Pharma News

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.

Zydus Cadila has received the final approval from the USFDA to market Telmisartan and Hydrochlorothiazide Tablets USP, in the strengths of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg.

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.

Researchers at the Swedish Medical Nanoscience Center at Karolinska Institutet have developed an innovative way of hacking conducting plastics so as to prevent bacterial growth using silver nanoparticles and a small electrical current. The method, which could prove to be useful in preventing bacterial infections in hospitals, is presented in the scientific journal Advanced Healthcare Materials.

Carrying extra weight could raise your risk of heart attack by more than a quarter, even if you are otherwise healthy. Researchers have found that being overweight or obese increases a person’s risk of coronary heart disease (CHD) by up to 28 per cent compared to those with a healthy bodyweight, even if they have healthy blood pressure, blood sugar and cholesterol levels.

Plants have been used to produce a new vaccine against poliovirus in what is hoped to be a major step towards global eradication of the disease.

Anthera Pharmaceuticals announced that the RESULT Phase 3 clinical study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis has been approved by the European Cystic Fibrosis Society Clinical Trial Network (ECFS CTN) Executive Committee.

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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.