Mon.Jul 17, 2023

article thumbnail

Novartis buys a preclinical biotech and its RNA drug technology

Bio Pharma Dive

For $500 million, Novartis will acquire DTx Pharma and its preclinical neurological disease drugs, marking the Swiss company’s latest investment in gene-silencing medicines.

article thumbnail

Fighting AMR with a value and subscription model 

Pharmaceutical Technology

The recent reintroduction of the Pasteur Act seeks to address the global threat that antimicrobial-resistant (AMR) infections pose, one subscription contract at a time.

217
217
Insiders

Sign Up for our Newsletter

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

article thumbnail

Apellis shares sink on reports of rare side effects with new vision loss drug

Bio Pharma Dive

An organization of retinal specialists flagged six cases of severe eye inflammation from commercial use of Syfovre. Apellis says the drug’s safety profile is consistent with testing.

Drugs 243
article thumbnail

FDA expands Veklury’s use to Covid-19 patients with severe kidney disease

Pharmaceutical Technology

The move follows a positive decision made by the EMA earlier this year, broadening the use of Veklury to the high-risk patient group.

246
246
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Westlake raises $450M in latest biotech venture fund

Bio Pharma Dive

Leaders from the firm said that, despite a turbulent biotech market, most of their existing limited partners returned to participate in the new fund, which will support approximately a dozen startups.

Marketing 236
article thumbnail

SNIPR celebrates US court’s favourable ruling on CRISPR patent

Pharmaceutical Technology

The US Federal Court overturned a previous ruling in the patent infringement case against Rockefeller University.

246
246

More Trending

article thumbnail

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

AuroBlog - Aurous Healthcare Clinical Trials blog

On July 13, 2023, the U.S. Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy.

Hormones 178
article thumbnail

FDA approves new RSV drug to protect infants, toddlers

Bio Pharma Dive

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

article thumbnail

ADR reporting with technologies can evaluate our capability to detect signals of adverse events: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

Adverse drug reactions (ADRs) reporting with the help of digital technologies will give us the opportunity to evaluate our capability to detect signals of adverse events.

Drugs 151
article thumbnail

The rise of the new pharma marketer in an evolving commercial model

Bio Pharma Dive

Meet the pharma marketer of the future, primed for personalization and powered by technology.

Marketing 246
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

July 17, 2023: NIH Pragmatic Trials Collaboratory Welcomes First Class of Fellows

Rethinking Clinical Trials

From left: Dr. Stephanie Ibemere and Dr. Kaitlyn McLeod The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators from underrepresented or minoritized groups with a scholarly interest in pragmatic clinical trials. “We are very excited to welcome the 2 inaugural fellows to the NIH Pragmatic Trials Collaboratory Fellowship Program and give them the education and tools that they need to launch their careers as pragmatic clin

Trials 130
article thumbnail

BridgeBio claims success in heart drug trial, rebounding from earlier failure

Bio Pharma Dive

The results come about two years after negative findings from an earlier phase of the study, and position the company to seek an approval in transthyretin amyloidosis cardiomyopathy.

article thumbnail

Vivoryon issues updates on its Alzheimer’s therapy programme

Pharmaceutical Technology

The complete data readouts of two-Phase II trials are expected in 2024, with an additional open-label extension study currently in the works.

Trials 130
article thumbnail

Lilly Alzheimer’s drug slowed disease by roughly half a year, new results show

Bio Pharma Dive

New data presented Monday at a research conference support the case for Lilly’s donanemab, which works in a similar way as the two Alzheimer’s medicines recently approved in the U.S.

Medicine 130
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

Australian CAI unveils new facility for cancer therapy development

Pharmaceutical Technology

The Centre for Advanced Imaging (CAI) of the University of Queensland in Australia has unveiled a facility to develop therapies for cancer.

article thumbnail

Optimize your drug development timeline with liquid-filled, hard-shell capsules

Bio Pharma Dive

With this highly marketable dosage form, scientists can effectively formulate poorly soluble drugs and supplements, while reducing development time and costs.

article thumbnail

Antengene’s multiple myeloma therapy receives approval in Hong Kong

Pharmaceutical Technology

Antengene has received approval in Hong Kong for a new drug application (NDA) for Xpovio (selinexor) to treat multiple myeloma (R/R MM).

Drugs 130
article thumbnail

AI startup raises funding to speed up number crunching in clinical trials

Outsourcing Pharma

The U.S. startup Readout AI has closed a pre-seed financing round to fuel the development of an artificial intelligence (AI)-based tool to speed up data analysis in clinical trials.

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

Lilly to acquire biopharma firm Versanis for $1.9bn

Pharmaceutical Technology

Eli Lilly and Company has signed an agreement for the acquisition of biopharmaceutical firm Versanis Bio in a deal totalling $1.925bn.

130
130
article thumbnail

Cumulus Neuroscience announces positive results from CNS-102 study for sclerosis and frontotemporal dementia

Outsourcing Pharma

Cumulus Neuroscience, a global digital health company focused on advancing neuroscience clinical trials and patient care, presented interim data from their first-in-class CNS-102 feasibility study at the European Network to Cure ALS Annual Meeting (ENCALS) in Barcelona, Spain.

article thumbnail

Eleven and Novo Nordisk partner to develop nucleic acid therapeutics

Pharmaceutical Technology

The companies will develop new molecules using Eleven's innovative DELiveri platform to treat cardiometabolic diseases.

article thumbnail

Amy Turnquist

Pharma Marketing Network

Amy Turnquist has more than 20 years of experience leading teams to create and deliver innovative, client-centric solutions that connect pharmaceutical brands with their HCP and consumer audiences. In her role as a Principal at North Highland, Amy helps healthcare organizations transform their engagement strategy, driving sustainable change and measurable impact by keeping people at the heart of every decision.

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

Futura Medical and Haleon partner to commercialise Eroxon gel in US

Pharmaceutical Technology

UK-based Futura Medical has signed a deal with Haleon to commercialise its OTC erectile dysfunction gel, Eroxon, in the US.

130
130
article thumbnail

New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in three NDAs. It is available from one supplier. There are fifty-five patents… The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 96
article thumbnail

Jobs signal: General and operational jobs in demand in Pharma

Pharmaceutical Technology

In the pharmaceutical sector, general and operational manager roles are the most in demand, according to Jobs data.

130
130
article thumbnail

FluMist Quadrivalent ‘unlikely’ to see great success in Japan

BioPharma Reporter

Japanâs Ministry of Health, Labour, and Welfare approved FluMist Quadrivalent in March 2023, marking the first approval of an intranasal vaccine in the countryâs history.

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

Korro Bio enters merger deal with Frequency Therapeutics

Pharmaceutical Technology

Korro Bio has signed a definitive merger agreement with Frequency Therapeutics to create a genetic medicines firm.

Genetics 130
article thumbnail

Boston Scientific’s New Deep Brain Stimulation Software Gets FDA Nod

XTalks

Boston Scientific’s Vercise Neural Navigator 5 Software for deep brain stimulation (DBS) has been granted approval by the US Food and Drug Administration (FDA). The Vercise Neural Navigator software is used to program Boston Scientific’s Vercise DBS devices for the treatment of Parkinson’s disease and essential tremor. The fifth iteration of the software is designed to be specifically used with the company’s Vercise Genus devices.

Doctors 96
article thumbnail

Sanofi and AZ advance immunization master plan with US nod for infant RSV drug Beyfortus

Fierce Pharma

Sanofi’s immunization scheme is starting to fall into place thanks to an approval that could propel it and its partner AstraZeneca to the front lines of the respiratory syncytial virus (RSV) scene. | Sanofi’s immunization scheme is starting to fall into place thanks to an approval that could propel it and its partner AstraZeneca to the front lines of the RSV scene.

Drugs 94
article thumbnail

Zolbetuximab Is a Promising Therapy for HER2-Negative Gastric Cancer

XTalks

Gastric cancer, which originates in the stomach, ranks among the most common cancers globally. Symptoms for early-stage gastric cancer often overlap with those of more mundane stomach-related ailments, leading to late-stage or metastatic diagnoses when cancer has spread from the original tumor site to other body tissues or organs. Gastroesophageal junction (GEJ) adenocarcinoma, a cancer originating at the junction where the esophagus meets the stomach, carries low five-year survival rates for me

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.