Pfizer announced that it received approval from the US Food and Drug Administration (FDA) for its intranasal migraine spray Zavzpret. The drug was acquired by Pfizer in its acquisition of Biohaven, joining Pfizer’s lineup of migraine drugs. The approval comes after clinical trial data showed that […]
Bristol Myers Scraps Cancer Drug Launch in Germany Over Pricing
Bristol Myers Squibb’s (BMS) cancer drug Opdualag will not be launched in Germany for the foreseeable future, despite its EU approval last September. The decision was made due to pricing conflicts with a 2010 drug pricing law in the nation that requires evidence that a new drug has a benefit over […]
EMA and FDA Parallel Review Program Sees Slow Uptake
Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only […]
New Vertex Cell Therapy for Diabetes to Hit the Clinic Soon
Shortly after receiving the nod from the US Food and Drug Administration (FDA), Vertex Pharma announced that it will soon bring its new application of its diabetes cell therapy to clinics by summer of this year. The therapy uses a special delivery method that removes the need for immune suppressants […]
Coherus Neulasta Biosimilar Autoinjector Gets FDA Approval
The US Food and Drug Administration has approved the use of an autoinjector version ofUdenyca Coherus Biosciences biosimilar to Amgen’s Neulasta, a drug that reduces the chance of developing febrile neutropenia after chemotherapy. While this is the first approved autoinjector version of the drug, […]
New US Bill Challenges Use of QALY in Drug Value Assessments
Quality-adjusted life years (QALY) is a metric widely used when determining the cost-effectiveness of a drug, often when deciding upon or recommending drug prices. A new bill was approved by the US House Energy and Commerce Health Subcommittee that would, if passed, end the practice of using QALY in […]
Merck Announces Foundry DevTools Data Library is Now Free on Github
Merck KGaA has announced that its Foundry DevTools library, created with Palantir Technologies, will be freely available to users on Github, an open-source repository of code and software development resources. Merck and other pharma giants have used the platform for drug development and real-world […]
BioMarin’s Gene Therapy for Hemophilia Gets Extended Review by FDA
BioMarin will have to face another delay on the review of its hemophilia A review by the US Food and Drug Administration. This comes after the company shared data from ongoing clinical trials in November of last year. The drug was previously rejected, but Biomarin’s analysts are optimistic about the […]
Merck’s MMRV Vaccine Gets FDA Approval for Intramuscular Delivery
The US Food and Drug Administration (FDA) has cleared intramuscular administration for measles, mumps, rubella, and varicella (MMRV) vaccines from Merck. This opens up more options for care providers and marks a shift from subcutaneous injections, which were the standard for the shot. The approval […]
Wegovy Gets NICE Recommendation and Novo Nordisk Plans UK Launch
The UK’s National Institute for Health and Care Excellence (NICE) gave Novo Nordisk’s weight loss drug Wegovy its recommendation for coverage today, March 8th. In response, Novo Nordisk is making plans to bring the wildly popular drug to the UK market. However, the drug will be more tightly […]
Transparency, Oversight, and Opt-in Consent Makes Patients More Open to Sharing Data
A newly published paper in JAMA Network Open found that patients are more likely to participate in patient data sharing programs if certain conditions are met. Survey data from 3,500 hundred patients showed that patients valued transparency, opt-in informed consent, oversight mechanisms, and […]
Moderna Optimistic About Cancer Vaccine Getting Accelerated Approval
Moderna’s president Stephen Hoge told attendees at Cowen’s Annual Healthcare Conference that the company is optimistic about its chances to snag accelerated approval for its mRNA-based personalized cancer vaccine. Hoge pointed out that data from December may not be enough, but there is enough time […]
Patient Advocacy Groups Embroiled in Copay Suit with PBMs
A rule from the Centers of Medicare and Medicaid Services (CMS) allows pharmacy benefit managers (PBMs) to ignore copay assistance programs from drug manufacturers when accounting for out-of-pocket drug costs for patients. Patient advocacy groups have filed suit against CMS to contest this rule from […]
Using Real-world Data to Take Better Baseline Patient Measurements
After recruitment and on-boarding, patients in clinical trials undergo a battery of baseline measurements. However, measurements can vary significantly from moment to moment and “normal” ranges are often wide. Therefore, an approach that uses multiple measurements could help reduce […]
Improving Health Equity Through More Representative Clinical Trials
Patients from marginalized or rural populations often have less access to clinical trials or distrust based on a long-standing history of medical exploitation. However, this disparity in patient populations is detrimental to health equity efforts, biasing research by skewing heavily toward primarily […]
Biden Administration Looks into Expanding Reach of Medicare Drug Pricing Negotiations
During a statement about his administrations budgetary plans, US president Joe Biden argued that more drugs should undergo Medicare pricing negotiations. In addition, he called on the process to go more quickly, considering that only a small number of drugs will be negotiated starting in 2026 under […]
Proposed US DEA Rules Necessitate In-Person Visits For Certain Drugs Prescribed Via Telehealth
New rules proposed by the US Drug Enforcement Agency (DEA) will require patients to have in-person visits when prescribing certain controlled drugs to patients who primarily receive care via telehealth. While many controlled drugs are targeted, the rules are an expansion to access for buprenorphine […]
EMA Committee Recommends Regeneron’s Libtayo + Chemotherapy Combo for Lung Cancer
Regeneron’s Libtayo (cemplimab-rwlc) has received a recommendation from the European Medicine’s Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for use in forms of non-small-cell lung cancer (NSCLC) as a combination therapy with a traditional chemotherapy agent. The […]
Talking Remote Care and Reimbursement with Bronwyn Spira of Force Therapeutics
The US Centers for Medicare and Medicaid Services (CMS) introduced new CPT codes last year, reducing barriers via remote care. In a new video by Managed Healthcare Executive, Force Therapeutics’ Bronwyn Spira talks about how these new codes affected outcomes and why outcomes-based reimbursement […]
Real-World Data Study Identifies Negative Health Outcomes in Long COVID Patients One Year Out
A newly published study in JAMA Health Outcomes found several adverse health outcomes in people living with long COVID one year after their initial infection. The researchers analyzed data from 13,435 people with long COVID symptoms and nearly 27,000 without it, finding that those with long COVID […]
FDA to Hold Adcomm on Eisai’s Leqembi Alzheimer’s Treatment by July 6th
The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another […]
Sanders Calls on Insulin Manufacturers to Follow Eli Lilly and Drop Insulin Prices
One day after Eli Lilly pledged to cut prices on its insulin products and implement some price caps, US Senator Bernie Sanders (I-VT), the current Senate health committee chair, has sent letters calling on Novo Nordisk and Sanofi to follow in kind. The move comes amid growing public attention is […]
US FDA Issues Emergency Use Authorization for First At-Home COVID and Flu Combo Test Kit
After a winter hallmarked by coexiting waves of COVID-19, seasonal flu, and RSV, the US Food and Drug Administration has given the Lucira COVID and Flu Home Test emergency use authorization (EUA). The at-home test kit is the first of its kind approved by the agency, simultaneously testing for […]
Vertical Integration Has Negative Impacts on Patient Outcomes
Although many health systems are moving toward vertical integration by acquiring private practices, the strategy may be hurting the bottom line and patients. A newly published study examined how vertical integration impacts patients undergoing colonoscopies and their subsequent healthcare costs […]
US Court Temporarily Shoots Down J&J’s Plan to Prevent Amgen from Releasing Stelara Biosimilar
A US District Court judge stopped J&J’s attempt to stop Amgen’s Stelara biosimilar from entering the market. The judge cited a “failure to comply,” noting that the Pfizer’s lawyers submitted documents exceeding the courts page limits. In addition, the lawyers only asked to go over the limit […]
UK Increases Statutory Scheme and VPAS Revenue Clawback Rates
The UK’s voluntary scheme for branded medicines pricing and access (VPAS) controls National Health Service (NHS) spending by requiring drugmakers to recoup the government for a portion of sales if spending exceeds a certain rate of growth. The new clawback rate for VPAS increased to 26.5% while the […]
iCAD to Present Real-World Evidence Supporting Profound AI as Diagnostic Tool for Breast Cancer
The medical technology company iCAD is set to present new real-world evidence (RWE) at the European Congress of Radiology (ECR) 2023 supporting its ProfoundAI software in assisting radiologists with breast cancer detection and assessment. The company will also display its Breast AI platform at its […]
ICER Updates Leqembi Price Range Recommendations
The Institute for Clinical and Economic Review (ICER) released an update to its recently released value assessment of the Leqembi (lecanemab). ICER changed its price recommendation for Eisei’s new Alzheimer’s treatment to a range of $8,900 to $21,500 per year. This price is higher than its initial […]
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already […]
Medicare Advantage Insurer’s Margins on the Rise
An analysis from the Kaiser Family Foundation shows that insurers in Medicare Advantage saw strong margins in 2021, twice that of other markers. This is leading many insurers to enter into the market and many others to redouble their efforts, Humana which announced it is pivoting away from the […]
