Bio Pharma Dive
SEPTEMBER 2, 2022
Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.
Pharmaceutical Technology
SEPTEMBER 2, 2022
Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Forma focuses on researching, developing and marketing new therapies for patients with sickle cell disease (SCD), rare hematologic diseases and cancers. Through the acquisition, Novo Nordisk plans to boost its presence in sickle cell disease and rare blood disorders.
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Bio Pharma Dive
SEPTEMBER 2, 2022
One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.
Pharmaceutical Technology
SEPTEMBER 2, 2022
Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. lenalidomide) + a steroid ± an anti-CD38 antibody.
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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
Bio Pharma Dive
SEPTEMBER 2, 2022
The company will cut 50 full-time positions and halt preclinical work on a pill for symptoms of autism in its second restructuring effort since April.
Pharmaceutical Technology
SEPTEMBER 2, 2022
The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average. Yet despite this promising data, it’s a well-known fact that drug launches are under-performing – with around two-thirds of new drugs successfully navigating the long and rocky approval process only
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 2, 2022
The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. Konvomep is also indicated for lowering the upper gastrointestinal bleeding risk in critically ill patients. It is a combination of a proton pump inhibitor (PPI), omeprazole, and sodium bicarbonate.
NPR Health - Shots
SEPTEMBER 2, 2022
People can get the Moderna booster if they're 18 or older, and the Pfizer-BioNTech version if they're 12 and up. In both cases, they must wait at least two months since their last COVID vaccine.
STAT News
SEPTEMBER 2, 2022
Sometime this weekend or early next week, pharmacies and doctors’ offices are going to start to receive Covid-19 boosters that have been reformulated to include protection against one of the sub-variants of Omicron. These boosters, from Pfizer and its partner BioNTech as well as from Moderna, are bivalent shots. They target two strains of the SARS-CoV-2 virus, both the original strain that all previous vaccines have protected against, and the Omicron sub-variants BA.4/BA.5.
NPR Health - Shots
SEPTEMBER 2, 2022
After the disruption and trauma of the pandemic, teachers are expecting kids to still need added support this year. They're adapting their lesson plans to start with a mental health check-in.
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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
STAT News
SEPTEMBER 2, 2022
I have worn many hats professionally. The most uncomfortable one is “doctor friend.” At best, it’s a request for a recommendation for a gynecologist or for advice on which antihistamine works best for allergies. But other times I have found myself in the role of interpreter between a friend and their physician, navigating serious health problems.
NPR Health - Shots
SEPTEMBER 2, 2022
An advisory committee to the CDC has endorsed updated versions of the Moderna and Pfizer-BioNTech vaccines that target the original coronavirus and two omicron subvariants. (Image credit: Pfizer Inc.
pharmaphorum
SEPTEMBER 2, 2022
The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The European Commission said it will move ahead with an accelerated authorisation of the bivalent shots, which include mRNA for the wild-type SARS-CoV-2 spike protein, as well as the original BA.1 subvariant of Omicron, in a divergence from the approach taken by the authorities in the US.
NPR Health - Shots
SEPTEMBER 2, 2022
NPR is asking for your submissions to capture the variety of ways the new abortion laws across the country are having an impact on people's lives.
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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.
STAT News
SEPTEMBER 2, 2022
WASHINGTON — Rahul Gupta is no stranger to the nationwide addiction crisis. Drug use and overdose defined his tenure as the top health official in West Virginia, arguably the state hardest hit by the epidemic, and before that as the health officer in the state’s largest county.
Drug Discovery World
SEPTEMBER 2, 2022
A recent study by the University of Colorado School of Medicine shows that diabetes drug metformin is effective for preventing severe illness from Covid-19. The CU School of Medicine was part of a multi-site clinical trial into the effectiveness of metformin, ivermectin and fluvoxamine in non-hospitalised adults with Covid-19. . The study, which launched in January 2021, included those who were vaccinated and those who were not, as well as people who were pregnant.
STAT News
SEPTEMBER 2, 2022
Forecasters have used all sorts of tools to gauge where the U.S. and the world are headed with Covid-19, ranging from epidemiologic models to historical ones. Here’s another possibility: prediction markets. Prediction markets use a wisdom of crowds approach to aggregate beliefs and predict future outcomes. They typically function through bets in futures contracts that pay out on expiration of defined “yes or no” outcomes.
XTalks
SEPTEMBER 2, 2022
Around 65 percent of US adults report headaches, eyestrain and neck/shoulder pain when using digital devices, reading or when doing detail work. This number is not surprising as most adults in America currently spend more than 9 hours each day using digital devices. Optometry, ophthalmology and neurology scientists uncovered that a majority of headache patients have a misalignment in their vision that causes certain symptoms when an extended time is spent on near work.
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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.
STAT News
SEPTEMBER 2, 2022
Good morning, everyone. I’m Jason Mast, the last of the understudies filling in while Ed is on vacation. On most mornings, I’d be pouring a hot cup, no cream, no sugar, but we’ve got a holiday weekend ahead and I’m out of beans. So I’ll be sipping on a Starbucks cold brew as we go through the news. It’s even got a touch of sweet cream.
XTalks
SEPTEMBER 2, 2022
The US Food and Drug Administration (FDA) has granted approval to Janssen Pharmaceutical Companies of Johnson & Johnson and AbbVie’s Imbruvica (imbrutinib) for pediatric patients with chronic graft-versus-host disease (cGVHD). This is Imbruvica’s first approval for a pediatric indication. The drug, which is available as a new oral suspension formulation, is intended for the treatment of pediatric patients one year of age and older with cGVHD who have failed one or more lines of systemic ther
NPR Health - Shots
SEPTEMBER 2, 2022
In the city of Nowshera, tent cities for flood refugees are springing up on college campuses. At one such haven, mothers spoke to NPR about their struggle to survive.
XTalks
SEPTEMBER 2, 2022
National Food Bank Day falls each year on the first Friday of September; this year, that day will be September 2. The day is honored to bring awareness to the persistent issue of hunger around the world, and while food banks receive attention and canned goods year-round, National Food Bank Day is a reminder that hunger must be eradicated. History of National Food Bank Day.
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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.
Pharma Times
SEPTEMBER 2, 2022
AI company has its breast cancer and colorectal therapies approved for use in Europe
Drug Discovery World
SEPTEMBER 2, 2022
Scientists from Tokyo University of Science have shed light on how various molecules are recruited in endocytosis, a cellular process of bringing in different types of materials from the outside. The results suggest key regulatory functions of the yeast Eps15-like protein Pan1p. The findings provide important insights into the process, which is central to disease prevention.
Pharma Times
SEPTEMBER 2, 2022
Research is evaluating the therapy among paediatric patients with severe malaria
Drug Discovery World
SEPTEMBER 2, 2022
Investment from Takeda ventures will fund the development of Zelluna Immunotherapy’s allogeneic T Cell Receptor Natural Killer (TCR-NK) cells for the treatment of cancer. The funds will enable the advancement of a lead TCR-NK product through manufacturing to Clinical Trial Application (CTA) / Investigational New Drug Application (IND) readiness and, continue the advancement of Zelluna’s platform with additional programmes reaching the preclinical stage.
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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.
pharmaphorum
SEPTEMBER 2, 2022
Novo Nordisk has doubled down on position in the sickle cell disease (SCD) category with a $1.1 billion agreement to acquire Forma Therapeutics, and its therapeutic candidate etavopivat, in phase 2/3 testing. The $20-per-share agreement was a premium of 92% over Forma’s closing share price yesterday, but its stock leaped after the deal was announced from $13.40 to just under the deal price.
Drug Discovery World
SEPTEMBER 2, 2022
The Tech Theatre, supported by DDW, at ELRIG Drug Discovery 2022 will feature a series of seminars focused on automation and technology for drug discovery. . Raj Patey, Business Development Director, MyGreenLabs, will be discussing The Sustainable Lab: Building a Global Culture of Sustainability in Science. . Patey spends much of his time working with lab suppliers to communicate their product sustainability to lab users and to reduce the environmental impact of the lab supply chain.
pharmaphorum
SEPTEMBER 2, 2022
A judge in the US has ruled in favour of Illumina in a dispute with the Federal Trade Commission (FTC) over its multibillion-dollar takeover of cancer diagnosis specialist Grail, which had been challenged on the grounds to could create a monopoly. The FTC as well as antitrust authorities in the EU filed objections to the merger, which would bring Grail back into Illumina after being spun out of the group a few years earlier, arguing that it would slow down the development of multi-cancer early d
Drug Discovery World
SEPTEMBER 2, 2022
Charles River Laboratories has added five new Charles River Accelerator and Development Lab (CRADL) locations in California and Washington. . CRADL provides flexible, turnkey vivarium rental space supported by Charles River’s technical and veterinary support expertise in key biohubs. This allows clients to start new projects, accelerating the early stage of research.
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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.
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