Basel, July 24, 2015 – Novartis today announced the US Food and Drug Administration (FDA) has approved Odomzo® (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
“The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring,” said Bruno Strigini, President, Novartis Oncology. “Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients.”
Sanofi and Regeneron Announce FDA Approval of Praluent® (alirocumab) Injection, the First PCSK9 Inhibitor in the U.S., for the Treatment of High LDL Cholesterol in Adult Patients
PARIS and TARRYTOWN, N.Y., July 24, 2015 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. read more
TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA Approval as the First and Only All-Oral, Interferon-Free Treatment for Genotype 4 Chronic Hepatitis C in the U.S.
NORTH CHICAGO, Ill., July 24, 2015 /PRNewswire/ — AbbVie (NYSE: ABBV), a global, research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. The approval of TECHNIVIE marks an important advancement in providing this historically difficult-to-treat population of HCV patients an opportunity for a cure. Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient’s blood 12 weeks after treatment (SVR12).1 TECHNIVIE is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B). read more
Kaiser Permanente Physicians to Provide Sideline Care as Special Olympics World Games Athletes Reach for the Gold
PASADENA, Calif.–(BUSINESS WIRE)–More than 650 Kaiser Permanente physicians will trade their exam rooms for a field, pool, track or course beginning Saturday, July 25, to provide sideline medical care at four of the seven hubs where the Special Olympics World Games Los Angeles (LA2015) will take place. This will include fields of play at USC, UCLA, the Los Angeles Convention Center, and the City of Long Beach. From the moment the delegations arrived in Los Angeles, Kaiser Permanente physicians have been giving their medical support to the athletes, and will continue to do so through the close of the World Games. read more
Charles River Laboratories Completes the Acquisition of Celsis International Ltd.
WILMINGTON, Mass.–(EON: Enhanced Online News)–Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has completed the previously announced acquisition of Celsis International Ltd. for $212 million in cash, subject to certain post-closing working capital adjustments. The acquisition complements Charles River Endotoxin and Microbial Detection’s (EMD) position as a leading provider of rapid endotoxin testing and bacterial identification for biopharmaceutical manufacturing, and creates the most comprehensive solution for rapid quality control testing of biopharmaceutical and consumer products. read more
FDA Approves Daklinza (daclatasvir) for the Treatment of Patients with Chronic Hepatitis C Genotype 3
PRINCETON, N.J.–(EON: Enhanced Online News)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza™ (daclatasvir), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA). This approval marks the first time patients with chronic hepatitis C virus (HCV) genotype 3 have a 12-week, once-daily, all-oral treatment option. Daklinza is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving this regimen. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir for 12 weeks. read more