Fierce Pharma

JANUARY 11, 2024

Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD). | Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD).

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PharmaVoice

JANUARY 11, 2024

As advanced therapies and patient perspectives strengthen their foothold in R&D, pharma is poised to deliver impactful treatments in record time.

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Fierce Pharma

JANUARY 11, 2024

With sales declining for aging MS drug Fampyra, Biogen has exercised an option to return licensing rights outside of the U.S. to Acorda Therapeutics.

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Sales 256

MedCity News

JANUARY 11, 2024

At CES 2024, menopause startup Amira launched The Terra System, a wearable cooling device that supports women battling hot flashes and helps them sleep through the night.

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Fierce Pharma

JANUARY 11, 2024

Pfizer is still hungry for ADC opportunities, including in the Far East. | Pfizer mused on ADC opportunities in China, while Takeda's R&D head revealed details behind the company's competitive TYK2 deal with Nimbus at this year's J.P. Morgan Healthcare Conference. Astellas received a manufacturing-related rejection for its gastric cancer candidate.

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Competition Pharma Manufacturing Healthcare 130

MedCity News

JANUARY 11, 2024

Generic competition has eroded sales of multiple sclerosis drug Ampyra, marketed as Fampyra outside the U.S. Biogen told Acorda Therapeutics that it’s terminating its ex-U.S. rights to Fampyra in order to focus on other priorities, which include expanding beyond MS.

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MedCity News

JANUARY 11, 2024

This year’s J.P. Morgan Healthcare Conference brought a bevy of news announcements — from acquisitions to partnerships to new products and more. This list compiles short summaries for seven of the event’s most notable announcements.

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European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). Ustekinumab biologic Once the European Supplementary Protection Certificate (SPC) for Stelara expires in July 2024, this will open up market entry as soon as possible for Uzpruvo, now that it is approved in Europe” Ustekinumab is a human IgG1κ monoclonal antibody (mAb).

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MedCity News

JANUARY 11, 2024

The hospital sector’s financial performance in November showed signs of continued stabilization and growth, according to Kaufman Hall’s latest monthly report. Hospitals should “take advantage of the relative stability and re-embrace strategic growth if they hope to see continued success in 2024,” stated Erik Swanson, one of the report’s authors.

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Marketing 104

pharmaphorum

JANUARY 11, 2024

Stada and Alvotech get EU approval for first biosimilar of Johnson & Johnson's Stelara in psoriasis, psoriatic arthritis and Crohn's disease indications

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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

MedCity News

JANUARY 11, 2024

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing.

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European Pharmaceutical Review

JANUARY 11, 2024

chronic neuropathic pain is at present, mainly managed with antidepressants… antiepileptic drugs… as well as opioids” Neuropathic pain affects over 400 million people worldwide, according to Hoba Therapeutics. In Europe, the prevalence of chronic neuropathic pain is estimated to be six–eight percent 1 of the general population. Drug development for pain management is “incredibly complex… mainly because the trials are so challenging to conduct”, the company highlight

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MedCity News

JANUARY 11, 2024

This year, ViVE will celebrate nurses throughout the event’s programming, highlighting how their role has evolved, the challenges they face and how they are spurring innovation in different models of care. The event is powered by HLTH and the College of Healthcare Information Management Executives (CHIME).

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Healthcare Healthcare Management 102

pharmaphorum

JANUARY 11, 2024

NICE has extended the NHS availability of Pfizer’s COVID-19 drug Paxlovid as millions of doses approach their expiry date

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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

European Pharmaceutical Review

JANUARY 11, 2024

ACC pioneered LAL testing methodology and was the first FDA-licensed company to manufacture LAL reagents. Throughout the years it has grown to be an internationally recognised leader in endotoxin detection. In 2021, they introduced the first commercially available sustainable bacterial endotoxin testing (BET) recombinant Cascade Reagent (rCR), PyroSmart NextGen®.

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Manufacturing FDA Pharmaceutical 72

PharmaTimes

JANUARY 11, 2024

The diagnostic system can deliver particles to the lungs via aerosol or a nebuliser

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pharmaphorum

JANUARY 11, 2024

CHMP has called in expert advisors to assist in the review of Eisai and Biogen’s Alzheimer's therapy Leqembi

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PharmaTimes

JANUARY 11, 2024

In 2022, around 8% of patients survived 30 days after a cardiac arrest

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Patients 101

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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

pharmaphorum

JANUARY 11, 2024

FDA has authorised imports from France of a life-saving antibiotic for syphilis that is in short supply in the domestic market

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FDA Marketing 81

Clarivate

JANUARY 11, 2024

At Clarivate TM , our mission is to advance the success of people and organizations through transformative intelligence and trusted partnership. We are proud to spotlight our women IP experts, whose professionalism and talent make up the core fabric of our endeavour. Continuing this blog series, we present Katie Clapham, Senior Director of IP Partnerships at Clarivate.

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Specialization 59

PharmaTech

JANUARY 11, 2024

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

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Manufacturing 59

ALULA

JANUARY 11, 2024

At ALULA, our love for animal s isn't just a quirk— it's a shared bond that shapes our culture. Although we focus on the human side of business, our shared affection for furry, winged, speckled, or finned friends is strong , and it creates a unique camaraderie. Given this common bond, we can’t pass up the opportunity to celebrate National Dress-Up Your Pet Day this January 14!

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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

JANUARY 11, 2024

Want to increase the probability success for your discovery mRNA program? Partner with TriLink BioTechnologies®. Since 2012, we’ve been the industry leader in custom mRNA synthesis for research and clinical applications. Read on to see how TriLink® is determined to deliver you success.

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Manufacturing 52

Rep-Lite

JANUARY 11, 2024

A Clinical sales specialist in medical sales is a professional in the healthcare industry who plays a crucial role in promoting and selling medical and healthcare products or services to healthcare providers, such as hospitals, clinics, and private practices. They act as a bridge between healthcare providers and the companies that manufacture or distribute healthcare products, ensuring healthcare professionals have access to the latest and most effective medical technologies and solutions.

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Sales Healthcare Healthcare Medical sales 52

Clarify Health

JANUARY 11, 2024

The managed care team at an academic medical center (AMC) in the northeast was preparing for negotiations with a payer partner. The challenge was they first needed to better understand the competitive landscape with insights into other health systems to figure out where they had the best opportunity to secure more favorable rates. Unfortunately, they were challenged with a lack of competitive rate insights outside of their health system, leaving them to rely on historical negotiation tactics and

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Pharmaceutical Commerce

JANUARY 11, 2024

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with relapsed or refractory acute myeloid leukemia.

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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

PharmExec

JANUARY 11, 2024

Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the best evidence for defense.

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Pharmaceutical 52

Impetus Digital

JANUARY 11, 2024

This is a guest article and does not necessarily reflect the views and values of Impetus Digital. The pharmaceutical industry is an important sector that we all rely on to keep us safe and maintain a good level of health. But with thousands of private and confidential records being stored digitally, the pharma industry can unfortunately fall victim to cybercrime, just as any other online business can.

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PharmExec

JANUARY 11, 2024

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia.

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FDA Patients 52

Pharmaceutical Technology

JANUARY 11, 2024

Innovent has reported positive Phase III results for mazdutide, Eli Lilly’s next-generation obesity asset that Innovent is developing as part of a 2019 deal with the company where it secured the rights to the dual glucagon-like peptide-1 (GLP-1) glucagon receptor agonist.

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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