Wed.Jan 10, 2024

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JPM24: Riding label expansions and launches, AZ plots course toward 'industry-leading growth' by 2030

Fierce Pharma

With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. | In AZ's push to reach industry-leading growth by 2030, confidence is key, chief financial officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference. Besides that goal, the company wants to be a top-3 player in its five disease areas of focus.

Leads 254
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How Digital Health Fundraising Took On a Different Shape in 2023

MedCity News

In 2023, digital health fundraising took on a bit of a different shape, according to a new Rock Health report. Startups tried out some creative ways to keep their businesses afloat — including series extension rounds, unlabeled fundraises and silent deals from existing investors.

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JPM24: BioMarin's new CEO Hardy says top priority is expansion of dwarfism drug Voxzogo

Fierce Pharma

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. | In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. The top priority for the former Genentech CEO is to accelerate and maximize the commercial potential of dwarfism drug Voxzogo.

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Reading the Tea Leaves for Cannabis Regulation

MedCity News

A decade after the first recreational marijuana dispensaries opened, will 2024 be the year that cannabis finally gets a get-out-of-jail-for-free card?

Medical 125
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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JPM24: After 'clearing the decks,' Alkermes ready to roll as pure-play neuroscience company

Fierce Pharma

Age 37 might be old for a “coming-out party,” but that’s the situation for Alkermes at this year’s J.P. Morgan Healthcare Conference, chief operating officer Blair Jackson said in an interview. | Age 37 might be old for a “coming-out party,” but that’s the situation for Alkermes at this year’s J.P. Morgan Healthcare Conference, said chief operating officer Blair Jackson.

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Commons Clinic Launches $100M Center to Advance Value-based MSK Care

MedCity News

Commons Clinic — a value-based physician group providing musculoskeletal care to patients in the Los Angeles area — announced the launch of its Center for Spine Economics, Outcomes & Research. The center will research and test new models that move spinal care out of the hospital and into community-based accountable care networks. The startup plans to invest $100 million in the center over the next decade.

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MedCity News is Accepting Applications for the Healthcare Startup Pitch Perfect Contest in Chicago

MedCity News

Each track will spotlight a different specialty area including: oncology, cardiology, women’s health and preventing burnout/supporting operational efficiency.

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JPM24: In booming obesity field, Novo Nordisk is 'just getting going,' CEO says

Fierce Pharma

Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. | Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. And to hear Novo’s CEO Lars Fruergaard Jørgensen tell it, the company is "just getting going" in the field.

Sales 194
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More Gen AI, Direct to Patient Models & Digital Health Top What’s On the Horizon in 2024: Q&A With Scott Snyder, Chief Digital Officer at EVERSANA

PharmExec

Snyder discusses potential trends for various technologies, including AI, digital therapeutics, and virtual reality.

Patients 115
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Butterfly Network CEO: 2024 is When We Get Our Mojo Back

MedCity News

From its heady unicorn days to being newly public to its current financial struggles, the portable ultrasound-on-a-chip company has seen it all. Now, its latest CEO has his work cut out for him. A return to revenue growth is what Joseph DeVivo is promising this year.

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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.

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AbbVie launches pump-based Parkinson’s drug in EU

pharmaphorum

AbbVie has launched its Produodopa therapy for Parkinson’s disease onto the market in the EU, becoming the first and only 24-hour subcutaneous infusion therapy for the neurodegenerative disorder.

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Vaccine demonstrates benefit in delaying cancer relapse

European Pharmaceutical Review

A lymph node-targeted cancer vaccine has shown potential to prevent relapse of KRAS-mutated pancreatic and colorectal cancers in patients who have had surgery, according to a Phase I trial led by US researchers. The results were published in Nature Medicine. Results from the cancer vaccine clinical trial In the trial, T cell responses were seen in 84 percent of all patients and in 100 percent of those in the two highest dose cohorts, including those who received the recommended Phase II dose o

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JPM: Precision Bio continues offload of CAR-T rights

pharmaphorum

Precision BioSciences licenses non-cancer uses of its allogeneic CAR-T therapy azer-cel to TG Therapeutics as it pivots to in vivo applications of its gene-editing technology

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Vertex’s CASGEVY therapy gains approval in Saudi Arabia

Pharmaceutical Technology

Vertex Pharmaceuticals has announced the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the first CRISPR/Cas9 gene-edited therapy.

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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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Elevance Health To Offer Smartphones to Some Medicaid Members

MedCity News

Elevance Health will provide smartphones with unlimited data, talk and text to some Medicaid members in 2024, it announced at CES 2024.

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Alphabet spinout SandboxAQ buys Good Chemistry

pharmaphorum

Quantum computing and artificial intelligence specialist SandboxAQ has bought Good Chemistry in a deal focused on drug discovery and material science

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One biotech’s 3 gene therapy hurdles: delivery, delivery and delivery

PharmaVoice

4DMT’s David Kirn is looking to the future of gene therapy with delivery methods that change the paradigm.

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UK study backs whole-genome screening for cancer care

pharmaphorum

UK study led by Genomics England drawing on 100,000 Genomes Project and real-world clinical data backs use of whole-genome sequencing in cancer care

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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.

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Barinthus Bio announces $47m project to advance MERS coronavirus vaccine

PharmaTimes

The partnership will advance VTP-500 from early development to phase 2 clinical trials

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Grifols rocked by fraud allegation from short seller

pharmaphorum

Spanish pharma Grifols has refuted claims by hedge fund Gotham City that it has manipulated its financial reporting by hiding exposure to debt.

Pharma 69
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Introducing Simtra BioPharma Solutions

PharmaTech

Franco Negron, CEO, Simtra BioPharma Solutions, discusses the company's expertise in supporting the development and manufacture of sterile injectables, its integrated approach to project management, and his expectations regarding the company's future in the industry.

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AbbVie's Lutikizumab Shows Promise in Treating Moderate to Severe Hidradenitis Suppurativa

PharmExec

Lutikizumab (ABT-981) will not advance to a Phase III trial in patients with moderate to severe hidradenitis suppurativa who previously failed anti-tumor necrosis factor therapy.

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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.

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Relative Bioavailability Trial of Nanotechnology-Enhanced Enzalutamide is Underway

PharmaTech

Nanoform has completed the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.

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How To Get A Job In Orthopedic Medical Device Sales With Joey Testa & Travis Harvey

Evolve Your Success

The magic about medical device sales is that anyone can get into the industry no matter the background; all it takes is having passion, commitment, and work ethic. This episode’s guests have the story to inspire you. At just 19 years old, Travis Harvey has created an entirely new life for himself getting into orthopedic medical device sales under Joey Testa.

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Shorla Oncology Announces FDA Acceptance of NDA for Novel Treatment for Breast, Ovarian Cancer

Pharmaceutical Commerce

The novel therapy in development to treat breast cancer and ovarian cancer is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s.

FDA 52
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Moderna Highlights Respiratory Product Pipeline at JP Morgan Healthcare Conference

PharmExec

Moderna’s vaccine revenue dropped from $18.4 billion in 2022 to $6.7 billion in 2023, however the company anticipates profitability this year powered by COVID-19 vaccine sales and the launch of its mRNA-based respiratory syncytial virus vaccine.

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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

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Microbiome innovation: have we forgotten the basics?

European Pharmaceutical Review

The human microbiome is a key player in our understanding of health and disease. This network of trillions of microorganisms residing in our gut and across our body has opened new avenues in medicine, offering the promise of innovative, minimally invasive therapies. As late-stage clinical development, manufacturing, quality control processes and regulation for microbiome-based treatments evolve, standardisation becomes a critical and complex challenge.

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Believe the hype? Mixed signals from AI’s impact on drug development

PharmaVoice

Although AI’s failure rates in drug development still leave room for improvement, today’s missteps feed tomorrow’s successes.

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FDA Accepts New Drug Application for Shorla Oncology's Novel Treatment for Breast, Ovarian Cancer

PharmExec

SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation.

FDA 52
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Switching sales: Investigating the financial impacts of FDA’s priority vouchers

Pharmaceutical Technology

The second of a two part-series on priority review vouchers investigates trends in the vibrant market of million-dollar vouchers and how companies use them.

Sales 52
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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.