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RSS FeedPosted by Michael Wonder on 14 Dec 2020
Diabetes drugs delay shows problem with PHARMAC’s funding model, doctor claims
14 December 2020 - Pharmac’s decision to delay funding approval for two new diabetes drugs has highlighted the shortcomings of ...
Posted by Michael Wonder on 14 Dec 2020
Janssen receives positive CHMP opinion for Spravato (esketamine nasal spray) for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
11 December 2020 - Positive opinion is based on results from two Phase 3 ASPIRE studies in adult patients with moderate ...
Posted by Michael Wonder on 14 Dec 2020
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
11 December 2020 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to standard of ...
Posted by Michael Wonder on 14 Dec 2020
Trastuzumab deruxtecan recommended for approval in the EU by CHMP for HER2 positive metastatic breast cancer
14 December 2020 - Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with ...
Posted by Michael Wonder on 13 Dec 2020
ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available
11 December 2020 - Findings from pivotal phase III BRIGHTE study demonstrated that the majority (60%) of heavily treatment-experienced adults randomised ...
Posted by Michael Wonder on 13 Dec 2020
Bristol Myers Squibb receives positive CHMP opinion for Inrebic (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis
11 December 2020 - If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade. ...
Posted by Michael Wonder on 13 Dec 2020
Seagen announces positive CHMP opinion for Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer
11 December 2020 - Recommendation for approval in the European Union based on results of pivotal HER2CLIMB trial. ...
Posted by Michael Wonder on 12 Dec 2020
CHMP recommends the approvals of Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and ankylosing spondylitis
10 December 2020 - If approved, Rinvoq will be the first oral, selective and reversible JAK inhibitor approved in three rheumatologic ...
Posted by Michael Wonder on 12 Dec 2020
Lexicon Pharmaceuticals receives fast track designation from the FDA for LX9211 for diabetic peripheral neuropathic pain
11 December 2020 - Lexicon Pharmaceuticals announced today that it has received Fast Track designation from the U.S. FDA for ...
Posted by Michael Wonder on 11 Dec 2020
Bavencio (avelumab) receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
11 December 2020 - Merck and Pfizer today announced that the CHMP of the EMA adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 11 Dec 2020
Alunbrig scores NICE backing for ALK positive lung cancer
11 December 2020 - Takeda’s Alunbrig (brigatinib) has been recommended by the UK’s NICE for patients with ALK positive advanced ...
Posted by Michael Wonder on 10 Dec 2020
Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotising soft tissue infection ("flesh eating disease")
10 December 2020 - Atox Bio today announced that the U.S. FDA has accepted to file the new drug application ...
Posted by Michael Wonder on 10 Dec 2020
Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
9 December 2020 - A federal watchdog is being asked to investigate the FDA for an “inappropriate collaboration” with Biogen ...
Posted by Michael Wonder on 10 Dec 2020
ICER to assess treatments for atopic dermatitis
10 December 2020 - Report will be subject of New England CEPAC meeting in July 2021; draft scoping document open to ...
Posted by Michael Wonder on 10 Dec 2020
X4 Pharmaceuticals receives rare paediatric disease designation from FDA for mavorixafor for the treatment of WHIM syndrome
10 December 2020 - X4 Pharmaceuticals today announced that it has received rare paediatric disease designation from the U.S. FDA ...