STAT

JUNE 26, 2024

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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Fierce Pharma

JUNE 26, 2024

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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FDA 128

STAT

JUNE 26, 2024

The Supreme Court appears ready to allow emergency abortions in Idaho, according to a document obtained by Bloomberg Law. The opinion was inadvertently posted to the court’s website briefly on Wednesday, Bloomberg reported. It is unclear whether it is the final version of the decision in Idaho v. United States, but suggests that the court will dismiss Idaho’s appeal of a lower court order.

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Documentation 142

Drug Topics

JUNE 26, 2024

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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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.

STAT

JUNE 26, 2024

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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pharmaphorum

JUNE 26, 2024

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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Fierce Healthcare

JUNE 26, 2024

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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STAT

JUNE 26, 2024

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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Insurance 132

Fierce Healthcare

JUNE 26, 2024

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

JUNE 26, 2024

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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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.

FDA

Fierce Pharma

JUNE 26, 2024

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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FDA 113

STAT

JUNE 26, 2024

WASHINGTON — As weight loss medications have exploded in popularity, a bill to allow Medicare to cover the drugs has languished virtually unchanged in Congress for a decade. Until now.

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pharmaphorum

JUNE 26, 2024

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

JUNE 26, 2024

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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Pharmaceutical Technology

JUNE 26, 2024

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

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Chemotherapy 125

STAT

JUNE 26, 2024

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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FDA 118

Drug Topics

JUNE 26, 2024

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

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STAT

JUNE 26, 2024

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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The Checkup by Singlecare

JUNE 26, 2024

People with diabetes need to be mindful of what foods and drinks they consume each day since the wrong combination of nutrients could lead to short-term problems, like blood sugar imbalances, as well as long-term problems, like higher risk of obesity , high cholesterol, high blood pressure, and heart disease. “The main [consideration] for people with diabetes is to maintain the right macronutrient balance and avoid high glycemic foods, including refined carbohydrates,” says Inna Melamed , Pharm.

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STAT

JUNE 26, 2024

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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Insurance 104

Fierce Healthcare

JUNE 26, 2024

Virtual physical therapy company IncludeHealth has inked a partnership with OrthoForum Value Network to expand the reach of its digital musculoskeletal care solution to more providers and | IncludeHealth has inked a partnership with OrthoForum Value Network to expand the reach of its digital musculoskeletal care solution to more providers and patients.

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STAT

JUNE 26, 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. 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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Pharmacy Times

JUNE 26, 2024

Mice with asthma that were fed bread with Saccharomyces cerevisiae UFMG A-905 yeast showed reduced airway inflammation and decreased IL-5 and IL-13 concentrations, and effects increased when combined with microcapsules.

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STAT

JUNE 26, 2024

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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FDA 105

Fierce Pharma

JUNE 26, 2024

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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STAT

JUNE 26, 2024

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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Pharmafile

JUNE 26, 2024

Abcuro has announced that it has completed the enrolment for its registrational phase 2/3 MUSCLE clinical trial, which aims to assess ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM). The post Abcuro completes enrolment for phase 2/3 IBM treatment trial appeared first on Pharmafile.

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The FDA Law Blog

JUNE 26, 2024

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.

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Fierce Pharma

JUNE 26, 2024

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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pharmaphorum

JUNE 26, 2024

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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Drug Topics

JUNE 26, 2024

A selection of studies presented at the American Diabetes Association 84th Scientific Sessions examined the use of CGM technology in type 2 diabetes.

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pharmaphorum

JUNE 26, 2024

Three of the four UK nations have agreed a long-term deal with Vertex Pharma for reimbursement of its cystic fibrosis therapies, ensuring permanent access to the drugs for eligible patients.The new agreement with England, Wales, and Northern Ireland marks the end of a long-standing and sometimes bitter dispute over the high cost of Vertex's CFTR modulator drugs.

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Drug Topics

JUNE 26, 2024

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

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Pharmacy Times

JUNE 26, 2024

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

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Independent Pharmacies 111