FDA Approves Medtronic’s Automatic Insulin Pump
Meditronic has scored a win with the long-anticipated approval of its MiniMed 780G insulin pump by the US Food and Drug Administration (FDA). The pump, which works in concert with the company’s Guardian 4 continuous glucose monitor to allow for automated insulin management, even bolus injections which weren’t automated by the previous version.
Rob Abbott Appointed as CEO of ISPOR
Earlier this month, ISPOR’s Board of Directors announced they appointed a new CEO to guide the organization, Rob Abbott. Mr. Abbott has over 20 years of executive experience and lead Health Technology Assessment International as CEO and executive director. He took over the new leadership role at ISPO after the retirement of the former CEO, Nancy S. Berg.
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.
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.
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.
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.
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.
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.
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 amyloid-targeted Alzheimer’s disease therapy, followed by its controversial accelerated approval.
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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 COVID-19 and the flu in patients experiencing respiratory symptoms characteristic of either disease.
The FDA Omnibus Reform Act: 8 Points to Remember
The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law last year, granting more power to the US Food and Drug Administration (FDA) to perform inspections at home and abroad. Learn more about the bill and 8 points to note in a recent Pharmaceutical Online article by professionals at Greenleaf Health. The first takeaway is that the bill gives many new inspection tools to the agency.
FDA Grants SpringWorks’ Desmoid Tumor Drug Priority Review
The SpringWorks Therapeutics, a spinoff of Pfizer, received priority review by the US Food and Drug Admnistration (FDA) for nirogacestat as a treatment for desmoid tumors. Patients taking the small molecule drug as a monotherapy had 71% lower risk of progression and had a better objective response rate compared to placebo.
FDA Lays Out Three Ways to Fight US Opioid Crisis in New Report
The US Food and Drug Administration (FDA) has outlined three steps in a newly released report that it can take to help combat the ongoing opioid crisis. The report, entitled the External Review of FDA Regulation of Opioid Analgesics Final Report, examines how the agency acted upon the 2017 findings of the National Academies for Sciences, Engineering, and Medicine (NASEM). The first is to evaluate study designs that consider public health for regulatory decision-making. In addition,
UK and US Reciprocal Drug Approvals Could Be on the Horizon
Marks & Clerk, an intellectual property firm based in London, says that reciprocal drug approvals between the UK and US may be on the horizon, potentially as early as 2024. The firm gleaned this information from a recent UK Medicines and Healtcare products Regulatory Agency guidance about international collaborations post-Brexit.
CMS to Try Out Reduced Payments for Drugs with Accelerated Approval
The US Centers for Medicare and Medicaid Services announced that it will test out a pilot program meant to push pharma companies to finish confirmatory studies on drugs that received accelerated approval. Patients and payer currently pay full price for these drugs, so CMS will try paying reduced price as a motivator to gather sufficient clinical evidence for a full approval.
Comparing Carve-In vs Carve-Out Financing for Behavioral Health Services on Medicaid
In recent years, many state Medicaid programs have moved from carve-out financing for behavioral health (BH) services to carve-in ones. A new article in Health Affairs covers this trend, which is driven in part by growing recognition that integrating care for physical health (PH) and BH improves care outcomes and lowers premature death.
FDA Shoots Down Avastin Biosimilar Over Manufacturing Issues
The US Food and Drug Administration (FDA) has denied Biocon and Viatris’ application for their biosimilar to Avastin, a monoclonal antibody therapy for multiple cancer types. The agency cited issues related to cleaning procedures and anti-contamination protocols it noted during facility inspections in Bengalaru, India, and Johor, Malaysia, last August. The company intends to address the issues and provide the agency with a Corrective and Preventative Action (CAPA) plan.
European Commission Expands Approval for AstraZeneca’s Heart Failure Drug
The European Commission has expanded its approval of AstraZeneca’s heart failure drug Forixga (dapaglifozin) for use in patients with mildly reduced or preserved left ventricular ejection fraction (LVEF), an important measure of heart function. The drug was previously indicated in use for heart failure patients with reduced LVEF and type 2 diabetes.
NICE Recommends CBT Apps for Childhood Anxiety
The UK’s National Institute for Health and Care Excellence (NICE) has issued a new guidance recommending the use of certain cognitive behavioural therapy (CBT) apps for children aged 5-18 living with anxiety. The guidance is the first for this class of app, as the decision was made through an early value assessment (EVA) pathway that accelerates the recommendation process.
Siemens Gets FDA and EU Approval for High-Performance Tumor Imaging System
The EU and the US Food and Drug Administration have given approval for Seimens’ Hypersight computed tomography (CT) imaging system. The device, meant to be paired with Seimens Varian radiotherapy systems, produces large, high-contrast images of tumors and surrounding organs in seconds.
FDA Approves Two New Treatments for Breast Cancer and Lymphoma
Eli Lilly and the Menarini Group have both gotten the nod from the US Food and Drug Administration (FDA) for their new cancer medications. Lilly’s therapeutic for relapsed or refractory mantle cell lymphoma, called Jaypirca, is only the fourth drug of its kind approved by the agency. It will cost $21,000 per month of treatment.
EMA Committee Announces Orphan Drug Application Changes to Improve Access to Rare Eye Disease Medications
Policies regarding orphan drug designations for a group of rare genetic eye diseases called inherited retinal dystrophies are changing, according to the European Medicines Agency (EMA). The changes would target terminology regarding the categories of disorders that are covered under the orphan drug designation, allowing drugs to be submitted into one or more of four subgroups.
DiaCarta Monkeypox Test Kit Issued Emergency Use Authorization by FDA
Earlier this month, the US Food and Drug Administration (FDA) issued an emergency use authorization for DiaCarta’s QuantiVirusTM MPXV test kit. The kit is a PCR test for monkeypox virus (MPXV) that tests for two separate regions of the MPXV genome to account for the chance of future mutations that would otherwise render the test void.
