February, 2024

article thumbnail

'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.

278
278
article thumbnail

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.

Pharma 162
article thumbnail

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.

143
143
article thumbnail

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.

article thumbnail

AI in Marketing & Sales: Today’s Tools, Tomorrow’s Potential

Speaker: Kevin Burke

AI is reshaping marketing and sales, empowering professionals to work smarter, faster, and more effectively. This webinar will provide a practical introduction to AI, focusing on its current applications, transformative potential, and strategies for successful implementation in your organization. Using real-world examples and actionable insights, we’ll examine how businesses are leveraging AI to increase efficiency, enhance personalization, and drive measurable results.

article thumbnail

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.

Biopharma 140
article thumbnail

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.

Patients 137

More Trending

article thumbnail

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

135
135
article thumbnail

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.

142
142
article thumbnail

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

FDA 131
article thumbnail

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.

article thumbnail

5 Ways You Can Win Faster with Gen AI in Sales

Incorporating generative AI (gen AI) into your sales process can speed up your wins through improved efficiency, personalized customer interactions, and better informed decision- making. Gen AI is a game changer for busy salespeople and can reduce time-consuming tasks, such as customer research, note-taking, and writing emails, and provide insightful data analysis and recommendations.

article thumbnail

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.

Patients 130
article thumbnail

Pfizer fleshes out oncology strategy, targeting 8 blockbuster cancer drugs by 2030

Fierce Pharma

In what CEO Albert Bourla called an update to a top priority at Pfizer, the company on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of antibody-dru | Pfizer on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of Seagen. The company aims to have at least eight blockbuster cancer drugs by 2030, with a focus on four main cancer types.

64
article thumbnail

Researchers identify new treatment target for genetic epilepsy

PharmaTimes

The rare neurodevelopmental condition CDKL5 is characterised by early-onset epilepsy

133
133
article thumbnail

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.

135
135
article thumbnail

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.

article thumbnail

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.

Food 126
article thumbnail

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.

article thumbnail

Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

310
310
article thumbnail

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.

Food 298
article thumbnail

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

article thumbnail

Already rolling in diabetes and obesity, Eli Lilly touts tirzepatide's midstage MASH win

Fierce Pharma

In a midstage trial, Eli Lilly’s star diabetes and weight-loss drug tirzepatide showed promise in fatty liver disease, a difficult-to-treat condition that doesn’t yet have an FDA-approved therapy.< | Eli Lilly's star diabetes and weight loss drug tirzepatide showed promise in fatty liver disease with a massive anti-MASH benefit accompanied by a "clinically meaningful" anti-fibrosis effect.

FDA 298
article thumbnail

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.

FDA 290
article thumbnail

Astellas' sales expectations are up for Padcev, down for Veozah

Fierce Pharma

Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has

Sales 286
article thumbnail

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.

Marketing 282
article thumbnail

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

article thumbnail

Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

279
279
article thumbnail

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic

Fierce Pharma

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10

article thumbnail

Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023

Fierce Pharma

With Merck reporting a whopping $25 billion sales haul for | With Merck reporting a whopping $25 billion sales haul for Keytruda on Thursday, the PD-1 cancer superstar appears to be the world’s top-selling drug in 2023. Keytruda looks set to take over the top spot from Pfizer and BioNTech’s Comirnaty, which ruled the previous two years, scoring sales of $55.9 billion in 2022 and $55.1 billion in 2021.

Sales 278
article thumbnail

Novartis CEO’s 2023 pay rises 21% as Roche's helmsman nets $11M in his first year

Fierce Pharma

After leading Novartis and Roche through pivotal years in 2023, the CEOs of the Swiss drug giants each netted multimillion-dollar compensation packages. | After leading Swiss drug giants Novartis and Roche through pivotal years, their CEOs have each netted multimillion-dollar compensation packages for 2023.

Leads 277
article thumbnail

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.

article thumbnail

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.

article thumbnail

Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350

Fierce Pharma

Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.

273
273
article thumbnail

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.

Education 273
article thumbnail

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.

article thumbnail

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.