Linda Goler Blount, MPH, to Join ICER Governance Board
Linda Goler Blount, MPH, has been elected to join the governance board of the Institute for Clinical and Economic Review. Blount has worked in health policy and is currently the president of the Black Women’s Health Imperative. She has built a career on addressing health disparities, especially those disproportionately affecting Black women and girls.
US FDA Still Mulling Over Biogen ALS Treatment Approval Despite Disappointing Phase III Results
Briefing documents from a US Food and Drug Administration (FDA) advisory committee show that Biogen’s ALS drug tofersen is still in the running for approval despite a recent failure in a Phase III trial. The favorable outlook is due, in part, due to its effects on reducing a key protein hallmark of the progressive disease.
US FDA to Review Ipsen’s Rare Bone Growth Disease Therapy
The US Food and Drug Administration (FDA) has set a date to decide on Ipsen’s new drug application for its drug candidate palovarotene in the treatment of fibrodysplasia ossificans progressive (FOP), a rare disorder where extra-skeletal tissues like muscles and tendons are converted into bone tissue. This would be the first therapy for the disabling, progressive condition.
FDA Adcomm Recommends Paxlovid for Mild-to-Moderate COVID-19
Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency extended the review period.
Exclusivity Loss Looms for Ten Key Drugs in 2023
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s Stellara, Sanofi’s Aubagio, and Takeda’s Vyvanse.
Housing Instability Worsens Health Outcomes
Astronomical rent and home prices are driving the ever-worsening affordable housing crisis. A newly published article in JAMA Network Open explores the link between housing instability and health outcomes, finding that displacement and unsafe living situations related to unaffordable housing are tied to worse mental and physical wellbeing.
Sanofi Cuts Insulin Prices and Sets Out-of-Pocket Price Cap
Hot on the heels of Novo Nordisk and Eli Lilly, Sanofi announced it will cut the price of its main insulin formulation, Lantus, in January of next year. Just outstripping the others, the cuts amount to a 78% price drop for the life-saving drug used by millions of people with diabetes. In addition, Sanofi set an out-of-pocket cap of $35 a month for patients.
Teppeza Improves Vision for Patients with Thyroid Eye Disease in Real-World Data Study
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 prospect for many high-risk individuals.
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 Biotech. The deal will see Gracell performing clinical and preclinical testing on certain cell therapies, the identities of which have yet to be revealed. Additionally, five of the therapies will be taken to market by Gracell.
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 [...]
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 therapy, or the lack thereof, with the VP of Science Policy at the Personalized Medicine Coalition Daryl Pritchard, PhD.
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 out a call for feedback. Responses are due by April 14th.
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 previous Oncology Care Model (OCM).
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 developmental delays.
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 Pfizer, Gilead, and AbbVie.
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 medical needs. The patient group had orgininally won their case in 2019 and 2020, but these wins were undone by court reversal last year.
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 manufactured at a tiny fraction of the price. The trend comes after legal troubles for several pharma companies over US insulin prices.
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 not be feasible in traditional clinical trial formats.
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, often long before it is medically advisable to pull back.
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 negotiations is longer for the former.
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 trials, a restriction put in place after last year’s approval and failed market release of Aduhelm.
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 Eliquis, among others.
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 those who speak Spanish primarily.
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 Market.
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 (SDoH) underlying this heath disparity. In addition, another abstract investigated the increased rate of childhood asthma-related respiratory infections in Black and Mexican-American patients.
