Wed.Jun 26, 2024

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Slideshow: Innovation in Diabetes Technology Could Improve Disease Management

Drug Topics

At ADA 2024, researchers presented findings from 4 studies that investigated the impact of various new diabetes technologies on managing the condition.

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Three months into bird flu outbreak in U.S. dairy cows, experts see deep-rooted problems in response

STAT

Three months since an outbreak of avian influenza in U.S. dairy cattle was declared, the country is failing to take the necessary steps to get in front of the virus and possibly contain its spread among cows, according to interviews with more than a dozen experts and current and former government officials. The country still does not have a sufficient testing infrastructure in place, nor a full understanding of how the virus is moving within herds and to new herds, experts say.

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Drug Topics Top 10: Most Read Stories From June 2024

Drug Topics

Check out this list of our top 10 most read stories from June 2024.

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National Academies proposes reimagining health care to fix ‘fundamental flaws’ that underlie inequity

STAT

The nation’s longstanding racial and ethnic health inequities will not improve unless Congress steps in to provide affordable health insurance for all and federal agencies start enforcing existing laws against discrimination and improve collection of racial and ethnic data, said the authors of a new report released Wednesday. Called “ Ending Unequal Treatment ,” it was issued by the National Academies of Science, Engineering, and Medicine some two decades after the groundbre

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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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CDC: Dengue Virus Poses Increased Threat in United States

Drug Topics

Cases of Dengue virus—the most common global arboviral disease—are on the rise.

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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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More Trending

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With FDA nod, Verona’s Ohtuvayre is set to Jack up the COPD market

Fierce Pharma

Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.

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Opinion: AI and rural health care: A paradigm shift in America’s heartland

STAT

The use of artificial intelligence is happening in “unlikely places.” So says a recent working paper published by the National Bureau of Economic Research. While much of the nation is debating the future of AI, health care providers in rural America are pioneering new uses of it in their practices. As the leader of the U.S.’s largest rural health care system, I predict the impact of AI on rural health care will be consequential.

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Amazon consolidates Clinic telehealth service into Amazon One Medical offering

Fierce Healthcare

Amazon continues to evolve its healthcare business more than a year after spending $3.9 billion on a primary care company. | Amazon continues to evolve its healthcare business more than a year after spending $3.9 billion on a primary care company. The online retail giant is now folding its Amazon Clinic telehealth service into its One Medical primary care platform.

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STAT+: Biotech accelerator Curie.Bio extends its reach with new $380 million fund

STAT

Industry veterans Alexis Borisy and Zach Weinberg had plenty of reasons to celebrate their new venture’s first success story. In November 2023, a small biotech called Forward Therapeutics became the first company to graduate from their startup accelerator, Curie.Bio. The accelerator had opened its doors less than a year prior, and this first launch was sign their program worked: Forward had come out the other side with enough promising data — and three drug candidates — to r

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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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HHS lowers 64 prescription drug prices under Medicare rebate program

Fierce Healthcare

Medicare enrollees will pay less for 64 prescription drugs from July though the end of September because drug companies raised prices faster than the rate of inflation, the Centers for Medicare &am | Medicare enrollees will see lower prices this quarter for certain drugs treating cancer and genetic disorders under action unveiled by CMS.

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Supreme Court rejects challenge to Biden’s use of bully pulpit to fight Covid misinformation

STAT

The Supreme Court on Wednesday rebuffed states and anti-lockdown advocates who said the government violated their First Amendment rights by asking social media giants to remove or limit coronavirus misinformation. The 6-3 decision frees federal officials to talk with social media companies about combating misinformation.The majority found that the states and advocates didn’t have standing to bring the case, because they didn’t show that the government’s actions harmed them o

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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CDC advisory panel opts for a go-slow approach on expanding usage of RSV vaccines

STAT

Makers of RSV vaccines for older adults saw their plans to try to expand usage hit a significant hurdle on Wednesday, when an expert committee that advises the Centers for Disease Control and Prevention on vaccines recommended changes that will likely see fewer older adults qualify for insurance coverage for these products. In a related move, the Advisory Committee on Immunization Practices opted not to make a recommendation yet on use of GSK’s Arexvy vaccine in adults 50 to 59, saying th

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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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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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STAT+: Journal retracts study tied to Micronoma’s effort to create cancer blood test

STAT

Nature retracted a high-profile paper that served as part of the scientific groundwork for Micronoma, a San Diego-based startup, on Wednesday. “Some of the findings of the article are affected and the corresponding conclusions are no longer supported,” Nature said in the retraction. The retraction comes after a team of researchers published work on the preprint site bioRxiv critiquing the Nature paper last August, describing what they called “fatal errors” in the pape

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Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's

Fierce Pharma

With U.K. consumer health giant Haleon slimming down and India’s Dr. Reddy’s Laboratories beefing up its over-the-counter offerings, the two have arrived at a deal that makes sense for both. | Haleon has continued its push to divest, selling its nicotine replacement therapy (NRT) business outside of the United States to Dr. Reddy’s for 500 million pounds ($633 million).

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FDA issues long-awaited draft guidance for enrolling more people of color in clinical trials

STAT

The Food and Drug Administration has drafted guidance aimed at getting drug companies and medical device makers to enroll more people of color and women in the clinical trials that test whether products work. The guidance is long-awaited. It’s the first step in carrying out a law that Congress passed in 2022, and it’s six months late. Congress sought to fix the chronic lack of diversity in clinical research by requiring that companies give the FDA their plans for enrolling patients

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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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Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval

Fierce Pharma

The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. | Even after the FDA has converted J&J’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod, the door to an accelerated approval in the same indication remains open, according to AstraZeneca spinout Dizal Pharma.

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Opinion: FDA: Don’t rush publishing your diversity guidance plan. Take your time and do it right

STAT

When Congress passed the Food and Drug Omnibus Reform Act (FDORA) in December 2022, it was hailed as a landmark step toward codifying diversity and inclusion in clinical trials. Under FDORA, sponsors of Phase 3 and other pivotal trials are required to submit a diversity action plan to the Food and Drug Administration along with their study protocol.

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EvolutionaryScale emerges with $142m for AI drug discovery

pharmaphorum

AI in drug discovery start-up EvolutionaryScale raises $142m in seed financing for its LLM-powered platform for designing protein structures.

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STAT+: Q&A: How Flagship’s Cellarity is using AI to understand cell disease biology before treating it

STAT

Flagship Pioneering launched Cellarity in December 2019. The startup says it’s using artificial intelligence and other computational technologies “to move away from reductionist drug discovery, and unravel the complexities of disease biology to produce ‘game-changing’ medicines out of reach previously.” Why does the company view traditional drug discovery as “reductionist”?

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We want your feedback!

pharmaphorum

Take part in the pharmaphorum reader survey 2024 and share your views on the latest trends and developments in the pharmaceutical industry. Your input helps us tailor our publication to meet your needs.

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STAT+: Pharmalittle: We’re reading about rejection of an AbbVie Parkinson’s drug, PBM markups on mail order, 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 so appetizing. And what better way to make the time fly than to keep busy.

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Non-cancer and HST focus are needed to speed up NICE guidance

pharmaphorum

To speed up NICE guidance, a focus on non-cancer and HST areas is essential. Learn more about the importance of these aspects in the NICE process.

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The Role of Community Health Workers in Improving Patient Outcomes

Pharmacy Times

Heath Mart, part of McKesson, offers an online resource to locate resources near independent pharmacies.

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Smith+Nephew takes sports injury message to Wimbledon

pharmaphorum

Smith+Nephew takes sports injury message to Wimbledon Phil.

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CDC immunization advisers vote to shrink recommendations for RSV vaccination

Fierce Pharma

The respiratory syncytial virus (RSV) vaccine showdown already saw a shakeup last month with a new competitor in Moderna’s mRESVIA. | The vaccines are now recommended for adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease. Previously, all adults aged 60 and older were advised for vaccination.

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Intellia says its CRISPR-based therapy can be redosed

STAT

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. It’s Wednesday, which means it’a also “The Bear” season 3 premiere day. For my Boston readers, know that Ayo Edebiri has been thinking deeply  about the tragedy of  the Great Molasses Flood of 1919.

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Sanofi asks for private equity bids for its consumer health unit: Bloomberg

Fierce Pharma

It finally appears to be go-time in Sanofi’s continuing effort to separate from its consumer health unit. | Sanofi has told prospective buyers of its consumer health unit to provide bids for its consumer division by the middle of July, Bloomberg reports. Private equity firms Advent International and PAI Partners are believed to be the most serious potential suitors.

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Regulatory Considerations Regarding the 503B to 503A Compounding Model For Community Pharmacies

Pharmacy Times

A review of the requirements for pharmacies considering ordering compounds from a 503B facility.

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After stock crash and staff cuts, Amarin wins bid to revive Vascepa patent lawsuit

Fierce Pharma

The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years. | Amarin is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish oil-derived heart med in the lower courts. But the legal development comes after a patent loss on Vascepa eviscerated its U.S. business.

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Akili lifted by FDA nod for adult ADHD digital therapeutic

pharmaphorum

Digital health company Akili will go into its merger with Virtual Therapeutics with FDA approval for its adult ADHD app

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