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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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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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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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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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.

Ethics 98
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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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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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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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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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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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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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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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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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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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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ATRAG formulations for lung disease

European Pharmaceutical Review

Swedish pharmaceutical company Vicore Pharma is developing treatments for diseases where the angiotensin II type 2 receptor (AT2R) has a central role in stopping and reversing disease pathology and where there is a large unmet medical need. The company’s lead candidate, C21, is an angiotensin II type 2 receptor agonist (ATRAG). It represents a new class of drugs capable of reducing pulmonary inflammation, proliferation, fibrosis, and vasculopathy.

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time