Fri.Mar 08, 2024

article thumbnail

FDA Approves Semaglutide for New Indication Involving Cardiovascular Disease

Pharmacy Times

Semaglutide (Wegovy; Novo Nordisk) reduces the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight when combined with the standard-of-care.

FDA 160
article thumbnail

STAT+: In stunning outcome, Amylyx’s ALS drug fails large clinical trial

STAT

Amylyx Pharmaceuticals said Friday that its treatment for ALS, called Relyvrio, failed to provide any benefit for patients in a large clinical trial — a stunning outcome that now has the company considering a voluntary withdrawal of the approved medicine from the market. “This is really hard for us, and it’s really hard for our team who care so much, but it’s so much harder for people with ALS and their families, and we have to keep that perspective,” said a so

FDA 145
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

President Biden Announces Desire to Cap Drug Prices for All Americans

Pharmacy Times

In the State of the Union Address, President Biden said he wants to expand the $2,000 out-of-pocket cap beyond seniors and allow Medicare to negotiate more costly drugs.

144
144
article thumbnail

STAT+: Amylyx ALS drug failure leaves patients, advocates, and researchers reeling — and wondering what’s next

STAT

The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians, forcing the community to consider just what to do with an approved medicine that doesn’t appear to work. Amylyx Pharmaceuticals’ announcement Friday that its drug, marketed as Relyvrio, failed to beat placebo in a pivotal study marks “a sad day for us, but we have to believe the data,” said Mary Catherine Collet, an ALS advocate.

FDA 145
article thumbnail

Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

article thumbnail

Guiding Women Within Health Care and the Significance of Self-Development, Improvement

Pharmacy Times

The vice president and chief pharmacy officer at City of Hope explains how she serves as a mentor for women within health care, the importance of networking, and staying educated.

132
132
article thumbnail

STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

U.S. regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. The new label indicates that Wegovy can reduce the risk of major heart complications — including heart attack, stroke or cardiovascular-related deaths — for people with overweight or obesity and existing heart disease, Novo said in a statement Friday.

Labelling 141

More Trending

article thumbnail

Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.

Labelling 136
article thumbnail

Breaking: FDA Approves Wegovy to Reduce Cardiovascular Risks in Overweight, Obesity

Drug Topics

Study results demonstrated the efficacy of semaglutide (Wegovy) in reducing cardiovascular risks in adults with overweight or obesity without diabetes.

FDA 123
article thumbnail

STAT+: In surprise move, FDA calls for advisory committee on Lilly’s Alzheimer’s drug

STAT

In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month. The drug, donanemab, succeeded in its Phase 3 trial , resulting in a 35% slowing of Alzheimer’s disease progression versus placebo.

FDA 131
article thumbnail

FDA Questions Donanemab Efficacy for the Treatment of Alzheimer Disease

Pharmacy Times

The FDA is convening a committee to discuss phase 3 data after the planned action date, which delays drug availability to patients.

FDA 149
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Industry Voices—A new reimbursement model is needed to ensure the future of community pharmacy

Fierce Healthcare

Community pharmacies are well positioned to make a difference in the lives of their patients by providing convenient access to quality, affordable clinical pharmacy services while closing gaps in c | The current environment of decreasing reimbursement and increasing drug costs is not sustainable for either chain or independent pharmacies.

article thumbnail

Belantamab Mafodotin Regimen Indicates Safety, Improved OS in Patients Treated With Multiple Myeloma

Pharmacy Times

Despite the belantamab mafodotin regimen improving overall survival in patients with relapsed or refractory multiple myeloma, the trial is ongoing to confirm the presented results.

122
122
article thumbnail

STAT+: IVF doctors demand full details on fluid that grows embryos amid CooperSurgical lawsuits

STAT

Patients from all over the country are filing lawsuits against medical supply giant CooperSurgical, alleging that fluid the company sent to in vitro fertilization clinics destroyed their embryos. The fluid, called culture media, is filled with nutrients that allow embryos to develop enough to ultimately be implanted into a uterus. CooperSurgical acknowledged that the batch of fluid may have stunted embryo growth in a product recall notice , but it hasn’t disclosed exactly what went wrong.

Labelling 127
article thumbnail

ViVE 2024: How Elevance Health is aiming to make its data insights actionable for providers

Fierce Healthcare

LOS ANGELES—Health insurers have access to a bevy of valuable data, and the push toward interoperability made it easier for those data to be shared with providers. | LOS ANGELES—Payers have access to a wealth of data, but the challenge now becomes making those data usable and useful for providers in a way that does not disrupt their workflows and interactions with patients.

Insurance 126
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

article thumbnail

Accelerating inclusion in innovation: Gender diversity in clinical research

pharmaphorum

Clinical research continues to struggle with a lack of representation within trial populations, and gender diversity in clinical trials remains a critical issue. Learn about the importance of gender diversity in clinical research trials and how it can accelerate inclusion in innovation.

122
122
article thumbnail

FDA Approves Nivolumab Plus Chemotherapy for Unresectable or Metastatic Urothelial Carcinoma

Drug Topics

A clinical trial showed that nivolumab plus chemotherapy significantly improved overall survival and progression-free survival compared with a chemotherapy combination alone.

article thumbnail

After trial failure, will Amylyx pull ALS drug Relyvrio off the market?

Fierce Pharma

After reporting the failu | After reporting the failure of a confirmatory trial of its amyotrophic lateral sclerosis drug Relyvrio (AMX0035), Amylyx Pharmaceuticals is uncertain whether it will pull the treatment from the market in the U.S. and in Canada, where it is known as Albrioza.

120
120
article thumbnail

Women in life sciences: Miruna Sasu

pharmaphorum

Celebrate International Women’s Day by learning about Miruna Sasu, a prominent female figure in the life sciences field and CEO of COTA. Explore how the company uses AI in the oncology space.

118
118
article thumbnail

Diabetes care is too fragmented and education gaps are rife, new report shows

Fierce Healthcare

More than half of diabetes patients believe that popular weight loss drugs alone may improve their health, according to a new report. | More than half of diabetes patients believe that popular weight loss drugs alone may improve their health, indicating that the hype around buzzy new medications may be creating some false hope.

118
118
article thumbnail

Bridging the gap: Uniting stakeholders through a digital ecosystem for holistic maternity care

pharmaphorum

Discover how a digital ecosystem can unite stakeholders in providing holistic maternity care, enhance maternal and postpartum care outcomes, and bridge the gap in healthcare services.

118
118
article thumbnail

Opinion: STAT+: It’s time to rethink everything about our approach to psychiatric drug development

STAT

In many ways, psychiatry is still flying blind. People experiencing mental health conditions are prescribed various drugs until one (or a combination) finally works — a painful process that can take years. As a psychiatrist and neuroscientist, I became increasingly impatient and frustrated with this ineffective way of treating patients. This guided the core question behind my research: Can biology explain how people with the same psychiatric disorder respond differently to the same treatm

113
113
article thumbnail

Women in life sciences: Angie Franks

pharmaphorum

Angie Franks is a prominent female figure in the life sciences industry and perfect to highlight on International Women's Day. Learn more about her contributions and achievements in healthcare and technology.

118
118
article thumbnail

Female Leadership, Empowerment, and Self-Advocating Key to Overcoming Gender Inequities in Health Care

Pharmacy Times

The vice president and chief pharmacy officer of City of Hope discusses obstacles women face in health care and how diversity, equity, and inclusion can be promoted within the space.

109
109
article thumbnail

A disabled artist’s journey from ‘Oh, sorry’ to social justice activism

STAT

Sonya Rio-Glick was born three months and six days premature, alongside her twin, in the summer of 1997. Both had health complications. Sonya had cerebral palsy but wasn’t formally diagnosed until she was 2, after a physical therapist approached her parents at a party. That’s when her family learned what had made Rio-Glick move differently since infancy.

115
115
article thumbnail

Exploring Electronic Cigarettes’ Success Among Other Tobacco Cessation Methods

Drug Topics

Researchers assessed the benefits of electronic cigarettes for tobacco cessation compared with varenicline and nicotine chewing gum.

112
112
article thumbnail

PhRMA seeks to revive Medicare price negotiations lawsuit, blasts Biden's request for IRA expansion

Fierce Pharma

As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.

115
115
article thumbnail

With 2 acquisitions under its belt and $80M from investors, Fabric is building tech to fix healthcare's capacity problem

Fierce Healthcare

With 2 acquisitions under its belt and $80M from investors, Fabric is building tech to fix healthcare's capacity problem hlandi Fri, 03/08/2024 - 12:51

124
124
article thumbnail

STAT+: UnitedHealth gives timeline for Change restoration: payments up by late next week

STAT

Change Healthcare’s parent company said it’ll have its electronic payment function up and running by late next week after a February cyberattack took many of its systems offline. Its claims network and software will take longer. UnitedHealth Group said clients will be able to reconnect to Change’s electronic payment system on March 15.

Hospitals 114
article thumbnail

WellSpan rolls out AI-driven clinical documentation tool from Nuance to free up providers' time

Fierce Healthcare

WellSpan Health is taking the burden off its providers by deploying an AI-driven clinical documentation tool from Nuance. | DAX Copilot, from Microsoft’s speech recognition subsidiary Nuance Communications, integrates with Epic to draft clinical notes during visits. This process happens within seconds, the company claims, and makes the note available for review and entry into the EHR by clinicians.

article thumbnail

Bristol Myers, overshadowed by ADC rival, wins FDA nod for Opdivo combo in bladder cancer

Fierce Pharma

Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck &amp | Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck & Co.’s Keytruda, has impressed in a high-profile treatment combo.

FDA 107
article thumbnail

Novo Nordisk’s oral amycretin tops Wegovy in obesity trial

pharmaphorum

Amongst Novo Nordisk's comprehensive business update to investors, attention latched onto early data for an oral obesity therapy that outperformed the company’s big-selling GLP-1 agonist Wegovy in a clinical trial. The drug, called amycretin and codenamed NN9487, is a dual agonist that targets both GLP-1 and amylin and is being developed in both oral and subcutaneous injection formulations.

104
104
article thumbnail

STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

100
100
article thumbnail

MindMed gets FDA breakthrough tag for LSD in anxiety

pharmaphorum

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.

FDA 104
article thumbnail

AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

119
119