Fierce Pharma

DECEMBER 12, 2023

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.

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MedCity News

DECEMBER 12, 2023

Sanofi, which markets the two primary treatments for Pompe disease, was trying to add a third one by licensing rights to a Maze Therapeutics drug candidate with a different therapeutic approach. A Federal Trade Commission complaint alleges the deal amounts to a monopoly player taking out its competition.

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Competition Marketing Biopharma Pharma 120

Fierce Pharma

DECEMBER 12, 2023

To complete its acquisition of Seagen, what did Pfizer need to do to satisfy antitrust concerns of the Federal Trade Commission? | By agreeing to donate royalties on its U.S. sales of bladder cancer drug Bavencio, Pfizer has received the go-ahead to finalize its $43 billion buyout of Seagen, the company said on Tuesday. Pfizer expects to close the merger on Thursday.

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Sales 289

MedCity News

DECEMBER 12, 2023

The Lower Costs, More Transparency Act has passed in the House with bipartisan support. The action is being applauded from several advocacy organizations.

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Prescription 124

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Fierce Pharma

DECEMBER 12, 2023

As waves of layoffs continue to hit the biopharma industry, Ferring Pharmaceuticals is trimming its headcount by 134 across its two U.S. locations. | The drugmaker will lay off 79 at its New Jersey headquarters and 55 at its microbiome subsidiary Rebiotix in Minnesota as a result of a "revised business strategy.

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MedCity News

DECEMBER 12, 2023

The integration of AI into cardiology workflows can help triage care automatically, ensuring the right physicians weigh in on patient data at the right time which may potentially improve clinical outcomes for all patients in need.

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MedCity News

DECEMBER 12, 2023

During the first three quarters of 2023, the prices for CMS’ 500 shoppable services increased by 2.0%, according to a new report. This figure is in alignment with the 1.9% U.S. inflation measured by the Personal Consumption Expenditures Price Index and below the overall U.S. inflation rate measured by the Consumer Price Index.

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Healthcare Healthcare 112

Fierce Pharma

DECEMBER 12, 2023

After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a | Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday.

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Manufacturing 201

European Pharmaceutical Review

DECEMBER 12, 2023

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. He discusses why NK cell therapy’s ability to generate ‘synthetic immunity’ in the body means this modality holds potential as an anti-cancer treatment.

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Pharma Engineering Safety Patients 108

Fierce Pharma

DECEMBER 12, 2023

Evofem has struggled to gain commercial traction with Phexxi. Now, it's selling itself after shares crashed dramatically over the last few years.

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Marketing 220

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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.

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MedCity News

DECEMBER 12, 2023

Zocdoc Founder and CEO Oliver Kharraz gave five predictions about how patient preferences will evolve in 2024. Some of them include Americans increasingly seeking cash-pay care options and an uptick in patients seeking mental health appointments before and after the presidential election.

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Patients 106

Fierce Pharma

DECEMBER 12, 2023

Another data face-off between the two anti-CD38 multiple myeloma drugs—Johnson & Johnson’s Darzalex and Sanofi’s Sarclisa—took place at the 65th American Society of Hematology meeting. | Another data face-off between the two anti-CD38 multiple myeloma drugs—J&J's Darzalex and Sanofi's Sarclisa—took place at the ASH conference. Both regimens showed strong efficacy in newly diagnosed patients, but only one result is considered practice-changing right now.

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Patients 188

MedCity News

DECEMBER 12, 2023

In the last episode of the year, Wrobel, CEO of an Indiana-based federally qualified health center, describes how a survey helped her and her community workers understand exactly how confident her patients are in managing their own care and the best way to help them with the ultimate goal of improving overall health equity.

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Fierce Pharma

DECEMBER 12, 2023

With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to sta | With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to stage a comeback in mantle cell lymphoma.

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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

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PharmExec

DECEMBER 12, 2023

While hurdles remain, home healthcare could deliver better patient-centered cancer care—providing improved outcomes, enhanced quality of life, and reduced strain on resources.

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Healthcare Healthcare Patients 105

MedCity News

DECEMBER 12, 2023

AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults.

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Biopharma Pharma 104

PharmExec

DECEMBER 12, 2023

Experts gauge whether the needle is finally moving on the effective structuring of outcomes centered payment agreements—from operational, technology, and acceptance standpoints.

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Pharma 103

MedCity News

DECEMBER 12, 2023

Talkspace is offering free self-guided mental health content to some female Evernow customers over the age of 40, while Evernow is offering discounted menopause care to Talkspace patients.

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Patients 104

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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

DECEMBER 12, 2023

The first stage of construction has officially begun on Lek Pharmaceuticals’ new biologics and biosimilars production centre in Lendava, north eastern Slovenia. Representing the largest foreign direct investment in Slovenia, the launch of the $400 million centre was attended by key Slovenian representatives, including the Prime Minister, Robert Golob.

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Pharmaceutical Manufacturing Medicine 94

MedCity News

DECEMBER 12, 2023

Integrations are incredibly destabilizing and stressful for impacted employees, as well as for those who “survive.” Organizations that are worth acquiring are successful and attractive because they are comprised of smart, talented people who have created that success.

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Pharmaceutical Commerce

DECEMBER 12, 2023

Founding Partner of Curatio Scientia speaks on her upcoming panel at Trade & Channel Strategies 2023.

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MedCity News

DECEMBER 12, 2023

While there will never be a perfect solution to preventing drug diversion 100% of the time, leveraging the right people, processes and technology is our best chance of keeping patients safe.

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Patients Biopharma 98

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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

PharmaTimes

DECEMBER 12, 2023

Around 240 million children worldwide are living with these types of disorders - News - PharmaTimes

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Pharmaceutical Commerce

DECEMBER 12, 2023

Bayer executive talks Enable Holistic Hub and Provider Services panel.

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European Pharmaceutical Review

DECEMBER 12, 2023

In recent years, nitrosamines have been detected in various medicines, leading to voluntary product recalls from the market. Nitrosamines analysis is, thus, key to ensuring safety and quality in the pharmaceutical industry. Global regulatory bodies now require pharmaceutical manufacturers to control and strive to mitigate the presence of N- nitrosamines in their products.

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Pharmaceutical manufacturing Safety Pharmaceutical Manufacturing 59

pharmaphorum

DECEMBER 12, 2023

BMS bolts on SystImmune bispecific ADC in $8.4bn deal Phil.

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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

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PharmaTimes

DECEMBER 12, 2023

Slow-growing cancer cells become more resistant to chemotherapy treatment - News - PharmaTimes

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Clarify Health

DECEMBER 12, 2023

A well-balanced and adequately resourced provider network is a strategic asset for payers in the highly competitive healthcare insurance market. Using advanced analytics, payers can build network optimization strategies to strategically refine and enhance the composition of their provider networks to improve accessibility, cost, quality, and outcomes.

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Networking Insurance Competition Healthcare 52

Pharmaceutical Commerce

DECEMBER 12, 2023

AstraZeneca's deal to acquire Icosavax is expected to bolster AstraZeneca’s Vaccines & Immune Therapies late-stage pipeline with IVX-A12, a potential first-in-class vaccine for both respiratory syncytial virus and human metapneumovirus.

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PharmExec

DECEMBER 12, 2023

The deal includes Icosavax’s lead investigational candidate, IVX-A12, a potential first-in-class vaccine being developed for both respiratory syncytial virus and human metapneumovirus.

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Leads 52

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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