Mon.Dec 18, 2023

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Assessing B-Cell Maturation Antigen Directed Therapies in Multiple Myeloma Treatment

Drug Topics

Three posters presented at the 65th American Society of Hematology Annual Meeting and Exposition looked into the efficacy and safety of the therapies.

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New Biomarker Shows Potential in Therapeutic Development for Alzheimer Disease

Pharmacy Times

Investigators analyzed the effects of harmful accumulation of HDAC6 in the brains of mouse models with Alzheimer disease to determine any changes in disease progression.

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STAT+: New Jersey’s telehealth restrictions cut off access to lifesaving care, lawsuit alleges

STAT

Since states started rolling back pandemic-inspired flexibilities that allowed physicians to easily practice telehealth across state lines, virtual health care providers have criticized state-based medical licensure rules as unnecessarily burdensome, expensive, and detrimental to patient care. Now, two of them are arguing in a lawsuit that they can also be unconstitutional.

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Expert: The Evolution of HIV Care, Treatment Options, How Pharmacists Can Assist in Providing Care

Pharmacy Times

Using information from clinical studies and her experiences working in the field, Stephanie Kirk describes treatment options that are on the horizon, and how removing stigma is key in HIV care.

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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.

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STAT+: ‘We’ve exhausted all avenues’: A small biotech may give up on its ultra-rare disease drug over frustration with FDA

STAT

Jamie Dubuque faces the future with a mixture of gratitude and trepidation. Her son, Declan, who turns 2 years old in January, survived a life-threatening episode of cardiac arrest that sent him to a hospital emergency room a year ago. But since being diagnosed with an ultra-rare disease, he has been treated with an experimental medicine that has transformed his day-to-day existence.

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Researchers Evaluate New Advancements for RSV Management, Treatment

Pharmacy Times

The most recent advances included an approved vaccine that could immunize both the elderly and pregnant women, along with the release of nirsevimab.

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Opinion: Alzheimer’s drug approvals show we need a reevaluation of patient advocacy

STAT

When faced with a loved one’s progressive neurodegenerative disease, like Alzheimer’s, or your child’s rare respiratory disease, you question why researchers and resource-backed pharma cannot bring a drug to market quickly enough to help your loved ones. Many people faced with this horror get involved to fight for better treatments.

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Kroger eyes opportunities in senior-focused primary care, rolls out service in Atlanta clinics

Fierce Healthcare

Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care. | Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care.

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STAT+: Here are the best biopharma CEOs of 2023

STAT

It’s that time of the year again when I recognize the Best Biopharma CEO of the year. This year’s selection is so deservingly obvious that I won’t fabricate suspense by starting with an honor roll of runners-up. More on those high-achieving folks later. Let’s get right to the main course: David Ricks of Eli Lilly is the runaway, rock star, who-else-could-it-be Best Biopharma CEO of 2023.

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To fight rare diseases, win the data battle first

pharmaphorum

To effectively combat rare diseases, it is essential to prioritise the collection and analysis of data. This article explores how pharmaceutical companies are leveraging AI and focusing on orphan drugs to tackle rare diseases.

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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.

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STAT+: Wegovy may have another helpful trick: fighting inflammation via the brain, study finds

STAT

As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms. A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.

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WeightWatchers rolls out telehealth clinic to prescribe weight loss drugs

Fierce Healthcare

WeightWatchers is adding its name to the growing list of companies providing telehealth weight loss management and access to buzzy GLP-1 medications. | WeightWatchers is adding its name to the growing list of companies providing telehealth weight loss management and access to buzzy GLP-1 medications.

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STAT+: Biden administration asks judge to toss out Humana’s Medicare Advantage audit lawsuit

STAT

The Department of Justice has asked a federal judge to dismiss a lawsuit brought by Humana, which alleged the government’s new audits of Medicare Advantage plans are unlawful. And if the lawsuit isn’t thrown out, the DOJ said in a new legal filing, at a minimum, it should be moved to a different federal court in Texas — away from a judge that has a track record of striking down federal health care laws.

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2024 Outlook: Will legislators pass meaningful reforms to PBMs? The jury is still out

Fierce Healthcare

There has been no shortage of conversation around pharmacy benefit managers this year, but actual action from legislators has been slow. | There has been no shortage of conversation around pharmacy benefit managers this year but actual action from legislators has been slow.

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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.

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Individuals Previously Infected with COVID-19 Face Increased Risk of Heart Rhythm Disruption

Pharmacy Times

Older individuals and individuals that experienced severe COVID-19 are at high risk of increased cardiac disturbances.

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Bristol Myers Squibb's Opdualag comes up short in late-stage colorectal cancer trial

Fierce Pharma

Bristol Myers Squibb’s PD-1/LAG3 combo Opdualag has more than proved its worth in melanoma since its first-in-class approval in 2022. | The company opted to cut the phase 3 Relativity-123 study after an analysis found that the trial was unlikely to achieve its primary endpoints in microsatellite-stable patients with metastatic colorectal cancer.

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Roflumilast Foam 0.3% Secures Major FDA Approval to Treat Seborrheic Dermatitis

Drug Topics

The foam formulation and once daily application of roflumilast foam 0.3%, the first FDA-approved drug for seborrheic dermatitis with a new mechanism of action in over 2 decades, makes it a favorable alternative to existing treatments.

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GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancer

Fierce Pharma

On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. | GSK has more positive data to report in endometrial cancer as the company's PD-1/PARP combination turned in a trial win. The combination could represent a threat to a rival therapy at AstraZeneca.

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2024 Outlook: How experts say payers will—or should—try to improve their Medicare Advantage star ratings

Fierce Healthcare

Payers need to properly adapt to changes made to the Medicare Advantage star ratings program or risk financial repercussions, industry experts told Fierce Healthcare. | Payers are being urged to prioritize health equity considerations more than ever before to improve their Medicare Advantage star ratings scores.

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Charles River snags clearance to produce Vertex and CRISPR's Casgevy from Tennessee plant

Fierce Pharma

Following a string of approvals in the United States and beyond, Vertex Pharmaceuticals continues to build out its manufacturing network for the world’s first CRISPR-based gene therapy, Casgevy.

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A Look Back: The Life Sciences Industry in 2023 and a View for 2024

PharmExec

In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be vital.

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STAT+: Structure Therapeutics GLP-1 pill cuts blood sugar, weight in early diabetes study

STAT

Structure Therapeutics said Monday that its experimental GLP-1 pill demonstrated a 1% lowering of blood glucose and slightly more than 3% weight loss relative to a placebo in a 12-week study involving participants with type 2 diabetes — results that are preliminary but don’t quite match a competing oral drug under development by Eli Lilly.

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2024 Outlook: Drug price negotiations, Braidwood highlights top legal cases to watch

Fierce Healthcare

Legal experts indicated they will be paying close attention to lawsuits surrounding the Medicare drug price negotiation program and Braidwood v. | Preventative services covered under the Affordable Care Act and the Medicare drug price negotiations program are two legal questions that will play out next year.

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Organon pays $50M upfront to pick up rights to pair of Eli Lilly migraine meds in Europe

Fierce Pharma

Organon, the women's health-focused spinoff of Merck, has picked up the rights to distribute and promote a pair of migraine medicines overseas. | Organon has unveiled a pact with Eli Lilly to take charge of Emgality and Rayvow marketing in Europe. Emgality is approved to help prevent migraines in adults who have at least four migraine days per month, while Rayvow is cleared for acute treatment of the headache phase of migraine attacks.

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STAT Virtual Event | Cancer’s Breakthrough Engine

STAT

Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. Since the development of Gleevec two decades ago, precision cancer medicines have become a driving force in biotech and a source of hope for cancer patients.

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Does coffee affect your cholesterol?

The Checkup by Singlecare

For coffee lovers, your morning cup of joe is a way of life. The smell, the flavor, the caffeine—it’s all part of your daily ritual. If you’re in the “I love coffee” club, you’re not alone. According to NIH , 75% of Americans are coffee drinkers, and almost 50% of us drink it daily. Because coffee is so widely consumed you likely take time to think about how it affects your body in the long-term.

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CHMP backs Biogen’s Skyclarys for Friedreich’s ataxia

pharmaphorum

Biogen’s Skyclarys is on course to becoming the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU after it was recommended by the EMA’s human medicines committee.

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Molina, Bright Health agree to lower sale price of embatted insurtech's MA business

Fierce Healthcare

The hits keep coming for embattled insurtech Bright Health. | The hits keep coming for embattled insurtech Bright Health. Ari Gottlieb, principal at A2 Strategy Group, told Fierce Healthcare that such a move was expected.

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Trends shaping the pharmaceutical industry in 2024

PharmaVoice

Advancements in cloud and AI technology will transform clinical trial efficiency and engagement.

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$260 million funding injection for Danish vaccines initiative

European Pharmaceutical Review

The Novo Nordisk Foundation has committed up to DKK 1.8 billion ($260 million) to establish a state-of-the-art research and vaccine development initiative in Denmark. Developed in partnership with the University of Copenhagen and Denmark’s Statens Serum Institut , the Foundation says this the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself.

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Eisai files biliary tract cancer drug tasurgratinib in Japan

pharmaphorum

Eisai files for approval in Japan for FGFR inhibitor tasurgratinib as a treatment for biliary tract cancers with FGFR2 gene fusions

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The legal pathway for experimental, ultra-rare disease treatments is rocky and expensive

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today, we see a small biotech on the verge of ending a rare-disease program thanks to FDA difficulties  — and how that impacts patients. We fete the best of this year’s biopharma CEOs (hint: GLP-1s), and talk about post-doc and patient advocacy reform.

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Kroger taps Better Health Group for senior-focused primary care at The Little Clinic

Drug Store News

Better Health Group's comprehensive MSO platform will help providers at The Little Clinic manage the primary healthcare needs of seniors with Medicare.

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STAT+: Pharmalittle: Illumina will divest Grail after court finds deal was anti-competitive; FDA found problems at Moderna facility

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that familiar routine of online meetings and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and brewing another cup of stimulation. Our choice today is caramel brûlée.

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