Thu.May 09, 2024

article thumbnail

In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

Fierce Pharma

Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuti | Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuticals and CRISPR Therapeutics?

Leads 227
article thumbnail

Astellas CEO Q&A (Part 1): There Is No Playbook on Cell and Gene Therapies

MedCity News

A Q&A with Naoki Okamura revealed that when it comes to cell and gene therapies, the CEO of Astellas Pharma believes risk-taking is a must for eventual success. The post Astellas CEO Q&A (Part 1): There Is No Playbook on Cell and Gene Therapies appeared first on MedCity News.

Pharma 106
Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Merck's Keytruda plus chemo comes up short as post-surgery therapy in newly diagnosed endometrial cancer

Fierce Pharma

While Merck & Co.’s Keytruda already boasts a pair of approvals to treat certain forms of endometrial cancer, a recent effort to prove the PD-1 inhibitor’s worth as a post-surgery add-on therap | While Merck & Co.’s Keytruda already boasts a pair of approvals to treat certain forms of endometrial cancer, a recent effort to prove the PD-1 inhibitor’s worth as a post-surgery add-on therapy in newly diagnosed patients has fallen short.

Patients 222
article thumbnail

Ascension Hospitals Across Several States Are Offline Following Cyberattack

MedCity News

On Wednesday, Ascension noticed that a hacker had infiltrated its systems. As the health system works with Mandiant to investigate the incident, clinical services remain disrupted at Ascension facilities across several states. The post Ascension Hospitals Across Several States Are Offline Following Cyberattack appeared first on MedCity News.

104
104
article thumbnail

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

article thumbnail

Pfizer puts 74 Swiss jobs on chopping block as it folds Seagen into its cancer operations

Fierce Pharma

After telegraphing more than a hundred potential layoffs in March in connection with plans to stop construction of a massive Seagen facility, Pfizer is plowing ahead with efforts to streamline its | Pfizer has proposed another round of staff reductions and role changes at legacy Seagen, this time hitting Seagen’s European headquarters in Switzerland, where 74 positions could be up for the chop.

221
221
article thumbnail

LogiPharma Europe 2024: Delivering Agility in Supply Chains Through Building Multimodal Cold Chain Networks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Cathy O'Brien, VP of Sales, UPS Healthcare discusses her masterclass on delivering agility in supply chains by building a multimodal cold chain network while also reducing risks at LogiPharma Europe 2024.

More Trending

article thumbnail

Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 1 of 4)

ALULA

In the US alone, 6.2 percent of the total population identify as AANHPI (Asian American, Native Hawaiian, Pacific Islander). May is dedicated to honoring people in the US with AANHPI heritage , so it’s a great time to celebrate their voices and experiences – and to reflect on how we can integrate their stories into our lives all year long , especially with our colleagues and teams.

98
article thumbnail

As Vyvanse generics bite, Takeda sets out on $900M restructuring plan

Fierce Pharma

In response to rapidly declining profits and the downfall of ADHD drug Vyvanse, Takeda is planning to throw 140 billion Japanese yen ($899 million) toward a company-wide restructuring campaign. | In a multi-year overhaul, the Japanese drugmaker plans to prioritize "organizational agility," procurement savings and tech efficiencies. It's all part of an effort to boost profit margins.

161
161
article thumbnail

Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 2 of 4)

ALULA

Welcome back to our series, begun here , on what today’s leaders and workers can learn from AA and NHPI people whose work demonstrates a profound commitment to behaviors with a lasting positive impact.

98
article thumbnail

Opportunities & Challenges of Digital Pathology Adoption in CDx Development

Fierce Pharma

In the dynamic world of life sciences, digital pathology stands out as a beacon of innovation, promising transformative changes in how pathologists engage, evaluate, and collaborate. | Sitting down with Agilent Technologies, we explore the challenges and opportunities of incorporating digital pathology solutions within companion diagnostics.

130
130
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

Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 3 of 4)

ALULA

We enjoyed exploring the story of Shuji Nakamura here , and we’re grateful to you for reading our series on what today’s leaders and workers can learn from AA and NHPI people whose work demonstrates a profound commitment to behaviors with a lasting positive impact.

97
article thumbnail

Fierce Pharma Asia—Takeda restructures; Lilly, Innovent tout GLP-1 win; BIO warns of decoupling damage

Fierce Pharma

Takeda has entered into a restructuring to achieve “organizational simplicity.” Innovent Biologics' GLP-1R/GCGR dual agonist, licensed from Eli Lilly, has notched a second positive phase 3 rea | Takeda launched a restructuring to achieve “organizational simplicity.” Innovent and Eli Lilly's GLP-1R/GCGR dual agonist notched a second positive phase 3 readout.

Biopharma 130
article thumbnail

Why Personalized Medicine Should Not Be Too Personalized

MedCity News

One irony of personalized or precision medicine (PM) is that it aims, against the advice of Hippocrates and Osler, to treat the disease, not the patient. The post Why Personalized Medicine Should Not Be Too Personalized appeared first on MedCity News.

article thumbnail

US gene therapy approvals create a big problem for Brazil. Regulators have to come together, FDA's Peter Marks says

Fierce Pharma

US gene therapy approvals create a big problem for Brazil.

FDA 180
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

article thumbnail

Why Consumers Leave Their Payer/Provider

MedCity News

Many consumers leave their provider because of navigation problems, while many leave their insurer because of experience issues, a new Accenture report found. The post Why Consumers Leave Their Payer/Provider appeared first on MedCity News.

article thumbnail

Oxford/AZ Covid-19 vaccine to be discontinued

European Pharmaceutical Review

Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca. “Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.

article thumbnail

New metric predicts burden of participating in trials

pharmaphorum

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

article thumbnail

Anixa expands cancer vaccine collaboration with Cleveland Clinic

Pharmaceutical Technology

Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.

98
article thumbnail

AlphaFold 3 takes structure predictions well beyond proteins

pharmaphorum

Google DeepMind and Isomorphic Labs' newly launched AlphaFold 3 extends the power of the AI model to 'all life’s molecules'

94
article thumbnail

OneChain’s CAR T trial treats its first cortical T-cell ALL patient

PharmaTimes

The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells

article thumbnail

US agencies collaborate to address regulation for biotechnology products

European Pharmaceutical Review

Regulatory agencies in the US across three sectors: agriculture and environmental, have produced a joint plan to “update, streamline, and clarify” regulations and oversight mechanisms for biotechnology products. The plan, developed by the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA), helps to address US President Biden’s related goals, including and improving the “transparency, predictability, coordination, and

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

Oregon and Lantern collaborate to develop drug candidate for various cancer indications

PharmaTimes

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024

Pharma 97
article thumbnail

Biologics on Target for the Future

PharmaTech

A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.

72
article thumbnail

NICE backs wider tumour profiling use in early breast cancer

pharmaphorum

NICE updates guidance on tumour profiling tests to steer adjuvant chemotherapy decisions to include lymph node-positive early breast cancer.

62
article thumbnail

CPHI North America: Industry Trends, Agenda Additions, and What to Expect at CPHI Milan

PharmaTech

Tara Dougal, content director, Pharma, Informa Markets, discusses successes and insights from this year’s CPHI North America and the agenda for the upcoming CPHI Milan.

Pharma 59
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

article thumbnail

Ensuring Global Access to LP-284

PharmExec

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, talks about ensuring global access to LP-284, particularly in regions with limited resources

Pharma 52
article thumbnail

A step by step guide to creating new promotional claims

Vodori

Adding a new claim to your campaign requires careful handling to ensure it's not only medically sound but also fits well with your campaign's goals. This guide will walk you through seven crucial steps to evaluate, fine-tune, and smoothly integrate new claims. From gauging relevance to assessing value, confirming reliability, and crafting clear messages, each step plays a vital role in shaping the outcome and effectiveness of your campaign.

Medical 52
article thumbnail

Verona Pharma Receives $650M Investment from Oaktree Capital Management and OMERS Life Sciences

PharmExec

Strategic financing from Oaktree Capital Management and OMERS Life Sciences is expected to support the US launch of ensifentrine, Verona’s promising chronic obstructive pulmonary disease treatment.

article thumbnail

The growth of clinical trials in Africa

Pharmaceutical Technology

Clinical trials are growing across Africa as the immense potential of the continent starts to be realised. Sponsors and CROs are tapping into the unsaturated patient pools, more diverse populations, and competitive operations costs.

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.