Fierce Pharma

AUGUST 17, 2023

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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Sales Pharma 225

MedCity News

AUGUST 17, 2023

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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Management 97

Fierce Pharma

AUGUST 17, 2023

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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Healthcare Healthcare 215

MedCity News

AUGUST 17, 2023

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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Fierce Pharma

AUGUST 17, 2023

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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MedCity News

AUGUST 17, 2023

As retail disruptors like CVS, Walgreens and Amazon buy more and more primary care assets, the healthcare industry is seeing an increased demand for physicians and advanced practitioners. In the case of nurse practitioners, this rise in demand is also boosting their salaries. Physicians’ starting salaries have remained relatively flat, but their average signing bonus grew.

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MedCity News

AUGUST 17, 2023

Femtech is the theme for the INVEST Digital Health Pitch Perfect competition in Dallas October 26. Seven startups will share the spotlight and present their approaches to improving women’s healthcare. Register today!

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Competition Healthcare Healthcare 92

Fierce Pharma

AUGUST 17, 2023

On a long road full of potholes, Ipsen has reached its destination—gaining FDA approval for Sohonos to treat an ultra-rare bone disease.

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FDA 246

MedCity News

AUGUST 17, 2023

Patients no longer need to be tied to traditional care delivery models to receive exceptional care. Providers, payers and policymakers must continue working together to expand home-based health care and meet the preferences and needs of our aging population.

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Patients 89

Fierce Pharma

AUGUST 17, 2023

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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Healthcare Healthcare Pharmaceutical 205

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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.

Safety

European Pharmaceutical Review

AUGUST 17, 2023

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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Manufacturing Medicine Physicians Safety 89

Fierce Pharma

AUGUST 17, 2023

Johnson & Johnson and Legend Biotech's Carvykti keeps growing despite a newly launched off-the-shelf option. | J&J and Legend Biotech's Carvykti kept growing despite a newly launched off-the-shelf option. Novo Holdings joined a $290 million investment in a Chinese R&D product and service provider. China is stressing biotech as a “major focus” as the country tries to woo foreign investment.

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Pharma 194

MedCity News

AUGUST 17, 2023

Visana Health’s seed funding was led by Flare Capital Partners and Frist Cressey Ventures and included participation from InHealth Ventures, Oxeon Partners, Pixel Perfect Ventures and Venture Investors. In total, the company has raised more than $13 million.

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Fierce Pharma

AUGUST 17, 2023

In this episode of "The Top Line," our Fierce reporters tackle topics like the trends we saw at Cannes Lions, the cancer drug shortage, and the top compensated CEOs in the industry.

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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

Distribution

PharmaVoice

AUGUST 17, 2023

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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Leads Pharma 98

Fierce Pharma

AUGUST 17, 2023

Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate (ADC) capabilities. | Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate capabilities. But a trial win for a small-molecule cancer drug makes the deal more attractive.

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European Pharmaceutical Review

AUGUST 17, 2023

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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Medicine Patients Pharmaceutical 82

PharmaTech

AUGUST 17, 2023

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

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Biopharma Manufacturing 75

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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.

Safety

European Pharmaceutical Review

AUGUST 17, 2023

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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Patients Pharma Medical Pharmaceutical 79

PharmaTimes

AUGUST 17, 2023

The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study - News - PharmaTimes

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PharmaTech

AUGUST 17, 2023

A panel of experts from bio/pharmaceutical companies discuss plasmids to establish specifications using a risk-based approach to manage supply, including the response to cell & gene therapy industry feedback, future outlook and re-evaluating plasmid risks.

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Management Pharmaceutical 52

PharmaTimes

AUGUST 17, 2023

The therapy involves long-term enzyme replacement therapy for aduls with Fabry disease - News - PharmaTimes

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

PharmaTech

AUGUST 17, 2023

With this agreement, Chiesi Global Rare Diseases will co-develop drug delivery systems with Aliada Therapeutics for large molecule therapeutics that can cross the blood-brain barrier.

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Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management. This 10 th 510(k) clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.

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FDA Food and Drug Administration Recruitment Management 52

PharmExec

AUGUST 17, 2023

In this Pharm Exec Podcast episode, Alice Valder Curran, life sciences regulatory expert and partner, Hogan Lovells LLP, discusses the biggest drug pricing challenges today, what companies should consider for drug pricing (from a legal perspective), the status and potential impact of the Inflation Reduction Act, and drug pricing recommendations.

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PharmaTech

AUGUST 17, 2023

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

Pharmaceutical Technology

AUGUST 17, 2023

Priority counties in Africa and Asia will soon receive state-of-the-art laboratories, new genome-sequencing technology, and a strengthened workforce.

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Pharmaceutical Commerce

AUGUST 17, 2023

Guidelines expected to assist companies with EPCIS-based sTI/TS data exchange as they prepare to meet November DSCSA deadlines.

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Pharmaceutical Technology

AUGUST 17, 2023

Innovent Biologics has secured approval from China's NMPA for SINTBILO to treat primary hypercholesterolemia and mixed dyslipidemia.

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PharmaTech

AUGUST 17, 2023

A major grant from the Bill & Melinda Gates Foundation will bolster efforts to fight the global HIV/AIDS epidemic.

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management