FDA Vocalizes Support for Moderna and Pfizer Vaccines for Children Under 5 One Day Before Advisory Committee
The US Food and Drug Administration (FDA) has signalled support for authorizing the Moderna and Pfizer COVID-19 vaccines for children [...]
Novavax COVID-19 Vaccine Awaits FDA Review of Manufacturing Data
On Tuesday, outside experts at the US Food and Drug Administration (FDA) voted 21 – 0 to give emergency approval [...]
Emergent and J&J Butt Heads Over Breaches of Contract
On Monday, June 6th, Emergent BioSolutions informed Johnson & Johnson that it will owe $420 million if the company terminates [...]
How Managed Care Pharmacists Can Improve COVID-19 Vaccination Rates for Underserved Populations
Despite seemingly widespread access to COVID-19 vaccinations in wealthier areas, many Americans in underserved populations have much more limited access. [...]
Bavarian Nordic in Talks with Governments to Produce Monkeypox Vaccines
As more cases of monkeypox spring up across the world, the German government has ordered 40,000 doses of monkeypox vaccines [...]
Emergent was Aware of COVID Vaccine Problems Six Weeks Before Alerting FDA
Contrary to what it told the US Food and Drug Administration (FDA), a new US House committee revealed that Emergent [...]
Johnson & Johnson Backs Out of Bavarian Nordic HPV and HBV Vaccine Collaborations
J&J has announced that it is pulling out of hepatitis B virus (HBV) and human papillomavirus (HPV) vaccine development partnerships [...]
Pfizer Takes Heat for Alleged Pandemic Profiteering
Several patient advocacy groups have accused Pfizer of profiteering off the pandemic. The company, which made ~$26 billion at the [...]
Moderna seeks FDA Emergency Authorization for Children Under 6
Moderna touts new data supporting the use of its COVID-19 vaccine Spikevax in children under 6 as it prepares to [...]
COVID-19 Vaccine Intellectual Property Compromise Praised by WTO Chief
Ngozi Okonjo-Iweala, current World Trade Organization chief, has expressed optimism to developments in intellectual property deliberations for COVID-19 vaccine technology. [...]
Moderna Evaluates Smaller Doses of COVID-19 Vaccine for Teens and Children
As Moderna waits for the FDA’s decision on emergency use authorization (EUA) of its COVID-19 vaccine for 12-17-year-olds at 100-microgram [...]
Webinar: Learning from the Pandemic to Accelerate AAV-based Gene Therapies
On Thursday, March 17th, Fierce Biotech and Cytiva present a webinar on applying lessons from the COVID-19 pandemic to accelerate [...]
FDA and Pfizer Step Away From COVID-19 Vaccine Expedited Review
The US Food and Drug Administration (FDA) and Pfizer are backing down from initial plans to fast-track approval of their [...]
Model Outlines the Cost of Vaccinating the World and the Human Cost of Doing Otherwise
A new model shows that vaccinating inhabitants of lower-middle and lower-income countries would save between 1.2 to 1.5 million lives [...]
EU and Africa Summit Overshadowed by Vaccine Access
A cloud of frustration about Europe’s refusal to share vaccine technology looms over a two day summit of African and [...]
2021 CDER Report: New Approvals Improve Patient Treatment Options
The Center for Drug Evaluation and Research (CDER) has released a new report detailing the 60 drugs the FDA approved [...]
Biden Administration Spent Billions of Hospital Covid-19 Funding on Vaccines and Therapeutics
In a move mirroring the Trump administration, the Biden Administration diverted almost $7 billion that was initially allocated to hospitals [...]
Vaccines and Value Assessment – 7 Updates
Navigating the evaluation requirements from health technology assessment (HTA) agencies and national immunization technical agency groups (NITAGs) is a must [...]
2022 Predictions: Ezekiel Emanuel Fireside Chat
Image by: Samuel Masinter (CC by 3.0) On Wednesday, December 1st, 2021, esteemed oncologist and policymaker Dr. Ezekiel [...]
Report on North America HEOR Market Forecast to 2027 Now Available
A new report discusses emerging and continuing trends in North America in health economics and outcomes research (HEOR). The report [...]
PhRMA Seeks to Address Health Disparities and COVID-19 Impact, Awards $150,000 in Community-Level Grants
PhRMA has announced four health disparity initiatives that will receive a quarter of $150,000. The programs tackle COVID-19 vaccine hesitancy, [...]
RWE Informs Decision-Making for Vaccines, Digital Therapeutics, and Medications
Real world evidence (RWE) is increasingly used in healthcare and pharma decision-making. A recent article explores its use in addressing [...]
Certara’s Vaccine Simulator Tool Effective in Predicting Timing of COVID-19 Vaccines
A recent study confirmed Certara findings regarding the interval between COVID-19 vaccine doses. Researchers are also using its Vaccine Simulator [...]
HealthVerity Waterfall Strategy Uses Open and Closed De-Identified RWD to Understand COVID-19 and Emerging Variants
Real world data (RWD) has already yielded remarkable insight throughout the COVID-19 pandemic. One data management strategy uses both open [...]
UnitedHealthcare Faces Pandemic Criticism; Pediatricians Voice Discontent With Low COVID-19 Vaccine Reimbursement Rates
UnitedHealthcare is reportedly paying providers around half the normal rate for administering COVID-19 vaccines. The payer is also shortchanging pediatricians [...]
