PMPRB report examines availability and pricing of new medicines

22 May 2024 - The Patented Medicine Prices Review Board (PMPRB) published the eighth edition of its annual Meds Entry Watch ...

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Issues, challenges and opportunities for economic evaluations of orphan drugs in rare diseases: an umbrella review

25 May 2024 - There are significant challenges when obtaining clinical and economic evidence for health technology assessments of rare diseases. ...

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FDA Advisory Committee Panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option

23 May 2024 - Shield remains on track to become the first FDA approved blood test that meets performance requirements for ...

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EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14

24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...

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Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe

23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...

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Verastem Oncology announces the initiation of a rolling submission of NDA to FDA seeking accelerated approval of avutometinib and defactinib combination for the treatment of adult patients with recurrent KRAS mutant low grade serous ovarian cancer

24 May 2024 - Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of ...

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Moving forward on Pharmacare for Canadians

24 May 2024 - Pharmacare legislation includes universal access to contraception and diabetes medications. ...

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Sobi receives US FDA fast track designation for emapalumab-lzsg being investigated in macrophage activation syndrome

24 May 2024 - Sobi North America today announced that the US FDA has granted fast track designation to emapalumab-lzsg being ...

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NICE and NHS England announce plan to enable innovative tech to be adopted quicker

23 May 2024 - NHS patients in England will benefit from faster access to the most innovative and cutting-edge medical technologies ...

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Camurus receives EMA acceptance of MAA filing for octreotide SC depot (CAM2029) for the treatment of acromegaly

23 May 2024 - Camurus today announced that the EMA has accepted for review the company’s marketing authorisation application for octreotide ...

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Bausch Health announces additional public drug plan listings for Uceris (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults

23 May 2024 - Bausch Health today announced additional Canadian public drug plan listings for Uceris (budesonide) aerosol foam to ...

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Antengene's Xpovio moves close to getting insurance benefits

3 May 2024 - Xpovio (selinexor), the first drug launched in Korea by Antengene, has won recognition to receive reimbursement ...

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Jiangsu to ‘reapply for US approval of rivoceranib combo therapy ASAP’

23 May 2024 - Hangseo Hengrui Pharmaceuticals said Thursday that it would meet with the US FDA as soon as ...

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Theriva Biologics announces fast track designation granted by the US FDA for VCN-01 for the treatment of metastatic pancreatic cancer

23 May 2024 - Theriva Biologics today announced that the US FDA has granted fast track designation to lead clinical candidate ...

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Historical archive of the Schedule of Pharmaceutical Benefits (1951- 2002)

23 May 2024 - The Department of Health and Aged Care has completed the digitisation, and is making available for public ...

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Setmelanotide acetate for the treatment of patients with obesity and hyperphagia in Bardet-Biedl syndrome (final guidance)

22 May 2024 - NICE has published final evidence-based recommendations on the use of setmelanotide acetate (Imcivree) for treating obesity ...

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