The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet tomorrow, January 14, to review and discuss Nektar Therapeutics’ (NKTR +1.2%) marketing application seeking approval to use opioid oxycodegol (NKTR-181) to treat adults with chronic low back pain.
Monday, January 13, 2020
Taro Pharmaceuticals recalls epilepsy drug
Taro Pharmaceuticals, a Hawthorne, N.Y.-based drugmaker, is recalling one lot of its drug, Lamotrigine, designed to treat epilepsy and bipolar disorder, after discovering it was cross-contaminated with a small amount of another drug substance.
The drugmaker said Jan. 10 it discovered the lot contained a small amount of Enalapril Maleate, a drug substance used to manufacture another drug at the same facility. Enalapril Maleate is used to treat congestive heart failure and hypertension.
Chronic exposure to Enalapril Maleate increases the risk of birth defects in a developing fetus.
Taro has not received any reports of adverse events related to the recall.
Consumers with the affected lot should return the Lamotrigine tablets to their pharmacy. Retailers, pharmacies and distributors should stop distributing or dispensing the affected product and return it to Taro.
Read the full news release here.
McKesson ups 2020 earnings guidance
PhaseBio to acquire pipeline assets of Viamet Pharmaceuticals
PhaseBio Pharmaceuticals (NASDAQ:PHAS) inks an agreement with Viamet Pharmaceuticals Holdings and its wholly owned subsidiary Selenity Pharmaceuticals to acquire all of their assets and intellectual property related to certain aldosterone synthase inhibitors including lead candidate SE-6440 (or VT-6440). The compound will be renamed PB6440 which PhaseBio plans to develop for treatment-resistant hypertension.
Under the terms of the agreement, Viamet will receive an upfront payment, milestones and tiered royalties on net sales. Specific financial terms are not disclosed.
Shares up 9% after hours.
Ligand Pharma out-licenses OmniAb platform to Pandion
Ligand Pharmaceuticals (NASDAQ:LGND) inks an agreement with Pandion Therapeutics granting the latter a non-exclusive global license to its OmniAb antibody discovery platform.
Under the terms of the deal, Ligand will receive an upfront fee, milestones and royalties on net sales. Specific financial terms remain confidential.
Qiagen teams up with Amgen on companion diagnostic for AMG 510
QIAGEN N.V. (NYSE:QGEN) will collaborate with Amgen (NASDAQ:AMGN) to develop a tissue-based companion diagnostic for cancer candidate AMG 510. The initial work will focus on non-small cell lung cancer but the agreement allows for development for other indications.
Financial terms are not disclosed.
Stemline Therapeutics sees Elzonris Q4 revenues of $11.8M
Stemline Therapeutics (NASDAQ:STML) -20.4% after-hours after announcing preliminary net revenues for Q4 and the full year.
STML estimates Q4 revenues for Elzonris, its treatment of adult and pediatric patients with blastic plasmacytoid dendritic cell neoplasm, totaled $11.8M, while FY 2019 revenues came in at $43.2M.
“Given the orphan nature and unique features of this disease, we believe patient starts were subject to significant quarterly variance – a phenomena that will likely continue throughout 2020,” the company says.
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