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 Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study.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

342

342

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.

147

147

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.

Vaccines 337

Vaccines 337

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.

147

147

Advertisement

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

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.

309

309

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.

Hospitals 109

Hospitals 109

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.

Pharmaceutical Companies 100

Pharmaceutical Companies Pharmaceutical Companies 100

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.

Hospitals 249

Hospitals Documentation 249

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.

Online Pharmacies 83

Online Pharmacies 83

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

Chemotherapy 230

Chemotherapy 230

Speaker: Joe Sharpe and James Carlson

In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.

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

Drug Pricing 88

Drug Pricing 88

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.

Drug Pricing 218

Drug Pricing Drug Development 218

Pharma Times

SEPTEMBER 18, 2024

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

99

99

STAT

SEPTEMBER 18, 2024

A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up. On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks.

Drug Development 206

Drug Development 206

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.

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

Chemotherapy 89

Chemotherapy Labelling Pharmaceutical Companies Pharmaceutical Companies 89

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

Labelling 215

Labelling 215

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.

62

62

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.

178

178

Advertisement

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.

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.

66

66

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.

Hospitals 170

Hospitals Drug Pricing Diabetes 170

BioPharma Dive

SEPTEMBER 18, 2024

The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.

59

59

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.

Hospitals 173

Hospitals 173

Advertisement

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.

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/ ).

59

59

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

Drug Development 59

Drug Development 59

Express Pharma

SEPTEMBER 18, 2024

In support of India’s aspirations in biomedical research and tech-enabled R&D, the Department of Biotechnology – Biotechnology Industry Research Assistance Council (DBT-BIRAC), a government of India enterprise announced a strategic partnership with catalyst funder and philanthropic organisation, Blockchain For Impact (BFI) at the recently concluded 4 th edition of Global Bio India, under the guidance of the Minister of Science, Jitendra Singh.

59

59

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).

59

59

Pharmaceutical Business Review

SEPTEMBER 18, 2024

This designation will offer potential benefits such as tax credits and fee waivers to facilitate the drug’s development. The ODD status is intended for potential treatments for diseases affecting fewer than 200,000 people in the US. This programme is designed to encourage the development of therapies for rare diseases by providing financial incentives.

59

59

pharmaphorum

SEPTEMBER 18, 2024

Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times too high and need to be brought in line with levels in other countries.

Compounding 59

Compounding Compounding Pharmacies 59

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.

Community Pharmacies 57

Community Pharmacies 57

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

66

66

Pharma Times

SEPTEMBER 18, 2024

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

Hospitals 72

Hospitals 72

Pharmacy Joe

SEPTEMBER 18, 2024

In this episode, I’ll discuss differences in heart rate in patients with sepsis and AFib between phenylephrine and norepineprhine. Episode 958: Sepsis and AFib heart rate differences with phenylephrine vs norepinephrine Subscribe on iTunes , Android , or Stitcher Phenylephrine, unlike norepinephrine, does not stimulate beta receptors and therefore should not raise a patient’s heart rate.

Hospitals 52

Hospitals Inpatient 52