Thu.Jul 27, 2023

article thumbnail

GSK confident in RSV vaccine launch, but sets expectations for ‘steady build’

Bio Pharma Dive

GSK expects its respiratory syncytial virus vaccine will be a multibillion dollar product. But at the beginning it’s predicting a slower launch than for its fast-selling shingles shot.

article thumbnail

GSK reports rise in profit in Q2 2023

Pharmaceutical Technology

GSK has reported an adjusted operating profit of £2.17bn in Q2 2023, which is an almost 8% increase from the £2.

189
189
Insiders

Sign Up for our Newsletter

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

article thumbnail

Lilly adds to case for Mounjaro’s weight-loss benefits with new study data

Bio Pharma Dive

The results showed that enrollees who’d already lost weight after diet and exercise shed pounds after receiving Mounjaro, while those who stopped treatment gained weight back.

245
245
article thumbnail

July 27, 2023: NIH Collaboratory Hosts Onboarding Session for Newest Demonstration Projects

Rethinking Clinical Trials

Leaders of the NIH Pragmatic Trials Collaboratory hosted an onboarding meeting for the program’s 3 newest Demonstration Projects. The projects joined the program under the UG3 cooperative agreement mechanism to support a 1-year planning phase in preparation for potential transition to a UH3 implementation phase. Access the complete materials from the onboarding session.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Merck, chasing Pfizer, claims study success for new pneumonia vaccine

Bio Pharma Dive

The pharma said its latest shot, which covers 21 strains of bacteria, cleared two Phase 3 trials and in some cases spurred a stronger immune response than Pfizer’s Prevnar 20.

article thumbnail

Cultural agility: the key to building trust with biopharma partners

Pharmaceutical Technology

Working in an industry with regular cross-border manufacturing and dealing with a global network of clients means adaptability is vital to maintaining good communications, building relationships, and managing teams effectively.

More Trending

article thumbnail

How smart hospitals private equity performed in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

In the global pharmaceutical industry, there were 7 private equity deals announced in Q2 2023, worth a total value of $950m, according to GlobalData's Deals Database.

130
130
article thumbnail

European VC Medicxi raises $400M for ‘asset-centric’ biotech investing

Bio Pharma Dive

Medicxi is the latest biotech investor to announce a new investment fund in 2023, despite a turbulent market that’s challenged many startups.

Marketing 130
article thumbnail

How did hiring in the Asia-Pacific pharma industry perform in Q2 2023

Pharmaceutical Technology

The Asia-Pacific pharma industry experienced a 4% drop in hiring activity in Q2 2023, led by Syngene International's 10% share, according to GlobalData

130
130
article thumbnail

What types of clinical research are there?

Antidote

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials. Clinical trials evaluate new drugs, devices, packaging, and behaviors in order to determine if these potential therapies work for particular conditions or patient populations.

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

How did hiring in the Asia-Pacific pharma industry perform in Q2 2023

Pharmaceutical Technology

The Asia-Pacific pharma industry experienced a 4% drop in hiring activity in Q2 2023, led by Syngene International's 10% share, according to GlobalData

130
130
article thumbnail

EMA publishes clinical trial plan for public health emergencies

Outsourcing Pharma

The EMA organized a task force made up of various stakeholders to gather insights on potential EU-level actions to improve the set up of clinical trials during public health emergencies.

article thumbnail

Precision and Personalized Medicine hiring activity decreased in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

The global pharmaceutical industry recorded a 11% drop in precision and personalized medicine hiring activity in Q2 2023, according to GlobalData

Medicine 130
article thumbnail

Ortho-Phthalates Retain FDA Approval for Food Packaging Despite Petitions

XTalks

Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. The agency also declined demands to overturn five earlier approvals regarding five distinct ortho-phthalates, alleged to significantly risk human health by leaching into food and beverage products.

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

AbbVie and Calibr expand partnership to advance clinical assets

Pharmaceutical Technology

AbbVie has expanded its strategic collaboration with Calibr for the advancement of multiple preclinical and early-stage clinical assets.

130
130
article thumbnail

5 Strategies to Strengthen Relationships with HCPs

Pharma Marketing Network

Developing strong and meaningful relationships with Healthcare Professionals (HCPs) is vital for healthcare organizations, pharmaceutical companies, and medical device manufacturers alike. These partnerships not only improve patient outcomes but also foster mutual trust and collaboration. In this blog, we will explore five effective strategies to enhance your relationship-building efforts with HCPs and ultimately achieve better healthcare outcomes.

article thumbnail

UK probes Novo’s Ozempic and Saxenda on user suicidal ideation

Pharmaceutical Technology

The UK MHRA has launched a probe into the use of Novo Nordisk’s GLP-1 receptor agonists for diabetes and a weight-loss treatment.

130
130
article thumbnail

DrugPatentWatch reveals NIH funding for patents

Drug Patent Watch

Here’s a summary of a new article that used DrugPatentWatch data: NIH Funding for Patents That Contribute to Market Exclusivity of Drugs Approved 2010–2019 and the Public Interest Protections of… The post DrugPatentWatch reveals NIH funding for patents appeared first on DrugPatentWatch - Make Better Decisions.

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

Oncology company Nexo Therapeutics raises $60m in Series A round

Pharmaceutical Technology

Nexo Therapeutics, a new small molecule oncology company, has raised $60m in a Series A financing round to support its platform

130
130
article thumbnail

Eli Lilly's tirzepatide aces 2 more late-stage obesity trials as FDA decision nears

Fierce Pharma

Eli Lilly continues to bolster the case for its dual GIP/GLP-1 agonist tirzepatide as a powerful weight loss agent. | Also known as Mounjaro in its approved type 2 diabetes indication, tirzepatide helped patients across two trials—Surmount-3 and Surmount-4—lose up to 26.6% of their body weight, Lilly said Thursday.

Trials 95
article thumbnail

How precision and personalized medicine private equity performed in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

In the global pharmaceutical industry, there were 2 private equity deals announced in Q2 2023, worth a total value of $11.1m, according to GlobalData's Deals Database.

Medicine 130
article thumbnail

Roche's star eye drug Vabysmo crosses blockbuster threshold as rival stalls at FDA

Fierce Pharma

To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark in the first half of 2023.

Drugs 94
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.

article thumbnail

How precision and personalized medicine M&A performed in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

In the global pharmaceutical industry, there were 6 M&A deals announced in Q2 2023, worth a total value of $220.2m, according to GlobalData's Deals Database.

Medicine 100
article thumbnail

Minority participation doubles average with Columbia Uni diversity drive

Outsourcing Pharma

Columbia University is running three separate efforts to improve diversity within clinical trials, and it released data showing that early improvements could be seen.

article thumbnail

How smart hospitals M&A performed in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

In the global pharmaceutical industry, there were 17 M&A deals announced in Q2 2023, worth a total value of $1.1bn, according to GlobalData's Deals Database.

100
100
article thumbnail

ABPI reacts to new vital vaccination report

Pharma Times

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

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

How artificial intelligence M&A performed in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

In the global pharmaceutical industry, there were 6 M&A deals announced in Q2 2023, worth a total value of $191.2m, according to GlobalData's Deals Database.

100
100
article thumbnail

First dose completed in phase 1 cannabinoid study

Pharma Times

OCTP aims to demonstrate the lead candidate’s safety, tolerability and pharmacokinetic profile - News - PharmaTimes

98
article thumbnail

How internet of things M&A performed in the pharmaceutical industry in Q2 2023

Pharmaceutical Technology

In the global pharmaceutical industry, there were 5 M&A deals announced in Q2 2023, worth a total value of $13.9m, according to GlobalData's Deals Database.

100
100
article thumbnail

Fierce Pharma Asia—Daiichi's leukemia nod; Astellas' protein degrader pact; Takeda's neuroscience setback

Fierce Pharma

Daiichi Sankyo's FLT3 inhibitor overcame FDA rejection to win an approval. Astellas signed another protein degrader deal, this time with PeptiDream. | Daiichi Sankyo's FLT3 inhibitor has overcome an FDA rejection to win an approval. Astellas signed another protein degrader deal. Takeda's enzyme replacement therapy flunked a mid-stage trial in a rare neurological disorder.

Protein 84
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.