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RSS FeedPosted by Michael Wonder on 20 May 2019
UCB announces Nayzilam (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the US
19 May 2019 - Nayzilam allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure ...
Posted by Michael Wonder on 20 May 2019
FDA's strengthened global inspection program helps ensure generic drug safety
17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines. ...
Posted by Michael Wonder on 18 May 2019
Athersys announces fast track designation from FDA for MultiStem program for acute respiratory distress syndrome
14 May 2019 - Athersys announced today that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory ...
Posted by Michael Wonder on 18 May 2019
Agile Therapeutics resubmits new drug application for its transdermal low-dose contraceptive patch, Twirla
17 May 2019 - Agile Therapeutics today announced it has resubmitted to the U.S. FDA the new drug application for its ...
Posted by Michael Wonder on 18 May 2019
U.S. FDA approves Gattex (teduglutide) for children 1 year of age and older with short bowel syndrome
17 May 2019 - Gattex is the only glucagon-like peptide-2 analogue approved that improves intestinal absorption in patients with SBS who ...
Posted by Michael Wonder on 17 May 2019
Celgene receives European Commission approvals for Revlimid (lenalidomide) and Imnovid (pomalidomide)-based triplet combination regimens for patients with multiple myeloma
16 May 2019 - The European Commission has approved two of Celgene’s IMiD based combination regimens. ...
Posted by Michael Wonder on 17 May 2019
Health Canada approves injectable hydromorphone to treat opioid addiction
16 May 2019 - Canada is first country to approve the pain drug for severe opioid use disorder, says Health ...
Posted by Michael Wonder on 16 May 2019
Instalment payments could be used across gene therapy space, Spark CEO says
16 May 2019 - In a fireside chat at the recently concluded Veeva Summit in Philadelphia, Jeff Marrazzo said payment over ...
Posted by Michael Wonder on 16 May 2019
FDA approves first anticoagulant (blood thinner) for paediatric patients to treat potentially life-threatening blood clots
16 May 2019 - The U.S. FDA today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of ...
Posted by Michael Wonder on 16 May 2019
Will drugs companies follow EU agency from London to Amsterdam?
16 May 2019 - Amid the bustling skyscrapers of London’s Canary Wharf, one building stands silent and shuttered — a ...
Posted by Michael Wonder on 16 May 2019
Sigma Healthcare leadership says it has received no worker reports of medicine mishandling
16 May 2019 - Sigma Healthcare's chief executive Mark Hooper has told investors that the company takes its obligations to ...
Posted by Michael Wonder on 15 May 2019
Hospital drug making venture picks antibiotics as first products
15 May 2019 - Nonprofit Civica Rx plans to begin distributing vancomycin hydrochloride and daptomycin before the end of September. ...
Posted by Michael Wonder on 15 May 2019
Drug prices in TV ads: how transparent are they?
15 May 2019 - A website launched by pharmaceutical giant Eli Lilly earlier this year leads with a daunting statement ...
Posted by Michael Wonder on 15 May 2019
Sigma Healthcare to face investor questions over claims it mishandled prescription drugs
15 May 2019 - Pharmaceutical supplier Sigma Healthcare will face shareholder questions over claims that it failed to properly handle ...
Posted by Michael Wonder on 15 May 2019
AbbVie announces US FDA approval of Venclexta (venetoclax) as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukaemia patients
15 May 2019 - FDA reviewed the submission under the real-time oncology review pilot program. ...