Tue.Apr 23, 2024

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

Pharma 329
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FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News.

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Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

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ReferralMD Expands Digital Front Door with Conversational AI Patient Registration & Intake

Referral MD

ReferralMD, a leader in healthcare technology solutions, is excited to announce the expansion of its Digital Front Door offering using the latest innovation in conversational AI. The Patient Registration & Intake Solution, powered by conversational AI, reimagines how patients engage with healthcare providers. With the healthcare technology market becoming more competitive than ever, ReferralMD differentiates itself with its comprehensive platform, including Digital Front Door, eConsults, R

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Eli Lilly inks deal to acquire Nexus manufacturing plant in WI as Mounjaro and Zepbound shortages drag on

Fierce Pharma

As doctors and patients in the U.S. | As doctors and patients in the U.S. grapple with widening shortages of the popular diabetes therapy Mounjaro and its obesity counterpart Zepbound, the maker of the tirzepatide drugs, Eli Lilly, is forging ahead on its quest to expand capacity for its injectable medicines.

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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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LogiPharma Europe 2024: LogiPharma Commercial Director Discusses Themes of the Show

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, talks themes of this year's event and future plans for the show.

Pharma 101
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Another delay for Abeona's topical gene therapy pz-cel as FDA sends out a rejection

Fierce Pharma

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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EC approves Pfizer’s Emblaveo for multidrug-resistant infections

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Pfizer’s EMBLAVEO (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.

Marketing 101
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Novartis 'actively' reviewing relationships with Chinese contractors amid US biosecurity crackdown: CFO

Fierce Pharma

As the BIOSECURE Act threatens to upend relationships with Chinese contractors and western biopharma companies operating in the U.S., Novartis has elected not to adopt a “wait and see” attitude.

Biopharma 203
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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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Neurodivergent Masking: A Hidden Contributor to the $2-Trillion Burnout Crisis

MedCity News

It can be tiring pretending to be someone you’re not. For many neurodivergent people at work, this is an everyday reality — and it’s burning them out. The post Neurodivergent Masking: A Hidden Contributor to the $2-Trillion Burnout Crisis appeared first on MedCity News.

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Novartis dials up 2024 sales outlook, preps for key expansions of 3 cancer drugs

Fierce Pharma

Novartis has increased its full-year sales guidance after pulling off a strong first quarter, even though three meds missed analysts’ expectations ahead of their key expansion opportunities. | Novartis has increased its full-year sales guidance after pulling off a strong first quarter, even though three cancer drugs missed analysts’ expectations ahead of their key expansion opportunities.

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Collaboration Now: Maximizing AI’s Potential in the Industry it Matters Most

MedCity News

No passing fad, AI in healthcare is here, and it’s already improving the lives of patients, healthcare workers, and researchers. How can we make a good thing even better? The post Collaboration Now: Maximizing AI’s Potential in the Industry it Matters Most appeared first on MedCity News.

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Vertex jumps to TreeFrog to enhance production of Type 1 diabetes cell therapy candidates

Fierce Pharma

Following success in cystic fibrosis and sickle cell disease, Vertex’s next big leap is Type 1 diabetes (T1D). | Following success in cystic fibrosis and sickle cell disease, Vertex’s next big leap is Type 1 diabetes. the Boston company develop three pipeline candidates in the indication will be French cell therapy developer and manufacturer TreeFrog Therapeutics.

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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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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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Don’t Let Inflation Bloat Your Drug Spending

MedCity News

Smart but easy tech upgrades can boost margins. The post Don’t Let Inflation Bloat Your Drug Spending appeared first on MedCity News.

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BMS inks CAR T cell therapy manufacturing deal with Cellares

European Pharmaceutical Review

Bristol Myers Squibb (BMS) and Cellares have announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies. The deal is valued at up to $380 million in upfront and milestone payments. The agreement will see BMS use Cellares’ fully automated cell therapy manufacturing platform for the clinical and commercial-scale manufacturing of select CAR T cell therapies.

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EU approves Pfizer antibiotic for superbug infections

pharmaphorum

Pfizer’s Emblaveo has been approved in the EU with a first-in-class indication in multidrug-resistant (MDR) infections. The drug – a combination of beta-lactam antibiotic aztreonam with beta-lactamase inhibitor avibactam – is the first drug of this type to get a green light from the European Commission to treat serious infections caused by MDR Gram-negative bacteria in adults.

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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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Inside J&J’s strategy to de-gender clinical trials

PharmaVoice

Mark Wildgust, vice president of global medical affairs for J&J's oncology division, shares strategies for making clinical trials gender- and trans-inclusive.

Medical 81
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Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

PharmaTimes

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually

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Why Headspace Is Launching Direct-to-Consumer Services

MedCity News

Headspace is going toe-to-toe with the likes of Talkspace and BetterHelp by bringing its mental health services directly to consumers — starting with text-based mental health coaching. The post Why Headspace Is Launching Direct-to-Consumer Services appeared first on MedCity News.

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Shakeup at BenevolentAI continues with job, programme cuts

pharmaphorum

BenevolentAI is embarking on another round of job losses, closing its US office, and shelving its software-as-a-service business to extend its cash reserves into the third quarter of 2025.

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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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Navigating an Uncertain Regulatory Environment for mRNA-based Products

PharmaTech

Regulations for mRNA products are evolving as the market for mRNA expands.

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Sanofi’s oral BTK programme gets back on track

pharmaphorum

Phase 3 readout allows Sanofi to prepare US and EU filings for oral BTK inhibitor rilzabrutinib in immune thrombocytopenia (ITP), its first indication

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Salesperson Development Hinges on A Clear Plan and Supportive Culture

Integrity Solutions

High-performing Sales organizations go beyond hiring for “measurables” and have well thought out plans, processes, coaching and salesperson development strategies in place. The annual NFL Draft is always full of intrigue for many reasons. The real-time drama unfolds as teams select what they consider to be the best 256 college football prospects over a three-day period.

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Boehringer Ingelheim and Ochre Bio partner on liver disease in deal worth over $1bn

PharmaTimes

Chronic liver disease and associated cirrhosis account for one million deaths every year

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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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Pharma Pulse 4/23/24: Meta Places Smart Assistants Across Its Apps, Burden of Pneumococcal Disease Consistent Across Age Groups & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 101
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Navigating Commercial Drug Development Technologies for Formulation Excellence

PharmaTech

Lonza Small Molecules is focused on leveraging its technologies and expertise to address solubility challenges and support drug development programs through commercialization.

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LogiPharma Europe 2024: Will Robinson Talks Planning LogiPharma

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, discusses the process of keeping the event relevant to the times.

Pharma 52
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Distributor Sales Training: Strategies For Building a High-Performing Sales Force

Spotio

Studies suggest that best-in-class companies close 30% of sales qualified leads , while average companies close 20%. How do you close that gap? Effective sales training. Every sales team needs solid training and ongoing coaching. But reps in the wholesaler and distributor industries need it more—mostly because margins are small and competition is fierce.

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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.