Fierce Pharma
OCTOBER 2, 2023
Novo Nordisk has joined the long list of biopharma companies that are challenging drug price negotiation provisions in the Inflation Reduction Act (IRA). | Two days after filing a lawsuit questioning the constitutionality of drug-price negotiations in the Inflation Reduction Act, Novo Nordisk has grudgingly signed on to the program. In addition, an Ohio court rejected a U.S.
MedCity News
OCTOBER 2, 2023
Healthcare-focused market research firm Trilliant Health published a report detailing the 10 most significant economic trends affecting U.S. healthcare stakeholders in 2023. Some of the main ideas covered in the report included Americans’ worsening physical and mental health, the industry’s shift away from traditional care pathways, and the way patients’ decision making is becoming increasingly driven by consumerism.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Fierce Pharma
OCTOBER 2, 2023
Even as Biogen weighs strategic options for its biosimilars unit, the group is celebrating an industry first. | The exact launch timing of the biosimilar remains unclear, but Roche said it expects competition to kick off in the second half of 2023.
MedCity News
OCTOBER 2, 2023
UNC Health published a study showing that Laudio’s automation software saved the health system $4.5 million in annual nurse turnover costs. The startup’s technology automates administrative tasks for frontline nurse managers — such as patient rounding, schedule making, and quality and safety checks.
Fierce Pharma
OCTOBER 2, 2023
Hot off an FDA approval for its Pompe disease combo treatment, Amicus Therapeutics has reeled in a major investor. | Amicus unveiled a $430 million financing pact with Blackstone Life Sciences and Blackstone Credit. The deal will see the asset manager furnish Amicus with a $400 million loan that will be used for the refinancing of existing debt, Amicus said in a press release.
European Pharmaceutical Review
OCTOBER 2, 2023
The Nobel Assembly has awarded Hungarian biochemist Katalin Karikó and US immunologist Drew Weissman the Nobel Prize in Physiology or Medicine 2023 for their breakthrough findings in RNA vaccine development. The discoveries by the two Nobel Laureates have revolutionised science’s understanding of how messenger RNA (mRNA) interacts with the immune system.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 2, 2023
The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.
Fierce Pharma
OCTOBER 2, 2023
After allowing generic competition and slashing the price of its multidrug-resistant tuberculosis (MDR-TB) med Sirturo (bedaquiline) in low- and middle-income countries, Johnson & Johnson has t | The move follows months of pressure from advocacy groups, who called on the company to increase access to its tuberculosis med.
PharmaVoice
OCTOBER 2, 2023
Eledon’s investigational ALS drug tegoprubart could also help prevent organ transplant rejections, the company says.
Fierce Pharma
OCTOBER 2, 2023
As a new age of price negotiations dawns in the U.S., drug cost watchdogs at the Institute for Clinical and Economic Review (ICER) are laying out their stance on two popular blood thinners. | ICER submitted a special report to CMS weighing evidence on Bristol Myers Squibb and Pfizer’s Eliquis and Bayer and Johnson & Johnson’s Xarelto to treat nonvalvular atrial fibrillation (NVAF), the condition where both drugs garner most of their prescriptions.
Advertisement
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.
MedCity News
OCTOBER 2, 2023
Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.
Fierce Pharma
OCTOBER 2, 2023
As Viatris looks to reestablish itself as a focused eye care company, the company is slimming down by shedding its over-the-counter, women’s healthcare and active pharmaceutical ingredient business | After reaching deals with various buyers, Viatris is pulling out of women's health and selling most of its over-the-counter products. It's also offloading the active pharmaceutical ingredient business in India.
European Pharmaceutical Review
OCTOBER 2, 2023
Due to observed clinical success, Acurx Pharmaceuticals, Inc. has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). In the trial, ibezapolstat and the control antibiotic vancomycin, a standard treatment for C. difficile infection, delivered high rates of clinical cure without any emerging safety concerns.
Fierce Pharma
OCTOBER 2, 2023
With FDA nod for rare disease drug Rivfloza, Novo Nordisk eyes showdown with Alnylam esagonowsky Mon, 10/02/2023 - 13:15
Advertisement
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
MedCity News
OCTOBER 2, 2023
A new PitchBook report listed several predictions for digital health companies in regards to weight loss drugs, including the potential for new weight loss startups and possible challenges for existing nutrition companies.
Fierce Pharma
OCTOBER 2, 2023
With Novo Nordisk, Eli Lilly and AstraZeneca leading the way, Big Pharma's sales will grow 4% annually through 2030: analysts kdunleavy Mon, 10/02/2023 - 15:19
PharmExec
OCTOBER 2, 2023
Kirsch discusses the complexity of the drugs and the verification process, along with EVERSANA’s new platform, ACTICS eAccess.
MedCity News
OCTOBER 2, 2023
A new J.D. Power report found that CVS ranks highest for telehealth satisfaction among direct-to-consumer companies, while UnitedHealthcare ranks highest among payers.
Advertisement
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
PharmaVoice
OCTOBER 2, 2023
The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.
European Pharmaceutical Review
OCTOBER 2, 2023
The European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for imetelstat, a first-in-class telomerase inhibitor as a treatment for transfusion-dependent anaemia in lower risk myelodysplastic syndromes (MDS). Commenting on the validation of the MAA, Dr John Scarlett, Geron’s Chairman and Chief Executive Officer declared: “Based on the clinical profile of imetelstat to date, we are optimistic about its potential to become a standard of care and address longsta
Pharmaceutical Technology
OCTOBER 2, 2023
The Physiology and Medicine Prize has gone to two researchers whose work laid the foundation for Pfizer and Moderna’s Covid-19 vaccines.
PharmaTimes
OCTOBER 2, 2023
The proposed changes could limit patients’s access to treatments and clinical trials - News - PharmaTimes
Advertisement
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.
Pharmaceutical Technology
OCTOBER 2, 2023
An NDA submission for EryDex is currently intended for Q4 2025, assuming positive Phase III study results.
PharmaTimes
OCTOBER 2, 2023
The study analysed and compared information from 65,000 MS patients - News - PharmaTimes
Legacy MEDSearch
OCTOBER 2, 2023
Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH).
pharmaphorum
OCTOBER 2, 2023
WHO clears Oxford malaria jab for immunisation programmes Phil.
Advertisement
Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmacy Times
OCTOBER 2, 2023
The origins of American Pharmacists Month trace back to October 1925, when radio stations nationwide aired special programming for a week to spotlight the pharmacy profession.
pharmaphorum
OCTOBER 2, 2023
Aviva backs £1bn cancer hub in London Phil.
PharmaVoice
OCTOBER 2, 2023
Leaders shaping the future of oncology and cancer care through grit and determination in the face of one of healthcare’s greatest challenges.
Pharmaceutical Technology
OCTOBER 2, 2023
The device allows patients to administer their therapy subcutaneously from home or in the clinic to increase flexibility in their daily lives.
Advertisement
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.
Expert insights. Personalized for you.
279 
Let's personalize your content