Sat.Sep 30, 2023 - Fri.Oct 06, 2023

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What Pharma Fears Most About AI

PharmExec

In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.

Pharma 105
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'Extremely concerning' chemo shortage persists despite FDA's efforts, national cancer group reports

Fierce Pharma

While the White House recently touted the FDA’s efforts to mitigate the ongoin | The National Comprehensive Cancer Network found that 72% of centers are still experiencing a carboplatin shortage, while 59% remain low on cisplatin. The survey follows a June report which found that nearly all centers had short supply of the chemotherapies.

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Health Equity Begins with Increasing Diversity in Clinical Research: AI Can Help

MedCity News

It’s critical that we address these examples of institutionalized bias and racism in how we approach clinical trials for drugs and devices. While it’s a daunting task, the path forward is surprisingly clear, and AI can be instrumental in the next step of overcoming unconscious biases inherent in clinical trial processes.

Biopharma 132
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LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Pharmaceutical Commerce

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

Pharma 124
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The PM360 Trailblazer Awards 2023 Winners

PM360

PM360 has announced the winners of its 15 th annual Trailblazer Awards. Established in 2009, the Trailblazer Awards recognize and honor outstanding companies, marketers, marketing teams, brand managers, and initiatives that have demonstrated innovation and achieved incredible results in the life sciences. In total, PM360 recognized 73 winners across eight overall categories: Companies of the Year, CEOs of the Year, Products of the Year, Marketer of the Year, Marketing Team of the Year, Lifetime

Education 122
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Novo Nordisk challenges CMS drug price negotiations, then signs on to the program

Fierce Pharma

Novo Nordisk has joined the long list of biopharma companies that are challenging drug price negotiation provisions in the Inflation Reduction Act (IRA). | Two days after filing a lawsuit questioning the constitutionality of drug-price negotiations in the Inflation Reduction Act, Novo Nordisk has grudgingly signed on to the program. In addition, an Ohio court rejected a U.S.

Biopharma 279

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CCC to Host Virtual Town Hall on AI, Licensing, and the Path Forward

Copyright Clearance Center

October 3, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider to organizations around the world, will host a Town Hall via LinkedIn Live on “AI, Licensing, and the Path Forward” on Thursday, 12 October, 10:00 EDT/15:00 BST/16:00 CEST. CCC’s Vice President, General Counsel Catherine Zaller Rowland and a panel of legal experts including Prof.

Training 118
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mRNA researchers awarded 2023 Nobel Prize

European Pharmaceutical Review

The Nobel Assembly has awarded Hungarian biochemist Katalin Karikó and US immunologist Drew Weissman the Nobel Prize in Physiology or Medicine 2023 for their breakthrough findings in RNA vaccine development. The discoveries by the two Nobel Laureates have revolutionised science’s understanding of how messenger RNA (mRNA) interacts with the immune system.

Medicine 107
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Biogen nabs FDA nod for biosimilar version of Roche's blockbuster Actemra

Fierce Pharma

Even as Biogen weighs strategic options for its biosimilars unit, the group is celebrating an industry first. | The exact launch timing of the biosimilar remains unclear, but Roche said it expects competition to kick off in the second half of 2023.

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SCAN Announces 10-Year Partnership With ApolloMed, Launches Female-Focused MA Plan

MedCity News

In a value-based partnership with ApolloMed, SCAN is launching a Provider Specific Plan called Compass. It is also announcing a Medicare Advantage plan designed for women called SCAN Inspired.

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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.

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FDA’s ‘ivory tower thinking’ ignores promising biomarkers, says a rare disease CEO

PharmaVoice

The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said the UltraGenyx CEO and a leading rare disease researcher.

FDA 111
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WHO recommends second malaria vaccine

European Pharmaceutical Review

The World Health Organization ( WHO ) has recommended a new vaccine, R21/Matrix-M, to prevent malaria in children. The R21 vaccine is the second malaria vaccine recommended by WHO. This follows the WHO’s recommendation of the RTS,S/AS01 vaccine for the disease in 2021. Novavax’s President and Chief Executive Officer, John Jacobs, declared that the company is “proud” of the role of its saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine.

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AstraZeneca ponies up $425M to settle US lawsuits over Nexium, Prilosec

Fierce Pharma

Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexiu | Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexium and Prilosec.

Medical 275
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How Are Digital Health Investors Shifting Their Focus In 2023?

MedCity News

The digital health sector’s quarterly investment trends seem to be stabilizing in 2023, according to a new report from Rock Health. The report noted investors are shifting their focus away from pandemic-era categories like telehealth and pharmaceutical R&D catalysts — instead, they’re interested in startups creating products for disease treatment, the improvement of nonclinical workflows and the enablement of value-based care.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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The ALS therapy keeping the human pig heart transplant pumping

PharmaVoice

Eledon’s investigational ALS drug tegoprubart could also help prevent organ transplant rejections, the company says.

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FUJIFILM Diosynth recruits new Quality leader

European Pharmaceutical Review

Maja Pedersen has been appointed as Chief Quality Officer (CQO), to lead FUJIFILM Diosynth Biotechnologies’ global quality team. Pedersen’s new role is effective immediately. As a member of the executive leadership team, she will report to President and CEO Lars Petersen, who was appointed in June this year. With 20 years of leadership experience in the life sciences and biopharma sector, Pedersen has previously had senior leadership positions in quality assurance (QA) and quality control ( QC )

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In splitting from Novartis, Sandoz makes muted market debut

Fierce Pharma

After more than a year of preparation, Sandoz has officially parted ways with Swiss drug giant Novartis. But the company's day-one valuation lagged what some analysts had projected. | The generics and biosimilar maker debuted on the SIX Swiss Exchange at 24 Swiss francs ($26.16) for a total valuation of about $11.2 billion. Analysts had previously published ranges of $11 billion to $26 billion for the company, according to Reuters.

Marketing 271
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Emerging Behavioral Health Technology: Keeping it Human-Centric

MedCity News

While it’s easy to be consumed by the latest technology and the potential influence it could have, it’s important to remember the ultimate role these platforms should play when it comes to improved patient outcomes.

Patients 122
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Drugmakers face uphill battle in Medicare negotiation suits

PharmaVoice

Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

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Lilly agrees $1.4 billion radiopharma acquisition

European Pharmaceutical Review

Eli Lilly and Company has agreed to acquire the radiopharmaceutical firm POINT Biopharma Global for $1.4 billion. According to Eli Lilly, it will action a tender offer to acquire all outstanding shares of POINT for total purchase price of approximately $1.4 billion. This will be payable once the deal has completed. What radioligand therapies will be developed under the acquisition agreement?

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Merck's COVID antiviral Lagevrio to hit commercial market in November, HHS says

Fierce Pharma

As long expected, the U.S. government is winding down its distribution of COVID-19 countermeasures. | The government will wind down its Lagevrio distribution ahead of the transition, the Administration for Strategic Preparedness and Response said.

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A Prescription for Social Needs: Why Human Connection is Medicine

MedCity News

Weaving companionship into health care as we would a blockbuster drug can help us circumvent expensive healthcare services like emergency department visits and hospitalizations.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Navigating Health Insurance Coverage for Innovative and Specialty Drugs: Q&A With Maria Kirsch, President of Patients Services at EVERSANA

PharmExec

Kirsch discusses the complexity of the drugs and the verification process, along with EVERSANA’s new platform, ACTICS eAccess.

Insurance 115
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Will novel antibiotic become front-line for C. difficile?

European Pharmaceutical Review

Due to observed clinical success, Acurx Pharmaceuticals, Inc. has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). In the trial, ibezapolstat and the control antibiotic vancomycin, a standard treatment for C. difficile infection, delivered high rates of clinical cure without any emerging safety concerns.

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Merck eyes new bladder cancer space with positive Keytruda trial in muscle-invasive disease

Fierce Pharma

Merck’s Keytruda is riding a winning streak in bladder cancer. | Merck’s Keytruda is riding a winning streak in bladder cancer. Following FDA approvals in the metastatic and non-muscle invasive settings, the anti-PD-1 therapy has delivered a positive readout in muscle-invasive urothelial carcinoma.

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Individuals Living with Kidney Disease Deserve More From Our Healthcare System

MedCity News

Policymakers must work to increase access to the Medicare Kidney Disease Education Benefit and expand the Medicare annual wellness benefit to include kidney disease screening. These reforms will catch disease at earlier stages and equip patients to better recognize their risk.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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5 FDA decisions to watch in the fourth quarter

PharmaVoice

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

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Moderna reveals optimistic data for influenza-COVID-19 vaccine

European Pharmaceutical Review

Positive interim results from Moderna’s Phase I/II trial of mRNA-1083 , an investigational vaccine designed to immunise against both influenza and COVID-19, have been released. There are several benefits of the combination vaccine as a preventative measure against these respiratory conditions, according to the pharmaceutical company. For example: higher patient compliance, easier administration and greater convenience.

Safety 97
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Sanofi weighs Mirati buy as KRAS cancer drug battle enters new phase: Bloomberg

Fierce Pharma

Mirati Therapeutics enjoyed a stock-price spike Thursday after rumors started swirling about a potential buyout by French drug giant Sanofi. | Mirati Therapeutics saw its stock price spike Thursday at the possibility of a buyout from Sanofi. The French pharma has been evaluating a potential acquisition of the KRAS drug developer, Bloomberg reports, citing unnamed sources.

Pharma 264
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Did Cigna Deserve its $172M Penalty?

MedCity News

Cigna recently agreed to pay $172 million to resolve allegations that it violated the False Claims Act. One expert said this is just a small part of the problem, while another called for more clarity from the government.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.