Pharmaceutical Technology
SEPTEMBER 19, 2024
An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.
Bio Pharma Dive
SEPTEMBER 26, 2024
In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.
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Fierce Pharma
SEPTEMBER 8, 2024
The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.
Bio Pharma Dive
SEPTEMBER 8, 2024
Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.
Rethinking Clinical Trials
SEPTEMBER 24, 2024
In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions.
pharmaphorum
SEPTEMBER 24, 2024
After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Antidote
SEPTEMBER 16, 2024
Receiving a Parkinson’s diagnosis is a life-altering event that nearly 1 million people in the United States have experienced. Parkinson’s disease symptoms can vary from person to person. Receiving a diagnosis often requires several steps. In this blog, we’ll be sharing more details about the disease and discussing opportunities for individuals to get involved in Parkinson’s research.
Fierce Pharma
SEPTEMBER 25, 2024
Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.
Bio Pharma Dive
SEPTEMBER 4, 2024
Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
Outsourcing Pharma
SEPTEMBER 17, 2024
One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
SEPTEMBER 5, 2024
Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.
Pharmaceutical Technology
SEPTEMBER 24, 2024
Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.
BioPharma Reporter
SEPTEMBER 10, 2024
Forge Biologics will help with the manufacturing of adeno-associated viruses (AAVs) in a collaboration with the non-profit Muscular Dystrophy Association (MDA) to develop gene therapies for neuromuscular diseases.
Fierce Pharma
SEPTEMBER 5, 2024
AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.
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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.
Bio Pharma Dive
SEPTEMBER 12, 2024
The offerings by Bicara, Zenas and MBX give a glimpse into what industry insiders describe as a backlog of mature startups waiting for the right opportunity to test public markets.
XTalks
SEPTEMBER 27, 2024
In a news release published yesterday, Pfizer announced it will voluntarily withdraw its sickle cell disease (SCD) therapy Oxbryta (voxelotor) from all markets worldwide. The company said it is also discontinuing all active clinical trials for voxelotor and expanded access programs around the world. Pfizer explained that it made its decision based on a full review of clinical data that indicates the “overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient popu
pharmaphorum
SEPTEMBER 5, 2024
A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches
Pharmaceutical Technology
SEPTEMBER 16, 2024
While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharmaceutical Commerce
SEPTEMBER 9, 2024
In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.
Fierce Pharma
SEPTEMBER 18, 2024
With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.
Bio Pharma Dive
SEPTEMBER 19, 2024
Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.
BioPharma Reporter
SEPTEMBER 17, 2024
The FDA has granted Orphan Drug and Rare Pediatric Disease Designations to Somiteâs cell replacement therapy for the treatment of Duchenne muscular dystrophy.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
pharmaphorum
SEPTEMBER 26, 2024
Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.
Pharmaceutical Technology
SEPTEMBER 11, 2024
As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.
FDA Law Blog
SEPTEMBER 11, 2024
By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API),
Fierce Pharma
SEPTEMBER 20, 2024
After more than a decade without any therapeutic advancements in chronic obstructive pulmonary disorder (COPD), people with the progressive disease suddenly have two new options, with more likely o | Regeneron and Sanofi have announced that the FDA has expanded the label of megablockbuster Dupixent to treat COPD. With the nod, Dupixent becomes the first biologic treatment for COPD patients in the U.S.
Bio Pharma Dive
SEPTEMBER 26, 2024
Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.
Pharmaceutical Commerce
SEPTEMBER 10, 2024
A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.
pharmaphorum
SEPTEMBER 26, 2024
MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac
Pharmaceutical Technology
SEPTEMBER 6, 2024
The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.
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