Thu.Nov 30, 2023

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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

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Why Generative AI Threatens Hospital Cybersecurity — and How Digital Identity Can Be One of Its Greatest Defenses

MedCity News

While more generative AI tools are becoming available in healthcare for diagnostics and patient communication, it is important for clinicians and healthcare staff to be aware of the security, privacy, and compliance risks when entering protected health information (PHI) into a tool like ChatGPT.

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AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field

Fierce Pharma

The sizzling antibody-drug conjugate (ADC) field is at the center of another major life sciences deal. | The sizzling antibody-drug conjugate field is at the center of another major life sciences deal. Hoping to redeem itself following the epic Rova-T failure, AbbVie is shelling out $10.1 billion in cash to acquire ImmunoGen, maker of the ovarian cancer treatment Elahere.

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Expert: The Rumored Humana/Cigna Combination Makes Sense

MedCity News

With Cigna mostly focused on the commercial market and Humana mostly focused on the Medicare Advantage market, the rumored combination rumors check out, according to one industry expert.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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How high-intent platforms help pharma brands engage action-oriented customers

Fierce Pharma

Way back in 2015 a post on the Think with Google blog made the bold claim that, for marketers, consumer intent is more powerful than demographics: “Intent beats identity. | GoodRx is a trusted, high-intent platform that helps providers and patients find what they need at the exact moment they are looking for something. Learn why intent matters more than demographics.

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Practice Risk Assessment: Do You Know What Your Patients Are Taking?

MedCity News

By revisiting practice workflows to implement more strategic habits of communication and documentation, clinicians can promote positive outcomes and mitigate practice liability risks at a time when patients maybe accessing care from myriad sources, some online.

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More Trending

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Alpha Sophia Helps Medtech Businesses Avoid Overpaying for Healthcare Commercial Intelligence

MedCity News

Alpha Sophia Founder and CEO Paul-Lukas Hoffschmidt explains how the company’s software diverges from competitors in healthcare commercial intelligence, by focusing on smaller medtech innovators.

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Fighting unauthorized GLP-1 knockoffs, Novo Nordisk files 2 new lawsuits against Florida companies

Fierce Pharma

Seven weeks after a federal judge dismissed (PDF) a Novo Nordisk’s lawsuit, which accu | Seven weeks after a federal judge dismissed a Novo Nordisk’s lawsuit, which accused a Florida pharmacy of selling unauthorized knockoffs of its GLP-1 Wegovy, Ozempic and Rybelsus, Novo has sued the same company. Brooksville Pharmaceuticals is the target of a refiled Novo lawsuit, this one claiming there are impurities in the company’s compounded versions of the popular weight loss treatments.

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AbbVie Tries Its Hand at ADCs Again With $10.1B Immunogen Acquisition

MedCity News

AbbVie announced plans to acquire Immunogen — and the biotech’s recently approved ADC treatment for ovarian cancer — for $10.1 billion in cash. The pharma giant is diving into ADCs again after a previous multibillion-dollar acquisition of a different ADC drugmaker ended up failing a few years ago.

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As GSK's RSV shot nears blockbuster threshold, CEO sees plenty of 'headroom for growth'

Fierce Pharma

As the battle between new respiratory syncytial virus (RSV) vaccines heats up, GSK is “delighted” with the progress it's made so far with Arexvy, the company's CEO Emma Walmsley has said. | As the battle between new respiratory syncytial virus vaccines heats up, GSK is “delighted” with the progress it's made so far with Arexvy, the company’s CEO Emma Walmsley said during a Reuters interview.

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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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Walgreens Unveils Tool To Help Patients Save on Prescriptions

MedCity News

The Walgreens Rx Savings Finder combines different third-party discount card options into one platform. It allows customers to search for a prescription, find a coupon for that prescription and text or email the coupon to themselves. They then show the coupon to a Walgreens pharmacist when they fill the prescription.

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Fierce Pharma Asia—AstraZeneca's KRAS bet; BeiGene's cancer deal; Coherus' PD-1 price

Fierce Pharma

Because of the recent Thanksgiving holiday in the U.S., we're highlighting two weeks' worth of biopharma news related to Asia. | AstraZeneca in-licensed a KRAS G12D inhibitor from China's Usynova. BeiGene bought global rights to a CDK2 inhibitor in a deal worth up to $1.3 billion. Coherus has priced the first Chinese PD-1 inhibitor to enter the U.S. market at a 20% discount to Merck's Keytruda.

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AbbVie agrees $10.1bn deal to buy ImmunoGen

pharmaphorum

AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.

Marketing 101
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Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing

Fierce Pharma

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. | It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. Reddy’s failure to uphold those standards has landed the Indian drugmaker in hot water with the U.S.

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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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How to succeed in biotech: A serial entrepreneur’s tips for surviving tough times

PharmaVoice

John Mulligan, founder of biotechs like Good Therapeutics and Bonum Therapeutics, discusses how biotechs can thrive when the market is against them.

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A Conversation With Sanofi’s Olivier Nataf on Scientific Innovation in Hematology Research

Fierce Pharma

Did you know nearly 1.3 million cases of blood cancer are diagnosed worldwide each year?1 | An inside look at Sanofi’s approach to hematology R&D: Q&A with new Global Head of Oncology, Olivier Nataf.

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Acquisition deal to back European biosimilars market

European Pharmaceutical Review

Biocon Biologics Ltd has successfully completed integration of Viatris’ biosimilar business in 31 European countries. Following the acquisition of substantially all global biosimilar business of Viatris in November 2022, and the related integration of over 70 emerging market countries in July 2023 and North America in September 2023, now that Viatris’ biosimilars operations have fully transitioned to Biocon Biologics Ltd in Europe, the company declared that this “represents another significant m

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The future of medicines information: A leap forward is now on the horizon

Fierce Pharma

Written by: Philippe Michiels, Principal Architect at Datapharm | Datapharm presents the case for standardizing digital formats of medicines information, which for too long has been characterized by unstructured data.

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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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FDA elevates chief scientist Bumpus to the number two role

pharmaphorum

FDA chief scientist Namandjé Bumpus has been named as principal deputy commissioner, replacing long-serving Janet Woodcock when she steps down early next year. Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency.

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With J&J settlement, Samsung Bioepis and Sandoz lock down Stelara biosimilar license

Fierce Pharma

As Johnson & Johnson’s top moneymaker Stelara nears its patent cliff, biosimilar makers are eager to launch their own versions of the blockbuster immunology med. | Samsung Bioepis' biosimilar, which Sandoz has agreed to commercialize, can launch on Feb. 22, 2025, pending an FDA approval. J&J has reached similar deals with other companies seeking to market their own Stelara biosimilars.

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Innovative technologies facilitate novel contamination-detection method

European Pharmaceutical Review

In a paper published in Microbiology Spectrum , researchers from Singapore have described a novel microbial contamination-detection method for T-cell cultures that can be achieved within 24 hours, therefore supporting cell therapy manufacturing. This is compared to traditional methods which take between seven to 14 days. Technology such as third-generation nanopore long-read sequencing and DNA extraction, alongside machine learning algorithms, computational analysis and optimisation, were utili

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FDA Issues Warning of Potential Adverse Events Associated With Antiseizure Drugs

PharmExec

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but serious and potentially fatal reaction linked to use of antiseizure medications.

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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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Generation bio cuts 40% of staff in blow for non-viral gene therapy sector

Pharmaceutical Technology

The move is a strategic response amid challenges faced by the non-viral gene therapy sector, with several startups closing this year.

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Cell and gene therapy: manufacturing and talent trends 2023

European Pharmaceutical Review

o find out about the current trends in cell and gene therapy manufacturing, EPR spoke to Cell and Gene Therapy Catapult (CGT Catapult)’s Chief Manufacturing Officer, Stephen Ward, and Chief Business Officer, Jeanette Evans. They highlighted key data from the organisations recently published good manufacturing practice (GMP) Manufacturing Survey and Skills Demand reports, which focus particularly on the UK’s landscape.

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The future of cell and gene therapy manufacturing

Pharmaceutical Technology

As more cell and gene therapies get approved to treat common conditions, scaling them up will be a challenge.

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Healthcare Moves: A Monthly Summary of Hires and Layoffs

MedCity News

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.

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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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School of Global Affairs and Ethox Centre launch new research hub

PharmaTimes

The new hub will unite researchers worldwide to exchange ideas and knowledge - News - PharmaTimes

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Building Effective Real World Evidence Studies to Support New Indications for Established Products

PharmExec

The use of real-world evidence can prevent pharma companies from performing studies based on flawed data.

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Gliosarcoma drugs in development, 2023

Pharmaceutical Technology

GlobalData tracks 49 drugs in development for Gliosarcoma by 39 companies/universities/institutes. The top development phase for Gliosarcoma is phase i, with 22 drugs in that stage.

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SMART and CAMP collaborate to develop safer T-cell therapies

PharmaTimes

The new method successfully performs sterility assessments within 24 hours - News - PharmaTimes

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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.