Fri.Sep 13, 2024

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After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug

Fierce Pharma

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.

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The Apple AirPods Pro Have a New Hearing Feature, Yet the Biggest Impact May be to Protect Us All From Noise

MedCity News

Apple’s new Loud Sound Reduction capability scans the environment 46,000 times a second for sudden peaks in sound, reducing them to a safe level. The post The Apple AirPods Pro Have a New Hearing Feature, Yet the Biggest Impact May be to Protect Us All From Noise appeared first on MedCity News.

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Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

Fierce Pharma

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.

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Into the unknown: How quickly can vaccines be developed for Disease X

Pharmaceutical Technology

R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.

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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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ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases

Fierce Pharma

Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.

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Why Former FDA & Verily Exec Amy Abernethy Is Launching a New Venture

MedCity News

This week, longtime healthcare veterans Amy Abernethy and Brad Hirsch teamed up to launch Highlander Health — a Dallas-based startup focused on accelerating clinical evidence generation. The post Why Former FDA & Verily Exec Amy Abernethy Is Launching a New Venture appeared first on MedCity News.

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Improved Access to CGM Data Empowers Providers and Patients to More Effectively Partner on  Diabetes Management

MedCity News

Continuous Glucose Monitoring tools are revolutionizing the way diabetes is managed, offering unparalleled benefits for both healthcare providers and patients. By providing continuous, accurate data, CGM is especially useful for remote monitoring, enabling timely interventions and leading to better user health. The post Improved Access to CGM Data Empowers Providers and Patients to More Effectively Partner on Diabetes Management appeared first on MedCity News.

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ESMO: GSK's Zejula misses survival goal in first-line ovarian cancer, as Pharma&'s combo disappoints

Fierce Pharma

In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. | In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. Another study showed that Pharma&’s attempt to enhance its Rubraca with Bristol Myers Squibb’s Opdivo seriously backfired.

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A Closer Look at FIT Tests – A Primer on the Various Options for Colorectal Cancer Screening

MedCity News

As we confront the sobering statistics and growing impact of colorectal cancer, it’s clear that more education about the various options for testing is needed to increase screening rates across the U.S. The post A Closer Look at FIT Tests – A Primer on the Various Options for Colorectal Cancer Screening appeared first on MedCity News.

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ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop

Fierce Pharma

As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. | AstraZeneca is detailing Truqap's pivotal trial flop in triple-negative breast cancer, a result that could raise additional doubts around the first-in-class AKT inhibitor.

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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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Charlie Health Partners with Cartwheel to Address the Student Mental Health Crisis

MedCity News

Through a new partnership, students at schools within Cartwheel’s network in need of higher acuity care can access treatment through Charlie Health. The post Charlie Health Partners with Cartwheel to Address the Student Mental Health Crisis appeared first on MedCity News.

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ESMO: Merck unpacks a mixed bag of gynecological cancer results for Keytruda

Fierce Pharma

Even for Merck’s oncology powerhouse Keytruda, the emerging role of immunotherapies in gynecological cancer treatment represents a bit of a mixed bag. | The company unveiled new data from its KEYNOTE-A18 study in late stage cervical cancer and its failed KEYNOTE-B21 trial testing Keytruda as an adjuvant therapy in newly diagnosed endometrial cancer.

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Apple AirPods get FDA okay for use as OTC hearing aids

pharmaphorum

It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.

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Who’s winning in biotech’s tight market?

PharmaVoice

Three of the largest fundraising rounds in 2024 show where investors are willing to place their bets in biotech.

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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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Lilly ramps up Irish manufacturing investment by $1bn

pharmaphorum

Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing sector.

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3 Biotech IPOs, $703M Raised for Clinical Trials in Cancer, Immunology & Endocrine Disorders

MedCity News

Bicara Therapeutics’ IPO raised $315 million raised for Phase 3 testing of a bifunctional antibody drug with potential to become a first-line treatment for head and neck cancers. Zenas BioPharma and MBX Biosciences also went public; all three companies upsized their IPOs. The post 3 Biotech IPOs, $703M Raised for Clinical Trials in Cancer, Immunology & Endocrine Disorders appeared first on MedCity News.

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FDA approves Roche’s Tecentriq Hybreza for cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

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Syneos Health Communications takes the crown at PM Society Digital Awards

pharmaphorum

The PM Society Digital Awards 2024, an annual event in the healthcare marketing industry sponsored by Twist Health, held its 15th ceremony at The Brewery in London on 12th September.

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

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Japan approves updated Covid-19 vaccine to tackle JN.1 variant

Pharmaceutical Technology

Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.

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Nxera and Cancer Research UK to present promising cancer drug trial at ESMO

PharmaTimes

Innovative immunotherapy drug HTL0039732 shows potential in trials

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US puts $25m behind Cellino's cell and tissue printing tech

pharmaphorum

Cellino Biotech has received funding from the US government to develop a scalable biomanufacturing platform for personalised regenerative medicines derived from patients' own stem cells.The $25 million award from the Advanced Research Projects Agency for Health (ARPA-H) will be used to develop Cellino's NEBULA system, which according to the firm's chief technology Matthias Wagner can "effectively print new cells and new tissues for patients using their own DNA.

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World Sepsis Day 2024 highlights need for better sepsis treatments

PharmaTimes

GlobalData emphasises importance of Improved clinical trials

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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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Sales Training Redefined: AI-Driven Onboarding and Realistic Role Play

Quantified

Introduction Sales enablement is transforming, driven by advancements in artificial intelligence (AI). Traditional sales training methods, while foundational, often fall short in delivering the speed, personalization, and realism required in today’s competitive market. AI is revolutionizing key pillars of sales enablement, particularly in onboarding new hires and conducting realistic role-play scenarios.

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New Frontiers in Technology: AI Use in Clinical Trial Patient Recruitment in Health Systems

Pharmacy Times

AI is significantly enhancing the efficiency of identifying and enrolling patients.

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Pacteon Adds to Automation Solution Exhibit for Pack Expo 2024

PharmaTech

Descon Conveyor Systems is joining Pacteon’s portfolio, and its product will be shown alongside those from Schneider Packaging Equipment and Phoenix Stretch Wrappers.

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Armed with $100m funding, F2G prepares to refile antifungal

pharmaphorum

UK biotech F2G has raised $100 million as it prepares to refile its olorofim candidate for invasive fungal infections, which was turned down last year by the FDA.The Manchester-based company said the new cash will help it to complete the late-stage development of olorofim, a novel oral antifungal for invasive aspergillosis and other serious fungal infections, to support the company during the regulatory review process, and prepare for a commercial launch in the US.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Experts Develop Multimodal Approach for Treating Long COVID, Other Post-Acute Infectious Syndromes

Pharmacy Times

In the absence of a common treatment for long COVID, researchers from around the world documented the best currently available therapies.

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How to Hire the Best Talent in Medical Sales

Rep-Lite

In the medical sales industry, competition is fierce and the demand for innovative healthcare products is high. Having a top-tier sales team isn’t just an asset—it’s a necessity for driving business growth. Without skilled sales professionals, even the best products can struggle to gain traction in a crowded market. So, how do you build a medical sales team that excels?

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Remote Interventions From Pharmacists Shown to Improve Blood Glucose Control for Type 2 Diabetes

Pharmacy Times

Data show the value of the pharmacist is clear for patients with type 2 diabetes, as their role can have a significant impact on reductions in hemoglobin A1c.

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APIIC Receives $14M Award for Development, Production of Three APIs

PharmaTech

The critical APIs that this funding will contribute to are used in the treatment of asthma, diabetes, and anxiety disorders.

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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