Fri.May 03, 2024

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CG follows big IPO with new results for bladder cancer drug

Bio Pharma Dive

Newly disclosed Phase 3 results presented Friday match findings the biotech disclosed last year, while offering a more comprehensive look at how its drug stacks up to rival therapies.

Drugs 313
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FDA grants RMAT designation to Taysha’s Rett syndrome gene therapy 

Pharmaceutical Technology

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

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Amgen shares soar as executives outline obesity drug push

Bio Pharma Dive

The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.

Drugs 295
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Angle signs AstraZeneca deal to develop prostate cancer assay

Pharmaceutical Technology

UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.

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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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Why selling to Novartis made sense for Mariana

Bio Pharma Dive

Conversations at this year's J.P. Morgan Healthcare Conference led to a $1 billion buyout that Mariana's CEO described as a "perfect marriage.

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Moderna reports $1.2bn net loss in Q1 2024

Pharmaceutical Technology

Moderna reported a net loss of $1.2bn in the first quarter (Q1) of 2024, a stark contrast to its net income of $79m in Q1 2023.

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More Trending

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Amgen reports a 22% increase in Q1 2024 net revenues

Pharmaceutical Technology

Amgen announced updates in the obesity space, with topline data for MariTide expected in late 2024.

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Boehringer will use Walgreens trials unit for obesity trial

pharmaphorum

Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim

Trials 133
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NHS to provide Pfizer’s Voxelotor to treat sickle cell disease

Pharmaceutical Technology

The NHS in the UK has announced plans to offer Pfizer's Voxelotor (Oxbryta), a new treatment option for sickle cell disease.

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International phase 3 clinical trial for new melanoma treatment recruits first patients

Pharma Times

The INTerpath-001 trial is evaluating Moderna/Merck’s mRNA-4157 in combination with Merck’s Keytruda

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

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ESCMID 2024: Advances in drug resistance testing

Pharmaceutical Technology

Techniques such as rapid nanomotion-based susceptibility testing, and MALDI-TOF-MS could be used to identify resistance mechanisms of several deadly organisms.

Drugs 147
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Apple gets FDA okay to use AFib tool in clinical trials

pharmaphorum

Apple gets FDA okay to use the atrial fibrillation history tool incorporated in some of its Apple Watch devices in clinical trials

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Lexicon plans another bid for Zynquista in type 1 diabetes

Pharmaceutical Technology

Despite failing to get an approval for type 1 diabetes in 2019, Lexicon plans to resubmit its NDA to the FDA by mid-2024.

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Cambridge researchers develop robotic nerve devices for neurological conditions

Pharma Times

Neurological disorders, such as epilepsy or chronic pain, affect over three billion people worldwide

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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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Optimisation in operations: from theory to practice

Pharmaceutical Technology

Operations managers get the longest-term value from technology by letting it work for them step-by-step, as a sustainable optimiser

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Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'

Fierce Pharma

Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. | Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. Federal Trade Commission has teed up a further extension on the deal’s review period.

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BridgeBio Oncology Therapeutics launches with $200m funding

Pharmaceutical Technology

BridgeBio Pharma has announced the launch of BridgeBio Oncology Therapeutics (BBOT), underpinned by $200m of private external capital.

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Price cut unlocks NHS use of sickle cell drug Oxbryta

pharmaphorum

Some NHS patients in the UK will finally be able to access Pfizer’s sickle cell disease therapy Oxbryta after agreement was reached on a price cut

Drugs 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ImmunityBio partners with Serum Institute for BCG vaccines

Pharmaceutical Technology

ImmunityBio has entered a worldwide agreement with the Serum Institute of India to secure a supply of BCG vaccine for all cancer types.

Vaccine 130
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Amgen's new Horizon products bolster top line despite continued Tepezza struggles

Fierce Pharma

During the Q&A portion of Amgen’s quarterly conference call Thursday, eight of the first nine questions were about the company’s investigational efforts in obesity. | The buzz about Amgen’s obesity prospects overshadowed the company’s solid work on the top line as revenue came in at $7.4 billion for a 22% increase. Much of the boost can be attributed to sales of products acquired in Amgen’s $27.8 billion buyout of Horizon Therapeutics, which was completed early in the fourth quarter of last

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Healthcare AI from Cera ‘could save NHS and UK £1bn a year’

pharmaphorum

AI-powered home healthcare model from Cera could save NHS and UK £1bn in 2026 if adopted nationwide, says new study

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Leo Pharma prepares to come for the topical JAK market as Incyte's Opzelura cream launch cools off

Fierce Pharma

Watch out, Incyte. Leo Pharma and its JAK inhibitor cream delgocitinib are coming to disrupt the topical atopic dermatitis market, currently inhibited by Incyte’s approved Opzelura. | Leo Pharma's delgocitinib, which the company calls a potential growth driver, could shake up the topical JAK market and put pressure on Incyte's approved Opzelura.

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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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Breaking down the challenges of donor recruitment and recallability

pharmaphorum

Donor recruitment and recallability remain key challenges for the disease research community. This post breaks down strategies to engage more healthy donors and boost recall rates.

Research 108
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GSK defends itself—again—after senator argues it withdrew popular asthma med to dodge price caps and Medicaid rebates

Fierce Pharma

GSK defends itself—again—after senator argues it withdrew popular asthma med to dodge price caps and Medicaid rebates fkansteiner Fri, 05/03/2024 - 09:54

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Pharma Pulse 5/3/24: Compounded, Counterfeit Semaglutide Poses Severe Risk to Patients, Thermo Fisher Scientific Launches New Testing Service & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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How Common Is Salmonella in Chicken? New USDA Regulations Target Frozen Products

XTalks

How common is Salmonella in chicken? This question becomes crucial as the US Department of Agriculture (USDA) mandates lower Salmonella levels in certain frozen chicken items. To combat food poisoning, US agriculture officials introduced a final rule last Friday, mandating significant reductions in Salmonella bacteria in specific chicken products. Starting in 2025, high levels of Salmonella in frozen breaded and stuffed chicken products will classify them as adulterated.

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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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Drugs facing the most patent expirations this year

Drug Patent Watch

Expiring drug patents are continuously driving innovation, as branded firms seek out new high-margin opportunities.

Drugs 59
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Velocity’s Hallandale Beach Site Earns Merck’s Significant Contribution to Clinical Trials Award

Velocity Clinical Research

Merck recently presented Velocity’s Hallandale Beach site with the Significant Contribution to Clinical Trials Award, specifically for being the top enroller of diverse participants in cardiovascular clinical trials in 2023. We’re grateful for the contributions of our Hallandale Beach site toward improving diversity in clinical trials, both in the workforce and in our participants.

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New patent expiration for APGDI drug MYRBETRIQ GRANULES

Drug Patent Watch

Annual Drug Patent Expirations for MYRBETRIQ+GRANULES Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier.

Drugs 59
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Real Chemistry Introduces IRIS, an Information Hub for All Things GLP-1 Drugs

XTalks

Healthcare company Real Chemistry announced its introduction of IRIS, an insights-as-a-service platform that will deliver all things related to GLP-1 drugs. This includes news on the obesity market, the latest info on current and future GLP-1 drugs and the overall growing influence of GLP-1 therapies. Real Chemistry provides AI-driven insights, marketing and communications for the healthcare industry.

Drugs 52
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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.