Blog
RSS FeedPosted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 30 Apr 2024
Johnson & Johnson receives positive CHMP opinion recommending full approval for Sirturo (bedaquiline) for treatment of multidrug-resistant tuberculosis
29 April 2024 - Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer ...
Posted by Michael Wonder on 29 Apr 2024
Soleno Therapeutics receives breakthrough therapy designation from US FDA for diazoxide choline extended release tablets in Prader-Willi syndrome
29 April 2024 - Designation is based on data from the Phase 3 program for diazoxide choline. ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves first drug for WHIM syndrome, a rare disorder that can lead to recurrent, life threatening infections
29 April 2024 - The US FDA has approved Xolremdi (mavorixafor) capsules in patients 12 years of age and older with ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
29 April 2024 - Today, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen) for recurrent or metastatic cervical ...
Posted by Michael Wonder on 29 Apr 2024
Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER positive breast cancer
29 April 2024 - Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression ...
Posted by Michael Wonder on 29 Apr 2024
Celltrion USA signs agreement with Express Scripts for its therapy for autoimmune diseases including the first FDA approved subcutaneous infliximab Zymfentra
28 April 2024 - Celltrion USA announced today that it has signed an agreement with Express Scripts, one of the nation's ...
Posted by Michael Wonder on 29 Apr 2024
Evernorth announces Humira biosimilar available at $0 out of pocket for Accredo patients in June
25 April 2024 - Biosimilar price will be about 85% lower than Humira. ...
Posted by Michael Wonder on 29 Apr 2024
Government boosts PHARMAC funding by $1.7 billion as inaugural medicines summit begins
29 April 2024 - The Government will boost PHARMAC’s budget by more than $1.7 billion over the next four years, ...
Posted by Michael Wonder on 29 Apr 2024
Idebenone for the treatment of patients 12 years and older with visual impairment associated with Leber’s hereditary optic neuropathy
24 April 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 29 Apr 2024
Life prolonging breast cancer drug recommended for PBS subsidy, but it is not time to celebrate
26 April 2024 - Breast Cancer Network Australia (BCNA) today welcomed a decision by the PBAC to recommend the life ...
Posted by Michael Wonder on 28 Apr 2024
Former Deputy Prime Minister Paula Bennett appointed new chair of PHARMAC
28 April 2024 - Former Deputy Prime Minister Paula Bennett has been appointed the new chair of the national drug ...
Posted by Michael Wonder on 27 Apr 2024
Highlights from the 22-25 April 2024 CHMP meeting
26 April 2024 - The EMA’s CHMP recommended eight medicines for approval at its April 2024 meeting. ...
Posted by Michael Wonder on 27 Apr 2024
Use evidence to support early coverage of gene therapy after accelerated approval
23 April 2024 - Gene editing and therapy to replace missing or defective genes is one of the most exciting ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 27 Apr 2024
New hope for Aussies battling early stage breast cancer
28 April 2024 - For the first time in 15 years women with an invasive form of early breast cancer ...