Thu.Sep 07, 2023

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FDA Accepts Biologics License Application for Crovalimab for Paroxysmal Nocturnal Hemoglobinuria

Pharmacy Times

Crovalimab achieved disease control and non-inferiority compared to eculizumab, which is the current standard-of-care for individuals with paroxysmal nocturnal hemoglobinuria.

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Group behind ProMED fires three top moderators amid strike

STAT

The organization that runs the infectious diseases surveillance system ProMED terminated at least three of the program’s top moderators on Thursday. The three were leaders of a strike that began in early August — one that is scheduled to end on Monday. Longtime moderators Marjorie Pollack and Maria Jacobs, along with associate editor Leo Liu, received notification from ISID CEO Linda MacKinnon that their consulting agreements with the International Society for Infectious Disea

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Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan

Fierce Pharma

Demand is so strong for Novo Nordisk’s obesity drugs that the only limitation on sales—in the short term—seems to be the company’s ability to produce them. | Promising heart data for Novo Nordisk's Wegovy are a "paradigm shift," according to J.P. Morgan, which has doubled its market projection for GLP-1 diabetes and obesity treatments to $71 billion for 2032.

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Opinion: What a viral study criticizing cancer screening gets very, very wrong

STAT

A recent study prompted CNN to report, “Most cancer screenings don’t ultimately give someone extra time beyond their regular lifespan.” Does that mean it’s time to dismantle the cancer screening infrastructure in the United States? Probably not. The complex math behind screening befuddled the researchers’ attempts to assess whether screening helped people live longer, leading to unsupportable conclusions.

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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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Who is Using FAIR Data in Life Sciences R&D Today?

Pharmacy Times

The importance of findability, accessibility, interoperability, and reusability has become even more significant to academics as government agencies increasingly require data openness and accessibility for funding eligibility.

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Ketamine can be transformative for people with suicidal thoughts — if they can access it

STAT

Every day, Marisa Russello was overwhelmed by suicidal thoughts. Even one negative thought might cause her to spiral. A writer working on her book manuscript, she’d be unable to change a word without questioning the entire project’s value altogether. Her depression made it hard to fall and stay asleep. She developed insomnia and took to sleeping during the day.

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STAT+: Why the drug industry’s opaque warnings on price negotiations fall short

STAT

Ever since Medicare was given power to negotiate prices for certain medicines, the pharmaceutical industry has argued the move will end badly for patients. Beyond complaining about price controls and unconstitutional mandates, the key message aimed at the American public has been that innovation will suffer. This is a familiar but tiring refrain.

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Patent cliffs, divestitures and maturing biotechs all point to more pharma M&A: analysts

Fierce Pharma

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. | Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.

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Not yet free from heroin’s grip, an ‘honest, funny man’ finds his way off the streets

STAT

PHILADELPHIA — Shaun Anderson hasn’t slept this late in the day in years. He still wakes up a few times throughout the night — a habit he’s developed trying to protect himself from being jumped while at his most vulnerable. This morning, however, he slept so deeply he didn’t hear his doorbell ring. He wasn’t used to even having a doorbell, or a regular place to sleep — housing is one of many things he’d lost to a decades-long battle with op

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Low-Dose Aspirin Could Reduce Diabetes Risk by 15% in Older Patients

Drug Topics

Presented as part of the Annual Meeting of the European Association for the Study of Diabetes (EASD) meeting, the study was designed as an analysis of the ASPREE trial.

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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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Obesity-Related Cardiovascular Disease Deaths Tripled in US From 1999 to 2020

Pharmacy Times

Black women had the highest rates of obesity-related cardiovascular disease deaths whereas other racial groups had more men experiencing obesity-related CVD deaths than women.

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What could fix cancer clinical trials’ longstanding diversity problem?

STAT

There’s a diversity problem in cancer clinical trials, and few know this better than Stephanie Walker. When she was diagnosed with stage 4 metastatic breast cancer, Walker said there was no one to help her figure out the system, not even a nurse or patient navigator. “I was told, ‘Well, you’re a nurse, you know you got this, you know it all,”’ said Walker, a hospice nurse for over 40 years and a patient advocate.

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Bexagliflozin (Brenzavvy): Advancing Diabetes Management With SGLT-2 Inhibition

Pharmacy Times

Beyond its primary role in diabetes treatment, SGLT-2 inhibitors have demonstrated versatility in various health aspects, offering benefits beyond glucose reduction.

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Florida Blue, Aledade tout $14M in savings from their value-based collaboration

Fierce Healthcare

Value-based healthcare with two-sided risk led to a savings of about $14 million over two years, according to the Florida-based insurance plan and national primary care provider company that overse | The collaborative effort by Florida Blue and Aledade not only led to $14 million in savings, but also a reduction in hospitalizations and emergency department visits, according to the companies.

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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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MorningRX: September 7, 2023

Drug Topics

Updated COVID-19 booster shots may be approved by Friday, health insurance costs continue to increase, and republicans with 3 house committees plan to introduce PBM reform bill.

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Biopharma’s rapid transition to omnichannel marketing

pharmaphorum

In today’s episode, sponsored by Veeva, we’ll hear a roundtable discussion on this fascinating topic featuring Victoria Serra Gittermann, European customer experience lead at Veeva Systems and Sebastian Noel, Veeva’s director of multichannel strategy – moderating a discussion with two executives with first-hand experience leading this change: Andy Eeckhout, global head of CRM and digital solutions at Advanz Pharma and Mokhtar Elsayed, head of global go to market commercial transformation at Sano

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BlueWhale Bio surfaces with $18M on mission to overhaul cell therapy production

Fierce Pharma

University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing. | Cell therapy manufacturer BlueWhale Bio uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by Danaher Corporation.

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Current Everolimus, Niraparib Combination Is Too Toxic for a Phase 2 Clinical Trial

Pharmacy Times

Investigators must find a different combination or treatment regimen using a dual blockade of the PARP and PI3K/AKT/mTOR pathway.

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J&J dumps high-dose Opsumit trial upon failure in rare type of pulmonary hypertension

Fierce Pharma

Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag. | J&J’s Janssen has decided to stop a phase 3 trial for a high dose of Opsumit in a subtype of pulmonary hypertension. With the flop, J&J loses a chance to challenge Bayer's Adempas.

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Seniors say these are the top barriers to healthcare: Alignment survey

Fierce Healthcare

What elderly individuals consider to be threats to their health and well-being changed slightly from last year to this year, perhaps reflecting the receding of the COVID-19 pandemic, but the usual | Inflation is likely making it harder for seniors to get the care they need, according to a survey from insurtech Alignment Health.

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AbbVie in line for hefty payout after Takeda breached supply contract on Lupron

Fierce Pharma

Thanks to a contract manufacturing deal with Takeda gone awry, AbbVie appears to be in line to receive hundreds of millions of dollars in damages. | The Delaware Court of Chancery sided with AbbVie in the damages portion of the case, granting the drugmaker nearly all of the $480.6 million it was seeking over a botched supply agreement for Lupron.

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STAT+: Amazon’s chief medical officers on where the company’s health care bets are headed next

STAT

The graveyard is littered with Amazon’s bets in health care: wearables , Care , the ill-fated Haven. Out of their ashes, a new health strategy has emerged at the tech goliath. And while its leaders insist that Amazon has no grand plan for health care, a flurry of moves in the last year offer a glimpse into its ambitions at a time when they seem more cohesive than ever.

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Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

Fierce Pharma

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq. | Roche may not receive the FDA's decision on a subcutaneous version of its cancer immunotherapy Tecentriq on time thanks to the agency's requirement for changes to the drug's manufacturing process.

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Instacart updates omnichannel, AI solutions for grocers

Drug Store News

Significant updates to Instacart Storefront and Caper Carts aim to help grocers bridge the gap between online and in-store shopping and deploy AI to offer more convenient, personalized experiences.

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STAT+: In boon for scientists, U.K. strikes deal to join E.U. Horizon research program

STAT

The U.K. has reached a deal to join the E.U.’s landmark Horizon research initiative , a move that will allow British scientists and companies to win funding from and collaborate with their European peers in the $100 billion program. Researchers and business groups have been calling for such a deal for months, warning that without membership, the U.K. risked being left behind even as it aspires to cement itself as a scientific and technology powerhouse.

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PhRMA keeps pummeling PBMs, launching fresh attack on power over pharmacy choice

Fierce Pharma

PhRMA has rounded up its attack ad team once again for another broadside against pharmacy benefit managers, zeroing in this time on the potential for insurers to profit from where prescriptions get | PhRMA has rounded up its attack ad team once again for another broadside against pharmacy benefit managers, zeroing in this time on the potential for insurers to profit from where prescriptions get filled.

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Biotech execs vie for a share of obesity drug boom: ‘It’s the early innings’

STAT

Pharma giants Novo Nordisk and Eli Lilly might’ve led the way into a new era of obesity drugs , but they’re not going to own it, biotech executives say.  “We’re really just at the beginning of what’s going to be a very long journey in a very large market,” said Nancy Thornberry, founding CEO of Kallyope, which is developing its own competing therapies.

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Amgen, J&J most vulnerable to IRA price negotiations in 2026: Moody's

Fierce Pharma

Now that the Centers for Medicare & Medicaid Services (CMS) has revealed its li | Now that the CMS has revealed its list of the first 10 drugs subject to Medicare price negotiations under the Inflation Reduction Act, it’s time to consider the financial implications for affected companies.

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Opinion: How health care systems can protect patients from sexual assault by providers

STAT

Health care providers have a sacrosanct relationship with patients. That unique position of trust also puts them in a position of power over their patients. Far too often — as exemplified by the recent case involving a New York doctor accused of drugging and assaulting his patients, or the former pediatrician facing more than 100 lawsuits by former patients — predators are able to exploit that power to sexually abuse patients.

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7 health benefits of chia seeds

The Checkup by Singlecare

Chia seeds, which come from the plant known as salvia hispanica, have gained a lot of praise as a superfood. However, “superfood” is not a technical nutritional term, and marketers often misuse it. There’s no technical definition for a superfood, per the Cleveland Clinic. Still, the word usually refers to foods with excellent nutritional profiles, such as chia seeds, meaning they’re high in nutrients and low in calories.

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Five Signs Your Pharmacy May Be Experiencing Burnout

Pharmacy Times

There are common symptoms experienced in the workplace that may be linked to hormones instead of stress.

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In the cards

Drug Store News

Prescription discount cards are popular among consumers, but they bring fees and their partnerships with PBMs may dilute profits. Some retailers are concerned.

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Back to school for biotech, Biogen’s potential pivot, & Illumina’s next chapter

STAT

Are there still too many biotech companies? How do you know when you’re in a bubble? And is there a wrong way to pronounce “TIGIT”? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Josh Schimmer and Eric Schmidt, two longtime analysts teaming up at Cantor Fitzgerald, join us for a back-to-school conversation as biotech enters the busy back third of 2023.

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Sally Beauty’s bondbar collection expands with hair color, treatments

Drug Store News

The latest additions to the collection include permanent hair color shades that have been designed with built-in bond repair, a shampoo and three styling products.

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