Browsing “October, 2020 | EVERSANA”

French MPs Vote for PLFSS Amendments Regarding ATU, RTU Schemes

Country: FRANCE | Region: EUROPE | Type: Policy | Keywords: #access #atu #budget #compassionate #drug #early #france #plfss #policy #spending PRICENTRIC BRIEF: French MPs have voted in favor of amendments to the Social Security Finance Bill 2021 (PLFSS 2021), regarding early access (RTU) and managed off-label use (ATU) scheme In accordance with the voting, the new “Early Stage” and “Compassionate Use” schemes will be implemented in order to ensure patients have early, temporary and exceptional […]

Canada Publishes Finalized PMPRB Guidelines Ahead of January 1, 2021 Implementation

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: : #clinicaltrials #druglaunch #excessivepricing #innovation #marketshare #patientaccess #pmprb #priceceilings #referencepricing(irp) #treatmentcosts PRICENTRIC BRIEF: The Patented Medicine Prices Review Board (PMPRB) has released the final version of the PMPRB guidelines, which are due to take effect on January 1, 2021 As noted by PMPRB, […]

Evoke and EVERSANA Announce Commercial Launch of Gimoti™

Product launch provides healthcare providers a novel treatment approach for patients suffering from symptoms of acute and recurrent diabetic gastroparesis SOLANA BEACH, CA, and CHICAGO, IL, October 26, 2020 – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, a leading provider of global commercial services […]

Pricentric Insights: What a Biden Presidency Could Mean for Drug Pricing in the U.S.

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #biden #debate #donald #drug #harris #joe #kamala #policy #presidency #pricing #states #trump #united PRICENTRIC BRIEF: With the final presidential debate looming tonight, October 22, and Election Day two weeks away, Democratic presidential nominee Joe Biden’s drug pricing proposals hang primarily on one overarching […]

UK’s MHRA Joins ACSS-Consortium, FDA’s Project Orbis

Country: AUSTRALIA, CANADA-ONTARIO, SINGAPORE, SWITZERLAND, UNITED KINGDOM, UNITED STATES | Region: ASIA & SOUTH PACIFIC, EUROPE, NORTH AMERICA, SOUTH AMERICA | Type: Regulation | Keywords: #acssconsortium #anvisa #concurrentsubmission #fda #healthcanada #hsa #hta #mhra #projectorbis #swissmedic #tga PRICENTRIC BRIEF: The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is officially joining the Australia-Canada-Singapore-Switzerland (ACSS) Consortium on January 1, 2021, after first shadowing the Consortium As noted by MHRA, “The addition of the UK brings the combined population of countries participating in the […]

Mirum Pharmaceuticals Announces Partnership With EVERSANA to Support Launch and Commercialization of Maralixibat for Alagille Syndrome in the United States

Agreement outlines commercialization and distribution services to support patients diagnosed with Alagille syndrome FOSTER CITY, Calif. — Oct. 15, 2020– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced it has partnered with EVERSANA™, a leading provider of commercial services to […]

Japan’s Ministry of Health Proposes Finalized Off-Year Re-pricing for All Medicines

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Pricing & Reimbursement | Keywords: #cost #generics #japan #medicines #mof #moh #nhi #off #patented #pricing #revision #sakigake PRICENTRIC BRIEF: Japan’s Ministry of Finance (MOF) has presented its proposal on the country’s planned off-year drug re-pricing, and called for a total revision of all products including patent-protected medicines, in order to reduce the financial […]

EMA Commences Rolling Review of Second COVID-19 Vaccine

 Country: NETHERLANDS | Region: EU28, EUROPE | Type: Regulation | Keywords: #biontech #chmp #covid19 #ema #pfizer #rollingreview #vaccine PRICENTRIC BRIEF: The European Medicines Agency’s (EMA) human medicines committee (CHMP) has commenced a rolling review of data for Pfizer and BioNTech’s potential COVID-19 vaccine candidate, BNT162b2 CHMP’s decision to start the rolling review of BNT162b2 is based on promising preliminary results from non-clinical trials and early clinical studies, in which it has […]

EPP’s Dynamics Talks | Life Sciences

Join EVERSANA’s Ed Corbett, Head of EMEA, at the upcoming European Pricing Platform’s Dynamic Talks series on November 5, 2020, at 3 PM CET / 2 PM BST / 9 AM EST. Register NOW! Achieving Launch Excellence in a Disrupted World Developing strategies focused on demonstrating real value and minimising risk Understanding the future of […]

DSCSA Guidelines – October Update

On November 27, 2023, all drug manufacturers must participate in an electronic package-level traceability system, commonly known as the “interoperability” requirement. EVERSANA is equipped to help manufacturers navigate this new guidelines and apply best practices. Let’s work together to make sure that you stay in compliance with the FDA and meet the demands of your […]