Fri.Dec 22, 2023

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2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue

Fierce Pharma

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.

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How pharma’s sales and marketing teams are starting to use AI

Dominic Tyer

Traditionally R&D’s province, the meteoric rise of AI has turbo-charged discussions about how commercial organisations can make use of artificial intelligence.

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J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk

Fierce Pharma

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carvykti.

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2023’s Wins and Losses in the Reproductive Health Space, Per 2 Advocates

MedCity News

Representatives from the Guttmacher Institute and NFPRHA shared their wins and losses for reproductive health in 2023. Their wins include states moving to protect contraception and the approval of Opill, while their losses include state enactments of abortion bans and the lack of funding for Title X.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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More ‘Faux-zempic’ found, this time in ‘legitimate’ US supply chain, FDA warns

Fierce Pharma

The FDA and Novo Nordisk are warning of c | The FDA and Novo Nordisk are warning of counterfeit versions of popular weight-loss treatment Ozempic that have been discovered in the “legitimate” United States supply chain.

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Using Informed Decision-Making to Reduce Staff Burnout and Transform Your Health System’s Productivity [Sponsored]

MedCity News

In a recent webinar, Dr. Christopher Newman of Mary Washington Healthcare discussed how utilizing the principles of informed awareness has transformed staff experience and facilitated a more productive, efficient, and engaged workforce.

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How to Ensure Health Equity Isn’t Just a Buzzword

MedCity News

Some healthcare organizations have reduced health equity to a buzzword, using the phrase superficially without a true commitment to dismantling systemic barriers. During a webinar, two industry leaders — AMA President Jesse Ehrenfeld and Emory Healthcare Chief Transformation Officer Amaka Eneanya — discussed why this approach must be avoided and explored how leaders can do better.

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Sanofi stops development of lung cancer drug

European Pharmaceutical Review

French pharmaceutical giant Sanofi announced that it is ending the development programme evaluating tusamitamab ravtansine as a monotherapy for certain patients with metastatic non-squamous, non-small cell lung cancer (NSCLC). The decision comes after interim analysis from a Phase III clinical trial , CARMEN-LC03, did not meet a primary end point. CARMEN-LC03, a randomised, open-label study was evaluating tusamitamab ravtansine as monotherapy compared to docetaxel in patients with metastatic non

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Helping to Close the Gap with Health Equity by Design

MedCity News

Health equity is not an abstract concept but a tangible goal that can be achieved through a deliberate and comprehensive approach. By focusing on the pillars of awareness and education, equal access to care, advocacy, and technology can begin to close the healthcare disparities gap.

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The Transformative Potential of AI and Machine Learning in Biomedical Research and Healthcare

PharmExec

Oxford Academic report explores the positive improvements these technological capabilities could bring to the industry.

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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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BMS strikes $14bn deal for Karuna Therapeutics

European Pharmaceutical Review

Bristol Myers Squibb (BMS) has agreed to acquire Karuna Therapeutics for a total of $14.0 billion, strengthening its neuroscience portfolio. Under the terms of the deal, BMS will acquire all outstanding shares of Karuna Therapeutics common stock for $330.00 per share in cash. This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023.

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2023 in review: Cancer vaccines dose up on advances with tailored approaches 

Pharmaceutical Technology

As the number of patients with cancers continues to grow globally, research into personalised cancer vaccines is vital.

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MeiraGTx sells XLRP gene therapy to Janssen

European Pharmaceutical Review

MeiraGTx has entered into an asset purchase agreement with Janssen Pharmaceuticals for the remaining interests in botaretigene sparoparvovec (bota-vec) a gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP). Under the agreement, MeiraGTx is to receive $130 million in upfront and near-term milestone payments. The company will receive up to an additional $285 million in cash payments upon first commercial sales of bota-vec in the US and EU, as well as for manufacturing technology

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A look back at 2023: Smith + Nephew

pharmaphorum

This year brought about a whole gambit of news and developments, of conferences and launches, all coming in thick and fast and excited about the pharmaceutical industry and healthcare system. Not least of these was Smith + Nephew’s opening of a new state-of-the-art surgical innovation and training centre in the heart of Munich, Germany, on 11th October.

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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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PHARMA BRAND PLANNING IN 2024: CONSIDER THESE 3 FACTORS

eMediWrite

Every year, pharma marketing teams engage in multi-phased, cross-functional, multi-organizational strategic planning and also in aligning work-stream dubbed “Brand Planning” by many in the industry. Brand planning is often a three-phased process that includes Strategic Planning, Tactical Planning, and Budget Planning. Every quarter, marketing teams (Consumer, HCP, and Payer) align on the brand’s mission, strategic imperatives, and high-level programs.

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FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

pharmaphorum

AstraZeneca and Ionis get first approval for ATTR polyneuropathy drug Wainua (eplontersen), a rival to drugs from Alnylam and Pfizer

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Revolutionizing Healthcare Recruitment: The Role of Medical Staffing Agencies in Talent Acquisition

Rep-Lite

In today’s competitive healthcare landscape, the role of medical staffing agencies stands as a critical force in sourcing and securing top-tier talent for crucial roles such as healthcare and medical sales representatives, along with medical device specialists. These agencies serve as integral partners in the talent acquisition process, offering specialized expertise and resources that streamline recruitment and elevate the quality of healthcare professionals entering the field.

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Bausch Health gets grant for implantable corneal and intraocular mask with controllable opacity

Pharmaceutical Technology

Improve Vision with Implantable Corneal and Intraocular Implants - Patent Granted to Bausch Health Companies Inc. Discover a method for clear visualization of the eye using a photochromic polymer mask and controlled external stimuli.

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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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Treating Psoriasis While Providing Patient Support

Pharmaceutical Commerce

Camille Lee discusses the impact of commercial availability of Bimzelx for the treatment of moderate-to-severe plaque psoriasis in adults, along with the value of patient assistance/affordability programs.

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Greater Gift: Spreading Gratitude in Clinical Research

Zymewire

As we all unwind for the holidays, we’re taking a break from the realm of prospecting in biopharma to highlight a group of folks who have woven the spirit of giving into the fabric of clinical research. Founded with a profound purpose – to elevate awareness, foster trust, and extend the gift of health to those in need – Greater Gift stands as a beacon of appreciation for unsung heroes of clinical trials.

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Angelini files patent for method and apparatus for producing fluff-free absorbent cores

Pharmaceutical Technology

Angelini Spa has filed a patent for a method and apparatus to produce fluff-free absorbent cores for sanitary articles. Discover how loose fibers and superabsorbent granular material are mixed and bound together to create an absorbent structure.

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FDA Approves Eplontersen for the Treatment of Adult Patients With ATTRv-PN

Pharmacy Times

The drug is the first medicine to be approved for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis that can be self-administered.

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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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10 of our most read articles in 2023

PharmaVoice

A presidential candidate, a changing biotech market and an enduring murder mystery — here are PharmaVoice’s most-read articles this year.

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BioNTech-DualityBio’s endometrial cancer ADC gains breakthrough status 

Pharmaceutical Technology

The US FDA has granted breakthrough therapy designation for BioNTech and DualityBio's BNT323/DB-1303 to treat advanced endometrial cancer.

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Growing Body of Data Suggest Nicardipine is Safe, Effective for Hypertensive Crises in Adults With Reduced Ejection Fractions

Pharmacy Times

In a study, most patients had specified SBP targets of less than 160 mmHg and all patients attained goal within a relatively short period of time.

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China approves Takeda’s Livtencity for post-transplant CMV infection

Pharmaceutical Technology

The China NMPA approved Takeda’s Livtencity to treat adults with post-HSCT or solid organ transplant cytomegalovirus infection/disease.

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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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Phase 2 Study Results Show Psilocybin Reduces Depressive Symptoms in Adult Patients With Cancer

Pharmacy Times

The investigators note that psilocybin’s effectiveness in treating depressive symptoms and the positive reception among patients with cancer are encouraging continued research.

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ImmunoScape and EDDC partner to develop TCR-based therapeutics

Pharmaceutical Technology

ImmunoScape has signed a collaboration with EDDC to develop new T cell receptor (TCR)-based bispecific molecules for solid tumours.

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Researchers Link Pandemic-Associated Financial Hardships to Severe, Persistent COVID-19

Pharmacy Times

Families that reported a lower income before the pandemic were more likely to experience hardships if headed by an adult with COVID-19 illness.

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Ono and EVQLV partner to develop new antibody drugs

Pharmaceutical Technology

Ono has signed an agreement with EVQLV to utilise its AI-powered antibody design engine for the development of new antibody drugs.

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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.