Fri.Feb 17, 2023

article thumbnail

PBMs Under Fire at Senate Hearing

Drug Topics

Senators lobbed harsh criticisms at pharmacy benefit managers during a legislative hearing.

469
469
article thumbnail

Pheast’s new CEO on how its ‘don’t eat me’ platform could deliver next-gen precision immunotherapies

PharmaVoice

Jacopo Leonardi’s latest venture is in the burgeoning field of macrophage inhibitors that could target a wide range of cancers.

246
246
Insiders

Sign Up for our Newsletter

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

article thumbnail

Patients Can Effectively Manage Type 2 Diabetes With Digital Therapeutics

Drug Topics

Two studies found digital therapeutics can help patients manage their type 2 diabetes effectively regardless of race or ethnicity.

386
386
article thumbnail

Current treatments for cramps aren’t cutting it. Why aren’t there better options?

STAT

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

145
145
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

New Biosimilars for Autoimmune Diseases Poised to Make Waves

Drug Topics

The launch of Amgen's adalimumab biosimilar Amjevita was just the start of a wave of biosimilars to treat autoimmune diseases.

247
247
article thumbnail

American Telemedicine Association announced 12 telehealth innovators challenge finalists

Fierce Healthcare

American Telemedicine Association announced 12 telehealth innovators challenge finalists aburky Fri, 02/17/2023 - 11:45

132
132

More Trending

article thumbnail

Despite rare disease market growth, pharma leaders see development obstacles ahead

PharmaVoice

Investment in rare disease research is increasing, but a new poll of PharmaVoice readers found that roadblocks remain.

130
130
article thumbnail

Becerra charges insurer claims of Medicare Advantage pay cuts 'categorically false'

Fierce Healthcare

Becerra charges insurer claims of Medicare Advantage pay cuts 'categorically false' rking Fri, 02/17/2023 - 10:13

Insurance 124
article thumbnail

Opinion: Improving patient safety shouldn’t be a financial calculation

STAT

A recent study of medical error published in The New England Journal of Medicine reached a shocking conclusion about patient safety: Nearly a quarter century after a highly publicized Institute of Medicine report on the prevalence of patient harm sparked vows to cut the rate by half in five years , “in-hospital adverse events” remain so common that they affect roughly one in four patients.

Hospitals 117
article thumbnail

Why Traditional Cybersecurity is Failing Healthcare

Fierce Healthcare

Why Traditional Cybersecurity is Failing Healthcare jpiatt Fri, 02/17/2023 - 16:24

118
118
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

FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The non-binding draft guidance gives insight into the agency’s current outlook and recommendations for standard and expedited programs in oncology.

Dosage 115
article thumbnail

Apellis wins FDA approval for first geographic atrophy drug

Fierce Pharma

Apellis wins FDA approval for first geographic atrophy drug fkansteiner Fri, 02/17/2023 - 18:06

FDA 115
article thumbnail

STAT+: FDA approves first treatment for leading cause of blindness in older people

STAT

The Food and Drug Administration approved on Friday the first treatment for geographic atrophy, a progressive eye disease and a leading cause of blindness in older people. The new drug, called Syfovre, is made by Apellis Pharmaceuticals.

FDA 112
article thumbnail

Private brand sales hit record

Drug Store News

In 2022, private label sales hit a new record, according to the Private Label Manufacturers Association.

Labelling 111
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

STAT+: Government watchdog calls for stronger oversight of for-profit research review boards

STAT

The federal government needs to boost its oversight of the institutional review boards that approve scientific studies and protect clinical trial participants, especially since more for-profit companies are taking running these reviews, a report from a government watchdog warns. Also known as ethics committees, institutional review boards occupy a crucial, but behind- the-scenes role in ensuring clinical studies are conducted properly.

108
108
article thumbnail

Just For Men debuts temporary brush-in, wash-out color

Drug Store News

Just For Men’s 1-day Beard and Brow Color is a dye-free temporary brush-in and wash-out color.

106
106
article thumbnail

STAT+: Medicare Advantage membership grows 7% for 2023

STAT

Nearly 31.2 million seniors and people with disabilities are now enrolled in a private Medicare plan, known as Medicare Advantage, according to new federal government data analyzed by STAT. That total is 7.1% higher than the 29.1 million people who had a Medicare Advantage plan in 2022. Although that annual growth rate is the lowest since 2016, the private plans now catch roughly half of the entire Medicare population.

Insurance 106
article thumbnail

Optum study: Accountable Medicare Advantage models produce better outcomes, greater efficiency

Fierce Healthcare

Optum study: Accountable Medicare Advantage models produce better outcomes, greater efficiency pminemyer Fri, 02/17/2023 - 13:40

105
105
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

Enzyme replacement therapy for alpha-mannosidosis gets FDA approval

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Lamzede ® (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and paediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme α-mannosidase. Giacomo Chiesi, Head of Chiesi Global Rare Diseases stated that symptoms of the disorder include “impaired hearing, speech and mobility that progress from childhood into adulthood.

FDA 105
article thumbnail

Opinion: 5 ways to address the shortage of health care workers

STAT

The shortage of health care workers in Maine, where I live and work, is a harbinger for the struggles the rest of the country will increasingly confront to hire and retain the individuals who make up the backbone of health care. Maine’s population is the oldest in the nation and is tied with Vermont as being the most rural state. Maine’s health care workers are also among the oldest in the country, with many practitioners approaching or even exceeding retirement age.

102
102
article thumbnail

Stemline Therapeutics receives FDA OK for Orserdu

Drug Store News

Orserdu (elacestrant) is the first and only treatment specifically indicated for patients with ESR1 Mutations in ER+, HER2- advanced or metastatic breast cancer.

FDA 98
article thumbnail

STAT+: Novartis CEO Vas Narasimhan talks PhRMA, gene therapy, and much more

STAT

Last week there was a change at the top of PhRMA, the trade group representing the drug industry. Novartis CEO Vas Narasimhan became the chair of the board of directors. Narasimhan has been CEO of Novartis since 2018. He sat down with STAT to discuss the industry’s struggles in Washington, the future of Novartis, and whether the deflated biotech sector is still a little overvalued.

102
102
article thumbnail

There are some tough-love lessons to be learned from the events of the past year

Drug Store News

An aging population combined with increasing numbers of people diagnosed with chronic diseases are among the top factors set to influence innovation in the generics drug market in 2023.

98
article thumbnail

Opinion: Another pharma industry flip-flop: Claims about the IRA’s effect on small-molecule versus biologic drugs

STAT

The Inflation Reduction Act of 2022 , which includes provisions requiring Medicare to negotiate lower drug prices for some of the United States’ most costly drugs, marks the first time in decades that the pharmaceutical industry has lost a major policy battle. So, as expected, drug corporations are attacking the new law. The industry’s latest red herring ?

98
article thumbnail

Pendulum rolls out proprietary probiotic blend

Drug Store News

Metabolic Daily is a proprietary probiotic supplement that looks to improve the metabolization of sugar and carbohydrates, the company said.

98
article thumbnail

STAT+: Ginkgo chief Jason Kelly is chairing a federal biotech advisory group. Is that a conflict of interest?

STAT

Ginkgo Bioworks CEO Jason Kelly has spent much of the last decade talking to almost anyone who will listen — investors, journalists, TV presenters, congressional committees  — about the importance of biotechnology to the future of, well, just about everything. This year, Kelly will have a chance to advocate more formally. In December, he was named chairman of a new 12-person congressional commission tasked with issuing a set of policy recommendations for how the U.S. governmen

98
article thumbnail

People on the move … Feb. 17

Drug Store News

Important personnel changes you should know this week about the Association for Accessible Medicines, Maesa and more.

97
article thumbnail

STAT+: Pharmalittle: Pfizer scraps half of participants in Lyme vaccine trial over quality issues; Ginkgo CEO may have possible conflict of interest

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up. We plan to tackle mounds of paperwork, promenade with the official mascot, catch up on our reading, and hold a listening party with Mrs. Pharmalot (the rotation will include this , this and this ).

article thumbnail

Blueprint gears up for Ayvakit expansion, with blockbuster sales on the line

Fierce Pharma

Blueprint gears up for Ayvakit expansion, with blockbuster sales on the line aliu Fri, 02/17/2023 - 10:17

97
article thumbnail

STAT+: French court hands Novartis and Roche another win in battle over antitrust allegations involving eye drug

STAT

A French appeals court has overturned a record fine levied three years ago against Novartis and Roche for allegedly engaging in anti-competitive practices, the second time this month the companies defeated a country’s antitrust authorities. The Autorité de la Concurrence, France’s competition watchdog, had accused Roche and Novartis of abusing their dominant position to sell a drug used to treat age-related macular degeneration to the detriment of an older and cheaper treatmen

98
article thumbnail

Fusion to acquire radiologand therapy for prostate cancer

European Pharmaceutical Review

Fusion Pharmaceuticals has announced the acquisition of an investigational new drug (IND) application for an ongoing Phase II trial evaluating the prostate specific membrane antigen (PSMA)-targeted alpha-emitting radiopharmaceutical 225Ac-PSMA I&T. Following closing of the acquisition of RadioMedix’s small molecule, the radiopharmaceutical will be known as FPI-2265. “With more than 250 patients treated with actinium-based radiopharmaceuticals targeting PSMA in investigator sponso

97
article thumbnail

STAT+: Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn

STAT

In the aftermath of the Food and Drug Administration’s Aduhelm debacle , the agency’s neuroscience chief Billy Dunn has another controversial approval decision to make. It will once again test his willingness to apply the FDA’s doctrine of “regulatory flexibility” to a medicine with less-than-convincing clinical data.

FDA 98
article thumbnail

Living Up to Its Promise: Can Omnichannel Deliver the ROI Pharma Needs to Keep Investing?

PharmExec

Webinar Date/Time: Mon, Mar 13, 2023 11:00 AM EDT

96