Mon.Sep 30, 2024

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After landmark rare disease approval, IntraBio ready to 'hit the ground running' with Aqneursa launch

Fierce Pharma

With its first approval in hand, privately held IntraBio is embarking upon the difficult task of marketing a drug for an ultra-rare disease. | With its first approval in hand, privately held IntraBio is embarking upon the difficult task of marketing a drug for an ultra-rare disease. Still, with months of prep work and outreach complete, the company is already proving it can hit the ground running.

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Roche turns to a startup in search for new breast cancer drugs

Bio Pharma Dive

The Swiss pharma is paying Regor Therapeutics $850 million to buy a pair of prospects it sees as potential successors to blockbuster medicines from Pfizer and Eli Lilly.

Medicine 299
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Neffy nasal spray: a game changer for asthma patients and epinephrine delivery?

Pharmaceutical Technology

The first needle-free epinephrine nasal spray, Neffy by ARS Pharmaceuticals, represents a significant breakthrough in emergency treatment for type I allergic reactions.

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Psychologist Explains How to Stop Using Food as a Coping Mechanism

AuroBlog - Aurous Healthcare Clinical Trials blog

(Aja Koska/E+/Getty Images) Have you ever noticed changes in your eating habits when you are sad, bored or anxious? Many people report eating either more, or less, as a way of helping them to cope when they experience difficult emotions.

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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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Prime to narrow gene editing research as it strikes deal with Bristol Myers

Bio Pharma Dive

The high-profile biotech is zeroing in on programs that serve as proof points for its technology, while seeking partners for other assets.

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mRNA Covid-19 vaccines may boost cancer immunotherapy effectiveness 

Pharmaceutical Technology

The retrospective study presented at ESMO 2024 involved about 2,400 patients with stage 3 or 4 non-small cell lung cancer.

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Pharmaceutical Technology Excellence Awards 2024: Medidata wins awards for Clinical Data Studio and Health Record Connect

Pharmaceutical Technology

Medidata is a winner in the Innovation, and Product Launches categories in the 2024 Pharmaceutical Technology Excellence Awards.

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Aktis raises $175M to fuel radiopharma drug development

Bio Pharma Dive

Among the investors in Aktis’ Series B round were Bristol Myers Squibb, Eli Lilly and Merck & Co., all of which have expanded their involvement in the radiopharma field.

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J&J clinches EC approval for first single-pill PAH combo

Pharmaceutical Technology

The European Commission approved Johnson and Johnson’s Yuvanci as the first single-pill combination therapy for PAH.

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September 30, 2024: New Guide From NIH Collaboratory Promotes Health Equity in Pragmatic Clinical Trials

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory’s Health Equity Core released a new Health Equity in Pragmatic Clinical Trials guide designed to help research teams define health equity and provide examples of how to promote it in clinical research. “Understanding what we mean by health equity is a fundamental step for integrating a health equity lens into research,” said Rosa Gonzalez-Guarda, cochair of the Health Equity Core and an associate professor and assistant dean in the Duke Un

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

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Keytruda and Opdivo: a decade review

Pharmaceutical Technology

PD-1 inhibitors have revolutionised cancer treatment over the last decade, with their success attributed to Keytruda and Opdivo.

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Accelerating precision oncology: The value of an end-to-end partner for therapeutic access

Bio Pharma Dive

Learn how optimal NGS solutions can help developers overcome challenges throughout targeted therapeutic development and the value of an end-to-end partner to help every step of the way.

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Modalis wins FDA rare paediatric designation for CMD CRISPR therapy

Pharmaceutical Technology

Modalis may receive a priority review voucher if its CMD gene therapy is approved by the FDA.

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Key factors shaping the future of clinical services organizations in the APAC market

Bio Pharma Dive

Clinical services organizations can help pharma with global drug development and clinical trial challenges.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Valerio Therapeutics announces acquisition of Emglev Therapeutics

Pharmaceutical Technology

Valerio Therapeutics, a developer of DNA Decoy therapeutics, has announced its acquisition of Emglev Therapeutics, a company specialising in single-domain antibody-based therapeutics.

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CDMOs eye industrywide growth in 2025 as many spurn BIOSECURE Act, CPHI research shows

Fierce Pharma

After experiencing a series of ups and downs in recent years, the biopharma contracting business is gearing up for a rebound in 2025. | Ahead of the CPHI conference in Milan, the events group has teased new research signaling an expected rebound for the CDMO industry—and a rejection of the BIOSECURE Act.

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SK pharmteco announces $260m production expansion in South Korea

Pharmaceutical Technology

SK pharmteco, a contract development and manufacturing organisation, has announced an investment of $260m to expand its small molecule and peptide production capabilities.

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Chiesi Biotech Center of Excellence opens to strengthen R&D in Italy

pharmaphorum

Chiesi Biotech Center of Excellence opens to strengthen R&D in Italy Nicole.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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LEO Pharma announces Enstilar NDA submission for plaque psoriasis in China

Pharmaceutical Technology

LEO Pharma has submitted a New Drug Application (NDA) to China's National Medical Products Administration for Enstilar, targeting the treatment of adult patients with plaque psoriasis.

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Genentech buys Regor's next-gen CDK inhibitors for $850M

pharmaphorum

Genentech buys Regor's next-gen CDK inhibitors for $850M Jonah.

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Blockchain leaders finesse tech to find fake drugs

Pharmaceutical Technology

Is the pharma industry ready to realise blockchain tech’s potential in tackling counterfeit drugs?

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The Latest Surrounding Rising Medicare Part D Premiums

Pharmaceutical Commerce

Why looming benefit changes—and the resulting unintended consequences—are a concern for patients.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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J&J, Legend solidify Carvykti's lead in earlier multiple myeloma with strong survival showing

Fierce Pharma

After putting on a strong performance in preventing disease progression in the earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’ Carvykti has once again mounted a maj | After putting on a strong performance in preventing disease progression, Johnson & Johnson and Legend Biotech’s Carvykti has once again demonstrated a major benefit—this time in prolonging patients’ lives.

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Preventing burnout and optimising pharmacist time with AI

pharmaphorum

Find out how AI can help prevent burnout and optimise pharmacist time in the pharmacy setting. Learn how technology can streamline processes and improve efficiency in this crucial healthcare profession.

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The Impact of Patent Expirations on Generic Drug Markets

Drug Patent Watch

Patent expirations have a significant impact on the pharmaceutical industry, particularly on the generic drug market. When a drug’s patent expires, other manufacturers can produce and market generic versions of the drug, leading to increased competition and lower prices.

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Cyclin Dependent Kinase 4 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Cyclin Dependent Kinase 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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Who Moved My Prescription? Part VI: Abandonment of Branded Prescriptions

Pharmaceutical Commerce

Why this trend is occurring and ways that drugmakers are pivoting in order to remedy the situation.

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Orismilast Closer to Phase III as a Promising Oral Treatment for Atopic Dermatitis

XTalks

Promising new data from UNION Therapeutics’ ADESOS Phase IIb study show orismilast’s potential as an effective oral treatment for moderate to severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024, the study highlighted significant improvements in key disease markers, positioning orismilast as a potential breakthrough in atopic dermatitis management.

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Closed and Collaborative: Mergers, acquisitions, and partnerships in July 2024

pharmaphorum

Discover the latest mergers, acquisitions, and partnerships in July 2024 involving Glycotope, Anacura, and JenaValve Technology in this insightful article. Stay informed on the closed and collaborative developments in these companies.

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CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog

By Alan M. Kirschenbaum & Sophia R. Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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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.