Tue.Feb 27, 2024

article thumbnail

Viking data suggest obesity drug could rival Zepbound, Wegovy

Bio Pharma Dive

The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

Drugs 306
article thumbnail

California Man Free of HIV And Cancer in Astonishing Medical Recovery

AuroBlog - Aurous Healthcare Clinical Trials blog

On the list of illnesses that nobody wants, cancer and HIV both rank pretty high, and Californian man Paul Edmonds had both. But ever since one particular treatment five years ago, he’s been free of both cancer and HIV.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Bristol Myers Squibb acquires RayzeBio for $4.1bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has announced the conclusion of its acquisition of RayzeBio, a radiopharmaceutical company, for $4.1bn.

261
261
article thumbnail

Janux shares triple on early cancer immunotherapy data

Bio Pharma Dive

Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.

Drugs 276
article thumbnail

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

article thumbnail

Novo Nordisk signs $1.46bn deal to develop molecular glue therapies

Pharmaceutical Technology

Novo Nordisk has partnered with US startup Neomorph to develop multiple molecular glue degraders for cardiometabolic and rare diseases.

article thumbnail

Minerva schizophrenia drug rejected by FDA

Bio Pharma Dive

The agency’s complete response letter knocks back Minerva’s attempt to secure approval of the drug over agency reviewers’ objections.

Drugs 152

More Trending

article thumbnail

Pharmaceuticals export grows 6.8% in January

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of drugs and pharmaceuticals during the month of January posted a growth of 6.84 per cent as compared to the same month of previous year. For the first 10 months of the current fiscal year pharma exports grew 8.07 per cent, according to the Central government.

Drugs 150
article thumbnail

Innovation takes precedence with AI use for techbios in pharma

Pharmaceutical Technology

The industry must utilise AI with the mindset to innovate over the desire to slash drug costs and reduce time to commercialisation.

Drugs 162
article thumbnail

February 27, 2024: HCSRN Announces Preconference Grant Writing Workshop, Extends Early-Bird Registration

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) extended early-bird registration for its 2024 Annual Conference to February 29. The conference will be held from April 9 to 11 in Milwaukee, Wisconsin. New this year, a preconference grant writing workshop will take place on Monday, April 8. The workshop will bring together experts throughout HCSRN to assist early investigators with NIH R series applications.

article thumbnail

Gilead’s Biktarvy gains FDA expanded indication approval for HIV

Pharmaceutical Technology

Gilead Sciences has received FDA approval for an expanded indication for Biktarvy to treat HIV patients with M184V/I resistance mutations.

article thumbnail

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

article thumbnail

Denali, fresh off study setback, gets $500M lift

Bio Pharma Dive

The infusion from unnamed private investors will bolster the company’s balance sheet days after a Sanofi-partnered ALS drug stumbled in a clinical trial.

article thumbnail

EMA CHMP recommends AstraZeneca’s Voydeya for PNH treatment

Pharmaceutical Technology

The EMA CHMP has recommended AstraZeneca's Voydeya for marketing authorisation to treat paroxysmal nocturnal haemoglobinuria (PNH).

Marketing 130
article thumbnail

AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

Trials 115
article thumbnail

Boehringer’s obesity drug shows efficacy for liver disease

Pharmaceutical Technology

The Phase II trial met its primary endpoint where 83% of patients saw an improvement in MASH compared to 18.2% on placebo.

Drugs 130
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

123
123
article thumbnail

Telix to expand US footprint with IsoTherapeutics acquisition

Pharmaceutical Technology

Telix Pharmaceuticals has signed an agreement for the acquisition of radiopharmaceutical company IsoTherapeutics.

130
130
article thumbnail

Why is pharma going gaga for radiopharmaceuticals?

pharmaphorum

Pharmaceutical companies are increasingly focusing on radiopharmaceuticals due to their potential in oncology and therapeutic applications. Learn more about why the industry is excited about radioisotopes in this article.

122
122
article thumbnail

One Up, One Down: Allecra scores FDA nod for antibiotic combo after Venatorx hit with rejection

Fierce Pharma

Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. | Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. The U.S. regulator has signed off on Allecra Therapeutics’ Exblifep as a treatment for cUTIs, including the severe kidney condition pyelonephritis.

article thumbnail

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.

article thumbnail

Accelerating the process, transforming therapies and advancing precision medicine

pharmaphorum

Next-generation technology is enabling drug discovery at an entirely new scale, accelerating the process, transforming therapies and advancing precision medicine, and resulting in better patient outcomes. In this podcast, Dr Mohit Jain, founder and CEO of Sapient, discusses personalised disease prediction, diagnostics, and therapies.

Medicine 116
article thumbnail

Live from SCOPE 2024: Talk of the Towne featuring Rare Patient Voice

Antidote

We’re here with Antidote’s tenth installment of Talk of the Towne, and it’s a very special one! We recently attended SCOPE 2024, where we met up with our partners at Rare Patient Voice and recorded our first Talk of the Towne episode live and in person.

105
105
article thumbnail

FDA says yes to Allecra, no to Venatorx UTI drugs

pharmaphorum

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.

Drugs 114
article thumbnail

Vaccine successfully lowers cholesterol in preclinical studies

Drug Discovery World

New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates. The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease. VXX-401 is a synthetic peptide vaccine designed to stimulate the immune system to produce antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), whi

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

Europe’s commercial leaders prepare for a faster trial-to-treatment pathway

pharmaphorum

Europe's commercial leaders are gearing up for a faster trial-to-treatment pathway, leveraging CRM technology to empower HCPs and sales teams.

Trials 115
article thumbnail

Rising Investment in Patient Support Drives a Greater Biopharma Focus on Measurement

Fierce Pharma

A seismic shift has occurred in the healthcare landscape. | Delivering on these heightened expectations has fueled the urgency to invest in patient engagement and support. As pharmaceutical companies' channel ever-increasing resources into these transformative initiatives, the need for robust and comprehensive measurement becomes not just an option, but an imperative, in order to validate allocation of resources and effectiveness of the investment.

74
article thumbnail

Looking to the future of clinical trials: Gene therapy, precision medicine, and the ongoing quest for rare disease solutions

pharmaphorum

Looking to the future of clinical trials: Gene therapy, precision medicine, and the ongoing quest for rare disease solutions Mike.

article thumbnail

Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues

Fierce Pharma

Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side ef | Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side effects—especially in kids.

82
article thumbnail

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.

article thumbnail

Minerva slumps as FDA finds fault with schizophrenia filing

pharmaphorum

FDA has turned down Minerva Neurosciences' marketing application for roluperidone as a treatment for the negative symptoms of schizophrenia

Marketing 114
article thumbnail

Biogen's Qalsody receives positive opinion from CHMP for ALS treatment in Europe

Outsourcing Pharma

Biogen Inc. has announced a significant advancement in the treatment of amyotrophic lateral sclerosis (ALS), commonly known as motor neuron disease (MND).

article thumbnail

Study rings warning bell over cancer therapy access in UK

pharmaphorum

UK cancer survival is lagging 10-15 years behind other countries due to lower rates of chemotherapy and radiotherapy, says UCL study backed by CRUK.

111
111
article thumbnail

Biogen's Qalsody receives positive opinion from CHMP for ALS treatment in Europe

Outsourcing Pharma

Biogen Inc. has announced a significant advancement in the treatment of amyotrophic lateral sclerosis (ALS), commonly known as motor neuron disease (MND).

article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.