August, 2024

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Pfizer joins Lilly in direct-to-consumer drive

pharmaphorum

Pfizer has become the latest big pharma group to launch a web-based platform that opens up a direct-to-consumer channel for medicines access.This morning, the company announced the launch in the US of PfizerForAll, a digital platform that it says provides access to same-day appointments with healthcare professionals – in-person or via a $35 telehealth visit – along with home delivery of medicines and diagnostics, vaccination appointments, and payment support.

Medicine 115
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BioNTech posts €808M loss as company continues to come to grips with seasonal COVID vaccine market

Fierce Pharma

While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.

Marketing 341
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How Often Do LLMs Hallucinate When Producing Medical Summaries?

MedCity News

Researchers at the University of Massachusetts Amherst released a paper this week showing that large language models tend to hallucinate quite a bit when producing medical summaries. The post How Often Do LLMs Hallucinate When Producing Medical Summaries? appeared first on MedCity News.

Medical 142
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Study reveals AI insights can predict development of disease a decade in advance

PharmaTimes

The study predicted the development of conditions including Alzheimer’s and heart disease

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AI in Marketing & Sales: Today’s Tools, Tomorrow’s Potential

Speaker: Kevin Burke

AI is reshaping marketing and sales, empowering professionals to work smarter, faster, and more effectively. This webinar will provide a practical introduction to AI, focusing on its current applications, transformative potential, and strategies for successful implementation in your organization. Using real-world examples and actionable insights, we’ll examine how businesses are leveraging AI to increase efficiency, enhance personalization, and drive measurable results.

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After an FDA rejection, here’s what’s next in the psychedelics pipeline

PharmaVoice

By rejecting the first MDMA therapy earlier this month, the FDA signaled to the psychedelic drug sector that the road to approval isn’t clear cut.

FDA 134
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AstraZeneca investment to increase biologic capacity in Sweden

European Pharmaceutical Review

AstraZeneca has announced the largest single investment in its Sweden Biomanufacturing Center in Södertälje, since the facility opened in 2021. The additional $135 million investment will increase the biopharmaceutical facility area by 50 percent. An existing building within AstraZeneca in Södertälje is set to be expanded by 2,700m 2 , the company explained.

Medicine 115

More Trending

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FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor

Fierce Pharma

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

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‘Great on Paper’: Why Primary Care Physicians Are Reluctant To Join Value-Based Care

MedCity News

Many primary care physicians are not participating in value-based payment models. A new study details why and potential solutions. The post ‘Great on Paper’: Why Primary Care Physicians Are Reluctant To Join Value-Based Care appeared first on MedCity News.

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New drug trial to investigate treatment for patients with bronchiectasis

PharmaTimes

200,000 people in the UK have what is considered a ‘hidden’ lung condition

Patients 126
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BMS’ KarXT nears schizophrenia approval, but AbbVie and others wait in the wings

PharmaVoice

With fewer side effects, the new wave of upcoming drugs could improve patient adherence, and the competition for a large projected market is getting fierce.

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5 Ways You Can Win Faster with Gen AI in Sales

Incorporating generative AI (gen AI) into your sales process can speed up your wins through improved efficiency, personalized customer interactions, and better informed decision- making. Gen AI is a game changer for busy salespeople and can reduce time-consuming tasks, such as customer research, note-taking, and writing emails, and provide insightful data analysis and recommendations.

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Novartis and Viatris sued by estate of Henrietta Lacks, whose cells were extracted for research in 1951

Fierce Pharma

The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.

Medical 330
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Bavarian Nordic scores $157M contract to replenish US supplies of smallpox/mpox vaccine Jynneos

Fierce Pharma

Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. | The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” Jynneos vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox.

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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

Safety 320
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Servier snags FDA approval for Voranigo, the 1st targeted therapy for a common type of brain tumor

Fierce Pharma

Servier has expanded its IDH drug armamentarium with the FDA approval for an IDH1/2 dual inhibitor. | Servier's Voranigo, or vorasidenib, is now the first systemic therapy for low-grade IDH-mutant brain cancer.

FDA 315
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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Eli Lilly rolls out direct patient access to weight loss star Zepbound—at a deep discount

Fierce Pharma

Eli Lilly has come up with a new way of supplying its popular weight-loss drug Zepbound that the company hopes could expand access while addressing other issues such as high prices and off-label co | Eli Lilly is offering its popular weight-loss drug Zepbound directly to consumers at a discount through its own online pharmacy. The company hopes the move could expand access while addressing other issues such as high prices and off-label cosmetic usage.

Patients 298
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With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time

Fierce Pharma

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

FDA 297
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As Novavax comes full circle, it's 'actively exploring' sale of Czech manufacturing plant

Fierce Pharma

It was 2020 and Maryland biotech Novavax was thinking big. It had a plan to become a COVID vaccine powerhouse, with enough manufacturing capacity to supply the U.S. | As Novavax presented its quarterly earnings, finance chief Jim Kelly said the company was “actively exploring” the sale of its manufacturing facility in the Czech Republic. Novavax purchased the site in May of 2020 for $167 million with the intent of it producing more than 1 billion doses annually there.

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To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

Fierce Pharma

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.

FDA 294
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Bayer layoffs hit Switzerland with 150 cuts at Basel consumer health hub: reports

Fierce Pharma

Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.

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Vertex lifts sales guidance as launch of gene therapy Casgevy picks up steam

Fierce Pharma

As growth in Vertex's cystic fibrosis portfolio buoys the company amid the launch of gene therapy Casgevy, the company is feeling confident enough to boost its revenue outlook for the year. | As of mid-July, around 20 patients completed the first step of Casgevy treatment by having their cells collected, up from five patients during the first quarter.

Sales 291
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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. | As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

Biopharma 289
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Pfizer to create 500 new jobs as it upgrades Australia manufacturing plant to help fight antimicrobial resistance

Fierce Pharma

Warning of a "silent pandemic" spreading across the globe, Pfizer is taking the fight against antimicrobial resistance (AMR) Down Under. | Pfizer announced Tuesday that it has invested 150 million Australian dollars (about $98 million) to build a new manufacturing facility at its Australian site in Melbourne, where the company will help produce new antimicrobial treatments aimed at addressing the rising tide of antimicrobial resistance.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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SCOTUS overturn of Chevron doctrine opens a Pandora's box for biopharma industry, expert says

Fierce Pharma

For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of federal agencies. | In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services.

Biopharma 280
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J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Fierce Pharma

Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.

Biopharma 280
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Lilly adds to tirzepatide's impressive pedigree with new data showing the med helps stave off diabetes

Fierce Pharma

Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show. | Already wildly popular in type 2 diabetes and obesity, Eli Lilly’s tirzepatide can help prevent one of the very diseases it’s meant to treat, new data show.

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Bristol Myers telegraphs layoffs in New Jersey, trimming 117 jobs in staggered wave of cuts

Fierce Pharma

Bristol Myers Squibb, while working its way through a major restructuring, has unveiled another round of layoffs in New Jersey. | Bristol Myers Squibb, while working its way through a major restructuring, has unveiled another round of layoffs in its home state of New Jersey.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

Fierce Pharma

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.

FDA 273
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Novo rekindles heart failure hopes for semaglutide with new pooled analysis

Fierce Pharma

After a regulatory hiccup earlier this month, Novo Nordisk’s heart failure ambitions for its obesity star Wegovy (semaglutide) are starting to get back on track. | Novo’s semaglutide cut the risk of combined cardiovascular death or worsening heart failure events by 31%, based on an incident rate of 5.4% in semaglutide patients versus 7.5% in those on placebo, the company said Friday.

Patients 272
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Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

Fierce Pharma

Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

FDA 271
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Purdue, after playing major role in US opioid epidemic, wins FDA nod for overdose-reversal injection

Fierce Pharma

As Purdue Pharma attempts to restore its image following its role in | As Purdue Pharma attempts to restore its image following its role in the U.S. opioid crisis, the Connecticut-based company has scored a win with a green light for a new overdose rescue treatment.

Pharma 271
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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.