STAT

NOVEMBER 5, 2024

A patient with sickle cell disease died while participating in a clinical trial of a CRISPR-based treatment from Beam Therapeutics, threatening to overshadow early signals of effective gene editing.  Beam said the patient succumbed to respiratory failure, deemed to be “likely caused” by a regimen of chemotherapy required to prepare the patient for BEAM-101, a treatment that uses the company’s new, more precise form of CRISPR gene editing called base editing.

Chemotherapy 357

Chemotherapy 357

PharmaVoice

NOVEMBER 5, 2024

Sernova’s technology helped type 1 diabetes patients achieve insulin independence in early- and mid-stage trials.

Diabetes 246

Diabetes 246

STAT

NOVEMBER 5, 2024

In a viral TikTok, a woman in the emergency room shares a message questioning why so many women in their 30s struggle with cancer and infertility, and suggests that birth control’s long-term hormonal disruption is the cause. Another influencer mocks the FDA inserts that accompany birth control, unfolding the long lists of side effects in videos to humorously repurpose them as “blankets” for napping or as tools for helping men grasp the harsh realities their partners face to

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PharmaVoice

NOVEMBER 5, 2024

Rallybio is headed into a mid-stage trial with enough cash through 2026, but the cyclical market has made the journey difficult.

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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

Communication

STAT

NOVEMBER 5, 2024

Three independent pharmacies have filed separate lawsuits accusing GoodRx, which markets a prescription drug discount card, of conspiring with several pharmacy benefit managers to fix reimbursement fees, the latest skirmish over the opaque pharmaceutical supply chain in the U.S. At issue are the behind-the-scenes transactions involving generic drugs, which account for an estimated 90% of the prescriptions written in the U.S. and, consequently, represent a lucrative market.

Independent Pharmacies 290

Independent Pharmacies Drug Pricing 290

BioPharma Dive

NOVEMBER 5, 2024

The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.

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pharmaphorum

NOVEMBER 5, 2024

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.

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STAT

NOVEMBER 5, 2024

Treatment with an experimental CAR-T therapy for multiple myeloma from Arcellx and Gilead Sciences resulted in zero cases of delayed neurotoxicity, including Parkinsonian symptoms and cranial nerve palsies, according to early results from a Phase 3 clinical trial reported Tuesday.  While still preliminary, the benign neurotoxicity assessment for the therapy, called anito-cel, suggests it could be a safer option for patients with multiple myeloma compared to Carvytki, a currently approved CA

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pharmaphorum

NOVEMBER 5, 2024

AstraZeneca's shares have fallen more than 8% on speculation about an anti-corruption probe in China, its second-largest market, wiping around $14 billion off its value.The sell-off appears to have been prompted by an article in Chinese financial media outlet Yicai which suggested that "dozens of senior executives" at AZ's Chinese subsidiary have been implicated in an ongoing insurance fraud case.

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STAT

NOVEMBER 5, 2024

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. Hope everyone takes it easy in what will be a long day today. Now let’s get into the biotech news.

Drug Pricing 267

Drug Pricing Drug Development 267

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BioPharma Dive

NOVEMBER 5, 2024

The death, which investigators linked to a preparatory chemo treatment rather than Beam's medicine, highlights the risks of using decades-old transplant drugs alongside cutting-edge CRISPR medicines.

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STAT

NOVEMBER 5, 2024

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Election Day is finally here. What to say? If you’re feeling at all grateful for STAT’s journalism today, consider supporting our newsroom. We’re currently offering 40% off our annual subscription.

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Express Pharma

NOVEMBER 5, 2024

New York-based Ichnos Glenmark Innovation (IGI), a clinical-stage biotech company focused on multispecifics in oncology, announced plans to present initial data from its Phase 1 study of ISB 2001 at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, California. ISB 2001, IGI’s first-in-class trispecific antibody, targets BCMA and CD38 on myeloma cells and CD3 on T cells and is currently under investigation in patients with relapsed/refractory multiple myeloma (r/r MM).

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STAT

NOVEMBER 5, 2024

Every few decades the United States launches a big science project. The original “moon shot” was kicked off by NASA’s Apollo Program in the 1960s. Its spiritual successor, the Human Genome Project, was launched in 1990 and concluded a dozen years later with the first sequenced genome. In 2016, the Cancer Moonshot debuted. Now is time for the next moon shot.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

Express Pharma

NOVEMBER 5, 2024

Novavax said on Tuesday that it has entered into a termination and settlement agreement with the UK Health Security Agency (UKHSA) related to its COVID-19 vaccine supply agreement. Under terms of the deal, the company and the UKHSA agreed to settle the outstanding amount under dispute related to upfront payments received by Novavax from the health agency.

Vaccines 103

Vaccines 103

STAT

NOVEMBER 5, 2024

Good morning, everyone, and how are you today? We are doing just fine, thank you, despite cloudy skies looming over the Pharmalot campus. After all, the birds are still chirping and crisp autumn breezes are wafting by. Moreover, this is an exciting day on this side of the pond, where millions of voters are casting their ballots in hopes of changing their world.

Chemotherapy 194

Chemotherapy 194

Express Pharma

NOVEMBER 5, 2024

Venus Remedies has received Good Manufacturing Practices (GMP) approval with Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia for its pre-filled syringe (PFS) facility at its Baddi unit. This marks the first PIC/S GMP accreditation for the PFS facility and adds to the GMPs already secured by the company from more than 25 regulatory authorities, including the WHO and European Union.

Pharmaceutical Manufacturing 103

Pharmaceutical Manufacturing 103

STAT

NOVEMBER 5, 2024

Tuesday’s oral arguments before the Supreme Court in a case involving billions in Medicare payments to hospitals revealed a split among the justices willing to show their cards.  The case, Advocate Christ Medical Center v. Becerra, concerns Medicare payments to safety net hospitals, known as disproportionate share hospital, or DSH, payments, which are designed to compensate them for treating low-income patients.

Hospitals 188

Hospitals 188

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.

pharmaphorum

NOVEMBER 5, 2024

Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult

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The Guardian - Pharmaceutical Industry

NOVEMBER 5, 2024

Pharmaceutical’s weight loss pill described as ‘underwhelming’, also piling pressure on share price AstraZeneca shares tumbled on Tuesday wiping £14bn off the value of Britain’s biggest drug maker, after a report that dozens of senior executives at its China unit could be implicated in an insurance fraud case in the country’s pharmaceutical sector. Also putting pressure on the share price, early data on AstraZeneca’s experimental weight loss pill published on Monday was described as “somewhat un

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pharmaphorum

NOVEMBER 5, 2024

Beam shines a light on phase 1/2 data with its base editing candidate for sickle cell disease ahead of a full presentation at ASH next month

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PioneerRx

NOVEMBER 5, 2024

Well, here we are: November, only two months until we welcome in the new year. As this year draws to a close, the last two months offer a powerful opportunity to.

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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

NOVEMBER 5, 2024

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.

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Drug Patent Watch

NOVEMBER 5, 2024

The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.

Biosimilars 80

Biosimilars 80

Outsourcing Pharma

NOVEMBER 5, 2024

Clinical trial results have revealed that semaglutide treatment significantly reduced hospital admissions in overweight and obese adults with heart disease.

Hospitals 85

Hospitals 85

The Pharmacist

NOVEMBER 5, 2024

An 'administrative barrier' to providing Covid-19 vaccinations persists beyond the pandemic and should be removed immediately, the National Pharmacy Association (NPA) chair has said. Nick Kaye told the UK Covid-19 Inquiry last night that 'both primary care networks and community pharmacy had to go through - for want of a better description, [an] accreditation process' […] The post ‘Administrative barrier’ to providing Covid jabs must be removed, inquiry told appeared first on The Pharmacis

Community Pharmacies 71

Community Pharmacies Vaccines 71

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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

BioPharma Dive

NOVEMBER 5, 2024

The company, which is only three years removed from one of biotech’s most lucrative IPOs, will cut jobs for a third time and invest more heavily in cell therapies for diabetes and lupus.

Diabetes 70

Diabetes 70

Pharmafile

NOVEMBER 5, 2024

The pilot aims to speed up the process for safely and securely finding participants for UK clinical trials, improving efficiencies and opportunities for people to take part in research and access innovative new medicines. The pilot will test a new model combining NWEH’s secure, tried and tested FARSITE platform, with the scale and depth of […] The post NorthWest EHealth (NWEH) announces a pilot to test a new model for finding and recruiting participants for clinical trials using the Clinic

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Big Molecule Watch

NOVEMBER 5, 2024

Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary (“CHO”) cell line—and in particular Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe). Alvotech stated that “unless and until the Agency has evaluated and concluded that the differences in sialylation between the proposed interchangeable biosimilar and the reference product, STELARA (uste

Biosimilars 62

Biosimilars 62

pharmaphorum

NOVEMBER 5, 2024

Learn the importance of having a standardised data model as your single source of truth in this insightful video interview. Gain valuable insights on data management and standardisation processes.

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Pharmaceutical Commerce

NOVEMBER 5, 2024

JAMA study indicates Canada may have a more resilient drug supply chain or different thresholds for reporting and responding to issues compared with the United States.

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