its option agreement with **Mayo Clinic** and signed a worldwide license agreement to a proprietary HER2neu vaccine technology, which was developed in the laboratory of **Keith Knutson** at Mayo Clinic. According to the company, the agreement gives TapImmune the right to develop and commercialize the technology in any cancer indication in which the Her2neu antigen is overexpressed. TapImmune says Phase 1 clinical trial data has demonstrated that the technology was safe, well-tolerated, and provided a robust immune response across a broad patient population.

Pharmaceutical company **Alk** presented new data at the 2016 Annual Congress of the European Academy of Allergy and Clinical Immunology in Vienna from the Grazak Asthma Prevention (GAP) trial with Grazak, the company’s allergy immunotherapy tablet against grass pollen allergy. The company says the data showed that Grazak treatment reduced the proportion of patients with asthma symptoms or use of asthma medication and also reduced the proportion of patients experiencing asthma symptoms during the entire five year trial period with the effect most pronounced during the two year post-treatment period. Also, the company adds that the GAP trial demonstrated the efficacy of Grazak on grass allergic rhinoconjunctivitis in children, with benefits persisting for two years after treatment.

**Janssen Research & Development** reports positive results from a Phase 2 study of canagliflozin, showing glycemic improvements in adults with Type 1 diabetes mellitus (T1DM) when treated with canagliflozin, a sodium-glucose co-transporter 2 inhibitor, plus insulin. The company says the 18-week Phase 2 trial evaluated 351 adults with inadequately controlled T1DM who were administered canagliflozin 100 mg, canagliflozin 300 mg or placebo as an add-on to insulin.

**Merck** has agreed to acquire **Afferent Pharmaceuticals** in a deal that could amount to $1.25 billion. Afferent Pharmaceuticals is a developer of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions. Its lead investigational candidate, AF-219, is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase 2b clinical trial for treating refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis with cough.

**Perrigo Company** believes it is the first to file an ANDA with FDA for ingenol mebutate gel (0.015% and 0.05%), the generic versions of **Leo Pharma/Leo Laboratories’** Picato gel (0.015% and 0.05%), indicated for the topical treatment of actinic keratosis. According to Perrigo, Leo Pharma A/S, Leo Laboratories Ltd. and Leo Pharma, Inc. filed suit in the U.S. District Court for the District of Delaware 6/10 alleging patent infringement, which formally initiates the litigation process under the Hatch-Waxman Act.