Thu.Oct 10, 2024

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Providing the Blueprint for Gen AI Adoption in Clinical Trials

ACRP blog

The increased accessibility of generative artificial intelligence (Gen AI) models like OpenAI’s ChatGPT and DALL-E has captured the popular imagination. You’d be hard-pressed now to find any leadership team in any sector that isn’t at least considering ways to leverage Gen AI. The technology uses patterns learned from data to create new content. Most industries have applied it to routine back office or administrative tasks, such as note-taking, helping to increase the efficiency of everyday pr

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Ex-Pfizer execs ‘threatened’ for supporting plans to shake up company, Starboard says

Bio Pharma Dive

In a letter to Pfizer’s board, the activist investor claimed former CEO Ian Read and CFO Frank D’Amelio were pressured to abandon a Starboard-led attempt to change the company’s direction.

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Merck unveils €290m biosafety testing facility in Maryland, US

Pharmaceutical Technology

Germany-based Merck KGaA has announced the launch of a new €290m ($317.6m) biosafety testing facility in Rockville, Maryland, US.

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Drugmakers are racing to find the next Wegovy. These obesity trials are ones to watch.

Bio Pharma Dive

Data readouts over the next six months could set expectations for how the highly lucrative market for weight loss therapies will look in the future.

Trials 279
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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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Lilly and insitro team up to develop AI-powered siRNA metabolic drugs 

Pharmaceutical Technology

Eli Lilly and insitro said the deals offers a “new paradigm” for collaborations between major pharmaceutical companies and smaller biotechs.

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New data underline cancer risk of Bluebird therapy for brain disease

Bio Pharma Dive

Seven young boys given Bluebird's Skysona later developed blood cancers, findings that could shape how doctors balance the gene therapy’s risks against its benefit.

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Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug

Bio Pharma Dive

The offering will fund testing of a potential rival to Amgen’s Tezspire and is already the sixth for an immune drug developer this year, the most since 2021.

Drugs 173
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England witnesses sharp rise in food allergy incidence

Pharmaceutical Technology

According to Lancet Public Health, the incidence of probable food allergy more than doubled in England between 2008 and 2018.

Allergies 130
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Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug

Bio Pharma Dive

The offering will fund testing of a potential rival to Amgen’s Tezpire and is already the sixth for an immune drug developer this year, the most since 2021.

Drugs 162
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Biogen scores breakthrough status for anti-rejection transplant medication

Pharmaceutical Technology

Biogen plans to start a Phase III trial for felzartamab as a treatment for antibody-mediated rejection, and two other indications in 2025.

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

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UnitedHealth, CVS push to remove FTC Chair Lina Khan from PBM case

Bio Pharma Dive

Attorneys argue Khan and two other commissioners are biased against pharmacy benefit managers and should recuse themselves from an ongoing lawsuit against the middlemen.

Pharmacy 130
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Paediatric type 2 diabetes faces significant underdiagnosis in China

Pharmaceutical Technology

As a risk factor for future serious health conditions, the early prevention, detection and management of type 2 diabetes are essential.

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Johnson & Johnson myeloma drug recommended for NHS use

Pharma Times

Teclistamab offers hope for patients exhausting treatment options

Drugs 127
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Bluebird bio’s Skysona led to seven cases of blood cancer in gene therapy trials

Pharmaceutical Technology

Whilst the events do not outline any new safety risks, the data gives a new understanding of the link between oncogenesis and Skysona.

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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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The number of AI medical devices has spiked in the past decade

Bio Pharma Dive

The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.

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CPHI Europe: Gummies as a drug delivery system could improve compliance

Pharmaceutical Technology

At CPHI Europe, an expert discussed the promise of gummies as a drug delivery system and their unique manufacturing challenges.

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Roche burnishes breast cancer portfolio with FDA approval for Itovebi, a threat to Novartis and AZ

Fierce Pharma

As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio. | As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio.

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Boehringer and Circle Pharma link to develop new cancer treatment

Pharmaceutical Technology

Boehringer Ingelheim and Circle Pharma have signed a partnership and licence agreement focused on developing a new cancer treatment.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Heart patient goes home hours after live-streamed valve replacement

Pharma Times

Sheffield cardiologists demonstrate cutting-edge TAVI procedure

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Arda Therapeutics secures $43m to develop cell depletion therapies

Pharmaceutical Technology

Arda Therapeutics has secured $43m in Series A financing led by Andreessen Horowitz to develop targeted cell depletion therapies.

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Activist investor Starboard accuses Pfizer of strong-arming former execs into backing CEO Bourla ahead of strategy meeting

Fierce Pharma

Activist investor Starboard accuses Pfizer of strong-arming former execs into backing CEO Bourla ahead of strategy meeting zbecker Thu, 10/10/2024 - 11:03

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UK celeb seeks funds to challenge NICE's Enhertu verdict

pharmaphorum

Media personality Nadia Sawalha is heading a fundraising effort to launch an appeal against NICE's recent rejection of a breast cancer therapy Enhertu.

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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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The Role of China in the Global Generic Drug API Market

Drug Patent Watch

China has emerged as a significant player in the global generic drug active pharmaceutical ingredient (API) market. The country’s vast production capacity, low costs, and strategic location have made it an attractive destination for pharmaceutical companies seeking to source APIs.

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Warren calls on FTC to scrutinize Novo Holdings' $16.5B Catalent buyout

Fierce Pharma

As Novo Holdings hopes to close its $16.5 billion acquisition of CDMO Catalent by the end of the year, the deal is facing a fresh round of lawmaker scrutiny. | In a letter to the chair of the U.S. Federal Trade Commission, Lina Khan, Sen. Elizabeth Warren is calling on the antitrust agency to “carefully scrutinize” Novo Holding’s multibillion-dollar bid for CDMO Catalent.

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Starboard claims Pfizer 'threatened' former leaders

pharmaphorum

Starboard Value alleges former Pfizer execs Ian Read and Frank D'Amelio were bullied into lending their support to current management

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Pfizer targets broad Talzenna approval in prostate cancer as trial meets patient survival goal

Fierce Pharma

In prostate cancer, Pfizer’s Talzenna already holds the broadest FDA approval within the PARP inhibitor class. | In prostate cancer, Pfizer’s Talzenna already holds the broadest FDA approval within the PARP inhibitor class. Now, with new data indicating the drug could prolong patients’ lives, the company is targeting an even wider label.

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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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EVERSANA partners Oracle on pharmacovigilance platform

pharmaphorum

EVERSANA partners Oracle on pharmacovigilance platform Phil.

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AstraZeneca licenses CSPC’s cardiovascular drug in $2 billion deal

Outsourcing Pharma

The big pharma company AstraZeneca has forged a licensing pact worth $2 billion with the Chinese firm CSPC Pharmaceutical Group for access to an experimental small molecule treatment for dyslipidemia.

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AI and new technologies: How the pharmaceutical industry is reinventing itself to meet ever more urgent needs

pharmaphorum

AI and new technologies: How the pharmaceutical industry is reinventing itself to meet ever more urgent needs Mike.

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Novartis freed from Swiss antitrust probe over Cosentyx patent strategy

Fierce Pharma

Switzerland’s Competition Commission (COMCO) has dropped its investigation into Novartis’ use of patent actions to quell competition for Cosentyx.

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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.