Fierce Pharma

OCTOBER 18, 2024

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.

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pharmaphorum

OCTOBER 18, 2024

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

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Leads 119

Fierce Pharma

OCTOBER 18, 2024

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.

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MedCity News

OCTOBER 18, 2024

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.

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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.

Sales

Fierce Pharma

OCTOBER 18, 2024

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.

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FDA 244

MedCity News

OCTOBER 18, 2024

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.

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MedCity News

OCTOBER 18, 2024

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.

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Fierce Pharma

OCTOBER 18, 2024

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.

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Manufacturing Pharma 237

pharmaphorum

OCTOBER 18, 2024

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

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Fierce Pharma

OCTOBER 18, 2024

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.

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Patients 130

Advertiser: ZoomInfo

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.

Sales

pharmaphorum

OCTOBER 18, 2024

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

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FDA 115

Pharmaceutical Technology

OCTOBER 18, 2024

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

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pharmaphorum

OCTOBER 18, 2024

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

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MedCity News

OCTOBER 18, 2024

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.

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Pharmaceutical Technology

OCTOBER 18, 2024

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

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Marketing Sales 107

MedCity News

OCTOBER 18, 2024

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.

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Patients 109

Pharmaceutical Technology

OCTOBER 18, 2024

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

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FDA 98

MedCity News

OCTOBER 18, 2024

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.

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Advertiser: ZoomInfo

In today’s ultra-competitive markets, it’s no longer enough to wait for buyers to show obvious signs of interest. Instead, sales teams must be proactive, identifying and acting on nuanced buyer behaviors — often before prospects are fully ready to make a purchase. In this eBook from ZoomInfo & Sell Better, learn 10 actionable ways to use these buyer signals to transform your sales strategy and close deals faster.

Sales Strategy

PharmaTech

OCTOBER 18, 2024

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

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Pharmaceutical Commerce

OCTOBER 18, 2024

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.

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PharmaVoice

OCTOBER 18, 2024

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

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Pharmacy Times

OCTOBER 18, 2024

The clinical hold is a result of a reported case of motor neuropathy in a phase 2 trial participant.

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FDA 63

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European Pharmaceutical Review

OCTOBER 18, 2024

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.

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Side effects Food and Drug Administration Food Patients 59

Pharmaceutical Commerce

OCTOBER 18, 2024

The latest news for pharma industry insiders.

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Ethics Pharma Media 59

Pharmacy Times

OCTOBER 18, 2024

The additions include Dextrose 70% intravenous (IV) solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution, which were affected by Hurricane Helene.

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FDA 58

PharmaTech

OCTOBER 18, 2024

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

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Advertiser: ZoomInfo

As prospects define their problem, search for solutions, and even change jobs, they are generating high-value signals that the best go-to-market teams can leverage to close more deals. This is where signal-based selling comes into play. ZoomInfo CEO Henry Schuck recently broke down specific ways to put four key buying signals into action with the experts from 30 Minutes to President’s Club.

Prospecting

Pharmacy Times

OCTOBER 18, 2024

Zolbetuximab is the first approved CLDN18.2-targeted treatment for gastric and gastroesophageal junction adenocarcinoma.

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FDA 54

PharmaTech

OCTOBER 18, 2024

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

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Pharmacy Times

OCTOBER 18, 2024

Recognizing repeat dosing efforts is important to improving outcomes in patients with Guillain-Barré syndrome who do not respond to IVIG.

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Patients 52

Pharmaceutical Technology

OCTOBER 18, 2024

A Phase IIb/III trial with infants entering their first respiratory syncytial virus (RSV) season met its primary endpoints.

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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

Patients