HPV vaccine use expanded in adults up to age 45 | Bluebird's MAA for thalassemia therapy accepted for EMA review | Karyopharm's multiple myeloma drug under FDA review
October 8, 2018
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HPV vaccine use expanded in adults up to age 45
Gardasil 9, a vaccine against nine types of human papillomavirus, has been approved by the FDA for use in men and women ages 27 to 45, expanding its use beyond patients ages 9 to 26 as previously approved by the agency. The decision was supported by overall safety evidence in a study that involved 13,000 men and women, as well as results of a study of 3,200 women that found Gardasil 9 was 88% effective in the prevention of some cancers.
CNN (10/6) 
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Health Care & Policy
Bluebird's MAA for thalassemia therapy accepted for EMA review
The European Medicines Agency accepted for review Bluebird Bio's marketing authorization application for LentiGlobin BB305, developed as a treatment for patients with transfusion-dependent beta-thalassemia and non-β0/β0 genotypes. The agency previously granted orphan drug and priority medicines designations to the candidate.
BioCentury (10/5) 
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Karyopharm's multiple myeloma drug under FDA review
Karyopharm Therapeutics' selinexor for patients with penta-refractory multiple myeloma was accepted by the FDA under priority review status. The agency set the PDUFA date for April 6, 2019.
Seeking Alpha (10/7) 
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Tegsedi OK'd for polyneuropathy associated with hATTR amyloidosis
Akcea Therapeutics and Ionis Pharmaceuticals' Tegsedi, or inotersen, was approved by the FDA as a treatment for patients with hereditary transthyretin amyloidosis-associated polyneuropathy. The drug will be accessed under a Risk Evaluation and Mitigation Strategy program.
MedPage Today (free registration) (10/6) 
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EMA, FDA accept Novartis' filing for multiple sclerosis drug
The FDA and the European Medicines Agency accepted Novartis' filing for secondary progressive multiple sclerosis drug candidate siponimod. The action date for the drug is expected in March for the US and late 2019 in Europe.
Reuters (10/8) 
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NHS England to cover Gilead's CAR-T therapy for adult B-cell lymphoma
The UK's National Health Service England has approved coverage of Gilead Sciences' chimeric antigen receptor T-cell therapy Yescarta, or axicabtagene ciloleucel, through the Cancer Drugs Fund for adult patients with primary mediastinal B-cell lymphoma and relapsed or refractory diffuse large B-cell lymphoma that has not responded to two or more prior therapies. A confidential price deal was reached between the two parties, and Yescarta will be available to up to 200 patients per year.
Medscape (free registration) (10/5),  BioCentury (10/5) 
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Company & Financial News
Emergent BioSolutions closes PaxVax deal
Emergent BioSolutions has purchased PaxVax for $270 million. PaxVax produces two specialty vaccines: Vivotif, the only oral vaccine approved for prevention of typhoid fever, and Vaxchora, the only FDA-approved vaccine for preventing cholera.
Seeking Alpha (10/5) 
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Orchard seeks to raise $172.5M in IPO
An initial public offering was filed by Orchard Therapeutics seeking to raise $172.5 million. Orchard, which has three lentiviral gene drug candidates in registrational trials, intends to use the proceeds to fund the European marketing of Strimvelis, build a manufacturing site and expand sales and marketing operations in the US and Europe.
BioCentury (10/5) 
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Food & Agriculture
Biotech crops being harvested in 3 states
Farmers in three states are now harvesting 16,000 acres of biotech soybeans, which are expected to be sold to consumers and also used in salad dressings, fry oil and granola bars in early 2019. Agriculture Secretary Sonny Perdue has said the department does not plan to regulate new biotech crops and has called the gene-editing technique innovative.
Bloomberg (tiered subscription model) (10/5) 
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Industrial & Environmental
Norway airlines required to use biofuel mixture in 2020
Airlines in Norway must use jet fuel mixed with 0.5% advanced biofuel beginning in 2020, according to the Ministry of Climate and Environment. "The government's goal is that by 2030, 30% of the airline fuel will be sustainable with a good climate effect," the ministry said.
Biofuels Digest (10/6) 
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
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