STAT

APRIL 30, 2024

The H5N1 bird flu virus has been around for decades, and the damage it wreaks on chickens and other poultry is well documented. But the recent discovery that the virus has jumped into dairy cattle — whose udders seem to be where the virus either infects or migrates to — has dumbfounded scientists and agricultural authorities. Questions for which there are pretty clear answers when it comes to birds are suddenly unsettled science in cows.

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Documentation 364

PharmaVoice

APRIL 30, 2024

From resurrecting an extinct species to improving regenerative medicines with plant-based materials, these biotechs are on the leading edge of science.

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STAT

APRIL 30, 2024

A national advisory panel significantly lowered the age recommendations for screening mammography on Tuesday, saying that all women should start breast cancer screening at age 40, rather than 50, and continue every other year until age 74. The previous recommendations from the panel, the United States Preventive Services Task Force, suggested that women make an individual choice on getting mammography from ages 40 to 49.

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PharmaVoice

APRIL 30, 2024

From its landmark CRISPR approval to its potential breakthrough drug for pain, Vertex’s development approach, led by chief scientific officer Dr. David Altshuler, is paying off.

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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

Communication

STAT

APRIL 30, 2024

WASHINGTON — Advocates of a federal ban on menthol cigarettes have spent the better part of the last decade trying everything — from federal lawsuits to holding mock funerals outside the White House — to convince Washington policymakers to remove the minty substance from cigarettes. Now, it seems, advocates may just have to sit around and wait.

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Safe Biologics

APRIL 30, 2024

On April 30, ASBM submitted comments to the European Medicines Agency’s (EMA’s ) Committee for Medicinal Products for Human Use (CHMP) as part of a public consultation period on the Agency’s “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development” The document expresses the EMA’s intent to streamline biosimilar development by reevaluating the role of clinical safety and efficacy data.

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Biosimilars Documentation 100

Safe Biologics

APRIL 30, 2024

In early April ASBM Chairman Ralph McKibbin joined with the Pennsylvania Nonmedical Switching Coalition to meet with members of the Pennsylvania House of Representatives Insurance committee to answer questions and advocate regarding the impact of nonmedical switching on patients in the state. PA State Senate bill 348 amends the Unfair Insurance Practices Act to prevent nonmedical switching and a House companion bill is pending.

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STAT

APRIL 30, 2024

WASHINGTON — The U.S. Drug Enforcement Administration  will move to reclassify  marijuana  as a less dangerous drug, The Associated Press has learned, a historic shift to generations of American drug policy that could have wide ripple effects across the country. The DEA’s proposal, which still must be reviewed by the White House Office of Management and Budget, would recognize  the medical uses of cannabis  and acknowledge it has less potential for abuse th

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BioPharma Dive

APRIL 30, 2024

The funds will help the cancer-focused startup Enlaza bring “several development candidates” towards human testing in the next few years, its CEO said.

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STAT

APRIL 30, 2024

Imagine having to make this decision: Your health care provider recommends that you take a specific medicine for an illness or condition but then tells you it hasn’t been tested in people like you. Do you take the medication, or refuse it? That’s the position the 3.5 million women who give birth each year in the U.S. are in when being counseled about taking medicines.

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pharmaphorum

APRIL 30, 2024

Learn about the exciting developments in healthcare delivery in the UK, including the IDX2 trial, NHS initiatives, NIHR research, and the Digital Delivery Team. Explore how these new delivery models are revolutionising healthcare.

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STAT

APRIL 30, 2024

Health care regulations in the United States were not designed to keep Americans healthy. The best example of this is what’s known as the medical loss ratio (MLR). This federal requirement establishes how much a health plan can spend on non-medical related items. The goal was to ensure that insurance dollars are being spent on health care, not administrative costs.

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BioPharma Dive

APRIL 30, 2024

Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.

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STAT

APRIL 30, 2024

Eli Lilly raised its full-year guidance on Tuesday while it reported strong first-quarter sales of Zepbound, even as the pharmaceutical company struggles to make enough of the obesity drug to meet the enormous demand. Lilly increased its adjusted earnings guidance for 2024 to a range of $13.50 to $14.00 per share, up from a prior forecast of $12.20 to $12.70 per share.

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Pharmaceutical Companies Pharmaceutical Companies 302

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

pharmaphorum

APRIL 30, 2024

For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.

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STAT

APRIL 30, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, I’m up bright and early today to report on earnings, with the help of some coffee (with  pasteurized milk)  and the  soundtrack  for the new Challengers movie.

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Drug Pricing Drug Development 261

Pharma Times

APRIL 30, 2024

GPT-4 is trained on datasets to offer eye-related advice, diagnosis and management suggestions

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STAT

APRIL 30, 2024

A controversial provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare Part D nearly $15 billion from 2015 to 2021 on just 15 medicines during that period, according to a new analysis. The provision is known as skinny labeling, which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed.

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Labelling Generic Medicine Biosimilars 258

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European Pharmaceutical Review

APRIL 30, 2024

The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A. Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B.

Biosimilars 98

Biosimilars Generic Medicine Chemotherapy Hospitals 98

STAT

APRIL 30, 2024

Akili Interactive on Tuesday announced it will lay off 46% of its staff and evaluate strategic alternatives amid sluggish sales of its prescription video game treatment for attention deficit hyperactivity disorder. The announcement comes ahead of the company’s first-quarter earnings release on May 14. Akili’s hunt for options follows dismal outcomes for other prescription digital therapeutics companies that have thrown in the towel after failing to build sustainable businesses.

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Diabetes 244

Digital Pharmacist

APRIL 30, 2024

Mother’s Day 2024 is right around the corner on Sunday, May 14th, so now is the time to find ways to make moms feel special at your pharmacy this year! estimated to be spent by US consumers on Mother’s Day Moms Currently in the US % of US adults expected to celebrate Mother’s Day Mother’s Day Ideas for Your Pharmacy As the third-largest retail holiday in the US, Mother’s Day is a great marketing opportunity.

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Communication Pharmacy Management 98

STAT

APRIL 30, 2024

Former MIT and Whitehead Institute star biologist David Sabatini, who lost his lofty positions after being accused of violating sexual harassment policies in 2021, is rejoining the Boston scientific community as head of a research group at a new laboratory under the umbrella of a Czech-based scientific institute. Sabatini, who has denied harassing anyone and filed litigation over the claims, has been working since last October in a senior research position at the Institute of Organic Chemistry a

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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.

Pharmaceutical Technology

APRIL 30, 2024

Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.

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STAT

APRIL 30, 2024

LA JOLLA, Calif. — About a half century ago, a barren ocean bluff here started sprouting research institutions, turning a backwater Navy town into a much-envied icon of high-tech jobs and biomedical discoveries. But after years of plunging federal grants and nagging national economic difficulties, the independent institutes on Torrey Pines Mesa are at a crossroads.

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Drug Development 238

European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Vikas Gupta (VG): In the years preceding the Covid pandemic, the ATMP s market, including both the innovators as well as the contract development and manufacturing organisations (CDMOs), was a bit too optimistic about its growth prospects as it was building significant manufacturing capacity focusing primarily on viral vectors.

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Vaccines 97

STAT

APRIL 30, 2024

Next-generation broadly neutralizing antibodies (bnAbs) have the potential to transform the fight against global health threats like HIV, malaria, and Ebola. The commercialization of these innovative antibody therapies could save millions of lives annually. But turning promise into reality requires foresight and commitment. Broadly neutralizing antibodies are a type of protein that can recognize and neutralize a wide range of pathogens, including multiple strains of viruses such as HIV.

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Drug Development 232

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Pharmacy Management

pharmaphorum

APRIL 30, 2024

California will start selling its own generic of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices

Drug Pricing 108

Drug Pricing 108

European Pharmaceutical Review

APRIL 30, 2024

Researchers in Germany have developed an technique to increase the speed of spectroscopic analysis , which typically takes from minutes to hours to acquire measurement. [the technique] can greatly accelerate data acquisition in ultrafast spectroscopy, particularly in higher-dimensional analyses” According to the paper published in the Journal of Ultrafast Science , the innovative technique “can greatly accelerate data acquisition in ultrafast spectroscopy, particularly in higher-dimensiona

Labelling 97

Labelling 97

pharmaphorum

APRIL 30, 2024

Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot therapies for a range of severe genetic diseases.

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Express Pharma

APRIL 30, 2024

Granules India has received approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, a wholly owned foreign subsidiary of the Company, for Colchicine Capsules, 0.6 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mitigare Capsules, 0.6 mg of Hikma International Pharmaceuticals (Hikma).

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Pharma Times

APRIL 30, 2024

An estimated 50% of human genes follow a circadian cycle, many of which are active in the liver

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