Fri.Oct 18, 2024

article thumbnail

Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy

Fierce Pharma

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

FDA 322
article thumbnail

Sanofi invests €300m in Orano Med's lead-based radioligands

pharmaphorum

Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c

Leads 112
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Baxter to import 18,000 tons of IV product by year-end as hurricane recovery efforts continue in NC

Fierce Pharma

As recovery efforts at the North Carolina plant hit by Hurricane Helene move at an “encouraging pace,” Baxter International is laying out new details on a sweeping importation plan to help critical | Baxter has said the first IV product shipments cleared by the FDA for temporary importation are set to arrive in the U.S. this weekend. By the end of the year, the company expects nearly 18,000 tons of product from Europe and Asia to reach The States.

FDA 313
article thumbnail

Nearly 7,000 US Healthcare Devices & Records Are Exposed to the Public Internet, Research Shows

MedCity News

New research shows that there are more than 14,000 unique IP addresses across the globe exposing patients’ potentially sensitive medical information on the public internet. Nearly half of these exposures are in the U.S. The post Nearly 7,000 US Healthcare Devices & Records Are Exposed to the Public Internet, Research Shows appeared first on MedCity News.

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

Gilead pulls Trodelvy's approval in bladder cancer after trial flop, FDA discussions

Fierce Pharma

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S. | After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S.

FDA 281
article thumbnail

Overcoming Pharma’s Major Pain Points and Pitfalls With AI

MedCity News

This technological shift not only boosts efficiency and profitability for pharmaceutical companies but also speeds up the delivery of innovative therapies to patients. The post Overcoming Pharma’s Major Pain Points and Pitfalls With AI appeared first on MedCity News.

More Trending

article thumbnail

Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure

MedCity News

Gilead Sciences’ Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial carcinoma in 2021. The post Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure appeared first on MedCity News.

FDA 109
article thumbnail

Novo Holdings' $16.5B Catalent buyout in crosshairs as consumer groups ask FTC to block the deal

Fierce Pharma

Novo Holdings is encountering more resistance as it aims to close its $16.5 billion acquisition of pharma manufacturing giant Catalent by the end of the year. | A dozen consumer groups and trade unions penned a letter to Lina Khan, chair of the U.S. Federal Trade Commission, urging the antitrust agency to block Novo Holdings’ proposed $16.5 billion buyout of CDMO giant Catalent.

article thumbnail

mRNA licensing agreements surge 800% amid GSK lawsuits

Pharmaceutical Technology

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

111
111
article thumbnail

How Patient Support Can Ease Transitions to the Part D Redesign in 2025

Fierce Pharma

Nancy McGee, VP & GM U.S. Patient Support Services, IQVIAJennifer Millard, VP U.S. Integrated Patient Support Services, IQVIA | The 2025 Medicare Part D redesign will eliminate the “donut hole” and reduce out-of-pocket costs. Patient support is crucial for a smooth transition and better patient outcomes.

Patients 130
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

Unify Digital Publishing with MLR Review to Speed Compliant Content to Market

MedCity News

Organizations are delivering digital experiences and content to HCPs on a much larger scale than was previously possible. Integrating digital tools will advance things even further and help marketers and MLR teams maintain brand consistency and ensure compliance across digital and content operations. The post Unify Digital Publishing with MLR Review to Speed Compliant Content to Market appeared first on MedCity News.

Marketing 102
article thumbnail

MSD preparing to take on Beyfortus with RSV antibody

pharmaphorum

MSD reveals the data that could unlock filings for clesrovimab, a rival to Sanofi and AstraZeneca's Beyfortus for preventing infant RSV infections

106
106
article thumbnail

New Study Shows That Waymark Reduces ED, Hospital Visits for Medicaid Patients

MedCity News

Waymark’s community-based interventions reduce hospital and emergency department visits and improve care quality, according to a new study. The company supports Medicaid patients by connecting them with community health workers, therapists, pharmacists and care coordinators in their area. The post New Study Shows That Waymark Reduces ED, Hospital Visits for Medicaid Patients appeared first on MedCity News.

Patients 102
article thumbnail

BenevolentAI CEO steps down as founders make a comeback

pharmaphorum

Jörg Möller's sojourn as CEO of BenevolentAI has come to an abrupt end, as the firm names co-founder Ken Mulvany as executive chair

110
110
article thumbnail

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

article thumbnail

Which Startups Will Present at HLTH?

MedCity News

Startups will take part in four different competitions at HLTH. There will also be plenty of opportunities to network. The post Which Startups Will Present at HLTH? appeared first on MedCity News.

article thumbnail

AbbVie gets continuous Parkinson's drug over the line in US

pharmaphorum

AbbVie has finally claimed FDA approval for its 24-hour Parkinson's therapy Vyalev, 18 months after the US regulator turned it down

FDA 108
article thumbnail

EMA Denies Authorization of Duchenne Muscular Dystrophy Treatment, Again

PharmaTech

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

98
article thumbnail

Intercept’s liver disease drug Ocaliva faces FDA approval delay

Pharmaceutical Technology

An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary cholangitis.

FDA 98
article thumbnail

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

article thumbnail

The Rise of GLP-1 Drugs and the Challenges of Proper Disposal

Pharmaceutical Commerce

With great power comes great responsibility. In this case, tackling these obstacles is vital to making sure that the positives of GLP-1s are not outweighed by the downfalls of improper waste disposal.

64
article thumbnail

Opioid addiction market to reach $2.4 billion across 8MM by 2033

Pharmaceutical Technology

Late-stage pipeline products could drive combined sales of approximately $171.4 million by 2033 in the 8MM.

Marketing 107
article thumbnail

Immunotherapy treatment enhances lymphoma survival, landmark study shows

European Pharmaceutical Review

A new immunotherapy treatment regimen (nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD)) provided a significant survival rate in advanced Hodgkin lymphoma patients, Phase III trial data shows. This new treatment could decrease long-term side effects including second cancers later in life and heart and lung conditions, according to the researchers.

article thumbnail

Clinical staff that feel like ‘tech support’ — and other issues a CRO exec contends with

PharmaVoice

From tech-related challenges to an ongoing staffing crunch, Parexel’s CEO explains what the clinical trials industry is up against.

65
article thumbnail

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.

article thumbnail

AAPS PharmSci 360 2024: The Future of Bioanalysis

PharmaTech

Xiao-Yan Cai, PhD, co-founder and CEO of Accurant Biotech, discussed collaborative efforts that must be undertaken between companies, and across scientific disciplines, to work together on continuing to develop medicines to save lives.

article thumbnail

FDA Grants Priority Review to GSK’s Gepotidacin for Uncomplicated Urinary Tract Infections

PharmExec

Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.

FDA 52
article thumbnail

AAPS PharmSci 360 2024: How AI is Helping to Ensure Companies’ GMP Health

PharmaTech

Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.

article thumbnail

FDA Approves Expanded Indication for Lumryz in Pediatric Patients with Narcolepsy

PharmExec

Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

CPHI Milan 2024: Growth and Sustainability in the Pharma Industry

PharmaTech

Anil Andrade, vice-president of Global Sales at ACG World, shared insights about the growth in demand in the pharma industry and efforts put forth to achieve sustainable operations.

Pharma 52
article thumbnail

The confluence of Biological and Data Science Revolutions Driving Innovations in Life Sciences, An MIT Sloan CDO Q&A with Mathai Mammen, CEO of Fogpharma

PM360

Given that you have led big pharma (J&J) and smaller firms (Theravance and now FogPharma), what are the career prospects and trajectory for mid-career / newly graduating students wanting to enter this vertical? What would be your advice for prospective professionals seeking a career in big pharma versus smaller firms, including startups? Mathai: There is no better time to join the biopharmaceutical industry than now, whether the company is small or large, intending to make medicines or in he

article thumbnail

Measuring the ROI of Marketing Efforts

PharmExec

In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how CMOs effectively measure the return on investment (ROI) of their marketing efforts in the pharmaceutical industry, particularly in light of the long-term nature of drug development and approval processes.

article thumbnail

Unresolved clawback issues obstruct Greece’s potential pharmaceutical framework agreement

Pharmaceutical Technology

A potential three-year framework agreement between the Greek government and the pharmaceutical industry, starting at the beginning of 2025, has been the focus of recent discussions between the Ministry of Health (MoH) and associations representing the pharmaceutical industry in Greece.

article thumbnail

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