Tue.Nov 19, 2024

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action

MedCity News

The DEA recently announced the third extension of Covid-19 flexibilities for the virtual prescribing of controlled substances. Telehealth advocates applaud this move but remain hopeful for a more permanent solution in the future. The post Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action appeared first on MedCity News.

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Endo expands clonazepam recall to cover more than a dozen additional batches

Fierce Pharma

After a labeling mix-up prompted a recall of a popular panic disorder drug this summer, Endo’s U.S. subsidiary is widening the scope of its product pull. | Endo USA is expanding its previous recall of orally disintegrating clonazepam tablets to include more than a dozen additional product lots. The recall is being issued thanks to an “error by a third-party packager” that led to certain cartons displaying the wrong strength and National Drug Code for the product they contain, Endo said.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

Medicine 104
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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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England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo

Fierce Pharma

Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.

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Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding

MedCity News

The Silicon Valley startup formerly known as Ciitizen relaunched as Citizen Health. The company seeks to empower patients with access to their complete health history — and it’s starting off by focusing on patients with rare diseases. The post Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding appeared first on MedCity News.

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More Trending

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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

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KnippeRx Transforms Patient Assistance Programs through Technology and Patient-Focused Solutions.

Fierce Pharma

KnippeRx Transforms Patient Assistance Programs through Technology and Patient-Focused Solutions.

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Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025?

MedCity News

What concrete strategies should employers pursue to control rising costs while ensuring the best member experience and clinical outcomes? The post Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025? appeared first on MedCity News.

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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

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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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Merck Gets a Shot of Confidence From Pivotal Test of SubQ Injectable Keytruda

MedCity News

Merck said topline Phase 3 results show an injectable version of Keytruda met the main goal of non-inferiority compared to the intravenously infused formulation that is the pharma giant’s top-selling product. Injectable Keytruda could help Merck compete against coming competition from biosimilars. The post Merck Gets a Shot of Confidence From Pivotal Test of SubQ Injectable Keytruda appeared first on MedCity News.

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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New PAGB research highlights importance of self-care for easy-to-treat conditions

PharmaTimes

The census found that 56% of people visit their GP for a UTI and 27% for thrush

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J&J plots filings after psoriasis drug clears phase 3 test

pharmaphorum

Johnson & Johnson has moved a step closer to filing a potential first-in-class therapy for psoriasis after the drug hit the mark in a phase 3 trial

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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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How Counterfeit Medicines Challenge Pharma Sales in Malaysia

Contrarian Sales Techniques

Imagine spending weeks building trust with a doctor or pharmacist, only to find out that counterfeit versions of your product are circulating in the market. It’s a reality for many of us in pharma sales in Malaysia. Counterfeit medicines aren’t just a risk to patients’ health – they’re a blow to the industry’s reputation and our efforts to promote genuine, high-quality treatments.

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FDA says no to Astellas' geographic atrophy drug

pharmaphorum

Astellas has suffered another major setback with geographic atrophy (GA) treatment Izervay, this time in the US. The company has received a complete response letter (CRL) from the FDA for a proposed update to the labelling for Izervay (avacincaptad pegol) that sought to include the results of the phase 3 GATHER2 trial and improve the drug's competitive profile against rival Syfovre (pegcetacoplan) from Apellis.

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Novartis and Ratio to progress next-gen radiotherapeutic

European Pharmaceutical Review

Novartis Pharma AG has agreed to a radiotherapeutic radioligand therapy-focused license and collaboration with Ratio Therapeutics. Through this deal, Ratio is eligible to receive milestone payments up to $745 million. The collaboration will utilise Ratio’s expertise in radioligand therapy and its technology platforms for development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.

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AHA 2024: CV effectiveness of GLP-1RA + Empagliflozin therapy in adults with T2D

Pharmaceutical Technology

SGLT-2I therapies reduce the risk of heart failure and this study clearly demonstrates the benefit of adding them onto GLP-1RA therapy.

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

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Spread of Seasonal Flu Returns to Pre-Pandemic Levels After End of COVID-19 Global Emergency

Pharmacy Times

Increased global capacity for surveillance could help monitor seasonal influenza to reduce the risk of vaccine mismatch and inform effective interventions.

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Challenges and Triumphs in Next-Generation Biotherapeutic Development

PharmaTech

Webinar Date/Time: Fri, Dec 13, 2024 11:00 AM EST

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Pharma Sales in Malaysia: Why Relationships Matter Even More in Rural Areas

Contrarian Sales Techniques

Rural areas in Malaysia offer a unique challenge for pharma sales reps. Here, it’s not just about the product – it’s about the person behind the pitch. Building relationships in these regions goes beyond professional boundaries; it’s about trust, community, and a willingness to go the extra mile – sometimes literally. Why Relationships Are Key in Rural Areas In rural Malaysia, the healthcare ecosystem is often smaller and more close-knit.

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The Power of Proof: KOL Case Reports and Testimonials in Pharma Marketing

eMediWrite

In the competitive world of pharma marketing, trust isn’t just desirable—it’s essential. Product managers and marketers often ask themselves: How do we communicate value effectively while building credibility? One proven way is by leveraging KOL endorsed case studies and testimonials. Why Case Studies Work Case studies work by offering real-world proof of your product’s effectiveness.

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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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Pii Invests in Prefilled Syringe Capabilities

Pharmaceutical Commerce

The CDMO is investing $3.6 million toward boosting its advanced labeling, automated visual inspection, and fill-finish tech.

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Potential Legal Action Against PD-1 Inhibitor Label Restrictions for Gastric Cancers

PharmExec

Ron Lanton, Partner, Lanton Law, discusses potential challenges that will come as a result of the FDA’s recent move to tighten label restrictions on PD-1 inhibitors for gastric cancers.

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FDA shares additional draft guidance on CGTs

Pharmaceutical Technology

The FDA has released a draft of new guidance addressing common FAQs about the development of potential CGT treatments.

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The Impact of Alzheimer’s Disease Treatments on Health Equity

Pharmaceutical Commerce

Could health system changes that improve patient access to medication have a positive effect on societal welfare?

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Does Southeast Asia have a growing role in vaccine development?

Pharmaceutical Technology

The upcoming clinical trial conferences will host talks on supply chain resilience, AI’s growing role and forging industry partnerships.

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Looking to history to prepare for America’s uncertain future

pharmaphorum

Listen to an insightful podcast interview with Jesse Mendelsohn as he discusses looking to history to prepare for America's uncertain future. Explore valuable insights and perspectives on the topic.

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Regenxbio eyes 2026 filing for Duchenne muscular dystrophy gene therapy

Pharmaceutical Technology

Regenxbio’s plans toward a BLA filing in 2026 after positive data from the Phase I/II AFINITY DUCHENNE trial.

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PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

PharmaTech

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

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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