Thu.Oct 10, 2024

article thumbnail

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

article thumbnail

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.

281
281
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

182
182
article thumbnail

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.

article thumbnail

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

article thumbnail

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.

article thumbnail

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 167

More Trending

article thumbnail

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 176
article thumbnail

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.

130
130
article thumbnail

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 157
article thumbnail

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.

article thumbnail

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

article thumbnail

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
article thumbnail

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.

article thumbnail

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.

120
120
article thumbnail

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.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

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.

article thumbnail

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.

article thumbnail

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

116
116
article thumbnail

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
article thumbnail

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.

article thumbnail

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.

110
110
article thumbnail

Pharmaceutical Technology Excellence Awards 2024: EMIS 

Pharmaceutical Technology

EMIS is a winner in the Innovation category in the 2024 Pharmaceutical Excellence Awards.

147
147
article thumbnail

Ono, Boehringer add to cancer pipelines with licensing deals

pharmaphorum

Ono Pharma and Boehringer Ingelheim both added to their cancer pipelines, licensing drugs from LigaChem Bio and Circle Pharma, respectively.Ono's deal with South Korean antibody-drug conjugate (ADC) specialist LigaChem is worth up to $700 million and covers a license to a preclinical-stage candidate for solid tumours, as well as an R&D collaboration to seek out other ADC candidates.

Licensing 100
article thumbnail

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.

article thumbnail

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

article thumbnail

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

111
111
article thumbnail

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.

94
article thumbnail

Evaxion’s AI-immunology platform shines in multiple clinical trials

BioPharma Reporter

Evaxionâs proprietary AI-Immunology platform has shown in clinical trials that it can select clinically relevant cancer vaccine targets.

article thumbnail

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.

article thumbnail

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.

article thumbnail

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.

article thumbnail

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.

87
article thumbnail

Heart patient goes home hours after live-streamed valve replacement

Pharma Times

Sheffield cardiologists demonstrate cutting-edge TAVI procedure

113
113
article thumbnail

Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug

Outsourcing Pharma

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

article thumbnail

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.