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RSS FeedPosted by Michael Wonder on 26 Sep 2018
Neurelis files new drug application with the FDA for Valtoco nasal spray, an investigational treatment for paediatric, adolescent and adult epilepsy patients
25 September 2018 - Neurelis today announced that the company has submitted a new drug application with the U.S. FDA for ...
Posted by Michael Wonder on 26 Sep 2018
FDA grants QIDP and fast track designations to Cidara Therapeutics’ rezafungin prophylaxis development program
25 September 2018 - Rezafungin designated for the prevention of invasive fungal infections in adults undergoing bone marrow transplantation. ...
Posted by Michael Wonder on 26 Sep 2018
Big pharma boosts drug prices as supplies run low, study reveals
26 September 2018 - Federal lawmakers have been griping about drug pricing for years, led most recently by President Donald ...
Posted by Michael Wonder on 25 Sep 2018
To include or not include drug prices in DTC advertisements
24 September 2018 - For quite some time, consumer groups, patient advocates, and even several medical professional societies have called ...
Posted by Michael Wonder on 25 Sep 2018
Synergy Pharmaceuticals strengthens coverage for Trulance (plecanatide) with key new market access wins
24 September 2018 - Synergy Pharmaceuticals today announced several new formulary wins improving Trulance 2018 and 2019 coverage status across major ...
Posted by Michael Wonder on 25 Sep 2018
Cost of clinical trials for new drug FDA approval are fraction of total tab
24 September 2018 - Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ...
Posted by Michael Wonder on 25 Sep 2018
Verastem Oncology receives FDA approval of Copiktra (duvelisib) capsules
24 September 2018 - Verastem today announced that the U.S. FDA has approved Copiktra, an oral inhibitor of phosphoinositide 3-kinase, and ...
Posted by Michael Wonder on 24 Sep 2018
Gilead subsidiary to launch authorised generics of Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C
24 September 2018 - List price of authorised generics to reflect discounts in the system today. ...
Posted by Michael Wonder on 24 Sep 2018
Avita Medical announces FDA approval of the Recell system for the treatment of severe burns in the U.S
21 September 2018 - Point-of-care regenerative medicine technology approved to treat second and third-degree burns using Spray-On Skin Cells product. ...
Posted by Michael Wonder on 24 Sep 2018
MicuRx announces receipt of FDA’s QIDP and fast track designations for contezolid and contezolid acefosamil
21 September 2018 - MicuRx Pharmaceuticals today announced the receipt of the qualified infectious disease product classification and grant of fast ...
Posted by Michael Wonder on 23 Sep 2018
Drug shortages may add $230 million to annual U.S. drug costs
22 September 2018 - Prescription drug shortages may drive up prices twice as much as they would rise with medicines ...
Posted by Michael Wonder on 23 Sep 2018
FDA proposes stiff fines for failing to report clinical trials
20 September 2018 - Pharmaceutical companies could face penalties of up to US$10,000 per day. ...
Posted 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 ...