The US Federal Trade Commission (FTC) has issued a new policy statement saying it will actively target pharmacy benefit managers (PBMs) and drugmakers in its efforts to lower the cost of insulin. The agency noted that it would increase its vigilance to stop actions that “block patients’ access to […]
OM1 Webinar – July 19th: Using Real-World Data to Explore and Demonstrate Comparative Effectiveness
Real-world data (RWD) can empower clinical trials and regulatory decisionmaking, but knowing which data to use and how best to implement it is tricky. In an upcoming webinar on July 19th, Jessica Paulus, SciD, Senior Director of Research/Epidemiology, will discuss the opportunities and issues […]
Webinar – July 26th: Optimize Your Value Story Through Integrated Evidence Generation – From Bench to Patient
Getting new, innovative treatments to patients requires an increasingly comprehensive set of evidence demonstrating their efficacy and value-effectiveness. Doing so efficiently requires an integrated evidence generation approach that relies on real-world evidence (RWE) and insights […]
ISPOR Europe 2022: Call for Abstracts – Deadline: 30 June
This November, health economics and outcomes research (HEOR) professionals from across Europe will gather at ISPOR Europe 2022 to share their latest findings, collaborate with colleagues, attend workshops led by HEOR experts and more. ISPOR is seeking research and case study abstract submissions for […]
EFPIA-EURORDIS Publishes Joint Statement on Patient Access to Rare Disease Medicines
The European Federation of Pharmaceutical Industries and a Associations has issued a joint statement with EURODIS Rare Diseases Europe on access to treatment for people with rare diseases. In the statement, the organizations put forward their shared goal to reduce disparities in access to treatments […]
Clovis Withdraws Approval Applications for Ovarian Cancer Drug Rubraca
Clovis Oncology has announced it will withdraw its FDA approval application for Rubraca, its third-line BRCA-mutated ovarian cancer drug. The company is also withdrawing its application for approval by the European Medicines Agency. The move comes after overall survival data found that a subset of […]
Real-World Data Study Finds Clear Differences Between Rheumatoid Arthritis Drug Classes
A new paper published in the Annals of Rheumatic Diseases found significant differences in the three main classes of rheumatoid arthritis drugs. The study used real-world data (RWD) from a European registry dataset of almost 32,000 rounds of treatment given to RA patients, showing that abatacept had […]
Lumanity Acquires Endpoint Outcomes, Creating a Unique and Comprehensive Health Economics and Outcomes Research Offering
Lumanity Acquires Endpoint Outcomes, Creating a Unique and Comprehensive Health Economics and Outcomes Research Offering Lumanity Acquires Endpoint Outcomes, Creating a Unique and Comprehensive Health Economics and Outcomes Research Offering World-class outcomes research capability teamed with […]
Healthcare stocks offer defence against inflation
Andy Acker, Janus Henderson Investors In the current scenario of 40 year-high inflation and rising interest rates, there is a reasonable chance of a recession in the next 12 to 18 months, said Andrew Acker, portfolio manager of JHI’s Global Life Sciences Fund. To defend against this macroeconomic […]
Analysts are starting to give their top stocks to own in a recession – Algulf
With the market selling off on fears of an imminent recession, individual stock analysts are starting to trot out their top stock picks to own in an economic downturn. A number of reports to clients of Wall Street banks this week focused on stocks that have resilient revenues and business models. […]
Pfizer, MorphoSys and Incyte Enter into Clinical Trial Collaboration for Monjuvi® (tafasitamab-cxix) in Combination with TTI-622, a Fusion Protein Directed Against CD47 | Business Wire
NEW YORK & BOSTON & WILMINGTON, Del.--( BUSINESS WIRE )--Pfizer Inc. (NASDAQ:PFE), MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ:MOR), and Incyte (NASDAQ:INCY) today announced a clinical trial collaboration and supply agreement to investigate the […]
Biosimilars to Surpass Valuation of US$ 85 Bn by 2031: Notes TMR Study
Demand for recombinant non-glycosylation proteins in biosimilars market rising on back of need for advanced and affordable treatments for chronic diseases worldwide; application of cutting-edge technologies to expand avenues Patent expiry of several important biological drugs to spur revenue […]
UK Labor Market Could Be Showing Tentative Signs of Softening
UK Labor Market Could Be Showing Tentative Signs of Softening 0803 GMT - U.K.'s labor market data for April and May suggest that worker shortages aren't actively getting worse, ING developed markets economist James Smith says in a note. The sharp rise in vacancies seen in 2H 2021 seems to be […]
Mayo Clinic Shares De-Identified Patient Dataset with BD in New Partnership
The health IT vendor Becton, Dickinson, and Company (BD) has partnered with the Mayo Clinic to gain access to its de-identified patient database, the Mayo Clinic Platform_Discover. The platform is a robust resource of electronic health records (EHR) from 10 million patients, with over a billion lab […]
Roche’s Amyloid-Targeting Alzheimer’s Drug Fails in Phase II Trial
Roche and Genentech released data from their Phase II API-ADAD trial showing their experimental Alzheimer’s disease drug crenezumab failed to prevent or reduce the cognitive decline that is indicative of the disease. The drug’s failure represents another setback to the growing number of experimental […]
ISPOR Publishes HTA Deliberative Process Guidance
ISPOR – The Professional Society for Health Economics and Outcomes Research has published a new guidance on deliberative processes for health technology assessment (HTA). The guidance, published in Value in Health, provides a detailed checklist for setting up an efficient and transparent […]
Learning from the AIDS Crisis to Combat Monkeypox
As the monkeypox outbreak spreads across the world, public health experts and decisionmakers look back to the peak of the AIDS crisis for guidance. The current outbreak has echoes of the AIDS crisis because monkeypox, much like HIV, is a virus that predominately affects men who have sex with men […]
Trade and Channel Strategies | December 12-14, 2022 | Philadelphia, PA – Hybrid Event
Advanced therapeutics can’t help patients if they can’t get to patients. At the upcoming Trade & Channel Strategies conference, senior-level directors and executives from pharma and biotech manufacturers will meet and share their insights on hot issues surrounding trade and distribution […]
BeiGene Announces Brukinsa™ (zanubrutinib) Is Approved in 50 Markets
BeiGene Announces BRUKINSA™ (zanubrutinib) Is Approved in 50 Markets BeiGene and NewBridge Pharmaceuticals To Bring BRUKINSA to Patients in MENA Region, Following Approval for Previously Treated Mantle Cell Lymphoma in Kuwait, Bahrain and Qatar BRUKINSA has Previously Been Approved by Regulatory […]
Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates | Business Wire
JERSEY CITY, N.J.--( BUSINESS WIRE )--Organon (NYSE: OGN), a global women’s health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights […]
Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates
Organon & Co Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates (Businesswire) 2022-06-13 14:30 Organon announces first biosimilars business deal with a global license agreement with […]
Chronic Disease Management Market Size, Share, And Forecast 2027
Market Overview Chronic disease management market size is expected to reach USD 4000 Million and it is predicted to register a CAGR of 14.5% during the forecast 2027. Persistent illness the board comprises of a predefined set of activities zeroed in principally on conveying top notch medical […]
Global Lymphoma Antibodies Market & Clinical Trials Report 2022-2028 – Polivy, Adcetris, and Zynlonta have Gained Approval for the Management of Lymphoma | Nachricht
DUBLIN, June 13, 2022 /PRNewswire/ -- The "Global Lymphoma Antibodies Market & Clinical Trials Insight 2028" report has been added to ResearchAndMarkets.com's offering.Global lymphoma antibody therapeutics market is expected to surpass US$ 6 Billion by 2028The global lymphoma antibody […]
Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates
Collaboration expands and underscores commitment to biosimilars portfolio and focus on women’s health with biosimilar candidates for osteoporosis and breast cancer Organon (NYSE: OGN), a global women’s health company with deep expertise in biosimilar commercialization, today announced that it has […]
Congressional Democrats Seek DOJ and FTC Investigation into Blood Thinner Price Hikes
Johnson & Johnson and Bristol Meyers Squib are facing increasing scrutiny from members of the US Congress after allegations of price-fixing. The two pharma giants’ blood thinners Xarelto and Eliquis have risen in price in tandem, a pricing pattern deemed suspiciously uncompetitive to some […]
ICER Signals Concern About Price for Amylyx’s ALS Drug
The Institute for Clinical and Economic Review (ICER) has released a draft report detailing their concerns surrounding Amylyx Pharmaceutical’s new ALS drug Albrioza/AMX0035. The drug has just been conditionally approved in Canada and will likely receive a decision from the US Food and Drug […]
SDOH May be Better Predictor of Health Outcomes than Race
Race has long been used as a predictor of health outcomes, but a recent panel of medical bias experts at the Philadelphia Alliance for Capital and Technologies argued that doing so may be hurting members of marginalized communities. Instead, all of the social determinants of health that intersect […]
Breaking: US FDA Approves Moderna and Pfizer’s COVID-19 Vaccines for Children 5 and Under
The US Food and Drug Administration’s (FDA) vaccine advisory committee (Adcomm) voted unanimously (21-0) to approve Moderna and Pfizer’s mRNA-based COVID-19 vaccines for children aged 5 and under. The anticipated approval was urged by many in the healthcare community due to the increasing numbers of […]
Supreme Court Issues Unanimous Decision in 340B Case in Favor of Hospitals
The US Supreme Court has issued its highly-anticipated decision in the Medicare 340B case, ruling unanimously in favor of hospitals. The American Hospital Association (AHA) and other health systems sued the US Department of Health and Human Services (HHS) over 340B reimbursement rates from 2018 and […]
Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis
Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis e067745 - Rebecca J Williams, acting director [1] , - Heather D Dobbins, lead results analyst [1] , - Tony Tse, analyst [1] , - Sandy D Chon, information technology manager [2] , - David Loose, […]
