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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-58/
- Published: 2022-01-17T12:00:00.000Z
- Updated: 2026-09-14T17:28:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5123294

**Adventrx Pharmaceuticals** has provided details on a Phase 3 clinical study it plans to initiate this quarter of ANX-188 (purified poloxamer 188) in sickle cell disease. The study will be conducted at about 40 sites mostly in the U.S. with a primary objective of demonstrating that ANX-188 reduces the duration of vaso-occlusive crisis in patients with sickle cell disease.

**Bayer** and **Qiagen** have agreed on programs to pair Qiagen companion diagnostic solutions with Bayer innovative targeted therapies for patients with solid tumors. The companies say they will also collaborate on development of novel technologies for patient profiling that may result in innovative research-use-only products for exploratory and translational medicine.

Biotechnology firm **Xbiotech** has reported a positive interim analysis of a Phase 2 study using a True Human monoclonal antibody (MABp1) in patients with Type 2 diabetes aiming to improve control of blood sugar levels by blocking inflammation in the pancreas. According to the company the study is designed to assess safety and pharmacokinetics of MABp1 in the diabetic patient population with a primary efficacy endpoint of glycemic control, as measured by glycated hemoglobin (HbA1c) levels, evaluates the ability of MABp1 to improve control of blood sugar levels by blocking inflammation in the pancreas.

**Watson Pharmaceuticals** has sold for about $117 million its Rugby over-the-counter pharmaceutical products and trademarks to the **Harvard Drug Group** a distributor and provider of private label OTCs and generic prescription products. The Rugby products include cough and cold, allergy, pain relief, nausea relief, nicotine gum, vitamin and nutritional supplement products sold across the U.S.

**Par Pharmaceutical** has entered into an exclusive acquisition and license agreement with **Handa** **Pharmaceuticals** to acquire Handa’s ANDA for quetiapine fumarate extended-release tablets, the generic version of **AstraZeneca**’s Seroquel XR, indicated to treat schizophrenia. Handa believes it is the first applicant to file an ANDA containing a Paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product.