February, 2024

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'The Top Line': Gene editing's next act

Fierce Pharma

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

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AI in Pharma: Navigating New Frontiers in Drug Discovery and Development

Pharma IQ

Bringing a new drug to market typically takes a decade or more and approximately US$2.5 billion. However, new technology, including AI, can dramatically shorten the drug discovery process and reduce t.

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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2024 Journal Citation Reports: Changes in Journal Impact Factor category rankings to enhance transparency and inclusivity

Clarivate

New – unified rankings for each of our 229 science and social science categories; no Journal Impact Factor (JIF) rankings for the arts and humanities categories The scholarly landscape is witnessing a significant increase in both the quantity and sophistication of fraudulent behaviors, posing a substantial threat to the integrity of the scholarly record.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Viking Therapeutics Obesity Drug’s Data Raise Best-in-Class Expectations

MedCity News

The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.

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Enhancing Patient Care: 4 Strategies for Life Sciences Companies

Salesforce

For many people, a sudden tingling in the leg or a feeling of numbness in the arm isn’t too much cause for alarm. The tingling or the numbness goes away after a little while, and they go on with their lives. But for Brooke Eby, an abrupt limp on her way to a conference one day ultimately led to a diagnosis of amyotrophic lateral sclerosis (ALS) at the age of 33.

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More Trending

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Positive results for MAIA’s SCLC treatment published in Nature Communications

PharmaTimes

The aggressive type of cancer accounts for 13% of all lung cancer cases worldwide

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MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

Pharmaceutical Technology

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

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New era for cell therapy as FDA OKs first for solid tumours

pharmaphorum

Iovance Biotherapeutics has become the first company to win FDA approval for a cell therapy used to treat a solid tumour, Amtagvi for melanoma

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Overcoming Hearing Healthcare Barriers to Realize Gene Therapy Promise

MedCity News

The preliminary results from three clinical trials administering gene therapy to address deafness from otoferlin mutations mark inspiring and incredible progress in hearing healthcare.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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The AI-Powered Path to Revolutionising Rare Disease Research

Pharma IQ

Explore how AI/ML can accelerate rare disease research and clinical trials, by enhancing inclusivity and efficiency, to deliver new drugs and therapeutics to patients. With insights from Dr. Harsha Ra.

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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

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Study reveals SARS-CoV-2 can infect dopamine neurons causing senescence

PharmaTimes

Dopamine neuron senescence is a hallmark of Parkinson’s disease

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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

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Roche’s Xolair is first medicine for food allergy in US

pharmaphorum

Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.

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Tampa General Hospital CEO on Change Healthcare Breach: They Are Going To Have To Give an Update Soon

MedCity News

In an interview at the Vive conference in Los Angeles, John Couris said that while he is sympathetic toward Change Healthcare’s current woes, he wants definitive answers soon.

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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.

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PBMs take bulk of blame as senators question BMS, J&J and Merck CEOs on high drug prices in US

Fierce Pharma

Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.

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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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FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Fierce Pharma

Mark your calendars, oncology drug and CAR-T therapy developers. | Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

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Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'

Fierce Pharma

While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.

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Travere's Filspari, J&J's Carvykti win support from CHMP in blitz of positive recommendations

Fierce Pharma

A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.

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AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires

Fierce Pharma

Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany

Fierce Pharma

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. | Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08 billion) into an expansion of its production facility in Pfaffenhofen an der Ilm, Germany.

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J&J consumer health spinoff Kenvue telegraphs 100-plus layoffs in California, New Jersey

Fierce Pharma

While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a swanky new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the tran | While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition.

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To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align

Fierce Pharma

Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.

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AstraZeneca hit CEO Pascal Soriot's $45B revenue goal after all. But is Enhertu approaching a plateau?

Fierce Pharma

With $45.8 billion in 2023 revenues, AstraZeneca has met the $45 billion-by-2023 goal CEO Pascal Soriot established in 2014 when he was fending off a takeover bid from Pfizer. | AstraZeneca has met the $45 billion-by-2023 revenue goal that CEO Pascal Soriot established in 2014. But questions have emerged for one of the company's key growth drivers.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Merck still in the market for deals in the $1B to $15B range, CEO says

Fierce Pharma

Even after the acquisitions of Prometheus and Acceleron, Merck is ready to make more deals in the $1 to $15 billion range, according to CEO Rob Davis.

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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

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Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Fierce Pharma

Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.

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Novartis, zeroing in on innovative meds, launches strategic review of India outfit

Fierce Pharma

A Novartis subsidiary in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines. | A Novartis subsidiary handling old products in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten