Sat.Aug 12, 2023 - Fri.Aug 18, 2023

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Congressman Launches Investigation into Medicaid Prior Authorization Denials

MedCity News

U.S. Representative Frank Pallone, Jr. (D-New Jersey) announced that he is looking into high prior authorization denial rates by Medicaid managed care health plans. It follows a report by the Office of Inspector General that found that Medicaid MCOs denied one out of every eight prior authorization requests in 2019.

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Biogen kicks off 1,000 layoffs as part of CEO Viehbacher’s ‘complete redesign’

Fierce Pharma

It was only last spring that Biogen started a | It was only last spring that Biogen started layoffs that eventually shrank the company’s headcount by nearly 900 people last year. Now, a fresh round of job cuts targeting 1,000 positions has kicked off at the struggling drugmaker. At the same time, Biogen is spending $7.3 billion to buy rare disease specialist Reata Pharmaceuticals.

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CDMO to manufacture SARS-CoV-2 intranasal vaccine

European Pharmaceutical Review

The National Institutes of Health (NIH) has chosen contract development, and manufacturing organisation (CDMO) Exothera SA to develop the manufacturing process for its intranasal vaccine against SARS-CoV-2 coronavirus to treat COVID-19. As an alternative drug delivery method to traditional injected vaccines, live, replicating, intranasal vaccines have potential for effectively interrupting transmission of COVID-19 by inducing the development of immunity in the respiratory tract.

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FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

PharmaTech

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

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

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Successful Drug Launches in a Digital-Forward Market: Q&A with Bridget Seay, Executive Director of Customer Experience & Commercial Consulting, epocrates

PharmExec

Bridget Seay of epocrates delves into drug launches in a digital-forward market, exploring how pharmaceutical companies can navigate complex patient journeys, strike a balance between traditional and digital marketing tactics, and ethically engage with healthcare professionals and empowered patients amidst ever-changing regulations.

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Moderna's updated COVID shot stands strong against new variants in first look at trial data, company says

Fierce Pharma

Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape, which includes a sh | Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape.

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Epic Is Integrating Abridge’s Generative AI Tool Into Its EHR

MedCity News

Epic announced that it will integrate Abridge’s clinical documentation tool into its EHR workflow. The startup’s generative AI tool listens to visits and creates a near-instant summary that adheres to physicians’ prototypical note structure.

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Celebrating 60 years: Explore the evolution of Derwent World Patents Index

Clarivate

Derwent World Patents Index (DWPI ) turns 60 this year. In this blog, Ed White, Senior Director and Principal Analyst, celebrates how DWPI evolved from a newsletter of patent abstracts into an integral part of the global patent system. With 22 years of experience in the intellectual property industry, Ed White is devoted to helping people capture the right insights from the world’s patent data.

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Merck's Keytruda will top pharma's sales rankings in 2028, with Roche taking the company category crown: Evaluate

Fierce Pharma

Despite all the upheaval in the pharma industry over the last few years, many familiar names will remain at the top of the industry's sales charts toward the end of the decade. | Merck cancer superstar Keytruda is projected to be the world’s top selling drug by a huge margin in 2028, according to a report by Evaluate. On its list of top 10 drugs by sales in 2028, Keytruda is expected to top the $30 billion mark, with no other therapy predicted to reach $20 billion in sales.

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CPHI to return to Milan in 2024

European Pharmaceutical Review

CPHI, the global pharmaceutical event that spans the entire supply chain from ingredients and finished dosages to machinery, bio, and packaging will return to Fiera Milano (Rho) in 2024. The exhibition, which will take place from 8-10 October 2024, is being hosted in Milan for the second time in three years in recognition of the massive pharmaceutical ingredients and manufacturing industry in the region.

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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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Maintaining the Right To Work as Independent Nursing Professionals Is a Fight for Equality

MedCity News

Staffing agencies are convincing hospitals that it is dangerous to hire nurses like me, telling them that us independent nurses are not equipped to provide quality patient care, and that hiring independent nurses could open the door for legal ramifications.

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How an AstraZeneca exec is leading the charge in the next immuno-oncology era

PharmaVoice

The pharma giant’s head of immuno-oncology is now charging toward the next step in the cancer fight with long-term survival and precision.

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MSF, trying to secure supplies of ViiV's Apretude, calls out new clauses in purchasing contract

Fierce Pharma

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company's long-acting HIV prevention drug, Apretude, | The advocacy organization has been trying to lock down supplies of ViiV's long-acting Apretude for more than a year. Now, it's asking the HIV-focused company to remove recently added clauses in the contract that it says derail transparency.

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Lilly completes biopharma acquisitions

European Pharmaceutical Review

Eli Lilly and Company has completed acquisition of two biopharmaceutical companies – Versanis Bio and Sigilon Therapeutics – and their lead assets focused on obesity and diabetes. Lilly announced the successful completion of its acquisition of clinical-stage Versanis Bio and its lead asset bimagrumab, an anti-obesity medicine. Under the terms of the deal – first announced in July – Versanis shareholders could receive up to $1.925 billion in cash, inclusive of the upfront payment and subs

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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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HHS Launches Civil Rights Investigation Into Vanderbilt’s Sharing of Transgender Patient Data

MedCity News

Vanderbilt University Medical Center is under federal investigation after it turned transgender patients’ medical records over to Tennessee’s attorney general. HHS launched the investigation a couple weeks after two VUMC patients filed a class-action lawsuit against the hospital for releasing their records to the attorney general.

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Researchers publish early results with new interleukin-targeting antibody

Pharmaceutical Technology

The biologic was able to halt disease progression in rheumatoid arthritis with the same effectiveness as gold-standard treatment Remicade.

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Lilly's $13.5M insulin pricing settlement gets pushback from 9 states

Fierce Pharma

Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. | In a Tuesday filing in New Jersey Federal Court, lawyers for several states urged U.S. District Judge Brian Martinotti to delay the approval of Lilly's proposed $13.5 million settlement unless it’s altered to make sure states can still file their own insulin pricing lawsuits.

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UK approval for Pompe Disease therapy

European Pharmaceutical Review

Amicus Therapeutics has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for Pombiliti ® (cipaglucosidase alfa) + Opfolda ® (miglustat) for adults living with late-onset Pompe disease. Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat (an enzyme stabiiser) for adults with the rare disease.

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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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74% of Medicare Beneficiaries Concerned About Medicare’s Long-term Sustainability

MedCity News

About 20% of Medicare beneficiaries are “very worried” about the long-term sustainability of Medicare, 54% are “somewhat worried” and 25% are “not at all worried,” according to an eHealth survey.

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HebeCell and Logomix partner to develop PSC-NK cells

Pharmaceutical Technology

HebeCell has forged a strategic collaboration with Logomix for researching and developing gene-edited natural killer cells (NK cells).

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GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies

Fierce Pharma

As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. | As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna.

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Immunotherapy combo could overcome melanoma anti-PD-1 resistance

European Pharmaceutical Review

Use of the immune checkpoint inhibitor immunotherapy drug ipilimumab plus nivolumab has been shown to be effective as second-line therapy in metastatic melanoma that is resistant to PD-1 inhibitors. In a Phase II clinical trial, the anti-cancer treatment extended progression-free survival (PFS) by 37 percent compared to participants who received ipilimumab alone.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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What Providers Need to Know About Fighting the Nursing Shortage Through Tech

MedCity News

A new Accenture report laid out considerations that hospitals should keep in mind as they adopt new technology aimed at improving nurse retention. Some of the report’s key recommendations for providers were to build a strong, cloud-based technology infrastructure and to involve nurses early on in the process of adopting a new digital tool.

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Bruker to buy cell biology company PhenomeX for $108m

Pharmaceutical Technology

Bruker has entered into a definitive agreement to acquire functional cell biology company PhenomeX for a total equity value of $108m.

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Bayer pledges $500K in drugs and cash relief to Maui following devastating wildfires

Fierce Pharma

In the aftermath of devastating wildfires on Maui, Bayer is standing up as one of the first pharmaceutical companies to offer relief. | Bayer is providing a cash donation of $250,000 to Maui, plus a donation of essential healthcare products also worth $250,000. Bayer has operated in Maui for more than half a century, the company said Wednesday. The Hawaiian island has been devastated by wildfires this month.

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CHMP to review MAA for geographic atrophy treatment

European Pharmaceutical Review

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). “This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide.

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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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Why 2 CEOs Are Clamoring For New Primary Care Payment Models

MedCity News

Fee-for-services payment models in the primary care ecosystem are doing a poor job of keeping Americans healthy and reducing the nation’s massive amount of healthcare spending, two CEOs of primary care companies said during a recent webinar. They argued that stakeholders in the primary care space need to come together to support more value-based care arrangements to reduce costs, advance population health and improve the patient experience.

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AbbVie achieves win for migraine prevention drug Aquipta in Europe

Pharmaceutical Technology

The decision brings the first daily oral migraine prophylactic to Europe, with plans to rollout the treatment as soon as possible.

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CSL gets top-line boost thanks to a post-pandemic boom in plasma collections

Fierce Pharma

With plasma collection as its stock-in-trade, the struggles of | With plasma collection as its stock-in-trade, the struggles of CSL during the coronavirus lockdown were understandable. But a surge in post-pandemic collections—and an $11.7B acquisition of Swiss blood specialist Vifor—has rekindled the growth of Australia’s largest biotech. With plasma collections up 31% and to a record level for the company, CSL reported revenue of $13.3 billion for fiscal year 2023.

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AbbVie gains EU migraine treatment approval

European Pharmaceutical Review

Recent EU approval means adults who have four or more migraine days per month can now access the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant). Authorisation of AbbVie’s AQUIPTA ® (atogepant) by the European Commission (EC) is based on two Phase III studies which demonstrated that “AQUIPTA provides significant and sustained reduction of mean monthly migraine days [for both chronic and episodic migraines ],” stated Dr Patricia Pozo-

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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.