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Top Stories
The transaction is part of Bristol-Myers Squibb's proposed acquisition of Celgene.
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A ruling in Oklahoma that Johnson & Johnson's marketing efforts created a public nuisance may establish a precedent of other jurisdictions.
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Industry News
A biosimilar to Eli Lilly's Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.
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GSK has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat.
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Supplier News
Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.
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AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the DAPA-HF trial primary endpoint.
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Bio/Pharma News
The new vaccine will offer protection against the Nipah virus after a single dose.
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The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.
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Regulatory News
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company's Zhejiang facility found falsified quality documents.
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FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.
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PROCESS VALIDATION
Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.
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MANUFACTURING
The approval of the first gene therapies and technology advances have spurred research and investment for new treatments and provided hope for patients.
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FORMULATION
New approaches seek to address formulation and delivery challenges for these complex molecules.
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QUALITY
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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UPCOMING WEBCASTS
The Evolution of Cellulose in Tableting Technology
Wednesday, September 25, 2019 at 10am EDT | 3pm BST | 4pm CEST
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Protecting Oxygen-Sensitive Formulations Throughout the Product Lifecycle
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From Basics to Best Practices: Exploring Bioassays and Binding Assays
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Considerations in Primary Packaging Component Selection for Parenteral Drug Delivery
Tuesday, September 17, 2019 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Identifying and Solving Scale-up Challenges in the Synthesis and Formulation of Small-Molecule APIs
Thursday, September 12, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery"
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The editors explore novel technologies for the formulation, manufacture,
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