Tue.Oct 08, 2024

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GSK says RSV vaccine protects against disease over three seasons

Bio Pharma Dive

Cumulatively, data showed the shot to be 63% effective across the three-year period. However, efficacy appeared to wane and GSK said it expects revaccination will eventually be needed.

Vaccine 162
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Boehringer kickstarts two Phase III trials as MASH therapy wins breakthrough status

Pharmaceutical Technology

The Phase III trials will evaluate survodutide in metabolic dysfunction-associated steatohepatitis (MASH), fibrosis and cirrhosis.

Trials 246
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Startup led by John Maraganore raises $135M to build ‘future of RNAi’

Bio Pharma Dive

“The time to re-enter the RNAi revolution is now,” said Robert Nelso=en, the managing director of Arch, which led the Series A funding round for City Therapeutics.

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Bayer and MOMA Therapeutics partner for oncology programme

Pharmaceutical Technology

Bayer has entered a collaboration with MOMA Therapeutics in which the two companies will advance a small molecule oncology programme.

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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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Sage continues downslide as Alzheimer’s study fails

Bio Pharma Dive

After a series of setbacks for dalzanemdor, some analysts now expect that Sage won’t reach profitability for awhile — and only if its cost structure undergoes significant changes.

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Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list

Fierce Pharma

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products.

Pharmacy 130

More Trending

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October 8, 2024: HCSRN Calls for Abstracts and Panel Presentations for 2025 Annual Conference

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel proposals for its 2025 Annual Conference until December 9, 2024. This year’s meeting will be held in St. Louis, Missouri, from April 8 to 10, 2025. Information about conference registration, preconference workshops, and accommodations is also available. Early-bird registration is open through February 21.

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Amgen and MediLink to collaborate on SCLC combination therapy

Pharmaceutical Technology

The companies will collaborate to hold a global Phase I combination trial of YL201 and Amgen’s Imdelltra for small cell lung cancer.

Trials 130
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Kyowa Kirin announces positive interim data for lymphoma treatment

Pharma Times

Real-world studies show effectiveness of mogamulizumab in routine practice

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“Strategic market positioning” needed for Ebglyss to rival Dupixent in atopic dermatitis

Pharmaceutical Technology

Less frequent dosing could provide Eli Lilly’s Ebglyss room to rival Sanofi and Regeneron’s blockbuster Dupixent.

Marketing 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pfizer, bracing for Hurricane Milton, pledges aid to emergency services and health support

Fierce Pharma

Editor's Note: Is your company bracing for Milton or working to provide aid in anticipation of the storm? | Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Hurricane Milton touches down this week.

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MHRA puts technology in the spotlight in 2024/25 business plan

Pharmaceutical Technology

The MHRA’s 2024/25 business plan focuses on improving service delivery for its customers, enabling access to new technologies.

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AI in Action: Accelerating the Drug Discovery Pipeline

Drug Patent Watch

A recent study published in Drug Discovery Today highlights the potential of artificial intelligence (AI) in revolutionizing drug discovery and development processes[1]. The research, conducted by a team from the University of Cambridge and AstraZeneca, explores how AI can be leveraged to enhance various aspects of pharmaceutical research, from target identification to clinical trials.

Drugs 123
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ViiV Healthcare to increase annual supply of long-acting HIV PrEP

Pharmaceutical Technology

ViiV Healthcare has announced plans to triple annual supply of long-acting cabotegravir for HIV PrEP to at least two million doses.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Unpacking EASD 2024: Key themes, topics, and influencers

pharmaphorum

Stay updated on the latest insights from EASD 2024 with a comprehensive breakdown of key themes, topics, and influencers. Learn more about the essential information you need to know.

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Innovent and ASK Pharm to commercialise limertinib for lung cancer

Pharmaceutical Technology

Innovent Biologics and ASK Pharm have signed a strategic partnership for the commercialisation of limertinib for the treatment of lung cancer.

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Merck's Keytruda stages comeback in head and neck cancer with trial win in earlier-stage disease

Fierce Pharma

Merck & Co. hopes a new positive trial readout can return Keytruda to glory in head and neck cancer. | Merck & Co. hopes a new positive readout can return Keytruda to glory in head and neck cancer about two years after a prior failure.

Trials 122
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Collaboration is critical to the future of healthcare, and events are the key to unlocking it

pharmaphorum

Collaboration is essential for the future of healthcare, and events play a pivotal role in fostering it. Learn how collaboration can drive innovation in healthcare through impactful events.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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GSK touts 3-year data on RSV shot Arexvy after CDC's narrower usage recommendation

Fierce Pharma

While recent CDC guidance threatens to shrink the market for a new class of immunizations, GSK continues to build the case for its first-to-market respiratory syncytial virus (RSV) shot Arexvy. | GSK on Tuesday unveiled fresh data from the late-stage AReSVi-006 study of Arexvy in RSV-triggered lower respiratory tract disease in older adults over the span of three full RSV seasons.

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Weight loss gold rush: Developers vie for next blockbuster treatment

pharmaphorum

Discover the latest advancements in weight loss treatments as developers race to create the next blockbuster solution. Stay informed about the cutting-edge options available.

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Astellas and AviadoBio announce exclusive gene therapy deal

Pharma Times

AviadoBio to receive up to £1.

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How pharma companies can build mutually beneficial relationships with biotech and digital health start-ups

pharmaphorum

How pharma companies can build mutually beneficial relationships with biotech and digital health start-ups Mike.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Popular proposals would result in no reductions, or modest reductions, in 2031 prices: CBO

Fierce Pharma

With the U.S. | The Congressional Budget Office found that only one out of the seven policies it reviewed would create notable reductions in prices. Still, that approach could affect market dynamics outside the U.S.

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NICE turns down Takeda colorectal cancer drug

pharmaphorum

Takeda's recently approved advanced colorectal cancer therapy Fruzaqla has been rejected by NICE for use by the NHS in draft guidance

Drugs 111
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The discovery of microRNA is awarded with the 2024 Nobel prize in medicine

BioPharma Reporter

This yearâs Nobel prize in physiology or medicine has been awarded to Victor Ambros and Gary Ruvkun for their groundbreaking research on microRNA.

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Scholar Rock preps filings after SMA antibody clears trial

pharmaphorum

Shares in Scholar Rock have gone into overdrive after the biotech reported positive phase 3 results with apitegromab in patients with spinal muscular atrophy (SMA), setting up regulatory filings in early 2025.The stock rocketed 362% after the announcement, taking Scholar Rock's market cap above $2.7 billion, as analysts started to talk about a blockbuster sales opportunity for the selective myostatin inhibitor.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Small molecules in focus as Recipharm bolsters global production facilities

Outsourcing Pharma

Months after divesting seven European sites, the Swedish contract development and manufacturing organisation (CDMO) Recipharm is expanding its manufacturing capacity with undisclosed investments in its small molecule offerings.

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Biogen, Talkiatry team up on postpartum depression

pharmaphorum

Biogen teams up with Talkiatry on telehealth programme for postpartum depression that could help drive sales of Zurzuvae

Sales 111
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Preparing for the US Biosecure Act - what does it mean for the pharma industry?

BioPharma Reporter

The US Biosecure Act was passed by the House of Representatives in September and seems likely to become law.

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Astellas places $2bn+ bet on AviadoBio dementia gene therapy

pharmaphorum

Astellas adds a gene therapy for frontotemporal dementia to its pipeline, via a $2.2bn+ option deal with UK biotech AviadoBio.

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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.