Fri.Feb 23, 2024

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STAT+: UnitedHealth cyberattack cripples pharmacies’ and hospitals’ ability to process insurance claims

STAT

Hospitals, pharmacies, and other health care providers are getting stuck in an insurance processing logjam after UnitedHealth Group disclosed a cyberattack within a recently acquired subsidiary that serves as a central hub for payments across the industry. The cyberattack and subsequent system outage within UnitedHealth’s Change Healthcare has caught the attention of federal law enforcement agencies.

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For Moderna, COVID vaccines were a ‘proof of concept’ — now comes the big test

PharmaVoice

Following Moderna’s COVID-19 vaccine success, therapeutics head Dr. Kyle Holen discusses scaling mRNA development to bring candidates to the finish line in oncology and more.

Vaccines 265
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As midwife-assisted home births rise, so too do high-risk births outside hospitals

STAT

Kay Kay Lineweaver’s first birthing experience in 2021 didn’t go as planned. Her baby was breech and the doctor wouldn’t allow her to try to give birth vaginally, so she ended up with an unwanted cesarean section. “[The obstetrician] wouldn’t even give me the option,” she recalled later in a podcast called “Healing Trauma Mamas.

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BioMarin preaches patience amid slow sales for hemophilia gene therapy

PharmaVoice

The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.

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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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STAT+: Amgen’s rheumatoid arthritis drug Enbrel targeted for first-in-the-nation price limit in Colorado

STAT

WASHINGTON — Colorado is pioneering a new way for states to crack down on prescription drug costs. In a first-in-the-nation move, a state board voted to create a payment limit for a widely prescribed Amgen drug used to treat arthritis, a step that may usher in a new era in which state governments take more aggressive action to control the cost of prescription medicines.

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The opportunities and challenges facing rare disease therapies developers

pharmaphorum

Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.

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More Trending

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BioMarin preaches patience amid slow sales for hemophilia gene therapy

BioPharma Dive

The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.

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STAT+: Ocular Therapeutix moves in the right direction, and Alnylam tries to calm some nerves

STAT

This week, an encouraging turnaround for Ocular Therapeutix, a chat with Alnylam’s CEO defending changes to the HELIOS-B study and talking up its hypertension treatment, and quick takes on Amylyx and obesity stocks. A Worst CEO gets some much-needed help For most of last year, Ocular Therapeutix CEO Antony Mattessich promised shareholders that he was close to nailing down a lucrative pharma partnership that would pay for late-stage clinical trials of the company’s treatments for de

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Bavarian Nordic gets swift EU review of chikungunya shot

pharmaphorum

Bavarian Nordic will get an accelerated review of its chikungunya vaccine CHIKV VLP at the EMA, as it tries to chase down a lead held by rival Valneva. The Danish pharma group said it is planning to file for approval of its vaccine in the first half of this year, adding the EU regulator’s human medicine committee, the CHMP, has said it will cut the review time from 210 to 150 days under its accelerated assessment procedure.

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STAT+: Oregon suspends a portion of its drug transparency law found to be unconstitutional

STAT

In a victory for the pharmaceutical industry, Oregon officials have suspended a portion of a contentious state law designed to bring more transparency to prescription drug pricing. For now, the Oregon Department of Consumer and Business Services will no longer require drug companies to compile annual reports on price increases, a key feature of a transparency law that was enacted in 2018.

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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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FDA will decide in June on Dupixent for COPD

pharmaphorum

The FDA has started a priority review of Sanofi and Regeneron’s Dupixent as a treatment for chronic obstructive pulmonary disease (COPD), which could become the first new treatment for the widespread and life-threatening disease in over a decade.

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STAT+: Annovis Bio delivers candor on its Parkinson’s study, even if it doesn’t inspire much confidence

STAT

Annovis Bio had my biotech bull%^&! meter running red after it made a late change to the design of a Phase 3 study in Parkinson’s disease. But then I got an extraordinary explanation from CEO Maria Maccecchini. Now, I’m less worried about data spin because, by her own admission, the odds that the study succeeds, post endpoint change, are a lot lower.

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AI improves adenoma detection in colonoscopies

pharmaphorum

AI software developed by Israeli medtech Magentiq-Eye has been shown to improve detection rates for adenoma, a precursor to colorectal cancer, in colonoscopy procedures

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Analysis reveals “superior efficacy” of long-acting injectable HIV treatment

European Pharmaceutical Review

An interim analysis of a Phase III trial has demonstrated superior efficacy of the long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva ( cabotegravir + rilpivirine), for HIV patients with a history of ART adherence challenges. “The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” shared Dr Kimberly Smith, MPH, Head of R&D at ViiV Healt

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STAT+: Stump Pharmalot: An Ask Me Anything with Ed Silverman

STAT

In 2023, STAT launched a brand-new home for our subscribers to connect with each other and with their favorite STAT journalists. On STAT+ Connect, you can find job postings; comment on STAT articles (since we have closed comments on article pages); discuss industry events with other people who work in biotech, pharma, public health advocacy, PR, and more; read insights and exclusive material posted by STAT reporters and editors; and watch events, including live interviews and text-based Ask Me A

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Identifying Trends Surrounding the Use of In-House Pharmacies for High-Cost Drugs

Pharmaceutical Commerce

A cross-sectional study investigates how this supply chain link helps increase Medicare Part D spending on self-administered specialty drugs.

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What do CEOs owe the world?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Today, we discuss how the FDA is holding firm in how it handles non-compliant trial sponsors and investigators, how PhRMA is rebuilding its ranks, and offer up a fabulous podcast.

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European Commission approves Pfizer's VELSIPITY® for patients with moderately to severely Active ulcerative colitis

World Pharma News

Pfizer Inc. (NYSE: PFE) announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

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After Roche’s exit, Blueprint passes Gavreto on to Rigel

pharmaphorum

After losing Roche as a partner, Blueprint Medicines has sold US commercial rights to RET inhibitor Gavreto to Rigel Pharma in a deal worth up to $117.

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Quality of pharmacy consultation rooms ‘variable’

The Pharmacist

Community Pharmacy England (CPE) has highlighted issues with the ‘variable’ quality of consultation spaces within community pharmacy. The negotiator has therefore called for improved funding to allow pharmacies to invest in their premises to support the roll out of new services – including Pharmacy First, which requires a consultation room to advise and treat patients. […] The post Quality of pharmacy consultation rooms ‘variable’ appeared first on The Pharmacist.

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FDA generic drug approvals rose in 2023 in bid for improved access

Pharmaceutical Technology

The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

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NHS offers preventative bowel cancer screening for patients with Lynch syndrome

Pharma Times

In England, around 1,100 cases of bowel cancer are caused by the inherited condition every year

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Four Keys to Success for Retail and Specialty-Lite Hub Services

Drug Channels

Today’s guest post comes from Nicole Grycan, VP of Commercialization at Phil, Inc. Nicole discusses how hubs can improve access and adherence. She outlines four success factors for manufacturers that use a digital hub partner. To learn more, register for Phil's upcoming webinar: Improving Access, Coverage, and GTN with a Digital Hub. Read on for Nicole’s insights.

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J&J secures EMA backing for earlier CAR-T use in multiple myeloma

BioPharma Dive

European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.

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Use Pharmacy First for free OTC meds to ‘genuinely free up GPs’, says CPE

The Pharmacist

Pharmacy First should be expanded to include free over the counter (OTC) medications for people on low incomes in order to really ease demand for GP appointments, Community Pharmacy England (CPE) chief executive Janet Morrison has suggested. She told a parliamentary inquiry this week that the cost of prescriptions was driving demand for GP appointments. […] The post Use Pharmacy First for free OTC meds to ‘genuinely free up GPs’, says CPE appeared first on The Pharmacist.

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AbbVie’s Skyrizi shows promise as personalised treatment for psoriasis

Pharma Times

The immunosuppressant reduced inflammation in patients with the skin condition after three days

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CSL, Travere close on EU approval of IgAN drug sparsentan

pharmaphorum

Travere and partner CSL Vifor close on EU approval of sparsentan for rare kidney disease IgA nephropathy, after CHMP's positive opinion on the drug.

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AbbVie announces its new CEO

European Pharmaceutical Review

AbbVie’s current President and Chief Operating Officer (COO) is set to replace the company’s existing CEO later this year. Robert Michael will become AbbVie’s new CEO on 1 July 2024. Richard Gonzalez will retire as the company’s CEO to become Executive Chairman, having served as the company’s CEO since its launch in 2013, AbbVie noted.

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Orchid Pharma gets USFDA approval for Exblifep

Express Pharma

Orchid Pharma has received approval by the United States Food and Drug Administration (USFDA) for its novel invention, ‘Enmetazobactam’. This development comes in close succession to the recent recommendation for approval by the European Medicines Agency (EMA). Enmetazobactam is the first completely invented-in-India Beta Lactamase Inhibitor. This USFDA approval paves the way for the introduction of Enmetazobactam in the US, the largest pharma market in the world.

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In search of the fabled tricorder

pharmaphorum

In search of the legendary tricorder using cutting-edge AI and MedTech. Discover the future of healthcare technology today.

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Revolutionizing clinical trials with generative AI: A discussion with IQVIA's Wing Lon Ng

Outsourcing Pharma

In the fast-evolving landscape of healthcare and pharmaceuticals, the role of technology, particularly artificial intelligence (AI), is becoming increasingly prominent.

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AI in Pharma: Navigating New Frontiers in Drug Discovery and Development

Pharma IQ

Bringing a new drug to market typically takes a decade or more and approximately US$2.5 billion. However, new technology, including AI, can dramatically shorten the drug discovery process and reduce t.

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AbbVie and Tentarix collaborate on oncology and immunology treatments

Pharmafile

AbbVie and Tentarix Biotherapeutics have announced that they have entered a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology. The collaboration is intended to utilise AbbVie’s expertise in oncology and immunology with Tentarix’s proprietary Tentacles platform.

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New patent expiration for Baudax drug ANJESO

Drug Patent Watch

Annual Drug Patent Expirations for ANJESO Anjeso is a drug marketed by Baudax and is included in one NDA. There are seven patents protecting this drug. Drug patent litigation for… The post New patent expiration for Baudax drug ANJESO appeared first on DrugPatentWatch - Make Better Decisions.

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