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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Trending Sources

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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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The Supreme Court appears set to reject Idaho’s near-total abortion ban

STAT

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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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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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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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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House panel proposes new strategy for Medicare to cover weight loss drugs Wegovy, Zepbound

STAT

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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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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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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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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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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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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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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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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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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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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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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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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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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Should you eat sourdough if you have diabetes?

The Checkup by Singlecare

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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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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Benzodiazepine Tapering Guidelines 2024 New Draft Guidelines!

Med Ed 101

I’ve encountered a significant proportion of patients who are on chronic benzodiazepines. Drug interactions, adverse effects, and other risks to my geriatric patient population are significant when using this class of medication. Benzodiazepine withdrawal is another real issue and one of the reasons why we try to limit their use to short-term only.

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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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Wales and NI follow England in backing Vertex CF therapies

pharmaphorum

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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IncludeHealth teams up with major orthopedic physician network to expand the reach of virtual physical therapy

Fierce Healthcare

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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ASCO 2024 - Warner Biddle and Ibrahim Elhoussieny

pharmaphorum

Discover the latest updates and advancements in cell therapy from ASCO 2024 featuring Warner Biddle and Ibrahim Elhoussieny of KITE Therapeutics, a subsidiary of Gilead. Stay informed on the cutting-edge developments in cancer treatment.

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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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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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Researchers Develop Bread With Probiotic Properties That Reduce Asthma Symptoms in Mice

Pharmacy Times

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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Abcuro completes enrolment for phase 2/3 IBM treatment trial

Pharmafile

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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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

The FDA Law Blog

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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Magazine: UK’s new Netflix-style funding model for antibiotics goes live

Pharmaceutical Technology

In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.

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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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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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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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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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