Industry News

Licorice roots have a diverse and flavorful history, having been used in ancient Egyptian times as a tea and in traditional Chinese medicines, all the way to a flavoring agent and as an ingredient in some licorice candies. Some women now take licorice extracts as supplements to treat hot flashes and other menopausal symptoms. But scientists caution that the substance could pose a health risk by interacting with medications.

The settlement resolves claims relating to the classification of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector for purposes of the Medicaid Drug Rebate Program. The question in the underlying matter was whether the EpiPen products were properly classified with the Centers for Medicare and Medicaid Services ("CMS") as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.

Sanofi announced that it filed a patent infringement suit against Merck Sharp & Dohme Corp.  in the United States District Court for the District of New Jersey. In its suit Sanofi alleges infringement of two patents.

Iovance Biotherapeutics, Inc a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology,announced that the first patient was dosed in its C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.

Applied Genetic Technologies Corporation a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, announced that it has filed an Investigational New Drug application (IND) with the U.S. Food and Drug Administration to conduct a Phase 1/2 clinical trial of the company's gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.

Sun Pharma to aquire US based Krystal Biotech in 7 million USD. Krystal Biotech is a biopharmaceutical company using gene therapy to develop treatments for patients suffering from rare debilitating disorders.

AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

Zydus Cadila has received the final approval from the USFDA to market Temozolomide Capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Acyclovir Ointment USP, 5%, the generic version of Zovirax® Ointment, 5%, of Valeant International Bermuda.