Results from a real-world data analysis show that Horizon Therapeutics’ Teppeza improves vision for patients with dysthyroid optic neuropathy (DON), a progressive eye disease related to thyroid dysfunction. Blindness is a leading fear of patients with the disease, making the therapy a promising […]
Seagen Shares Patent Rights to Cell Therapy with Gracell Biotech
Recent SEC filings show that Seagen, recently bought out by Pfizer, will share patent rights to experimental cell therapies with Gracell Biotechnologies. The deal will see Gracell performing clinical and preclinical testing on certain cell therapies, the identities of which have yet to be revealed. […]
New Startup Launches Platform to Simplify Telehealth Insurance Verification Process
The new startup Opkit, formed by two former Brex software engineers, has launched a new platform to simplify the process of insurance verification for telehealth services. Currently, the process is slowed down by the need to accept insurance from across state line and the mish-mash of different […]
Talking Real-World Evidence and Individualized NSCLC Therapy with Daryl Pritchard
Precision therapy for non-small cell lung cancer (NSCLC) could save patients’ lives, but access to these treatments and the required genomic and biomarker testing are out of reach for many. In a new OncLive interview, Ashling Wahner talks about recently presented research into the impact of targeted […]
US CMS Releases Guidance on Upcoming Drug Price Negotiations
The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put […]
Oncologists Skeptical of Enhancing Oncology Model
Despite being largely onboard with value-based care models, oncologists speaking at the Association of Community Cancer Centers (ACCC) 2023 meeting were skeptical of the upcoming Enhancing Oncology Model (EOM) developed by the US Centers for Medicare and Medicaid Services (CMS). The EOM replaces the […]
FDA Allows Dose Increase in Dravet Syndrome Clinical Trial
The US Food and Drug Administration (FDA) has released a hold blocking a Phase I/IIa clinical trial testing an increased dose of STK-001, Stoke Therapeutics’ drug candidate for Dravet syndrome. Dravet syndrome is a rare form of severe childhood epilepsy that comes with a short life expectancy and […]
US HHS Picks 27 Drugs for Inflation Rebates
A recent rule will let the US Department of Health and Human Services (HHS) require drugmakers to pay back rebates on drugs that increase in price faster than inflation. The department has announced its list of the first 27 drugs to face this process, including therapeutics from pharma giants like […]
Beneficiaries File Appeal Against UnitedHealth Victory in Mental Healthcare Coverage Case
A group of UnitedHealth members are filing an appeal to a recent court case against the company regarding its mental healthcare coverage practices. The class-action lawsuit alleged that United was basing its coverage decisions on patient claims based on the whims of the finance department, ignoring […]
Novo Nordisk Announces 75% Price Drop on Insulin in US
Novo Nordisk has announced it will cut US insulin list prices by 75%, following in the footsteps of Eli Lilly who announced a $35 dollar a month copay price cap a few weeks prior. The news is a relief to patients and advocacy groups who’ve long protested the high prices of the drug, which is […]
Modern Drug Development Depends on RWD
Drug developers and other life sciences organizations now have access to troves of real-world data (RWD) that can accelerate research and market access efforts. RWD and the real-world evidence generated let researchers study the effects of drugs in real-world conditions and make comparisons that may […]
Medicare Advantage AI Tools Stripping Care from Older Adults
Medicare Advantage insurers, like many payers, are increasingly relying on artificial intelligence (AI) to make reimbursement decisions, resulting in some older adults being denied access to adequate care. The tools are used to determine exactly when the plan can stop paying for care, […]
Biotechs Already Feeling the Effects of the Inflation Reduction Act
The drug pricing provisions of the US Inflation Reduction Act have yet to kick in but are already driving decisions in biotechs. To start, investors like Peter Kolchinsky are recommending that biotechs move to biologics instead of small molecule drugs since the waiting period prior to Medicare […]
US Veteran’s Administration to Cover Alzheimer’s Drug Leqembi
The US Veteran’s Administration has decided that it will cover Leqembi, Eisai and Biogen’s new therapeutic for Alzheimer’s disease. The announcement comes just weeks after the Centers for Medicare and Medicaid Services (CMS) decided not to expand coverage of the drug to patients outside of clinical […]
Which Drugmakers Will Face US Drug Pricing Negotiations in 2026?
Although many likely contenders have been named, the first slate of drugs to face Medicare drug pricing negotiations in 2026 is yet to be determined. The first 10 drugs to be selected will be announced in September, likely including cancer drugs from AbbVie and Pfizer and BMS’s blood thinner […]
Language Barriers Worsen Asthma Care and Outcomes
English second language (ESL) Hispanic patients face significant barriers to adequate care, worsening health outcomes. Research presented at this year’s American Academy of Allergy, Asthma & Immunology meeting shows these health disparities are present for Hispanic people with Asthma, especially […]
Pharma’s Take on Drug Pricing Data Transparency in South Korea
Korea’s drug pricing policies are complex and lack transparency, according to Eli Lilly Korea’s General Manager Christopher J. Stokes. Stokes notes that he has spent considerable time talking with other pharma leaders, who generally agree with his take on the complicated nature of the South Korean […]
Research Details Health Disparities in Childhood Asthma and Eczema Based on Race and Ethnicity
Health disparities in asthma and eczema have been observed in Black children, but little research has explored the combination of the two. In research presented at this year’s American Academy of Allergy, Asthma, and Immunology (AAAAI) meeting, researchers explored the social determinants of health […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
