STAT

MARCH 14, 2024

A new study suggests the antiviral drug obeldesivir may be effective in curing Ebola Sudan infections, for which there are currently no approved vaccines or treatments. Scientists at the University of Texas Medical Branch in Galveston tested the drug, made by Gilead, in primates, starting treatment 24 hours after the animals were given what should have been a lethal dose of Sudan ebolavirus by intramuscular injection.

Vaccines 355

Vaccines Drug Development 355

BioPharma Dive

MARCH 14, 2024

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

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STAT

MARCH 14, 2024

WASHINGTON — Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT. Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law , the Food and Drug

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Labelling 353

Pharma Times

MARCH 14, 2024

In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancers

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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

MARCH 14, 2024

The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat the serious liver disease known as MASH. The pill, called Rezdiffra, is made by Madrigal Pharmaceuticals. Metabolic dysfunction-associated steatohepatitis, or MASH, is often associated with obesity. The accumulation of fat in the liver causes inflammation, which leads to fibrosis, or liver scarring, and can progress in more advanced stages to cirrhosis, cancer, and the need for a liver transp

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BioPharma Dive

MARCH 14, 2024

The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.

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BioPharma Dive

MARCH 14, 2024

Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with Wuxi-AppTec, a major contract manufacturer to the biopharmaceutical industry.

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STAT

MARCH 14, 2024

Have you heard the news? I’m launching a weekly email newsletter starting on March 28. It’s called Adam’s Biotech Scorecard and it’s exclusively for STAT subscribers. One catch: We need you to sign up, which you can do here. What should you expect to see in my newsletter each week? Unfiltered, uncompromising, and (hopefully) valuable insight and analysis from the intersection of Wall Street and biotech.

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pharmaphorum

MARCH 14, 2024

Researchers have developed an artificial intelligence algorithm to assist in the diagnosis of lymph node cancer from medical images that has an accuracy of around 90%. The team carried out a retrospective study on the deep learning model, using PET-CT scans from more than 5,000 patients treated for lymphoma at Memorial Sloan Kettering Cancer Centre in the US and the Medical University of Vienna in Austria.

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STAT

MARCH 14, 2024

LONDON —   AstraZeneca said Thursday it would purchase the French firm Amolyt Pharma in a deal worth up to $1 billion, picking up a rare disease drug in a pivotal trial. The acquisition includes an upfront payment of $800 million in cash, plus another $250 million if regulatory milestones are met.   AstraZeneca framed the deal for Amolyt, which has focused on treatments for rare endocrine diseases, as a boost for its own rare disease pipeline.

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Pharmacy Management

Express Pharma

MARCH 14, 2024

Understanding the integrated stress response is an important next step towards grasping the importance of target engagement biomarkers within ALS The recently concluded AD/PD 2024 International Conference on Alzheimer’s Disease (AD) and Parkinson’s Disease (PD) focused on innovative approaches poised to revolutionise the treatment of amyotrophic lateral sclerosis (ALS) and the use of neurochemical biomarkers in ALS drug development.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals Drug Development 103

STAT

MARCH 14, 2024

What happens when an approved drug doesn’t work? Why don’t patients want gene therapy? And is MASH still a big deal? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Bioethicist Holly Fernandez Lynch joins us to discuss the case of Amylyx Pharmaceuticals’ treatment for ALS and what its failure means for drug development.

Drug Development 247

Drug Development 247

pharmaphorum

MARCH 14, 2024

AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.

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STAT

MARCH 14, 2024

Rise and shine, everyone, another busy day is on the way. We can tell because the official mascots are especially enjoying the Pharmalot grounds now that spring is springing and various work crews are dotting the nearby environs. This is an especially busy day for us, in fact, since we are hosting a session later on biosimilars — mark your calendar for 1 p.m.

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Biosimilars 236

Pharma Times

MARCH 14, 2024

Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisions

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STAT

MARCH 14, 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, everyone. Damian here with a reminder that my colleague Ed Silverman is hosting a discussion today about the long-awaited arrival of Humira biosimilars and all they portend for drug costs, insurance coverage, and pharma revenues.

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Biosimilars Drug Pricing Drug Development 231

European Pharmaceutical Review

MARCH 14, 2024

In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Diabetes Labelling Immunity Immunization 95

STAT

MARCH 14, 2024

Editor’s note: A livestream of this event will be embedded below at 1 p.m. ET. Several biosimilar versions of Humira, which for years has been the world’s best-selling medicine, entered the U.S. market over the past year. What has that meant for insurance coverage and the way drugmakers are marketing these medicines? Join leading experts to discuss the impact on the industry and patients.

Biosimilars 204

Biosimilars 204

Express Pharma

MARCH 14, 2024

New facility to improve access to high quality and affordable brands in more patient friendly packs USV announced the opening of a dedicated new manufacturing plant in Baddi, Himachal Pradesh. The new dedicated facility will improve access to high quality and affordable brands in more patient friendly packs. The plant was inaugurated by Debabrata Bhadury, Director, USV in the presence of USV Chairperson Leena Gandhi Tewari and Managing Director Prashant Tewari.

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European Pharmaceutical Review

MARCH 14, 2024

In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Diabetes Labelling Immunity Immunization 94

Pharmaceutical Technology

MARCH 14, 2024

The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.

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pharmaphorum

MARCH 14, 2024

Munich-based antibody-drug conjugate (ADC) specialist Tubulis has completed a sizeable Series B2 financing that shows sustained investor appetite for the ADC category, particularly for companies with technologies that can enhance the safety of these drugs.

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World Pharma News

MARCH 14, 2024

AstraZeneca announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key

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pharmaphorum

MARCH 14, 2024

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

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European Pharmaceutical Review

MARCH 14, 2024

Research by Terrones-Fernandez et al. has demonstrated a simple, novel system for preparing microbiological culture media, and consequently, development of a new sterilisation method. To evaluate the new sterilisation system, the researchers compared the microbiological properties of media prepared in a microwave (for different exposure times) with those of autoclaved sterilised media.

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Compounding 88

Pharmaceutical Technology

MARCH 14, 2024

The funds will be used to expand Zephyr AI's headcount and enhance datasets.

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European Pharmaceutical Review

MARCH 14, 2024

Overall, the goal of expanded facility is to strengthen [SK biosciences] manufacturing capabilities for global supply [of the pneumococcal conjugate vaccine candidate GBP410]” SK bioscience has announced its manufacturing plant L HOUSE, in Andong, Gyeongsangbuk-do, South Korea, is set to have a facility expansion. The new space will be provide a production base for the next-generation pneumococcal conjugate vaccine candidate GBP410 (SP0202), jointly developed by SK bioscience and Sanofi.

Vaccines 85

Vaccines 85

The Pharmacist

MARCH 14, 2024

The community pharmacy negotiator has condemned the ‘significant problems’ with IT systems it said the sector has faced this week. Community Pharmacy England (CPE) underlined the frustration, ‘additional work and stress’ the issues were causing for pharmacy teams and reiterated that ‘pharmacies must not end up being out of pocket because of IT problems which […] The post CPE leader calls out 'significant problems’ with community pharmacy IT appeared first on The Pharmacist.

Community Pharmacies 73

Community Pharmacies 73

European Pharmaceutical Review

MARCH 14, 2024

Boehringer Ingelheim and Sosei Group Corporation (Sosei Heptares) have agreed a new partnership, which could result in the development of a new schizophrenia treatment targeting GPR52. The companies will work to develop and commercialise Sosei Heptares’ portfolio of first-in-class GPR52 agonists, a novel G protein-coupled receptor (GPCR) target, with the aim of providing a novel precision treatment that addresses positive, negative, and cognitive symptoms of schizophrenia.

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The Pharmacist

MARCH 14, 2024

The government has committed to ensuring NHS pulse oximeters work across all skin tones, following an independent review into equity in medical devices. And it said it will ‘drive forward work’ to remove racial bias from data sets used in clinical studies and improve transparency around the development of medical devices and clinical tools that […] The post Government promises to tackle racial bias in pulse oximeters and clinical trials appeared first on The Pharmacist.

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BioPharma Dive

MARCH 14, 2024

The deal gives AstraZeneca a prospect in late-stage testing for parathyroidism and bolsters a rare disease portfolio that mainly consists of drugs from Alexion.

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Pharmafile

MARCH 14, 2024

AstraZeneca has announced that it has entered into a definitive agreement under which it will acquire Amolyt Pharma for up to $1.05bn, with the focus on adding to AstraZeneca’s Alexion’s rare diseases pipeline. The acquisition is intended to expand Alexion’s late-stage rare disease pipeline as well as its bone metabolism franchise, including the addition of […] The post AstraZeneca to acquire Amolyt Pharma for up to $1.05bn appeared first on Pharmafile.

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Drug Patent Watch

MARCH 14, 2024

Annual Drug Patent Expirations for METAXALONE Metaxalone is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Appco, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Sandoz, and… Source

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Putting Patients First Blog

MARCH 14, 2024

A Recap of HLC 2024 March 14, 2024 By: Bhriana Onuoha, Senior Manager, Communications Last month, over 150 patient organizations, partners of patient organizations, business and industry representatives, and thought leaders networked in the sunny desert of Scottsdale, AZ, for the National Health Council’s (NHC’s) 2024 Health Leadership Conference. This three-day conference was held at Hotel Valley Ho and sessions centered on the theme, Th e Urgency of Now: “Think Patient. ” The conference kick

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Communication 59

Express Pharma

MARCH 14, 2024

Includes portfolio of metabolics, oncology, and critical care products in India and a 10-year supply agreement with Eris Biocon Biologics will sell its Indian branded formulations to Eris Lifesciences in a deal worth INR12.42 billion. This represents an accretive multiple of 3.4x of revenues and 18x of EBITDA. The transaction is expected to close by April 15, 2024, and will include a 10-year supply agreement with Eris.

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Diabetes 59