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.

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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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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.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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More Trending

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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.

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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

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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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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.

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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

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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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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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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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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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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.

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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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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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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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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.

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Astellas, Poseida Therapeutics Ink Allogeneic Cell Therapy Agreement

Pharmaceutical Commerce

Collaboration will be oncology based—centered around allogeneic CAR-T cell therapy product candidates—and will provide Poseida with up to $550 million if certain milestones are met.

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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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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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$75m in funding to develop tenosynovial giant cell tumour mAb 

Drug Discovery World

SynOx Therapeutics has closed a $75m Series B financing round, which will be used to generate registrational Phase III clinical and CMC data for emactuzumab, the company’s potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of tenosynovial giant cell tumour (TGCT). TGCT is a type of tumour that affects the soft tissue lining of joints and tendons and is a highly debilitating disease often impacting large, important joints such as the knee, hip and ankle.

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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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ExoXpert partners with Neucore Bio for advanced exosome loading 

Drug Discovery World

ExoXpert has partnered with Neucore Bio to leverage ExoXpert’s platform for evaluation of advanced exosome loading. Under the agreement, ExoXpert will test and optimise efficient loading of proprietary payloads into exosomes as part of Neucore’s Fibroblast EV Engineering (FiXE(R)) discovery platform. “This collaboration is an important step in the loading validation and application of our FiXE platform using advanced, non-viral exosomes for therapeutic delivery,” said Dr Kenneth

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Teva and Alvotech Further Strengthen Their Relationship, Reach Biosimilar Commercialization Deal

Pharmaceutical Commerce

Per the US strategic partnership agreement, the adalimumab high-concentration interchangeable biosimilar will be distributed under the Quallent Pharmaceuticals private label.

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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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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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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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