Wed.Nov 20, 2024

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STAT+: RFK Jr. is exploring a plan to upend Medicare’s physician payments system

STAT

WASHINGTON  — People close to Robert F. Kennedy Jr. are exploring a proposal that could upend how physician payment is determined in America, four sources familiar with the process told STAT.

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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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A new device for delivering drugs without needles draws inspiration from the elegant squid

STAT

Doctors have been using needles as a way to inject people with drugs since the 1600s. Today they’re often used for biologic drugs, which are too large to deliver via pills because they would be dissolved by stomach acid. Now a group of bioengineers is hoping to give drug delivery an update with a device that draws inspiration from cuttlefish and other sea creatures.

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Johnson & Johnson, Merck lay off workers in China as local headwinds take a toll

Fierce Pharma

Johnson & Johnson and Merck are laying off workers in Chi | Johnson & Johnson and Merck are laying off workers in China, according to a story from Bloomberg which cites reports from Chinese news outlets.

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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

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STAT+: New details on a risky medical device show need for more FDA transparency, researchers say

STAT

Tonya Brand was horrified to find a piece of metal poking out of her inner thigh while relaxing at her house in Georgia in 2011. She had no idea what it could be.  It was only after extensive imaging that her doctors realized what had happened: A medical device that had been implanted in her two years earlier to catch blood clots had broken and was now migrating to different parts of her body.

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PBMs strike back at FTC, claim administrative process is unconstitutional

Fierce Healthcare

The country’s largest pharmacy benefit managers and group purchasing organizations are going on offense against the Federal Trade Commission (FTC). | Major PBMs are countersuing the Federal Trade Commission, claiming the agency is biased and has too much authority to upend the industry.

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Rochester Pharmacy Access Coalition Uniting to Fill Gaps from Pharmacy Closures

Drug Topics

A collection of hospitals in Rochester, New York, have teamed up to create better access to prescription drugs and combat the city’s pharmacy desert issue.

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STAT+: Kura licenses leukemia drug to Japanese drugmaker

STAT

Kura Oncology has signed a global partnership with the Japanese drugmaker Kyowa Kirin to develop and sell Kura’s experimental treatment for acute leukemia, the companies said Wednesday.  Kyowa is paying $320 million to Kura in exchange for global licensing rights to the drug, called ziftomenib, which is in a late-stage clinical trial for a genetically defined type of advanced leukemia.

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Plasma specialist Grifols shrugs off private equity firm Brookfield's potential €6.5B takeover offer

Fierce Pharma

With Spanish plasma specialist Grifols turning down a potential multi-billion-dollar takeover bid, it’s likely back to the drawing board for Canadian private equity outfit Brookfield. | Grifols’ board of directors on Tuesday rebuffed private equity firm Brookfield’s potential 6.45 billion euro buyout offer, recommending management reject the deal that it argues “significantly undervalues the company’s fundamental prospects and its long-term potential.

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Opinion: The term ‘vegetative state’ has no place in modern medicine

STAT

A stroke, a traumatic brain injury — at any moment, any one of us could leave behind our normal state of consciousness and start to require ’round-the-clock care. Sometimes, a patient displays regular cycles of wakefulness and sleep without regaining the capacity for normal voluntary action. This is a tragic situation for the patient’s family — but what, if anything, might the patient themselves be experiencing?

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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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Jazz's HER2 bispecific snags FDA nod, teeing up showdown with AZ and Daiichi's Enhertu

Fierce Pharma

A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate Enhertu | A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star ADC Enhertu.

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AI-guided decisions can devastate lower-income Americans. This group wants to change that

STAT

In 2016, the Arkansas Legal Aid Center was flooded with calls. People on a Medicaid program that provided in-home care assistance were having their caregiving hours cut. Reducing the hours for somebody with quadriplegia or cerebral palsy was devastating, said Kevin De Liban, an attorney with the organization at the time. “People are lying in their own waste, people are getting bed sores from not being turned.

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Rapid growth spurt for UCB's Bimzelx continues with hidradenitis suppurativa nod marking 5th FDA approval

Fierce Pharma

It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. | The latest nod positions Bimzelx to go head-to-head with Novartis' Cosentyx in the hidradenitis suppurativa market.

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Investors tell Silence Therapeutics to shush 

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. Today, we meet Pfizer’s new chief scientific officer, ponder why the stock for Silence Therapeutics dropped despite promising data, and see that pharma executives aren’t too worried about Robert F.

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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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Study Finds Nearly 75% of Adults 25 and Older Have Overweight or Obesity

Pharmacy Times

If patterns and trends were to continue, the authors predict that nationwide overweight and obesity prevalence in adults will surpass 80% by 2050.

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Opinion: Paying a visit to ‘Mom & Dad’s Nipple Factory’

STAT

When Randi Johnson was undergoing treatment for breast cancer, her husband, Brian, often felt at a loss to help. But then, when he and Randi met with a surgeon to discuss reconstructing her breast, he was struck by something he could do. The Midwestern father of five, a lifelong tinkerer, decided to make his wife the best possible prosthetic nipple.

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Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 

Pharmaceutical Technology

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

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STAT+: Doubling down on its strategy, Pfizer names its head of oncology as new research chief

STAT

Pfizer said its chief oncology officer, Chris Boshoff, will head all of the company’s research and development efforts in addition to keeping his current duties overseeing the company’s scientific and commercial efforts in cancer. Boshoff replaces Mikael Dolsten, who led research and development at the drug giant for 15 years and who announced his plans to retire in July.

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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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Assessing SGLT-2 Inhibitors in Patients with T2D, Cardiovascular Complications

Drug Topics

Three research posters presented at the American Heart Association’s 2024 Scientific Sessions looked into the use of SGLT-2 inhibitors in patients with type 2 diabetes and cardiovascular complications.

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MSD says subcutaneous Keytruda matches IV form

pharmaphorum

MSD's subcutaneous formulation of top-selling cancer drug Keytruda was non-inferior to the current intravenous version in a head-to-head trial

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Evaluating Empagliflozin’s Impact on Cardiovascular Outcomes in Patients with T2D | AHA 2024

Drug Topics

Two posted presented at the American Heart Association’s 2024 Scientific Sessions explored empagliflozin among patients with type 2 diabetes and cardiovascular risk.

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Investigators Present New Data About HPV Vaccine, Supporting Its Use

Pharmacy Times

Data from the BROADEN and PROGRESS studies were presented at the International Papillomavirus Conference 2024 in Edinburgh, UK, from November 12 to 15.

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Sage wilts as Huntington's prospect flunks trial

pharmaphorum

Sage Therapeutics' run of bad news has continued with a failed phase 2 trial of dalzanemdor as a treatment for Huntington's disease

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Roche files patent suit to fend off potential Evrysdi generics from Zydus, Natco

Fierce Pharma

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

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Pfizer bags EU okay for haemophilia drug Hympavzi

pharmaphorum

Pfizer's Hympavzi has become the first once-weekly subcutaneous treatment for people living with severe haemophilia B in the EU

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Early Asthma Onset Associated With Memory and Executive Function Difficulties in Children

Pharmacy Times

Inflammation associated with asthma in children could perturb neurodevelopment.

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Real-Time Pharmacist Feedback Improves Heart Failure Medication Management | AHA 2024

Drug Topics

Results of a study at the Veterans Health Administration found that feedback and education led to better medication outcomes for patients.

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Q&A: Reducing Mental Health Stigma Starts in Pharmacies

Pharmacy Times

Lenora Newsome, PD, president of the National Association of Boards of Pharmacy, explores how pharmacists can support mental health.

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On a roll, CDMO Samsung Bio strikes $668M production tie-up with European pharma

Fierce Pharma

On the back of several strong quarters and a year already chock-full of manufacturing accords, Korean CDMO Samsung Biologics is adding yet another project to its contract manufacturing Rolodex. | Samsung Biologics said it inked a series of production pacts with an unnamed European pharma in a tie-up worth a total of $668 million. Samsung’s latest undertaking, which will see the CDMO provide manufacturing services to its client through 2031, brings the company’s cumulative new contract value this

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NICE blames companies for breakdown in Enhertu talks

pharmaphorum

Discussions aimed at making AstraZeneca and Daiichi Sankyo's Enhertu available to breast cancer patients on the NHS have been abandoned

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Tran Pham: Breaking barriers and building biopharma solutions

Outsourcing Pharma

From discovering her knack for chemistry in high school to proving her expertise in male-dominated spaces, Tran Pham has built a dynamic career in biopharma.

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STAT+: Pharmalittle: We’re reading about Pfizer’s new R&D head, Merck and J&J job cuts in China, and more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not particularly appealing. And what better way to make the time fly than to keep busy.

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Glox Therapeutics Awarded £1M PACE Grant to Accelerate Development of Precision Antibiotics Against Antimicrobial-resistant Pathogens

Pharmafile

20 November 2024 – Glasgow, UK –: Glox Therapeutics, a company pioneering the development of precision antibiotic therapies based on naturally occurring bacteriocins, today announced it has secured £1 million in grant funding from PACE (Pathways to Antimicrobial Clinical Efficacy), one of the UK’s largest public-private initiatives targeting early-stage antimicrobial medicines and diagnostic discovery.

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