Wed.Nov 08, 2023

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HPV vaccines are so effective that new screening policies may be in order, suggests study

STAT

Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published today in Cell Host & Microbe. The randomized control study included more than 60,000 women from 33 Finnish communities born in 1992, 1993, and 1994.

Vaccines 363
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An at-home flu vaccine? If approved, it could open the door to more DIY options

PharmaVoice

A new way to administer vaccines at home could help AstraZeneca reach a wider market for FluMist, the nasal influenza vaccine.

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Eli Lilly gets FDA approval to sell Mounjaro as obesity drug called Zepbound

STAT

Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes, has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market. The Food and Drug Administration’s long-awaited approval of the drug, which will be marketed under the name Zepbound for obesity, is a major milestone for Lilly.

Diabetes 363
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A new delivery method muscling its way into the RNA space

PharmaVoice

With an AOC platform targeting muscle diseases, Avidity Biosciences hopes to break open the possibilities of RNA.

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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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STAT+: In the fight against cancer, it’s boom times for radiopharmaceuticals

STAT

When Ken Song was getting ready to leave his job as the CEO of a small biotech in 2020, he wasn’t sure what was next. But he knew one thing. “I deliberately said I’m not going to do oncology. Oncology is so crowded. Everybody thinks they have the solution, but the reality is, it’s all noise,” he said. That was until late March 2020, when he received two phone calls from two different investors, both pondering about the same thing: Was it possible to make more e

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What if a CRISPR cure isn’t such an easy choice?

BioPharma Dive

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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More Trending

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Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

Pharma Times

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes

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STAT+: Sanofi CEO defends company’s move to abandon profit guidance and boost research

STAT

LONDON — Sanofi CEO Paul Hudson on Wednesday defended his company’s recent moves to abandon future profit guidance and up its investment in its own research programs, arguing that the dramatically negative market response didn’t reflect the potential rewards that could stem from the plan. “Would I have liked the stock market reaction to be more generous?

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Lilly weight loss drug approved by FDA

BioPharma Dive

The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.

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Why do some CAR-T cancer patients have severe complications? Data points to latent virus

STAT

The therapy, an infusion of CAR-T cells designed to kill the lymphoma, was going well. Nearly a month after the treatment, the engineered cells had crushed the cancer, and the patient, a 49-year-old woman in the Netherlands, appeared to be cancer-free. But two weeks later, something was wrong. The patient couldn’t remember having been in the hospital or, indeed, ever being treated for lymphoma.

Hospitals 295
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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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Masterclass on Leveraging Real-World Evidence (RWE) for Building Pharma Brands

PharmaState Academy

This is "not to be missed" Masterclass for Pharma Marketers! ???????????: To be awarded with 3CPhE (Continuing Pharma Education) points. Seats Booked: 14 / Seats Left 16 Registrations Open Limited Seats Interest Form For Next Batch We limit the number of participants in a batch so that high-quality interactive learning can happen. In case you have missed this batch, you can fill out the Interest form for the next batch.

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Why preventative care is such a tough sell in the U.S., according to chronic disease experts

STAT

WASHINGTON — With the prevalence of some chronic diseases trending up, the U.S. needs to revamp its approaches to preventative care and disease management, experts said at the Milken Future of Health Summit on Tuesday. Already, 6 in 10 Americans live with a chronic condition , and 4 in 10 live with at least two. Factors such as the U.S.’s aging population, delayed care during Covid-19, and the rising prevalence of obesity are only exacerbating the problem, said Karen Hacker, the Ce

Diabetes 294
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FDA Approves Zepbound for Chronic Weight Management

PharmExec

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

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STAT+: Biotech incubator Curie.Bio graduates its first startup

STAT

Curie.Bio, the new biotech investment firm and incubator launched earlier this year by a group of industry veterans including Alexis Borisy and Zach Weinberg, has graduated its first startup. The startup, Forward Therapeutics, is coming out of the incubator with three drug candidates for chronic inflammatory disorders. It also just closed its first major financing round: a $50 million Series A round led by BVF Partners, with participation from RA Capital Management and OrbiMed.

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New hubs receive over £32m to improve access to vaccines in LMICs

Pharma Times

Communicable diseases account for 50% of all deaths in LMICs - News - PharmaTimes

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STAT+: Senate panel clears PBM reforms, safety-net hospital payments

STAT

WASHINGTON — A prominent Senate panel on Wednesday passed a new package of health policy reforms that would rein in certain pharmacy middlemen practices and ensure Medicare patients aren’t paying more than insurers do for medications. The package passed the committee 26-0 with no amendments added. Sen. Ron Johnson (R-Wis.) didn’t vote.

Hospitals 275
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Medical Research Network's Edward Triebell on the shifts and statistics in clinical research's digital trends

Outsourcing Pharma

Executive director of Medical Research Network's (MRN's) digital health, Edward Triebell, joined OSP for a Q&A where he shared some interesting shifts and statistics about digital trends in clinical research.

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STAT+: FDA’s Califf wants to get the public as excited about life expectancy as cures

STAT

WASHINGTON — It’s easy to get people worked up about cures, but they don’t seem to be bothered by falling life expectancy, and Food and Drug Administration Commissioner Robert Califf would like to figure out how to connect the two. The United States has one of the lowest life expectancy rates among wealthy nations. Post-pandemic, the average American life span is down to 76.4 years.

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Reasons Why Patients Don’t Respond To Iron

Med Ed 101

Iron therapy can be life-changing for some anemia patients and help them improve their energy and ultimately, their quality of life. Sometimes anemia isn’t responsive to iron. In this article, I discuss my top reasons why patients don’t respond to iron therapy. Adherence When I consider reasons why patients don’t respond to iron, I always […] The post Reasons Why Patients Don’t Respond To Iron appeared first on Med Ed 101.

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STAT+: FDA approves high blood pressure device from Recor Medical

STAT

The Food and Drug Administration approved a surgical system used to reduce blood pressure from Recor Medical, the company announced Wednesday. The treatment, called renal denervation, is controversial in the cardiology community due to its unclear efficacy. Renal denervation is a treatment for patients who cannot manage standard doses of blood pressure medication — whether because the drugs aren’t effective enough for them, create overwhelming side effects, or become too cumbersome

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Biocon Biologics signs pact with Eris Lifesciences for divesture of dermatology and nephrology branded formulations business units in India

Express Pharma

Biocon Biologics has entered into a definitive agreement with Eris Lifesciences (Eris) for the divesture of its dermatology and nephrology branded formulations business units in India that mostly comprised of its legacy small molecules’ brands. The transaction is a ‘Slump Sale’ that will enable a seamless transfer of the product brands and employees associated with these businesses.

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Opinion: Listen: Putting an end to a racist ‘diagnosis’

STAT

The term “excited delirium” has been used for years by law enforcement and other first responders, including health care workers, to describe people who exhibit behavior that is considered “out of control.” This diagnosis has been applied again and again, even posthumously, as a justification for extreme, and sometimes deadly, interventions by law enforcement.

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Lupin launches Rocuronium Bromide Injection in US

Express Pharma

Lupin announced the launch of Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials, after Lupin’s alliance partner Caplin Steriles (Caplin) received an approval for its ANDA from the United States Food and Drug Administration (US FDA). Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials is the generic version of Zemuron Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA and is indicated for inpati

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BioMarin’s new CEO inherits a profitable company, a pioneering gene therapy, and a brewing activist challenge

STAT

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 close look at an en-vogue idea in oncology, an awkward welcome for a new CEO, and a twist on the classic drug pricing backlash.

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Oligonucleotides: The Next Therapeutic Wave on the Market? (AAPS PharmSci 360)

PharmaTech

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation, considers that status of oligonucleotides on the market.

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STAT+: Pharmalittle: FTC challenges ‘inaccurately or improperly’ listed patents; Elliott builds stake in BioMarin

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is coconut rum — and get started. To help you along, we have assembled another laundry list of items of interest for you to peruse.

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Rapid HPLC method could improve formulation QC studies

European Pharmaceutical Review

A paper published by Research Square has described a rapid, simple, accurate and precise high-performance liquid chromatography with diode-array detection (HPLC-DAD) method for levofloxacin determination in liquid pharmaceutical formulations. The effectiveness of levofloxacin can be impacted by its stability in pharmaceutical formulations. This impacts the effective concentration of the drug, Mohammed et al. noted.

Dosage 92
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Myasthenia gravis market to generate sales of $6.7 bn across 7MM by 2032: GlobalData

Express Pharma

The market for myasthenia gravis (MG), an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue, is set to experience a compound annual growth rate (CARG) of 8.3 per cent across the seven major markets (7MM*) from $3 billion in 2022 to $6.7 billion in 2032, forecasts GlobalData. GlobalData’s latest report, “Myasthenia Gravis: Opportunity Assessment and Forecast,” identified the influx of several new disease-modifying therapies (DMTs) within the past two years as th

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Innovative insomnia study aims to overcome major clinical trial bottleneck

European Pharmaceutical Review

For UK patients with severe insomnia, for whom existing therapies have not worked, a new, decentralised clinical trial is set to evaluate chloral hydrate as a short-term treatment. Evaluating chloral hydrate for insomnia While chloral hydrate is already an established treatment for insomnia, much of the published clinical data in adult patients is dated, according to clinical trials company Lindus Health and global lifecycle management healthcare company Pharmanovia.

Dosage 91
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Major issues in clinical research addressed by AI-powered community

Outsourcing Pharma

myTrialsConnect, a research community powered by artificial intelligence (AI) has been launched following a partnership between Elligo Health Research and Avallano.

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Access Insights 2023: Biosimilars, Specialty Generics’ Impact on Sites of Care

Pharmaceutical Commerce

Session explores how on-market products have done, and what to expect from new biosimilars.

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Paywalls threaten healthcare professional engagement on social media

pharmaphorum

Paywalls threaten healthcare professional engagement on social media Mike.

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Immunotherapy plus an investigational cancer drug improves anti-tumor effects

World Pharma News

An investigational therapy for solid tumors could be especially effective when combined with immunotherapy to target a specific kind of cancer cell, a research team at Duke and Harvard have found. Led by Lee Zou, Ph.D., chair of Duke’s Department of Pharmacology & Cancer Biology, the researchers focused on the way some cancer cells impede normal DNA repair to fuel tumor formation.

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To Build AI Maturity, Start With Quick Wins

PharmExec

Companies must determine the right ways to utilize AI.

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Biogen says growth is coming, but won’t specify when

BioPharma Dive

CEO Chris Viehbacher said the company has “the elements to think about a return to topline growth.” Yet, that goal hinges on the successful commercialization of multiple new products.

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