Thu.Jan 25, 2024

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Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more information on the cases that it has seen.

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Inside California’s Free Digital Health Platforms Supporting Child Mental Health

MedCity News

The California Department of Health Care Services launched the Behavioral Health Virtual Services Platform last week. The platform includes two digital health solutions: BrightLife Kids (developed by Brightline) for parents/caregivers and kids ages 0 to 12 and Soluna (developed by Kooth) for teens and young adults ages 13 to 25.

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PTC's re-examination bid for DMD drug Translarna falls short in Europe

Fierce Pharma

A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end. | A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end.

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Key Trends from the 2024J.P. Morgan Healthcare Conference

MedCity News

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry.

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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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In downsizing mode, Sage will move headquarters to a smaller space

Fierce Pharma

Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Ther | Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Therapeutics was on its way to becoming a “leaner and stronger company.” Part of that mission will come to fruition later this year with a move of its headquarters in Cambridge, Massachusetts.

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Bladder Cancer Therapies Developer Raises $380M in the First Biotech IPO of 2024

MedCity News

CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments.

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AWS to Infuse Another $20M Into Its Health Equity Program

MedCity News

AWS is funneling an additional $20 million into its health equity initiative, bringing the company’s total investment in the program to $60 million. As AWS continues to advance the mission of this program, the company is focusing on three main priorities: increasing access to high quality care, building resilient communities, and mitigating the harmful effects of climate change.

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Fierce Pharma Asia—Carvykti faces FDA adcomm; AZ drug picks up world-first approval; Samsung Bio's year of growth

Fierce Pharma

The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. | The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. AstraZeneca has won a world-first approval for its rare blood disorder add-on therapy in Japan.

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Eli Lilly EVP of Global Quality to retire

European Pharmaceutical Review

Eli Lilly and Company’s Executive Vice President of Global Quality, Johna Norton, is ending her lengthy tenure with the company this summer and retiring after 34 years of service. However, she will continue in her current role and remain as part of Eli Lilly’s Executive Committee of until 31 July 2024. “Johna’s career has been built on her commitment to ensuring that our medicines are produced with the highest quality standards.

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Novel Approaches Are Essential for Enabling Patient-First Outcomes in Value Based Care Models

MedCity News

Despite the significant challenges to improving U.S. health outcomes while reducing healthcare spending, I am heartened by the exciting ways in which government organizations and the private sector are innovating and deploying new technologies that can achieve these goals.

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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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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023. In addition to approaches evaluating E&L, the draft guidance also discussed evaluation of impurities and degradation products.

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INVEST 2024 Is Only 4 Months Away: Here’s a Sneak Peek at the Agenda

MedCity News

Panel discussions will include investment trends, women’s health, value-based care, employer health and more. Startups will also have the opportunity to meet with investors as part of our Ask the Investor program. The conference will be held May 21-22 at the Ritz Carlton in Chicago. Register today!

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. They detail the medication’s intended use, proper administration, potential side effects and precautions. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe.

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AZ may get government aid for UK vaccines facility; report

pharmaphorum

UK government is reported to be considering financial aid for AstraZeneca to seal a deal to expand a vaccines manufacturing facility in Speke

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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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Researchers identify gene that causes heart defects in Down syndrome

PharmaTimes

Around 50% of babies born with the condition are affected by heart defects

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Remote Parkinson’s monitoring tech backed by NICE

pharmaphorum

NICE firms up guidance backing NHS use of five digital health wearables for remote monitoring of Parkinson's disease patients

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Evaxion Biotech to develop new vaccines for cancer

Pharmaceutical Technology

Evaxion Biotech has announced plans to develop customised cancer vaccines by targeting a category of AI-discovered tumour antigens.

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Synnovation’s $102m round heads latest biotech financings

pharmaphorum

Our latest crop of biotech financings features rounds for Synnovation Therapeutics and Adicet Bio, Calluna Pharma, Accent Therapeutics, GenEdit and IMU Bio

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

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Unveiling the World of Clinical Recruiters

Rep-Lite

What’s the purpose of a career clinical recruiter? Clinical recruiters are specialized professionals within the healthcare industry, dedicated to filling vacancies in roles directly related to patient care or clinical research. They connect qualified candidates to institutions and companies while leveraging their in-depth knowledge of the healthcare field, specific specialties, and the intricacies of hiring within each domain.

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Glenmark licenses cancer drug from China’s Alphamab, 3D Med

pharmaphorum

Indian pharma Glenmark has licensed rights to subcutaneous PD-L1 inhibitor envafolimab from China’s Alphamab and 3D Medicines

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How to Improve Team Culture for Extraordinary Results

ALULA

In today’s workplace, it’s easy to wake up and find ourselves in a funk. A short break, chat with a mentor, or bit of self-care usually does the trick! But what happens when an entire team gets in a funk? The solution is less clear, and the impac t can strike a long-term blow to p erformance and engagement.

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Financing figures reveal resilience of UK biotech in 2023

pharmaphorum

UK biotech shows "resilience" in 2023, raising £1.

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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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Stop Feeling Like a Pinball: Four Foundations of Effective Performance Coaching That Take Just a Few Minutes a Day

ALULA

The first month of 2024 is almost over , and leaders are already finding themselves feeling like a pinball at work: bouncing around between meetings, reports, and decisions without finding – or taking – opportunities to prioritize something that guarantees swift productivity and progress: performance coach ing their people.

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Indication for Zynrelef Expanded to Include Orthopedic, Soft Tissue Procedures

Pharmaceutical Commerce

Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

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Winners of the 2024 Pharmapack Europe Awards are Announced

PharmaTech

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

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FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies

PharmExec

FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Warns Against Risk of Hypocalcemia in Patients With Kidney Disease Taking Prolia

Pharmaceutical Commerce

FDA adds Boxed Warning that the osteoporosis medication increases the risk for severe hypocalcemia in patients with advanced chronic kidney disease, especially among those undergoing dialysis

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How to use predictive analytics in healthcare to better anticipate market shifts

Clarify Health

In the healthcare sector, the strategic use of predictive analytics is crucial for providers aiming to maintain competitiveness. Leveraging data allows them to more accurately anticipate and adapt to market shifts and evolving patient needs. By effectively employing predictive analytics, healthcare providers can ensure they remain responsive and ahead of competitors.

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FDA Adds Boxed Warning to Amgen’s Prolia for Increased Risk of Severe Hypocalcemia

PharmExec

Severe hypocalcemia was found to be more common among patients with advanced chronic kidney disease with mineral and bone disorder who are taking Prolia for osteoporosis.

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Tremfya Produces Significant Improvements in Scalp Psoriasis in People of Color

Pharmaceutical Commerce

Patients treated with Tremfya (guselkumab) saw major improvements in scalp psoriasis clearance, itch reduction, and patient-reported health-related quality of life.

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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