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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-83/
- Published: 2016-07-24T12:00:00.000Z
- Updated: 2026-09-14T21:16:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136268

**Chronos Therapeutics** has acquired three pre-clinical development programs targeting central nervous system diseases from a subsidiary of **Shire**. Chronos has acquired all intellectual property, know-how, development and marketing rights for each program, and Shire becomes a strategic equity investor in Chronos and is eligible for milestone payments on product approvals.

**Johnson & Johnson** subsidiary **Acclarent** has agreed to pay $18 million to settle a federal whistleblower false claims lawsuit alleging that the company marketed a sinus device for a drug delivery use not approved by FDA, and causing healthcare providers to submit false claims to Medicare and other healthcare programs. The settlement comes two days after a federal jury in Boston acquitted two former Acclarent executives on felony charges, but they were found guilty of misdemeanor charges of introducing adulterated or misbranded medical devices into interstate commerce. Former Acclarent executives **William Facteau** and **Patrick Fabian** were indicted on 10 counts of introducing adulterated or misbranded medical devices into interstate commerce, one count of conspiracy, three counts of securities fraud, and four counts of wire fraud. The government alleged that the two engaged in a scheme to fraudulently drive up Acclarent revenues and stock valuation by illegally marketing a medical device known as the Relieva Stratus Microflow Spacer for uses not cleared or approved by FDA.

**Ziopharm Oncology** says a patient has died in an ongoing multicenter Phase 1 study involving gene therapy candidate Ad-RTS-hIL-12 plus orally administered veledimex in recurrent or progressive glioblastoma or grade 3 malignant glioma. “The patient death resulting from intracranial hemorrhage in the third cohort of this Phase 1 study was deemed unrelated to study drug following the receipt and analysis of additional information by the sponsor and the study’s safety review committee,” it says. The study remains open for enrollment, and Ziopharm says it will provide further updates on the progress of the study, including longer-term survival follow up, at an appropriate meeting later this year.

**Astellas UK** has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI), which is recognized by the UK government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements, including the pricing scheme for medicines in the UK. The suspension is the result of “serious breaches of the ABPI Code of Practice for the Pharmaceutical Industry,” the organization says in a release.

**Eiger BioPharmaceuticals** says the first patient has been dosed in a Phase 2 ULTRA 24-week study at Stanford University, which is evaluating the effects of ubenimex in patients with secondary lymphedema of the lower limb(s) who are optimized on physical therapies. The company describes ubenimex as a well-characterized, oral, small-molecule, inhibitor of leukotriene A4 hydrolase, which blocks the production of leukotriene B4, an inflammatory mediator implicated in lymphedema.  
  
**AbbVie** and **Bristol-Myers Squibb** (BMS) will collaborate on a clinical trial to evaluate the safety, tolerability and efficacy of AbbVie’s biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) in combination with BMS’ Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC). The companies say the trial will explore the combination of BMS’ immuno-oncology agents, which are designed to alleviate immune suppression, in conjunction with AbbVie’s investigational antibody drug conjugate to drive improved and sustained efficacy and tolerability above the current standard of care.

**QuVa Pharma**, a recently formed national platform for sterile compounding pharmacy services, says it has acquired an FDA-approved 160,000 square-foot biotech pharmaceutical facility in New Jersey to extend its production capability and capacity to deliver ready-to-use compounded sterile drug preparations to hospitals in the eastern half of the U.S.