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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PharmaVoice

JUNE 26, 2024

The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.

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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 343

PharmaVoice

JUNE 26, 2024

Weight loss market leaders are warning patients and healthcare providers about the risks associated with knockoff versions of their popular obesity meds — and taking legal action.

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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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BioPharma Dive

JUNE 26, 2024

Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

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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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BioPharma Dive

JUNE 26, 2024

The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.

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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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Pharmacy Management

Welltopia Pharmacy

JUNE 26, 2024

Zenith supplement is a new and effective weight loss solution for people suffering from overweight problems. Weight loss is a significant health challenge that affects millions of people worldwide. The prevalence of obesity and overweight conditions has surged, leading to various health complications such as diabetes, cardiovascular diseases, and joint problems.

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Diabetes 111

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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Drug Patent Watch

JUNE 26, 2024

This is an example from the DrugPatentWatch AI Research Assistant, which is available with DrugPatentWatch subscriptions. The DrugPatentWatch AI Research Assistantuses sophisticated AI algorithms to understand and process your questions, delivering precise answers. It goes beyond simple keyword matching, comprehending the intent and context of questions to provide meaningful and relevant responses.

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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 Pharmacist

JUNE 26, 2024

EXCLUSIVE Pharmacy closures in deprived areas are not only impacting physical access to a local pharmacy. They may also be exacerbating health inequalities for those who are less likely to access online services. The Pharmacist’s exclusive mapping of pharmacy closures suggested that the most deprived areas in England have lost nearly five times as many […] The post Analysis: Pharmacy closures risk exacerbating digital divides appeared first on The Pharmacist.

Online Pharmacies 101

Online Pharmacies 101

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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Drug Patent Watch

JUNE 26, 2024

Introduction In the rapidly evolving landscape of pharmaceutical patent disputes in China, injunctive relief has emerged as a critical tool for patent holders. This legal remedy, which aims to halt infringement activities swiftly, plays a pivotal role in protecting intellectual property (IP) rights and fostering innovation.

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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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Drug Pricing Drug Development 209

Express Pharma

JUNE 26, 2024

Dr. Reddy’s Laboratories announced that its subsidiary Dr. Reddy’s Laboratories SA has signed a definitive agreement with Haleon, a consumer healthcare company, for the purchase of shares of Northstar Switzerland SARL, a Haleon group company, to acquire Haleon’s global portfolio of consumer healthcare brands in the Nicotine Replacement Therapy (“NRT”) category outside of the United States.

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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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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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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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FDA Law Blog: Biosimilars

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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Pharmaceutical Business Review

JUNE 26, 2024

The funding round was spearheaded by Asabys Partners and saw contributions from Eli Lilly and Charcot-Marie-Tooth Research Foundation in the US. Existing investors, including AdBio Partners, PMV, V-Bio Ventures, VIB and Gemma Frisius Fund also participated. AGT100216 is a small molecule HDAC6i with a distinct mechanism-of-action, showing promise for Charcot-Marie-Tooth disease (CMT) and chemotherapy-induced peripheral neuropathy (CIPN).

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Chemotherapy 97

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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Express Pharma

JUNE 26, 2024

NIDO Group, a warehouse automation player, announced its collaboration with 1Pharmacy, a tech solutions company powering stakeholders across the pharmaceutical supply chain to revolutionise their order fulfilment and sorting processes. The goal of this partnership is to optimise operations and digitalise the entire value chain, which can result in enhanced efficiency, reduced errors, and streamlined processes.

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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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BioPharma Dive

JUNE 26, 2024

The failure of a Phase 3 trial led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

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Express Pharma

JUNE 26, 2024

The success of the COVID-19 mRNA vaccines highlighted the major advantages of utilising mRNA technology in vaccine development. Consequently, the FDA has awarded a rising number of review designations to mRNA vaccines in recent years. In 2023, a record nine designations were awarded to mRNA vaccines for eight conditions, displaying the FDA’s commitment to encouraging the development of these products across a broader range of indications, says GlobalData.

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pharmaphorum

JUNE 26, 2024

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

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Express Pharma

JUNE 26, 2024

Cipla signed a non-exclusive Patent License agreement with Takeda Pharmaceutical for ‘Vonoprazan’ for the Indian market for treating acid-related illnesses among patients. This deal is meant to commercialise the drug in India under Cipla’s own trademark brands. Vonoprozan (oral tablets) is a novel potassium-competitive acid blocker (P-CAB), used for the treatment of related disorders – Gastroesophageal Reflux Disease (GERD).

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