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RSS FeedPosted by Michael Wonder on 24 May 2019
FDA approves first PI3K inhibitor for breast cancer
24 May 2019 - Today, the U.S. FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved ...
Posted by Michael Wonder on 24 May 2019
AveXis announces innovative Zolgensma gene therapy access programs for US payers and families
24 May 2019 - Annualised cost of Zolgensma is USD 425,000 per year for 5 years; 50% less than multiple established ...
Posted by Michael Wonder on 24 May 2019
FDA approves innovative gene therapy to treat paediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
24 May 2019 - The U.S. FDA today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less ...
Posted by Michael Wonder on 23 May 2019
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...
Posted by Michael Wonder on 23 May 2019
Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range
23 May 2019 - Novartis AG’s top executive said on Wednesday it expects to price its gene therapy for spinal ...
Posted by Michael Wonder on 23 May 2019
Iovance Biotherapeutics announces breakthrough therapy designation for LN-145 for treatment of advanced cervical cancer patients who have progressed on or after chemotherapy
22 May 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted breakthrough therapy designation to Iovance TIL therapy ...
Posted by Michael Wonder on 23 May 2019
Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001
22 May 2019 - AV001 granted priority review. ...
Posted by Michael Wonder on 22 May 2019
Agile Therapeutics announces FDA acceptance of the NDA resubmission of Twirla
22 May 2019 - FDA assigns Prescription Drug User Fee Act goal date of 16 November 2019. ...
Posted by Michael Wonder on 22 May 2019
FDA approves Sorilux for adolescent plaque psoriasis
22 May 2019 - Mayne Pharma is pleased to announce that the US FDA has approved Sorilux (calcipotriene) foam, 0.005% ...
Posted by Michael Wonder on 22 May 2019
House Committee proposes 6% increase in FDA funding for FY 2020
22 May 2019 - The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the ...
Posted by Michael Wonder on 22 May 2019
U.S. FDA grants priority review of Invokana (canagliflozin) sNDA for the treatment of chronic kidney disease in patients with type 2 diabetes
22 May 2019 - Application was submitted in March 2019 based on landmark phase 3 CREDENCE renal outcomes study published in ...
Posted by Michael Wonder on 22 May 2019
Lilly selling half-price version of popular Humalog insulin
22 May 2019 - A half-price version of Eli Lilly's popular Humalog insulin is now available, following the company's promise in ...
Posted by Michael Wonder on 22 May 2019
PolyPid receives a second QIDP designation for D-PLEX100 in abdominal surgery
21 May 2019 - PolyPid Ltd announced today that the United States FDA has granted a second qualified infectious disease product ...
Posted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations
21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...
Posted by Michael Wonder on 21 May 2019
Google sister company Verily is teaming with big pharma on clinical trials
21 May 2019 - Pharma companies are looking to work with Verily, which is part of the Alphabet umbrella, as they ...