Mepolizumab gains FDA nod for pediatric severe eosinophilic asthma | Elite Pharma's generic version of Tylenol with Codeine gains FDA nod | FDA approval granted to tenapanor for adult IBS with constipation
September 13, 2019
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Mepolizumab gains FDA nod for pediatric severe eosinophilic asthma
An expanded indication for GlaxoSmithKline's Nucala, or mepolizumab, gained the FDA's approval as a treatment for pediatric patients with severe eosinophilic asthma between the ages of 6 to 11. The subcutaneous injection received FDA approval in 2015 as a supplementary maintenance therapy for patients with severe asthma aged 12 years or older.
Medscape (free registration) (9/12) 
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Health Care & Policy
Elite Pharma's generic version of Tylenol with Codeine gains FDA nod
The FDA gave its approval for the generic version of Johnson & Johnson's Tylenol with Codeine, or acetaminophen and codeine phosphate, manufactured by Elite Pharmaceuticals. The generic tablets are available in various dosage strengths.
Seeking Alpha (9/12) 
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FDA approval granted to tenapanor for adult IBS with constipation
FDA approval granted to tenapanor for adult IBS with constipation
The FDA has approved Ardelyx's Ibsrela, or tenapanor, to treat adult irritable bowel syndrome with constipation, to be taken twice daily in 50-mg doses. Patients who have or are suspected of having mechanical gastrointestinal obstruction are not advised to take Ibsrela.
Medscape (free registration) (9/12) 
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Scotland seals access agreement with Vertex for cystic fibrosis drugs
A five-year access agreement was finalized between Scotland's Scottish Medicines Consortium and Vertex that will provide about 400 eligible Scottish patients with cystic fibrosis access to Symkevi, or tezacaftor and ivacaftor, and Orkambi, or lumacaftor and ivacaftor.
PharmaTimes online (UK) (9/12) 
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NICE approves BioMarin's Batten disease therapy; NHS to fund treatment
The UK's National Institute for Health and Care Excellence issued a positive recommendation for BioMarin's Brineura, or cerliponase alfa, for the treatment of the extremely rare inherited condition called Batten disease. Because of NICE's backing, the National Health Service announced it will now fund the treatment after reaching a pricing deal with BioMarin.
PMLive (UK) (9/12),  The Telegraph (London) (tiered subscription model) (9/11) 
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Company & Financial News
Jiangsu Hansoh, Atomwise enter drug discovery deal worth up to $1.5B
The Jiangsu Hansoh Pharmaceutical Group and Atomwise have partnered to design and discover possible treatments for up to 11 unnamed target proteins for oncologic and other therapeutic areas, a deal valued up to $1.5 billion. Atomwise uses artificial intelligence technology to help determine the binding capability of small molecules to a target protein.
Genetic Engineering & Biotechnology News (9/12) 
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$1B-plus deal to advance cell therapy candidate for chronic back pain
Mesoblast, an Australian cell therapy developer, will collaborate with the Grunenthal Group of Germany to advance development of its candidate, MPC-06-ID, an allogeneic cell therapy indicated for the treatment of discogenic chronic back pain. The deal grants Grunenthal exclusive development and marketing rights in Europe and Latin America, with Mesoblast eligible for an upfront payment of $150 million and over $1 billion in potential milestone payments.
BioPharmaReporter (9/12) 
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BioNTech's planned Nasdaq IPO valued at nearly $100M
BioNTech of Germany has submitted documents for its planned Nasdaq initial public offering and expects to raise almost $100 million, an amount much lower than analysts estimated. The funds will support future preclinical and clinical programs for cancer indications, which include chimeric antigen receptor T-cell therapies, messenger RNA drugs, T-cell receptors and others, as well as the expansion of its laboratories and manufacturing plants.
Labiotech (Germany) (9/12) 
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Food & Agriculture
Oxitec proposes to release biotech mosquitoes in the Fla. Keys
The government of Florida received a proposal from British firm Oxitec to test its biotech Aedes aegypti mosquitoes, a breed that normally transmits deadly diseases such as dengue and Zika, by releasing them in the Florida Keys to propagate with local mosquitoes. Oxitec's biotech mosquitoes are sterile and have been successfully tested in Jacobina, Brazil.
WUSF-FM (Tampa, Fla.) (9/12) 
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Industrial & Environmental
Australian project converts sugarcane, cotton into usable materials
The federal government of Australia will fund a midstage Queensland University of Technology project that converts sugarcane and cotton biomass into animal feed, fuels and bio-based plastics. Sugarcane waste is being converted into jet fuel, while chemicals produced from the biomass are being used to manufacture plastic beer and soft drink bottles.
Manufacturers' Monthly (Australia) (9/13) 
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