The Institute for Clinical and Economic Review published their Draft Evidence report for what could be one of the biggest reviews of 2020. The review of Ulcerative Colitis (UC) impacts big players in Immunology – all of which will need to bring their A-Game to this class review. Due to COVID-19, the meeting will be […]
Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #actionadate #b-celltherapy #fda #multiplesclerosis #novartis #ofatumumab #sbla PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) issued a notice to Swiss-based Novartis explaining that the agency has extended its review of the supplemental Biologics License Application (sBLA) for ofatumumab, a targeted B-cell therapy for relapsing multiple sclerosis (MS) The FDA is now expected to make a decision […]
Country: ARGENTINA, BANGLADESH, BELGIUM, BRAZIL, CHILE, EGYPT, INDONESIA, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PORTUGAL, SOUTH AFRICA, SRI LANKA, URUGUAY | Region: AFRICA, ASIA & SOUTH PACIFIC, EUROPE, MIDDLE EAST, NORTH AMERICA, SOUTH AMERICA | Type: Policy | Keywords: #access #affordability #c-tap #covid-19 #healthtechnologypool #iprights #vaccines #voluntaryscheme #who PRICENTRIC BRIEF: Thirty countries and a variety of international partners and institutions have signed the World Health Organization’s (WHO) COVID-19 Technology Access Pool (C-TAP), an initiative first proposed by Costa Rican President Carlos Alvarado to make vaccines, tests, treatments, and other health technologies used in […]
Region: NORTH AMERICA | Type: Policy | Keywords: #cms #copayment #diabetes #insulin #lowercosts #medicaid #medicare #oopcosts #partdseniorsavings PRICENTRIC BRIEF: The Centers for Medicare & Medicaid (CMS) announced that over 1,750 standalone Medicare Part D prescription drug plans and Medicare Advantage plans with prescription drug coverage applied to offer lower insulin costs under the Part D Senior Savings Model for the 2021 plan year Through this, participating plans will provide […]
Region: NORTH AMERICA | Type: Regulation | Keywords: #astrazeneca #daiichisankyo #deruxtecan #enhertu #orphan #trastuzumab PRICENTRIC BRIEF: The FDA has granted Orphan Drug Designation to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of patients with gastric cancer, including gastroesophageal junction cancer The designation was supported by data from the Phase II DESTINY-Gastric01 trial, in which Enhertu demonstrated a statistically significant and clinically meaningful improvement in objective response […]
Country: UNITED KINGDOM, UNITED STATES | Region: EUROPE, NORTH AMERICA | Type: Drug Launch | Keywords: #astrazeneca #az #azd1222 #coronavirus #covid19 #distribution #manufacturing #r&d #supplychain #vaccine PRICENTRIC BRIEF: AstraZeneca (AZ) concluded the first agreements for over 400 million doses of a COVID-19 vaccine and secured manufacturing capacity for a total of one billion doses so far, the company announced, with the first doses set to be delivered in September 2020 AZ has […]
Country: DENMARK, FINLAND, ICELAND, NORWAY, SWEDEN | Region: EUROPE | Type: Pricing & Reimbursement | Keywords: #access #bluebird #finose #genetherapy #jointhta PRICENTRIC BRIEF: Bluebird bio has been invited to enter joint negotiations with Nordic countries Denmark, Finland, Iceland, Norway, and Sweden to ensure quick and equal access to its gene therapy Zynteglo (autologous cd34+ cells encoding βAT87Q-globin gene) for transfusion-dependent β-thalassemia Zynteglo will be the first new drug […]
Country: NETHERLANDS | Region: EUROPE | Type: Policy | Keywords: #access #healthcare #hta #medicines #netherlands #personalized #reform #structure PRICENTRIC BRIEF: The Netherlands’ Innovative Medicines Association (VIG) believes that the current system structure in the Netherlands is not quite ready for personalized medicine ONVZ is the only health insurer in the Netherlands that reimburses pharmacogenetic research to do something about the changes, as it stands The news comes as the costs of […]
Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #deciphera #fda #projectorbis #qinlock #realtimeoncologyreview PRICENTRIC BRIEF: The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.) The New Drug Application (NDA) […]
The Institute for Clinical and Economic Review (ICER) has been very responsive to the current public health pandemic, from adjusting their review timelines to assessing COVID-19 impact on drug pricing and patient access. Within a few days of Gilead’s remdesivir gaining emergency approval by the U.S. Food and Drug Administration (FDA), ICER has published an […]
