Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2018
The FDA announces Patient Engagement Advisory Committee meeting on utilising real world data from patient-driven platforms that connect and empower patients
21 September 2018 - On 15 November 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting ...
Posted by Michael Wonder on 21 Sep 2018
Adverum Biotechnologies receives fast track designation for ADVM-022 gene therapy for the treatment of wAMD
19 September 2018 - ADVM-022 is a unique single-administration gene therapy delivered intra-vitreally for the treatment of wAMD. ...
Posted by Michael Wonder on 20 Sep 2018
Generics would hit the market faster under Senate bill, saving more than 3 billion dollars, says CBO
19 September 2018 - Lower-price drugs would hit the market faster under a bipartisan bill awaiting a vote in the ...
Posted by Michael Wonder on 20 Sep 2018
Pfizer granted FDA breakthrough therapy designation for 20 valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults aged 18 years ands older
20 September 2018 - Breakthrough therapy designation designed by FDA to expedite the development and review of drugs and vaccines which ...
Posted by Michael Wonder on 19 Sep 2018
FDA smashes record for most ANDA complete responses in one year
19 September 2018 - The US FDA has issued more complete responses for abbreviated new drug applications in 2018 than ...
Posted by Michael Wonder on 19 Sep 2018
Pharming receives complete response letter from FDA
19 September 2018 - Additional clinical trial data for prophylaxis of HAE requested. ...
Posted by Michael Wonder on 19 Sep 2018
Can patient advocates help make Akcea the next Sarepta and overcome the FDA’s rejection?
18 September 2018 - Patients with a rare disease are asking the FDA a question the agency rarely hears: Is ...
Posted by Michael Wonder on 19 Sep 2018
Janssen submits new drug application to U.S. FDA seeking approval of erdafitinib for the treatment of metastatic urothelial cancer
18 September 2018 - Janssen announced today that a new drug application has been submitted to the U.S. FDA seeking ...
Posted by Michael Wonder on 18 Sep 2018
Harvard Professor's attack on pharma's clinical trials is absurd
18 September 2018 - Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as ...
Posted by Michael Wonder on 18 Sep 2018
FDA grants Lin BioScience rare paediatric disease status for LBS-008 to treat Stargardt disease
17 September 2018 - Designation enhances FDA orphan drug designation for Phase I candidate targeting incurable blindness in children. ...
Posted by Michael Wonder on 17 Sep 2018
FDA approves device for treatment of acute coronary artery perforations
17 September 2018 - The U.S. FDA today approved a device intended to treat acute coronary artery perforations, or tears in ...
Posted by Michael Wonder on 17 Sep 2018
FDA grants rare paediatric disease designation to Cellectar Biosciences’ CLR 131 for the treatment of osteosarcoma
17 September 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131 ...
Posted by Michael Wonder on 17 Sep 2018
Antimicrobial resistance: FDA discusses reimbursement reforms
17 September 2018 - Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for ...
Posted by Michael Wonder on 17 Sep 2018
Sun Pharma and SPARC announce US FDA approval of Xelpros to treat open-angle glaucoma or ocular hypertension
14 September 2018 - Xelpros (latanoprost ophthalmic emulsion) 0.005% for topical ophthalmic use is the first and only benzalkonium chloride-free (BAK-free) ...
Posted by Michael Wonder on 16 Sep 2018
Teva announces U.S. approval of Ajovy (fremanezumab-vfrm) injection, the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults
14 September 2018 - Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Ajovy (fremanezumab-vfrm) injection for the preventive ...