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RSS FeedPosted by Michael Wonder on 14 Sep 2022
TRACON Pharmaceuticals announces fast track designation by the FDA for envafolimab for the treatment of the soft tissue sarcoma subtypes of UPS and MFS
14 September 2022 - TRACON Pharmaceuticals announced today that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 14 Sep 2022
Jazz Pharmaceuticals receives SMC approval for reimbursement of Sativex
14 September 2022 - Therapy is for the treatment of spasticity due to multiple sclerosis. ...
Posted by Michael Wonder on 14 Sep 2022
NICE inks another early full stop on the appraisal of a cancer medicine
14 September 2022 - Once again, the sponsor decided not to provide an evidence submission. ...
Posted by Michael Wonder on 14 Sep 2022
Lupin receives Health Canada approval for Rymti (biosimilar etanercept)
13 September 2022 - Rymti is Lupin’s biosimilar etanercept approved for all indications of the reference product. ...
Posted by Michael Wonder on 14 Sep 2022
Health Canada approves Keytruda (pembrolizumab) as adjuvant treatment for adults and children with stage IIB or IIC melanoma following complete resection
13 September 2022 - Approval is based on the Phase 3 KEYNOTE-716 trial. ...
Posted by Michael Wonder on 14 Sep 2022
PHARMAC announces medicines bundle to provide more treatment options for New Zealanders
14 September 2022 - PHARMAC is considering funding two medicines as part of a new bundle agreement that would offer ...
Posted by Michael Wonder on 14 Sep 2022
Independent review of paracetamol overdose
14 September 2022 - The TGA has published an independent expert report examining the incidence of serious injury and death ...
Posted by Michael Wonder on 14 Sep 2022
aTyr Pharma receives FDA fast track designation for efzofitimod for treatment of systemic sclerosis-associated interstitial lung disease
13 September 2022 - Second fast track designation for efzofitimod clinical program. ...
Posted by Michael Wonder on 13 Sep 2022
Anthos Therapeutics announces that abelacimab has received FDA fast track designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation
8 September 2022 - This is the second fast track designation issued by the FDA for abelacimab. ...
Posted by Michael Wonder on 13 Sep 2022
CStone announces China’s NMPA has accepted and granted priority review to the supplemental new drug application for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma
13 September 2022 - GEMSTONE-201 is the largest registrational clinical study of an anti-PD-(L)1 antibody reported so far in patients with ...
Posted by Michael Wonder on 13 Sep 2022
CADTH partners with international health technology assessment bodies to boost collaboration on shared challenges
6 September 2022 - Six health technology assessment bodies from three continents will join forces to collaborate on a range of ...
Posted by Michael Wonder on 13 Sep 2022
Explainer: how the US drug pricing law affects Medicare and its members
13 September 2022 - U.S. President Joe Biden last month signed the $430 billion Inflation Reduction Act, authorising the federal ...
Posted by Michael Wonder on 13 Sep 2022
FDA finalises guidance on submitting RWD/RWE in application cover letters
13 September 2022 - To help better track submissions that include real world data and real world evidence, the US ...
Posted by Michael Wonder on 13 Sep 2022
Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
Posted by Michael Wonder on 13 Sep 2022
ICER publishes final evidence report and policy recommendations on treatments for amyotrophic lateral sclerosis
13 September 2022 - Majority of independent appraisal committee voted that evidence is adequate to demonstrate that both AMX0035 and oral ...