Michigan Minds Podcast: Addressing Health Disparities through Health Policy Research
Social determinants of health (SDoH) are a driving factor in health disparities, especially those faced by marginalized and rural populations. In the latest episode of the Michigan Minds Podcast, University of Michigan professor Paula Lantz, PhD talks about SDoH, birth rates, and how public policies can be used to address health disparities on the population level.
Biden, the GOP, and the Future of Medicare
As the US Congress deliberates over the Biden administration’s recently released budget proposal, uncertainty looms over the future of Medicare funding. President Biden and most Republicans have pledged not to cut funding from the program, but some outliers within the GOP are pushing for cuts. These potential cuts could take one of a three different forms, according to Kaiser Health News correspondent Julie Rovner in a new NPR interview.
Positive Trial Data for AstraZeneca Lung Cancer Immunotherapy Sets the Stage for Battle with Merck’s Keytruda
Astrazeneca reported promising data for its non-small cell lung cancer (NSCLC) immunotherapy Imfinzi, setting the stage for a market showdown with Merk’s Keytruda. The therapy, when added to chemotherapy, improved event-free survival in patients undergoing surgery for early stage NSCLC. Once entering the market, the drug is set to be a strong competitor with Keytruda.
Lilly and Boehringer’s Type II Diabetes Drug Gets Expanded Approval from FDA for Use in Children
Eli Lilly and Boehringer Ingelheim secured approval from the US Food and Drug Administration (FDA) to expand the indications of its diabetes drug Jardience. The new indications include children under 10 with type 2 diabetes, a growing population in recent years. The drug would be the first in its class for patients in this age group, opening up a new avenue for early life diabetes management.
New Trial Data Sinks Astellas’ Hopes to Expand Indication for Leukemia Drug
Astellas reported new trial data for Xospata that bodes poorly for its chances at an expanded indication as an add-on in the treatment of acute myeloid leukemia (AML), an aggressive blood cancer. The data showed that addition of Xospata after stem cell therapy did not improve relapse-free survival at 2-year followup.
Leveraging Real-World Data in Research and FDA Approval Applications
The US Food and Drug Administration (FDA) has increasingly encouraged drug developers to use real-world data (RWD) and the real-world evidence (RWE) generated from it in applications. As a result, more and more companies are using RWD and RWE in novel clinical trial designs, applications to extend indications, and in post-approval studies.
Pfizer Secures FDA Approval for Intranasal Migraine Spray
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 the spray yielded significant improvements in acute pain relief for users.
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 current alternatives. While clinical trial data showed the drug to be more effective than the standard of care in treating advanced melanoma, the endpoints used are a sticking point for the Gemeinsamer Bundesausschuss (G-BA).
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 22 drugs getting simultaneous review in the past five years.
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 after delivering stem cells that can restore the function of insulin-producing pancreatic cells.
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, it’s far from the only biosimilar.
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 drug value-assessments. Proponents of the ban say relying on QALY undervalues the positive effects of therapeutics on people with disabilities.
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 evidence (RWE) analysis. This move marks a first for the platform.
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 drug’s odds based on the new data.
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 covers three of Merck’s MMRV vaccines.
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 controlled than in the US or EU markets, where the drug has taken off with celebrities and influencers.
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 privacy.
Hard to Define, Harder to Find Patients: Using AI & Real-World Data to Understand Treatment Resistant Depression
Mental health conditions can take a staggering toll on an individual physically, socially and financially. Many patients languish with [...]
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 to generate new data that may tip the scales.
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 the Trump Administration.
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 this uncertainty and improve clinical trials.
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 white, upper-middle class, urban participant populations.
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 the Inflation Reduction Act.
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 treatment for patients with opioid use disorder.
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 recommendation comes as the company releases promising phase III clinical trial data.
