Thu.Mar 14, 2024

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BeiGene finally snags FDA approval for PD-1 drug Tevimbra after long delay, Novartis breakup

Fierce Pharma

Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead. | Twenty months after the FDA's original target decision date, BeiGene has finally received the U.S. go-ahead for its PD-1 inhibitor Tevimbra.

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GE HealthCare & Mass General Brigham Have a Plan to Accelerate Their AI Research

MedCity News

At HIMSS, GE HealthCare and Mass General Brigham announced that they are integrating foundation models into their collaborative AI research and development. Foundation models could help developers create healthcare AI tools “10 times faster than in the past,” according to Parminder Bhatia, GE HealthCare’s chief AI officer.

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Bristol Myers nabs new FDA nod as Breyanzi brings CAR-T class to chronic lymphocytic leukemia

Fierce Pharma

Just as BeiGene’s Brukinsa encroaches on C | Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf.

FDA 299
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A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

FDA 132
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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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NICE not sold on Vertex, CRISPR's groundbreaking sickle cell gene therapy Casgevy without more data

Fierce Pharma

Ever since Vertex and CRISPR therapeutics scored a groundbreaking U.K. | In its draft guidance, the U.K.'s cost effectiveness watchdog recognized the need for the sickle cell therapy but needs more data from Vertex on its effectiveness in an updated managed access proposal.

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AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

MedCity News

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug.

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More Trending

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GLP-1s Alone Are Not the Answer to America’s Obesity and Chronic Illness Crises

MedCity News

Obesity/overweight is a significant causal factor in chronic illness and cancer. Weight loss can help people with obesity/overweight avoid and/or manage chronic illness. GLP-1s cause weight loss. So, are GLP-1s the answer to America’s obesity and chronic illness crises? Not if we overlook a key problem at the heart of both challenges: lack of access to nutritious food in the land of plenty.

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Biocon continues to divest with $150M sale of insulin and other brands to Eris

Fierce Pharma

Biocon and Eris have expanded a previous agreement, with Biocon selling Indian branded formulations businesses to Mumbai-based Eris for $150M.

Sales 246
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Eli Lilly-backed Zephyr AI secures $111m for precision medicine tech

Pharmaceutical Technology

The funds will be used to expand Zephyr AI's headcount and enhance datasets.

Medicine 124
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GLP-1 surge, oncology stars to power industry's earnings growth over the next 18 months: Moody's

Fierce Pharma

The commercial frenzy of GLP-1 medicines from Eli Lilly and Novo Nordisk has not only resulted in skyrocketing revenue for both companies, it's also expected to be a major driving force behind the | Booming demand for GLP-1 medicines from Novo Nordisk and Eli Lilly has prompted Moody's Ratings to move its 12- to 18-month industry earnings outlook to "positive" after sticking to "stable" since 2022.

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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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Swedish researchers develop new AI computer model to detect lymphatic cancer

PharmaTimes

In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancers

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HiLabs Secures $39M for AI-Powered Data Management Solutions

MedCity News

HiLabs’ Series B funding round was led by Denali Growth Partners and Eight Roads Ventures and included participation from F-Prime Capital. In total, HiLabs has raised about $41 million.

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AstraZeneca buys rare disease firm Amolyt for $1.05bn

pharmaphorum

AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.

Pharma 115
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Roche partners with Cardiff researchers to uncover new research into dementia

PharmaTimes

Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisions

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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

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Cybin bags breakthrough tag for psychedelic depression drug

pharmaphorum

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

FDA 115
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EMA pins lack of long-term data as rationale for Novartis’ failed Vijoice bid

Pharmaceutical Technology

The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.

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Deep learning model ‘detects 90% of lymphatic cancer cases’

pharmaphorum

Researchers have developed an artificial intelligence algorithm to assist in the diagnosis of lymph node cancer from medical images that has an accuracy of around 90%. The team carried out a retrospective study on the deep learning model, using PET-CT scans from more than 5,000 patients treated for lymphoma at Memorial Sloan Kettering Cancer Centre in the US and the Medical University of Vienna in Austria.

Medical 111
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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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

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German biotech Tubulis raises €128m for ADC trials

pharmaphorum

Munich-based antibody-drug conjugate (ADC) specialist Tubulis has completed a sizeable Series B2 financing that shows sustained investor appetite for the ADC category, particularly for companies with technologies that can enhance the safety of these drugs.

Safety 105
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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Build My Health Webinar Highlights New Age for Physician Practices with Rise of GLP1 Drugs for Obesity [Sponsored]

MedCity News

In a webinar last week, BuildMyHealth CEO and Co-founder Dr. Jonathan Kaplan shared how physician practices not only can access the weight loss drug by working with compounding pharmacies, but also use BuildMyHealth to provide this drug to their own patients who are suitable candidates for the drug.

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Innovative method could offer cost-effective sterilisation approach

European Pharmaceutical Review

Research by Terrones-Fernandez et al. has demonstrated a simple, novel system for preparing microbiological culture media, and consequently, development of a new sterilisation method. To evaluate the new sterilisation system, the researchers compared the microbiological properties of media prepared in a microwave (for different exposure times) with those of autoclaved sterilised media.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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BIO casts WuXi adrift and backs crackdown on Chinese biotech

pharmaphorum

BIO will sever ties with WuXi AppTec and support the BIOSECURE Act, which would ban federal contracts with Chinese biotechs on national security grounds

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Manufacturing facility expansion to advance next-gen vaccine

European Pharmaceutical Review

Overall, the goal of expanded facility is to strengthen [SK biosciences] manufacturing capabilities for global supply [of the pneumococcal conjugate vaccine candidate GBP410]” SK bioscience has announced its manufacturing plant L HOUSE, in Andong, Gyeongsangbuk-do, South Korea, is set to have a facility expansion. The new space will be provide a production base for the next-generation pneumococcal conjugate vaccine candidate GBP410 (SP0202), jointly developed by SK bioscience and Sanofi.

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Elranatamab Maintains or Improves Symptoms and Health Status of Patients With Multiple Myeloma

Pharmacy Times

This finding was evident in both examined groups and regardless of the patients' B-cell maturation antigen-directed therapy status.

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Boehringer collaboration could advance first-in-class schizophrenia treatments

European Pharmaceutical Review

Boehringer Ingelheim and Sosei Group Corporation (Sosei Heptares) have agreed a new partnership, which could result in the development of a new schizophrenia treatment targeting GPR52. The companies will work to develop and commercialise Sosei Heptares’ portfolio of first-in-class GPR52 agonists, a novel G protein-coupled receptor (GPCR) target, with the aim of providing a novel precision treatment that addresses positive, negative, and cognitive symptoms of schizophrenia.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Breakthrough Therapy Designation Granted to Novel Psychedelic Molecule CYB003 for Major Depressive Disorder

Pharmacy Times

At 4 months, 75% of participants achieved remission and no longer showed signs of depression symptoms in a phase 2 clinical trial.

FDA 59
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Almirall to license Eloxx’s ZKN-013 for rare skin conditions

Pharmaceutical Technology

Almirall has signed a licence agreement to gain the rights for Eloxx Pharmaceuticals’ ZKN-013 for rare dermatological disease indications.

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FDA Approves Maralixibat for Treatment of Pediatric Patients With PFIC

Pharmacy Times

The drug is indicated for patients 5 years of age and older with progressive familial intrahepatic cholestasis and cholestatic pruritus in pediatric patients with Alagille syndrome.

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Unveiling the Roadmap: Navigating Medical Sales Rep Requirements

Rep-Lite

Medical sales representatives are the medium through which medical companies sell their healthcare products to providers like hospitals and clinics. They build relationships, understand needs, and offer tailored solutions to these healthcare providers. Medical sales rep requirements include technical knowledge of medical equipment and technologies, sales skills, and interpersonal abilities.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A