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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-128/
- Published: 2019-09-15T12:00:00.000Z
- Updated: 2026-09-15T01:49:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134769

**Mylan** says it will acquire **Meda** AB in a $7.2 billion cash-and-stock deal. This was the third attempt by Mylan to buy the Swedish company.The offer, recommended by Meda’s board, valued the company at $9.9 billion, including debt.

**RedHill Biopharma** has submitted to FDA a Phase 2 study protocol for Bekinda (ondansetron) 12 mg for its use in treating diarrhea-predominant irritable bowel syndrome. The company says it recently concluded a “successful” first-in-man pharmacokinetic study to support the planned Phase2I study. A Phase 3 study with Bekinda 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in the second half of this year. Bekinda is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, that is being studied in multiple gastrointestinal indications.

**Eisai Inc.** says results from its pivotal Phase 3 study of the use of Halaven (eribulin mesylate) Injection (0.5 mg per mL) in certain types of soft tissue sarcoma were published online by *The Lancet*. According to the company, evaluated overall survival in previously treated patients with advanced liposarcoma or leiomyosarcoma treated with Halaven compared with those treated with dacarbazine. It says the results demonstrates a survival benefit with eribulin in patients with advanced liposarcoma. FDA approved Halaven 1/28 for treating patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

**NanoViricides, Inc.** has entered into an agreement with **Baylor College of Medicine** for evaluating the efficacy and potency of its nanoviricides drug candidates in a small animal model of ocular virus infections. The company says the goal of these studies is to help select clinical drug development candidates for treating certain ocular viral diseases including herpes keratitis in humans.

**Capsugel** and **Pulmatrix, Inc.** have formed a collaboration to develop novel inhaled therapeutics to treat serious pulmonary diseases. Under the agreement, Capsugel will have exclusive rights to manufacture clinical trial and commercial batches of iSPERSE-based inhaled therapeutic candidates being developed by Pulmatrix and its potential development partners, according to the companies. Also the companies say Capsugel will combine its spray drying process development, scale-up expertise and commercial manufacturing capabilities at its Bend Research facility in Bend, OR with Pulmatrix’s iSPERSE (inhaled small particles easily respirable and emitted) technology.

**ImmunoCellular Therapeutics** has entered into an agreement with **Stanford University** for an option to evaluate and license intellectual property related to identifying T cell receptors developed in the laboratory of Prof. **Mark Davis**, director, Stanford Institute for Immunity, Transplantation and Infection, and The Burt and Marion Avery Family Professor of Immunology at Stanford University School of Medicine. ImmunoCellular’s **Steven Swanson** says the company’s “strategy is to integrate complementary breakthrough technologies by using modified stem cells from the patient to develop antigen-specific killer T cells that can directly attack and potentially eradicate tumors and prevent their recurrence.”