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RSS FeedPosted by Michael Wonder on 22 Sep 2020
ICER posts draft scoping document on therapies for multiple myeloma
22 September 2020 - Document open to public comment until 13 October 2020. ...
Posted by Michael Wonder on 22 Sep 2020
NICE publishes draft guidance on new use for Kyprolis
22 September 2020 - The guidance relates to the use of carfilzomib with dexamethasone and lenalidomide for patients with previously ...
Posted by Michael Wonder on 22 Sep 2020
Medeor Therapeutics’ transplant immune tolerance therapy receives regenerative medicine advanced therapy designation from FDA
22 September 2020 - Medeor Therapeutics today announced that the U.S. FDA has granted a regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 22 Sep 2020
Prescription drug and health care costs are rising
21 September 2020 - Over the last 100 years, the practice of medicine has come a long way. ...
Posted by Michael Wonder on 22 Sep 2020
ADC Therapeutics submits biologics license application to the U.S. FDA for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
21 September 2020 - Submission based on efficacy and safety data from LOTIS 2 clinical trial. ...
Posted by Michael Wonder on 22 Sep 2020
CHMP grants positive opinion for expanded use of Otsuka’s Deltyba (delamanid) in children and adolescents weighing at least 30 kg treated for pulmonary multi-drug resistant tuberculosis
21 September 2020 - This label extension of Deltyba (delamanid) represents a new treatment option for children and adolescents with pulmonary ...
Posted by Michael Wonder on 22 Sep 2020
Health Canada approves Inrebic (fedratinib), first new treatment in nearly a decade for patients living with myelofibrosis
21 September 2020 - Inrebic provides new, once-daily oral option for patients affected by rare bone marrow cancer. ...
Posted by Michael Wonder on 22 Sep 2020
Knight and TherapeuticsMD announce Health Canada approval of Bijuva
21 September 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Bijuva (estradiol and progesterone) capsules by Health ...
Posted by Michael Wonder on 21 Sep 2020
UK regulators contend biosimilar efficacy trials are redundant
19 September 2020 - Comparative biosimilar efficacy trials are unnecessary to demonstrate that drug candidates are equivalent to reference products, ...
Posted by Michael Wonder on 21 Sep 2020
A deal on drug prices undone by White House insistence on ‘Trump Cards’
18 September 2020 - The White House and the pharmaceutical industry were nearing a major deal to lower drug prices. Then ...
Posted by Michael Wonder on 21 Sep 2020
Crinetics Pharmaceuticals receives rare paediatric disease designation from FDA for CRN04777 for the treatment of congenital hyperinsulinism
21 September 2020 - Crinetics Pharmaceuticals today announced that the U.S. Food and Drug FDA has granted rare paediatric disease designation ...
Posted by Michael Wonder on 21 Sep 2020
Family's $50,000 cost for dad's life-extending bowel cancer medicine
17 September 2020 - With a supportive wife, five daughters and eight grandchildren, Tony Sullivan has something to fight for. ...
Posted by Michael Wonder on 21 Sep 2020
The next step in TLV's review of pricing of stock preparations
21 September 2020 - In the process of reviewing the pricing of stock preparations, TLV contacted the pharmaceutical companies concerned during ...
Posted by Michael Wonder on 21 Sep 2020
Revised opioids PBS listings from 1 October 2020
21 September 2020 - Commencing 1 October 2020, the PBS listings for opioid medicines will change. ...
Posted by Michael Wonder on 21 Sep 2020
Lynparza recommended for approval in the EU by CHMP for BRCA mutated metastatic castration-resistant prostate cancer
21 September 2020 - Only PARP inhibitor to improve overall survival versus new hormonal agent treatments in advanced prostate cancer. ...