Sat.Sep 23, 2023 - Fri.Sep 29, 2023

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NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer

Fierce Pharma

NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer aliu Wed, 09/27/2023 - 10:40

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Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

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AstraZeneca and SAS link up on AI and analytics

PharmaTimes

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

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Startup Syntax Bio Leverages CRISPR to Transform Cell Therapy Manufacturing

MedCity News

Syntax Bio’s technology platform uses CRISPR to direct stem cells to become a desired cell type in a process that’s more scalable and less expensive than current methods. The startup is raising a Series A round of financing to further demonstrate the potential of its technology.

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5 Ways You Can Win Faster with Gen AI in Sales

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.

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Eli Lilly moves to settle with whistleblower who flagged alleged manufacturing shortfalls

Fierce Pharma

After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlem | After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlement talks.

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Elderly exclusion: Clinical trials still fall short enrolling older adults

PharmaVoice

Despite high rates of disease in older populations, systemic issues are keeping them out of research studies.

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More Trending

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Digital Therapeutics: A Panacea for Care or Overvalued Health Tech?

MedCity News

Digital therapeutics will be one of the topics discussed at INVEST Digital Health scheduled for October 26 at Health Wildcatters headquarters in Pegasus Park in Dallas. Register today!

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Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fierce Pharma

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.

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Virtual Reality Headset Takes EEG Measurements

Medgadget

Researchers at the University of Texas at Austin have developed an electroencephalogram (EEG) sensor that is incorporated into a virtual reality headset. The technology can measure brain activity while someone is undergoing an immersive virtual reality experience. The device may assist in enhancing medical virtual reality interventions, such as those used to treat post-traumatic stress disorder or phobias, by revealing brain activity during different tasks or experiences that help clinicians to

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Women in Life Science Denmark launches leadership drive

PharmaTimes

Initiative has been designed to support career advancement for women across the life sciences - News - PharmaTimes

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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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Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

MedCity News

Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.

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Will Big Pharma engage in Medicare price negotiations? The verdict's not in

Fierce Pharma

Will Big Pharma engage in Medicare price negotiations?

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Driving Dosage Form Developments

PharmaTech

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

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UKHSA reaches vaccine deal with CSL Seqirus

PharmaTimes

Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes

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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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Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy

MedCity News

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

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Novartis targets first-line use for radiotherapy Lutathera with trial win in neuroendocrine tumors

Fierce Pharma

More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.

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Karuna Therapeutics files for FDA approval for schizophrenia treatment

Pharmaceutical Technology

Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.

FDA 111
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Chemo-free regimen demonstrates efficacy in NSCLC

European Pharmaceutical Review

Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III MARIPOSA study is the first to show a clinically meaningful benefit in a chemotherapy-free regimen compared to the small molecule treatment TAGRISSO ® ( osimertinib ). This is based on positive topline results for Rybrevant ® (amivantamab-vmjw) in combination with lazertinib, as first-line anti-cancer treatment in locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).

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

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4 States Received Enhanced Medicaid Funding During Covid Despite Wrongly Terminating Coverage

MedCity News

New York, Florida, Texas and Minnesota terminated Medicaid coverage for some enrollees for “unallowable or potentially unallowable reasons” during the Covid-19 public health emergency, according to a recent Office of Inspector General report.

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After Amicus scores FDA nod for Pompe disease combo, it's game on with Sanofi

Fierce Pharma

Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. | Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. Nearly a year later, the Philadelphia company has gained its long-awaited green light.

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CCC Pilots AI-disambiguated Researcher and Institution Data in RightFind Navigate

Copyright Clearance Center

September 28, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces the availability of AI-disambiguated data and enriched metadata, for researchers and institutions, within RightFind Navigate through a pilot for its customers. CCC also announces several powerful new features of the RightFind Suite.

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AI-supported spectroscopy delivers superior pharmaceutical packaging QC

European Pharmaceutical Review

A paper published in the IEEE Sensors Journal has demonstrated 100 percent inline pharmaceutical packaging content verification by combining standard diffuse reflectance MOEMS-EC-QCL spectroscopy with artificial intelligence (AI). It described how a quantum cascade laser (QCL)-based blister-verification sensor with verification via backscattering mid-infrared (IR) spectroscopy substance chemical identification can support blistering machines to achieve a better inline content verification.

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10 Ways to Leverage Buyer Signals and Drive Revenue

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.

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Costco Takes On Healthcare, Though Differently From Other Retailers, Experts Say

MedCity News

Costco is partnering with Sesame to offer Costco Members discounted pricing on virtual health services, including primary care and mental health. But the move is a little different from other retailers like CVS Health and Walgreens.

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Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder

Fierce Pharma

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

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Portsmouth NHS Trust maternity team enhances patient experience

PharmaTimes

Patient waiting times to receive an appointment have reduced from 6-8 weeks to just 24 hours - News - PharmaTimes

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Finding New Value in Drugs: Q&A With Darius Lakdawalla, Chief Scientific Officer at EntityRisk

PharmExec

Lakdawalla speaks about how drugs aren’t being properly valued.

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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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After NASH Hopes Are Dashed, Intercept Pharma Agrees to $794M Buyout

MedCity News

Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

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Roche condemns 'act of counterfeiting' as authorities in Pakistan crack down on unapproved Avastin use

Fierce Pharma

After several diabetic patients received a sham version of Roche's Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug unt | Authorities in Pakistan are investigating the use of altered versions of Roche's Avastin after several diabetic patients who received a sham version of the drug lost their sight.

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NHS Confederation research supports investment in NHS services

PharmaTimes

Report shows that if the health service invests in community services hospital admissions will reduce - News - PharmaTimes

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Lymphoma maintenance therapy delivers promise in CTCL

European Pharmaceutical Review

Resminostat (Kinselby) has been clinically proven to postpone disease progression, new data from one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date has revealed. The treatment is an oral small molecule class I, IIb and IV histone deacetylase (HDAC) inhibitor. Data from the RESMAIN resminostat study Findings from the RESMAIN study of the maintenance therapy could significantly change clinical practice in advanced CTCL, according to the company.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.