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TXT Advisors Unanimously Back GW Cannabidiol Drug [2633 Words] [ Price : $8.95]
The FDA Central Nervous System Drugs Advisory Committee unanimously recommends approval of GW Pharma’s Epidiolex, a cannabidiol drug to treat to rare childhood epilepsies.
04/19/2018
 
 
TXT Reviewers Voice Olumiant Safety Concerns [2941 Words] [ Price : $8.95]
FDA medical reviewers tell members of the Arthritis Advisory Committee they have serious safety concerns about Lilly’s proposed arthritis drug Olumiant.
04/19/2018
 
 
TXT Arthrosurface Shoulder Device Cleared by FDA [119 Words] [ Price : $8.95]
FDA clears an Arthrosurface 510(k) to market the OVOMotion Shoulder Arthroplasty System that the company says is intended to provide surgeons with an approach that results in increased exposure to the glenoid, minimizes bone removal, and is designed for patients with painful or severely disabled shoulder joints.
04/19/2018
 
 
TXT AstraZeneca’s Tagrisso OK’d for First-line Lung Cancer [1201 Words] [ Price : $8.95]
FDA expands approval for AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have certain epidermal growth factor receptor mutations.
04/19/2018
 
 
TXT API GMP Guidance Answers [2641 Words] [ Price : $8.95]
FDA releases an ICH guidance with answers to questions about its Q7 guidance on good manufacturing practices for APIs.
04/19/2018
 
 
TXT FTC Appeals Shire Vancocin Case Dismissal [2774 Words] [ Price : $8.95]
Attorney Jennifer Thomas says the FTC decision to appeal an adverse ruling in its Vancocin case against Shire demonstrates its concern with the lower court’s ruling that it had failed to make its case.
04/19/2018
 
 
TXT Draft Guide on Inhalation Drug Products [83 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products — Quality Considerations.”
04/19/2018
 
 
TXT SpeeDx M. genitalium Test Cleared by FDA [122 Words] [ Price : $8.95]
FDA clears a SpeeDx 510(k) for its ResistancePlus MG Positive Control kit, a diagnostic test that simultaneously detects M. genitalium and genetic markers for antimicrobial resistance.
04/19/2018
 
 
TXT Court Says Lap-Band Claims Preempted [2778 Words] [ Price : $8.95]
Attorney Michelle Yeary says an Alabama federal court has ruled that all of a plaintiff’s claims against Allergan charging negligence and other issues in a case involving the company’s Lap-Band for weight loss are preempted by federal law.
04/19/2018
 
 
TXT FDA Warns About Endoscope Connectors [2731 Words] [ Price : $8.95]
FDA says healthcare providers should not use the Erbe USA Erbeflo 24-hour multi-patient endoscope connector because it does not adequately mitigate risks of cross-contamination.
04/18/2018
 
 
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