United States

Press Release Archive

11/25/2015
Seqirus receives FDA approval for FLUAD™ (Influenza Vaccine, Adjuvanted) for adults aged 65 years and older
Seqirus announced today that the US Food and Drug Administration (FDA) has approved Fluad™ (Influenza Vaccine, Adjuvanted) to help protect those aged 65 years and older against seasonal influenza. Fluad is the first adjuvanted seasonal influenza vaccine approved in the United States; it was specifically developed for the adult population aged 65 and older.1 More.

11/09/2015
CSL brands world’s no. 2 influenza vaccine provider as Seqirus
Global biotherapeutics leader CSL Limited announced that its influenza vaccines business will begin operating under the brand Seqirus effective today, following the merger of the recently-acquired Novartis influenza business and its existing vaccines and pharmaceutical business bioCSL. More.

10/29/2015
CSL convenes industry and government leaders to discuss improving influenza vaccination rates and pandemic preparedness
Today, at Pennsylvania Bio’s Life Sciences Future conference, CSL Chief Executive Officer Paul Perreault convened a panel of industry, advocacy and government leaders to discuss opportunities to make improvements in U.S. influenza (flu) vaccination rates and pandemic flu preparedness. More.

07/31/2015
Update on Novartis influenza vaccines acquisition
CSL Limited (ASX:CSL; USOTC: CSLLY) today announced that it has secured the necessary approvals required to proceed with the acquisition of the influenza vaccines business of Novartis and that it is working with Novartis to bring forward the close date for the transaction. The Company also said the new CSL subsidiary resulting from the acquisition will be called Seqirus. More.

07/13/2015
bioCSL Inc. Begins Shipping AFLURIA for the 2015-2016 US Seasonal Influenza Campaign
bioCSL Inc. announced today it has begun shipping AFLURIA, Influenza Vaccine in advance of the 2015-2016 influenza season. In support of improving seasonal influenza vaccination rates to protect public health, bioCSL will deliver more than 18 million doses of AFLURIA to the US market, a 20 percent increase over last year. More.

06/17/2015
BioCryst Licenses Worldwide Rights to Commercialize RAPIVAB® Influenza Treatment to CSL Limited
BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX) and CSL Limited (ASX:CSL) (USOTC:CSLLY) - BioCryst Pharmaceuticals, Inc., a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, announced today that it has licensed RAPIVAB (peramivir injection) for the treatment of influenza to CSL Limited, a global biopharmaceutical company. More.

11/25/2014
New PSA Reminds College Students That Vaccination is the Best Form of Protection Against Dangerous Flu Virus
Although the Centers for Disease Control and Prevention (CDC) recommends that everyone six months of age and older get a flu vaccine every season,1 college-aged adults have documented vaccination rates of just 8 to 30 percent.2,3,4,5 To help educate this vulnerable group and encourage vaccination, a collaboration of flu stakeholders launched a new Public Service Announcement (PSA) to broach a serious topic with college-aged adults. bioCSL Inc. has partnered on the PSA with Families Fighting Flu and Alana's Foundation, two nonprofit organizations of families who have lost children to, or whose children have suffered serious health complications due to the flu, that work to increase vaccination rates. More.

10/27/2014
CSL to acquire Novartis’ influenza vaccine business
CSL Limited has today announced an agreement to acquire Novartis’ global influenza vaccine business for US$275 million, which will be combined with CSL’s existing vaccines and pharmaceutical subsidiary, bioCSL. More.

10/20/2014
bioCSL Inc. Completes 2014‐15 Flu Season Shipment of AFLURIA®
bioCSL Inc. announced today that it has completed shipment of 16.2 million doses of AFLURIA® (Influenza Vaccine) for the 2014-2015 season and is now sold out. The Company’s distribution of 16.2 million doses represents a 45 percent increase in doses compared with the 2013-14 flu season for AFLURIA®. More.

08/19/2014
FDA Approves Use of AFLURIA® Influenza Vaccine with PharmaJet’s Needle-Free Injector
PharmaJet® Inc., the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL Inc., the maker of AFLURIA® (Influenza Vaccine) today announced the U.S. Food and Drug Administration (FDA) has approved the PharmaJet Stratis® 0.5mL Needle-Free Jet Injector for delivery of AFLURIA in individuals aged 18 to 64 years. This is the first needle-free delivery system approved by the FDA for the administration of an inactivated influenza vaccine. More.

08/05/2014
bioCSL Inc. Launches AFLURIA® Shipping Campaign for 2014-2015 Seasonal Influenza
bioCSL Inc. announced today it has commenced shipping its seasonal influenza vaccine AFLURIA® (Influenza Vaccine) for the 2014-2015 flu season. U.S. providers who ordered AFLURIA may be able to begin vaccinating as early as this month. More.

04/28/2014
bioCSL Supports Public Health Efforts in Laos with Donation of more than 700,000 Doses of Seasonal Influenza Vaccine
bioCSL, formerly CSL Biotherapies, has announced the donation of more than 700,000 doses of its influenza vaccine to the Partnership for Influenza Vaccine Introduction, an innovative program - spearheaded by the US Centers for Disease Control and Prevention (CDC) and the Task Force for Global Health (TFGH) - that helps low- and middle-income countries reduce annual morbidity and mortality from influenza. The program helps eligible countries create or expand public vaccination program infrastructures within their borders. This year marks the second consecutive year that bioCSL has donated vaccine to the program. More.

02/26/2014
CSL Biotherapies Inc. renamed bioCSL Inc.
CSL Biotherapies Inc. announced today it has changed its name to bioCSL Inc., effective February 21, 2014. This change is pursuant to the Australian, New Zealand and German renaming of the company, which occurred one year ago. More.

09/25/2013
CSL Biotherapies completes 2013-14 season AFLURIA® shipments
CSL Biotherapies Inc. announced today it has finalized shipment of 11 million doses of AFLURIA®, its seasonal influenza vaccine for the 2013-2014 season. Completion of the 2013-14 shipping campaign will ensure that healthcare providers using AFLURIA® are able to conduct their immunization programs as planned. More.

08/06/2013
CSL Biotherapies initiates shipments of its seasonal influenza vaccine to U.S. customers.

CSL Biotherapies Inc. announced today that shipment of its seasonal influenza vaccine for the 2013-2014 season has started.

More.

09/10/2012
CSL Biotherapies awarded US Government Contract for Influenza Pandemic Preparedness and Response
CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced it has been awarded a contract by the United States (U.S.) Department of Health and Human Services to supply pre-pandemic and pandemic vaccine antigens and related services to the U.S. national stockpile. More.

12/21/2009
Findings of Australian trial of CSL’s Pandemic (H1N1) 2009 ‘swine’ flu vaccine in children published in Journal of the American Medical Association (JAMA)
CSL Limited, Australia's leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL’s pandemic H1N1 2009 'swine' flu vaccine. Results of the trial demonstrate a robust immune response after a single dose in children as young as 6 months of age, which is further enhanced by the administration of a second dose given three weeks later. More.

11/12/2009
CSL Biotherapies obtains FDA licensure for use of its thimerosal-free pandemic Influenza A (H1N1) 2009 Monovalent Vaccine in children
CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's application for accelerated approval of its seasonal flu vaccine, Afluria® (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older. More.

09/28/2009
CSL Biotherapies reaches agreement with Merck & Co. on rights to market and distribute Afluria® in the U.S.
CSL Biotherapies and its parent company, CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, have reached an agreement with Merck & Co., Inc. on rights to market and distribute Afluria® in the United States under an exclusive, six-year agreement effective September 3, 2009. Afluria, a CSL product, is a non-adjuvanted trivalent seasonal influenza vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials. More.

09/16/2009
CSL Biotherapies Announces FDA Marketing Approval of its Monovalent Pandemic (H1N1) 2009 Influenza A Vaccine
CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world’s leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental biologics licensing application for licensure of its monovalent pandemic (H1N1) 2009 influenza A vaccine for active immunization of persons age 18 years and older against influenza disease caused by the H1N1 virus. More.

09/10/2009
CSL Demonstrates Robust Immune Response from Single (15mcg) Dose of Monovalent Pandemic (H1N1) 2009 Influenza Vaccine in Healthy Adults
CSL Limited, Australia’s leading biopharmaceutical company, announced today that preliminary data from the first study of its candidate pandemic H1N1 vaccine demonstrated a robust immune response in healthy adults after a single unadjuvanted15mcg dose. More.

08/24/2009
CSL Biotherapies Announces Start of U.S. H1N1 Vaccine Clinical Trials
CSL Biotherapies has announced the initiation of the company’s first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. More.

08/18/2009
U.S. FDA Licenses CSL Biotherapies’ New U.S. Influenza Vaccine Filling and Packaging Facility in Illinois
CSL Biotherapies, a subsidiary of CSL Limited, one of the world's leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA) has licensed the company’s newest vaccine filling and packaging facility, located in Kankakee, Ill. The facility, part of an investment to expand CSL’s U.S. influenza vaccine production capabilities, includes a high-speed, single-dose vaccine syringe filling line. More.

07/27/2009
CSL Biotherapies Starts Shipment of Seasonal Influenza Vaccine for the 2009-2010 Flu Season
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of thimerosal-free seasonal influenza vaccine, announced today that it has begun shipment of its seasonal influenza virus vaccine to a national network of U.S. distributors for the 2009-2010 season. CSL Biotherapies plans to deliver more than eight million doses of the vaccine, the majority of which will be in single-dose, thimerosal-free, pre-filled syringes. More.

07/09/2009
CDC, AWHONN and CSL Biotherapies Partner to Educate Healthcare Providers on the Impact of Novel H1N1 Pandemic on Influenza Management in Pregnant Women
To address public health concerns about the novel influenza A pandemic virus – H1N1 -- and the implications of it on the upcoming influenza (flu) season, the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) hosted a late-breaking educational session for healthcare providers who are on the front-lines of care for pregnant women at the AWHONN 2009 annual convention. Funded by CSL Biotherapies, “A Tale of Two Flus: A Focus on Seasonal and Novel H1N1 During Pregnancy” featured speakers from the Centers for Disease Control (CDC) and provided valuable insights and recommendations in the months leading up to the Fall flu season. More.

05/29/2009
CSL Biotherapies contracts with U.S. Department of Health and Human Services (HHS) to provide Novel A (H1N1) influenza vaccine antigen
King of Prussia, PA—CSL Biotherapies, Inc. announced today that it has signed a contract with the U.S. Department of Health and Human Services (HHS) to provide Novel A (H1N1) influenza vaccine antigen in bulk form to support HHS’ pandemic influenza preparedness efforts. The initial order under contract will be for an amount of at least $180 million. CSL Biotherapies anticipates initial delivery of the antigen by September, subject to regulatory approval. The new vaccine antigen will be tested in clinical trials funded by HHS. More.

03/23/2009
National Influenza Vaccine Summit Announces Recipients of the 2009 Immunization Excellence Award Winners
The National Influenza Vaccine Summit announces the recipients of the Annual National Influenza Vaccine Summit (NIVS) Immunization Excellence Awards: Overall 2008-09 Season Activity: Sickness Prevention Achieved Through Regional Collaboration (SPARC), Lakeville, CT and Newton, MA; Healthcare Personnel Campaign: Children’s Hospitals and Clinics of Minnesota, Saint Paul, MN;18 years and younger Campaign: The Wellness Company, Providence, RI; Coalition Campaign: Maryland Partnership for Prevention, Owings Mills, MD; and Corporate Campaign: MinuteClinic CVS/pharmacy, Minneapolis, MN, and National Women’s Health Resource Center, Red Bank, NJ. More.

12/22/2008
CSL Biotherapies Announces Influenza Vaccine Pre-Booking Open for the 2009-2010 Flu Season
CSL Biotherapies, a subsidiary of one of the world’s leading manufacturers of influenza vaccine, today announced that healthcare providers now have the opportunity to pre-book the company’s influenza virus vaccine through either www.mercuryfreefluvaccine.com or the toll-free number, 1-888-435-8633. The majority of CSL Biotherapies’ vaccine supply for the 2009-2010 flu season will be offered as thimerosal-free, single-dose, pre-filled syringes. To help increase access to the thimerosal-free vaccine, CSL Biotherapies will offer value programs for a limited time to healthcare providers who pre-book through authorized distributors. More.

11/14/2008
Jesse Palmer Throws a "Season Pass" at Influenza Awareness to College Students Nationwide
To increase flu vaccination rates among college students, CSL Biotherapies is partnering on Season Pass© with Jesse Palmer, ESPN co-host of "College Football Live" and former pro football player. Season Pass is a novel program designed to immunize as many college students as possible during the 2008-2009 influenza (flu) season. College students are at risk for contracting the flu due to their close living quarters and frequent contact with other students. Season Pass aims to educate college students about influenza prevention and motivate them to visit their on-campus health center to get vaccinated. More.

10/16/2008
CSL Biotherapies Launches www.mercuryfreefluvaccine.com, An Online, Order-As-You-Go Service for Thimerosal-Free Influenza Vaccine
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, today announced an innovative online quick-ship ordering system, enabling healthcare providers and other purchasers to buy CSL Biotherapies' thimerosal-free flu vaccine for adults directly from the company. This new purchasing platform (accessible at www.mercuryfreefluvaccine.com) offers customers enhanced access to a thimerosal-free product in the quantity they need, whenever they need it. More.

09/04/2008
CSL Biotherapies Announces First Shipments of Afluria® Thimerosal-Free Influenza Vaccine for the 2008-2009 Flu Season
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that it has begun shipment of its influenza virus vaccine in the U.S. for the 2008-2009 season. CSL plans to deliver more than six million doses of Afluria and the majority of the supply will be in single-dose, thimerosal-free, pre-filled syringes. More.

05/13/2008
CSL Marks 40 Years in the Influenza Vaccine Market
CSL Limited today celebrated its 40th year as a leading manufacturer of influenza (flu) vaccine.  The company’s vaccine, Fluvax®, is a Thiomersal-free influenza vaccine that is approved for use in adults and children in Australia and New Zealand.  This vaccine is known as Afluria™, Enzira™, Nilgrip™, and X-Flu™ in 17 different countries, including the US and European markets.  Additionally, CSL supplies the antigen used to manufacture the flu vaccine in 24 countries.  More.

04/03/2008
CSL Biotherapies Announces Afluria® Pre-Booking Open
CSL Biotherapies announced today that healthcare providers now have the opportunity to pre-book Afluria® (influenza virus vaccine) through either www.afluria.com or at the company’s toll-free number 1-888-435-8633. CSL Biotherapies, which entered the U.S. market last season, plans to produce approximately 6 million doses of Afluria for delivery in time for the upcoming season. The majority of the Afluria supply for the upcoming season will be in single-dose, thimerosal-free, pre-filled syringes. More.

10/17/2007
CSL Biotherapies Starts U.S. Shipments of Influenza Vaccine
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that it has begun shipment of its influenza virus vaccine in the United States for the 2007-2008 season. More.

09/28/2007
CSL Biotherapies announces FDA marketing approval of Afluria®
Global biopharmaceutical company with strong vaccine heritage affirms commitment to help address critical U.S. public health need More.

06/05/2006
CSL Biotherapies, A New Entrant Into U.S. Flu Market, Starts Influenza Vaccine Biological Licensure Trial
Enrollment will begin for a pivotal influenza vaccine clinical trial sponsored by the National Institutes of Health (NIH), CSL Biotherapies announced today. The study will assess the safety and immunogenicity of single-dose and multi-dose formulations of influenza vaccine and has been designed to meet U.S. Food & Drug Administration (FDA) requirements. More.

02/07/2006
CSL Limited to Apply for License to Market Influenza Vaccine in the U.S.
CSL Limited (ASX: CSL), a global, specialty biopharmaceutical company headquartered in Melbourne, Australia, today announced plans to introduce its influenza vaccine into the U.S. market. More.

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