Thu.Aug 01, 2024

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Lilly obesity drug shows heart benefit in late-stage trial

Bio Pharma Dive

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

Drugs 311
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NICE recommends BeiGene’s MZL tablet for NHS use

Pharmaceutical Technology

The UK NICE has recommended BeiGene’s Zanubrutinib for marginal zone lymphoma (MZL) for use on the National Health Service (NHS).

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Moderna shares fall amid lower sales outlook for RSV, COVID shots

Bio Pharma Dive

The biotech cited competitive pressure and “very low” expected sales in Europe for its latest guidance cut, which sent shares down by nearly 20%.

Sales 303
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Otsuka snaps up Jnana with its phenylketonuria drug for $800m

Pharmaceutical Technology

The acquisition is expected to conclude in Q3 this year and will see Otsuka adding Jnana’s phenylketonuria therapy to its portfolio.

Drugs 246
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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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UniQure restructuring to claim 300 jobs

Bio Pharma Dive

The job cuts affects 65% of UniQure’s workforce and include the gene therapy developer’s recent sale of a manufacturing plant to Genezen.

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Takeda’s revenue climbs by 14.1% in Q1 FY2024

Pharmaceutical Technology

Takeda has reported a revenue of Y1,208bn for Q1 FY2024, a 14.1% increase from Y1,058bn in the corresponding period of FY2023.

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More Trending

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Valneva and LimmaTech partner for shigellosis vaccine development

Pharmaceutical Technology

Valneva and LimmaTech have signed a deal to potentially develop the first marketed shigellosis vaccine.

Vaccine 246
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Cigna CEO promises ‘aggressive’ defense of pharmacy benefit managers

Bio Pharma Dive

David Cordani’s comments to investors Thursday come as the payer blew past Wall Street’s expectations for the second quarter, helped by significant growth in its health services division — including PBM Express Scripts.

Pharmacy 221
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Indian life sciences sector integrating technologies in R&D efforts

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian life sciences sector is making strides by integrating quantum computing, artificial intelligence (AI), machine learning (ML), advanced analytics, big data, internet of things (IoT) and blockchain into their research and development efforts.

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Jim Wilson, prominent gene therapy researcher, to depart UPenn

Bio Pharma Dive

Wilson, who founded UPenn’s gene therapy program three decades ago, will step down to start two new spinouts, Gemma Bio and Franklin Biolabs.

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

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Study finds ovarian cancer-treated women less likely to develop breast cancer

Pharma Times

Combined, ovarian and breast cancer affect over 60,000 women in the UK every year

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As sales climb, Biogen ‘convinced’ the worst is over for Leqembi

Bio Pharma Dive

On a call with reporters, CEO Chris Viehbacher pointed to trends showing the Alzheimer’s drug is “on the right path” to becoming the lucrative product the company envisioned.

Sales 189
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HilleVax slashes workforce by 40% after norovirus vaccine trial failure

Pharmaceutical Technology

HilleVax’s norovirus vaccine HIL-214 failed to meet key endpoints in its Phase IIb trial in infants prompting the company to let go of 41 employees.

Vaccine 130
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Otsuka buys startup Jnana, adding to uptick in private biotech M&A

Bio Pharma Dive

The $800 million deal hands Otsuka a drug that’s shown promise in early testing in phenylketonuria, and is the fourth buyout of a privately held biotech in the last two weeks alone.

Drugs 140
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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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AAIC 2024: MCI patient reflects on Leqembi trial experience

Pharmaceutical Technology

During a session at the 2024 Alzheimer’s Association International Conference (AAIC), which concludes today, Ralph Carmona shared his experience of being diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease.

Trials 130
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Another IRA lawsuit bites the dust with ruling on Novo Nordisk case; company pledges to appeal

Fierce Pharma

Like clockwork, another lawsuit challenging the constitutionality of the Inflation Reduction Act's (IRA's) price-setting measures has been shot down in the courts. | The ruling from the New Jersey federal court marks the latest in a string of rejections as various drugmakers have taken to the courts to fight the drug pricing legislation.

Drugs 122
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AAIC 2024: Eisai presents positive long-term data with Leqembi

Pharmaceutical Technology

Patients treated with Leqembi over three years have demonstrated a slowing of Alzheimer’s disease progression.

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Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in Asia

Fierce Pharma

Like many other biopharma companies, Kyowa Kirin is in restructuring mode. | Kyowa Kirin is planning “a significant reduction” in its small molecule drug discovery research activities and will trim certain manufacturing roles. The company is also divesting its Chinese operations as part of a larger restructuring in the Asia-Pacific region.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AbCellera and Lilly broadens antibody discovery partnership

Pharmaceutical Technology

AbCellera Biologics has broadened its partnership with Eli Lilly to discover therapeutic antibodies for various diseases.

Antibody 130
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Changing Faces: May and June 2024 supplier and digital hires

pharmaphorum

Changing Faces announces new supplier and digital hires for May and June 2024, including AxoSim, ERS Genomics, Newcells Biotech, SHINE Technologies and more. Stay updated with the latest industry developments.

Genome 115
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Molecure and Avicenna link to develop cancer drugs

Pharmaceutical Technology

Molecure has announced a research partnership with Avicenna Biosciences to advance drugs targeting USP7 for treating cancer.

Drugs 130
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After series of patent lawsuits, Novartis doubles down in Entresto defense with FDA complaint

Fierce Pharma

Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.” | Novartis has filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories.

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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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Understanding ICH Guideline Q14

Pharmaceutical Technology

Q14 is a new guideline detailing the elements of minimal and enhanced approaches for analytical procedure development. While the traditional minimal development approach remains valid, the advanced approach employing QbD principles requires additional development data and knowledge.

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Bayer files first application of menopause drug elinzanetant

pharmaphorum

Bayer files elinzanetant as a non-hormonal treatment for menopausal symptoms, with Astellas' first-to-market Veozah in its sights

Hormones 115
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NHS Scotland, AZ and Scottish universities partner for kidney health research

Pharma Times

The collaboration aims to develop new medicines to reduce chronic kidney disease in Scotland

Research 115
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Changing Faces – Pharma and biotech May and June 2024

pharmaphorum

Stay updated on the latest hiring news and developments from Pfizer, Lilly, Gilead, Epsilogen, and other pharma and biotech companies in May and June 2024 with Changing Faces.

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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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Eli Lilly, after tirzepatide's late-stage cardio win, plots regulatory filings this year

Fierce Pharma

Eli Lilly, after tirzepatide's late-stage cardio win, plots regulatory filings this year esagonowsky Thu, 08/01/2024 - 09:40

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Going beyond the hype: Embracing AI for strategic advantage

pharmaphorum

Discover how AI is revolutionising the medical and pharmaceutical industries. Learn how to leverage AI for strategic advantage and stay ahead of the competition in this insightful article.

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Moderna takes axe to '24 sales guidance, sending shares lower

Fierce Pharma

The post-pandemic period has posed serious challenges for financial forecasters at the top mRNA vaccine makers, as evidenced by Pfizer's

Sales 111
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South Africa's HIV Research: Unlocking the mysteries of elite controllers

pharmaphorum

South Africa occupies a pivotal position in the global battle against HIV. As of 2022, it is home to around 7.8 million individuals living with HIV, representing the largest HIV burden in the world. However, it is this very challenge that has placed South Africa at the leading edge of innovative HIV research, with potential ramifications for the millions affected by the disease globally - and that starts with elite controllers.

Research 114
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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.