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

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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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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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Sandoz to file for approval of aflibercept biosimilar

European Pharmaceutical Review

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. The study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar a

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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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Obesity, diabetes drugs push Novo Nordisk and Eli Lilly to top of pharma's growth pack in Q2

Fierce Pharma

As the coronavirus surged and subsided, several biopharma companies experienced exaggerated revenue spikes and troughs. | Thanks to sales of their metabolism drugs, Novo Nordisk and Eli Lilly posted the biopharma industry’s largest revenue gains in the second quarter—by far. Meanwhile, only six of the industry’s top 20 firms experienced revenue decreases, with Pfizer's sales dropping a whopping 54%.

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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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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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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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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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Stada in 'exploratory talks' about possible sale, CEO says, but nothing is certain

Fierce Pharma

Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. | Responding to recent acquisition rumors, Stada Arzneimittel's CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.

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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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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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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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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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Pfizer attempts to ward off generic competition to pricey heart med Vyndamax with patent lawsuit

Fierce Pharma

Just four years into the rollout of Pfizer's pricey heart medication Vyndamax, the company is already playing patent defense against a potential copycat. | Along with the Scripps Research Institute, the drug giant claims the proposed copycat would step on a Pfizer patent and two Scripps patents.

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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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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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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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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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Thermo Fisher lays off 200-plus at clinical-stage cell and gene therapy factory in Florida

Fierce Pharma

As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers such as Bristol Myers Sq | As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers like Bristol Myers Squibb and Emergent BioSolutions haven’t been immune. Now, Thermo Fisher Scientific is among the latest to plot hundreds of job cuts.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Publishers, Internet Archive Agree to Consented Judgment

Copyright Clearance Center

A stipulated permanent injunction prevents the Internet Archive from offering unauthorized copies of books to the global public.

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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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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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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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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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Report: Hospitals Mark Up Medication Prices by 500%

Pharmaceutical Commerce

Analysis requested by PhRMA indicates that these facilities charge anywhere from two to seven times what they originally paid.

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Nurses’ Mental Health Is Improving, But It’s Still Far From Where It Needs to Be

MedCity News

A recent survey on nurses’ mental health offers some reasons for cautious optimism. The survey showed that nurses’ mental health has continued to improve since its bleakest days during the peak of the pandemic. However, most nurses said they remain unhappy with their employer’s efforts to prioritize their mental wellbeing.

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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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Leprosy potentially endemic in Central Florida

Pharmaceutical Technology

The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.

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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.