PaxVax announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted yesterday on a recommendation for the use of Vaxchora™, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora received marketing approval from the U.S. FDA on June 10, 2016. The…
Kite Pharma Opens State-of-the-Art T-Cell Therapy Manufacturing Facility
Kite Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT™) products for the treatment of cancer, opened a new commercial manufacturing facility in El Segundo, California. Over 300 employees, investors and company partners attended the unveiling of the 43,500-square-foot, state-of-the-art plant. The facility has been designed to produce chimeric antigen…
AHF’s ‘Gilead Greed Kills!’ Protest Continues
Over the past week, AIDS Healthcare Foundation (AHF), the largest global AIDS organization, hosted protests targeting Gilead Sciences over the company’s AIDS and hepatitis C drug pricing and policies. On June 15, 50 AIDS advocates protested in front of the drug company’s headquarters in Foster City, CA in an effort to bring the message home to company’s employees and executives during the lunch…
Dr. Reddy’s to Acquire Product Portfolio from TEVA for U.S. Market
Dr. Reddy’s Laboratories has entered into a definitive agreement with Teva Pharmaceutical Industries Ltd. and an affiliate of Allergan plc to acquire a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the U.S. for $350 million in cash at closing. The acquired portfolio consists of products that are being divested by Teva as a precondition to its closing…
AHF Leads AIDS Drugs Protest Against Gilead
On Wednesday morning, June 8 th, AIDS Healthcare Foundation (AHF), the largest global AIDS organization, zapped AIDS drug kingpin Gilead Sciences with an “only-in-California” AIDS drug pricing protest in the form of a rolling caravan during the annual Goldman Sachs Healthcare Investor Conference being held at the exclusive Terranea Resort in Rancho Palos Verdes, CA. The protest caravan featured a hearse, a double-deck…
Missouri Governor Signs Bill, Approving Substitution of Interchangeable Biologics
The Biotechnology Innovation Organization (BIO) and Missouri Biotechnology Association (MOBIO) commend Governor Jay Nixon for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines. Governor Nixon signed Senate Bill 875 this week, following recent passage in both the Missouri Senate and House of Representatives. The policies outlined in the bill align with BIO’s principles on biologic substitution,…
CHPA Applauds Alaska Lawmakers for Age-18 Sales Law on Cough Medicine
The Consumer Healthcare Products Association (CHPA), the trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, released the following statement in support of an Alaska law prohibiting the sale of OTC medicines containing the cough suppressant dextromethorphan (DXM) to minors. “CHPA thanks Governor Bill Walker for signing the bill into law and House…
Biogen’s Infliximab Biosimilar Approved by EU
The European Commission (EC) granted marketing authorization in the European Union (EU) for FLIXABI ®, an infliximab biosimilar referencing Remicade ®i. FLIXABI was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. FLIXABI is indicated for the treatment of adults with rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.…
Dr. Reddy’s Acquires Six OTC Brands
Medivation Urges Stockholders to Reject Sanofi’s Attempt to Replace Medivation Board of Directors
Medivation, Inc. urged its stockholders to reject Sanofi’s attempt to replace the company’s entire Board of Directors with hand-picked nominees through a proposed consent solicitation, which Medivation believes is a tactic for Sanofi to facilitate its substantially inadequate and opportunistically-timed proposal to acquire Medivation. Medivation expects to promptly file consent revocation materials with the U.S. Securities…