Fri.Sep 27, 2024

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Womein in Science - engineering life’s mysteries: Joaquima Guix Salichs’ journey

Outsourcing Pharma

Joaquima Guix Salichs is the director of engineering and extraction technology at Bioiberica, where she leads a team of scientists focused on advancing extraction methods and solving large-scale industrial challenges.

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FDA, after delay, clears Regeneron and Sanofi drug for COPD

Bio Pharma Dive

Dupixent is the first biologic medicine approved in the U.S. for the lung condition, though competitors from GSK, AstraZeneca and Roche could follow.

Medicine 306
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UNICEF secures one million mpox vaccines for Africa

Pharmaceutical Technology

Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.

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J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers

Bio Pharma Dive

New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug data and Biogen ended a Sage collaboration.

Drugs 222
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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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BMS wins approval for schizophrenia drug acquired from Karuna

Pharmaceutical Technology

The FDA has approved the first treatment for schizophrenia that targets cholinergic receptors rather than dopamine receptors.

Drugs 246
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From PDURS to D2C, Frontiers Health speaks to cutting edge healthcare news

pharmaphorum

Stay up to date on cutting edge healthcare news, from PDURS to D2C, with Frontiers Health. Explore the latest in digital health trends and innovations.

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More Trending

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World leaders seek 10% cut in antibiotic resistance deaths

pharmaphorum

World leaders seek 10% cut in antibiotic resistance deaths Phil.

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Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market following FDA approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market.

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SEC charges Cassava over 'misleading' Alzheimer's claims

pharmaphorum

Cassava Sciences will pay $40m to settle SEC charges that it made misleading claims about a phase 2b study of Alzheimer's candidate simufilam.

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Tempus AI expands oncology collaboration with Takeda

Pharmaceutical Technology

Tempus AI has announced an expanded collaboration with Takeda to enhance oncology research and development.

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

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Could GenAI auto-generate entire regulatory dossiers?

pharmaphorum

Discover how GenAI leverages cutting-edge technology to automate the generation of regulatory dossiers, saving time and resources for your organization. Explore how GenAI can streamline the process and enhance efficiency.

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Compounding pharmacies caught in counterfeit controversy

Pharmaceutical Technology

Customised medication providers come under scrutiny as weight management copycat drugs raise safety concerns.

Pharmacy 147
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Pruritus in PBC: Understanding its impact and the need for raising awareness

pharmaphorum

Pruritus, or itching, is a common symptom of Primary Biliary Cholangitis (PBC). Learn more about its impact and the importance of raising awareness about this condition.

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FDA greenlights Regeneron’s Dupixent for the treatment of COPD

Pharmaceutical Technology

With an approval based on two pivotal Phase III studies, Dupixent is now the first-ever biologic indicated for treating COPD.

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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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Sanofi's Dupixent scores double COPD win in US, China

pharmaphorum

Sanofi's Dupixent scores double COPD win in US, China Jonah.

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Biomea’s stock bounces back as FDA lifts clinical hold on diabetes trials

Pharmaceutical Technology

The US FDA placed a full clinical hold on two diabetes trials for Biomea’s menin inhibitor after reports of liver toxicity.

Trials 130
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Pfizer Removes Sickle Cell Med Oxbryta from Markets

XTalks

In a news release published yesterday, Pfizer announced it will voluntarily withdraw its sickle cell disease (SCD) therapy Oxbryta (voxelotor) from all markets worldwide. The company said it is also discontinuing all active clinical trials for voxelotor and expanded access programs around the world. Pfizer explained that it made its decision based on a full review of clinical data that indicates the “overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient popu

Marketing 105
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Direct-to-patient communication: Bridging the gap in medication adherence

Pharmaceutical Technology

Direct-to-patient communication is emerging as a powerful solution to the challenges of non-adherence to medication. By leveraging innovative technology, patients can receive personalised reminders, educational content, and support.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BMS ends decades-long drought in novel schizophrenia drugs

pharmaphorum

BMS' acquisition of Karuna looks set to pay off after it gets FDA approval for the schizophrenia drug at the heart of the $14bn takeover

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Physicians highlight need for improved non-opioid treatments for opioid use disorder

Pharmaceutical Technology

Opioid use disorder (OUD) is a chronic neurological disorder characterised by the compulsive, repeated use of opioids, leading to prolonged self-administration.

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Bavarian Nordic nets large mpox vaccine supply pact, boosts revenue outlook after string of deals

Fierce Pharma

In the latest of several recent mpox vaccine supply deals, Bavarian Nordic plans to provide 1 million doses of its shot, Jynneos, to affected African countries through an agreement with UNICEF. | The agreement is the latest in a string of mpox vaccine supply deals that have come in response to the ongoing outbreak in Africa.

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Phare Bio receives ARPA-H funds for AI drug discovery platform

Pharmaceutical Technology

Phare Bio has received up to $27m from the Advanced Research Projects Agency for Health (ARPA-H) to advance its drug discovery platform

Drugs 130
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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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Roche's PNH drug PiaSky backed for NHS use by NICE

pharmaphorum

NICE backs Roche's PiaSky for NHS treatment of paroxysmal nocturnal haemoglobinuria, the first drug that can be self-administered by patients.

Drugs 89
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AstraZeneca’s Tagrisso gains FDA approval for stage III NSCLC

Pharmaceutical Technology

The FDA has approved AstraZeneca's Tagrisso (osimertinib) to treat adults with unresectable stage III EGFR-mutated NSCLC.

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Travere pumps brakes on late-stage enzyme replacement therapy study, citing production scale-up problems

Fierce Pharma

Shortly after winning full FDA approval for its rare kidney disease drug Filspari, San Diego’s Travere Therapeutics has run into trouble with its enzyme replacement candidate pegtibatinase. | Travere is pausing enrollment in its Harmony study evaluating pegtibatinase in classic homocystinuria to make improvements on manufacturing scale-up for commercial production and to fully enroll the phase 3 trial.

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Coverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success

WCG Clinical

Coverage Analysis for Oncology Slides Download The post Coverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success appeared first on WCG.

Trials 59
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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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Fierce Pharma Asia—Daiichi, AZ's ADC setback; Fosun, Kite JV's separation; Yuhan's busy week

Fierce Pharma

AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead Sciences' Kite will bow out of its China joint venture with Fosun Pharma. | AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead's Kite will bow out of its China joint venture with Fosun Pharma.

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Syncromune’s Innovative Approach to Solid Tumor Immunotherapy

XTalks

Syncromune, a privately held, clinical-stage biopharmaceutical company headquartered in Fort Lauderdale, Florida, is innovating immunotherapy for cancer treatment. The company’s mission is to develop groundbreaking therapies that significantly enhance response rates and potentially improve survival outcomes for patients with metastatic solid tumor cancers.

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After Sanofi's first-line myeloma nod, J&J strikes back with new tranche of Darzalex data

Fierce Pharma

Following the FDA's green light for a combo regimen of Sanofi’s Sarclisa in patients with newly diagnosed multiple myeloma last week, J&J has wasted little time hitting back with new data on it | Following the FDA's green light for a combo regimen of Sanofi’s Sarclisa in patients with newly diagnosed multiple myeloma last week, J&J has wasted little time hitting back with new data on its own cancer quartet leveraging the company’s subcutaneous oncology stalwart Darzalex Faspro.

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The Benefits of Real-Time ePRO/eCOA in Clinical Trials: Stay Ahead with Instant Insights

Crucial Data Soutions

Clinical trial delays cost everyone. They cost sponsors in the traditional, dollars-and-cents way. However, they also cost patients and their. The post The Benefits of Real-Time ePRO/eCOA in Clinical Trials: Stay Ahead with Instant Insights appeared first on Crucial Data Solutions.

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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.