STAT

SEPTEMBER 18, 2024

Last year, a Springer Nature journal published a study surveying 1,700 parents of adolescents and young adults with gender dysphoria. Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study. But the story didn’t end there. Ongoing fallout from the paper and its retraction has opened up an internal rift among academic editors and journal staff that led to one editor’s resignation, as first reported by Retrac

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PharmaVoice

SEPTEMBER 18, 2024

Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.

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STAT

SEPTEMBER 18, 2024

At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa. It felt to many like a generational moment.

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Vaccines 348

PharmaVoice

SEPTEMBER 18, 2024

The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.

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Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

STAT

SEPTEMBER 18, 2024

The cyberattack that forced Ascension to shut off access to its electronic health records cost the nonprofit hospital system roughly $1.3 billion, according to STAT’s analysis of financial documents the health system released Tuesday evening.

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Hospitals Documentation 342

vizient

SEPTEMBER 18, 2024

The awards recognize the achievements of participating hospitals and health systems in patient care quality and supply chain excellence and were announced Sept. 17 in Las Vegas.

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Hospitals 140

The Pharmacist

SEPTEMBER 18, 2024

The General Pharmaceutical Council (GPhC) has proposed new guidance to safeguard against the risks of online prescribing, including of weight loss medication. This follows 'significant risks to patient safety when online questionnaires have inappropriately been the only mode of consultation used', which the GPhC said it had observed through its inspections and investigations.

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Online Pharmacies 118

STAT

SEPTEMBER 18, 2024

Amid debate over potential abuse of the U.S. patent system by the pharmaceutical industry, moves by some drugmakers to expand their patent claims appear to be delaying the arrival of lower-cost generic medicines to the marketplace, according to a STAT analysis.  At issue are use codes, which are brief descriptions of a type of patent claim that focuses on the specific use of a medicine, or the “method of use” in legal vernacular.

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Generic Medicine Drug Pricing 306

pharmaphorum

SEPTEMBER 18, 2024

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

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Drug Pricing 122

STAT

SEPTEMBER 18, 2024

A House committee on Wednesday passed a bill to renew a program aimed at aiding development of drugs for rare diseases in children , putting it in a better position to be added to government funding legislation.  The pediatric rare disease priority review voucher program is set to end on Sept. 30. The legislation would extend the program until Sept. 30, 2029.

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Speaker: Joe Sharpe and James Carlson

Running a small business is no small feat. Payroll management, in particular, can be one of the most time-consuming and complex parts of that equation. Yet, businesses that crack the code on streamlining these processes often discover not just savings, but new avenues for growth. Our expert speakers will share actionable insights and real-world examples of how businesses have reduced overhead and improved payroll efficiency.

pharmaphorum

SEPTEMBER 18, 2024

In a new solution spotlight, learn more about the Aktiia Medical Grade Wearable, a clinically validated device engineered to deliver precise blood pressure readings passively, irrespective of the user's position—be it sitting, lying down, or standing.

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STAT

SEPTEMBER 18, 2024

In 2017, at the age of 42, Susan Whitehead was diagnosed with an early form of breast cancer after discovering a lump in her breast. She embarked on a challenging path of treatment, including a recurrence with stage 2 cancer four years later. Susan underwent two lumpectomies, a mastectomy, radiation, and chemotherapy. Throughout this process, she was steadfast in her resolve to seek the best possible care, which included demanding a controversial full-body scan that led to an unexpected discover

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Chemotherapy 272

Express Pharma

SEPTEMBER 18, 2024

Pfizer has launched the company’s first dedicated commercial analytics centre in India called, ‘the Analytics Gateway’. The centre comprises a talented and experienced pool of data and analytics experts. The Analytics Gateway set up in Mumbai, is expected to accelerate data science and AI solutions to meet Pfizer’s ambitions in modernising marketing and creating an agile sales force.

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STAT

SEPTEMBER 18, 2024

Biotech companies routinely compete to develop and commercialize products. But these rivalries are seldom as publicly heated as what has played out on social media this week between two firms racing to develop new ways to screen for colon cancer. Over the weekend, during the leadup to Exact Sciences announcing data from a blood-based colon cancer test, Guardant Health co-CEO AmirAli Talasaz challenged Exact’s CEO, Kevin Conroy, in a LinkedIn post that was unusually confrontational.

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Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

pharmaphorum

SEPTEMBER 18, 2024

Novartis' Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over rival Verzenio from Eli Lilly

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STAT

SEPTEMBER 18, 2024

Roivant Sciences continues its dealmaking hot streak, announcing Wednesday that it would sell one of its subsidiaries to pharma company Organon in a deal worth $1.2 billion. Organon is buying Roivant subsidiary Dermavant and its topical treatment Vtama. The drug is currently approved to treat various forms of the skin condition plaque psoriasis. But analysts and Organon see the real potential in Dermavant’s standing application with the Food and Drug Administration to expand the drug

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Labelling 239

Drug Patent Watch

SEPTEMBER 18, 2024

The biopharmaceutical industry is constantly evolving, with the demand for complex biologics on the rise. To stay competitive, companies must navigate the complexities of biopharmaceutical development while managing costs effectively. One key strategy for achieving this balance is partnering with Contract Development and Manufacturing Organizations (CDMOs).

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STAT

SEPTEMBER 18, 2024

A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives. Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth.

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Hospitals 236

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.

Pharma Times

SEPTEMBER 18, 2024

It is hoped that the tool will improve the diagnostic pathway and free up radiologists’ time

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Hospitals 108

STAT

SEPTEMBER 18, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. My colleague Ed Silverman, who I view as the foremost expert on drug patents (and coffee flavors), has been taking a closer look at patent claims to bring us an exclusive analysis. We get into all of that today.

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Drug Pricing Drug Development 235

Pharmaceutical Technology

SEPTEMBER 18, 2024

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

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Labelling 98

STAT

SEPTEMBER 18, 2024

Hello, everyone, and how are you today? We are muddling along, but the middle of the week is upon us, 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 so appetizing. And what better way to make the time fly than to keep busy. So we are digging about the pantry and firing up our coffee kettle to get things started.

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Hospitals Drug Pricing Diabetes 215

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Pharmacy Management

Express Pharma

SEPTEMBER 18, 2024

Industry reactions to the recently approved Bio E3 policy -‘Biotechnology for Economy, Environment, and Employment’ have been largely positive. The policy aims to foster high-performance biomanufacturing, aligned with national initiatives of the Government of India such as the ‘Net Zero’ carbon economy and Mission LiFE ( Lifestyle for the environment). ( [link] ministry-of-science-and- technology-releases-new-bioe3- policy/ ).

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Pharmaceutical Technology

SEPTEMBER 18, 2024

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

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Express Pharma

SEPTEMBER 18, 2024

Radioligand therapies (RLTs) have received prominent attention from major pharmaceutical companies in treating prostate cancer. Bayer’s Xofigo (radium-223 dichloride) demonstrated the proof-of-concept with its FDA approval for castration-resistant prostate cancer (CRPC). Interest in RLTs has since peaked, with Novartis acquiring developer Advanced Accelerator Applications and the highly effective Pluvicto (lutetium [177Lu] vipivotide tetraxetan), targeting prostate-specific membrane antigen (PSM

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Chemotherapy Labelling Pharmaceutical Companies Pharmaceutical Companies 82

The Pharmacist

SEPTEMBER 18, 2024

The treatment of minor illnesses and the urgent supply of medicines under the Pharmacy First service should be made accessible to walk-in patients, Community Pharmacy England (CPE) has told The Pharmacist. The negotiator's ask, which it is using in its influencing and public affairs work, comes as The Pharmacist's recent roundtable with community pharmacy and […] The post All parts of Pharmacy First should be open to walk-ins, says CPE appeared first on The Pharmacist.

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Community Pharmacies 80

Express Pharma

SEPTEMBER 18, 2024

Lupin announced that it has entered into a non-exclusive patent license agreement with Takeda Pharmaceutical Company, to commercialise Vonoprazan Tablets in the Indian market. The drug will be marketed under the brand name Lupin’s Lupivon and will be available in two strengths – 10 mg and 20 mg. Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India.

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Pharmaceutical Companies Pharmaceutical Companies 81

The Pharmacist

SEPTEMBER 18, 2024

BREAKING The National Pharmacy Association (NPA) is balloting its members on working to rule amid growing concerns over funding and budget cuts, it has announced today. If passed, thousands of pharmacies across England, Wales and Northern Ireland could take collective action before Christmas, in an unprecedented move for the sector. The ballot, which will be […] The post BREAKING: NPA to ballot pharmacists on working to rule appeared first on The Pharmacist.

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Pharma Times

SEPTEMBER 18, 2024

The conference will return to Vienna AirportCity on 23 to 24 October 2024

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Express Pharma

SEPTEMBER 18, 2024

The United States Food and Drug Administration (US FDA) conducted a Pre-Approval Inspection (PAI) of the new injectable facility Eugia Steriles (a subsidiary of Eugia Pharma Specialities) situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, from March 28, 2024 to April 05, 2024. The unit has received the Establishment Inspection Report (EIR) and the inspection is closed.

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World Pharma News

SEPTEMBER 18, 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS ZUNOVO is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people livi

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. Specifically, FDC Act 201(ff)(3)(B) provides that a dietary supplement does not include: (i) an article that is approved as a new drug under section 355 of [the FDC Act], certified as an antibiotic under section 357 of [the FD

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Drug Development 59