MedCity News
APRIL 1, 2024
The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?
Fierce Pharma
APRIL 5, 2024
After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma. | After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers’ CAR-T therapy Abecma into the earlier treatment of multiple myeloma.
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PharmaVoice
APRIL 3, 2024
AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.
Pharmaceutical Commerce
APRIL 5, 2024
In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.
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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
MedCity News
MARCH 31, 2024
AliveCor CEO Priya Abani argues that Apple has made a habit of taking intellectual property from smaller medical device firms in order to improve the functionalities its Apple Watch. She also believes that Apple has been able to avoid taking accountability for this by “bombarding” smaller companies with litigation it knows they won’t be able to afford — a claim that medical IP lawyers have backed up.
Fierce Pharma
APRIL 1, 2024
While the market for COVID-19 vaccines has been shrinking lately, an investigation into text messages between Pfizer CEO Albert Bourla and the European Commission’s President Ursula von der Leyen r | The European Public Prosecutor’s Office (EPPO) took over the investigation into COVID vaccine negotiations between the European Commission's president and Pfizer's CEO Albert Bourla, Politico reports.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Commerce
APRIL 2, 2024
In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, explores the two major strategies big pharma companies are employing amid current macro challenges and efforts to offset looming patent losses to blockbuster brands.
MedCity News
APRIL 3, 2024
In a letter, several stakeholders urged the Drug Enforcement Administration to release a revised proposed rule on the virtual prescribing of controlled substances. This comes as Covid-19 flexibilities that allow controlled substances to be prescribed via telehealth without an in-person exam are set to expire at the end of the year. The post 200 Stakeholders Push DEA for Updated Proposed Rule on Virtual Prescribing of Controlled Substances appeared first on MedCity News.
Fierce Pharma
APRIL 2, 2024
Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply. | Four dose strengths are now expected to be in short supply through April, according to the FDA. The agency previously expected the squeeze to let up at the end of March.
pharmaphorum
APRIL 4, 2024
A small study of Sanofi’s lixisenatide has suggested that the GLP-1 agonist could slow down the progression of Parkinson’s disease, pointing to another potential use for the fast-growing drug class.
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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.
PharmaTech
APRIL 5, 2024
Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.
MedCity News
APRIL 1, 2024
Ever since the Covid-19 pandemic pushed telehealth to the forefront of American healthcare modalities, the genie has emerged from the lamp to quite a mixed crowd of cheerleaders and cheaters.
Fierce Pharma
APRIL 5, 2024
Vertex CEO Reshma Kewalramani, M.D., made $20.6 million in 2023, which was an increase of 30% from her $15.9 million pay in 2022.
PharmaVoice
APRIL 1, 2024
Gender diversity in leadership “doesn’t just happen,” — it requires institutional change, from investing in women’s startups to providing more generous family leave.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
pharmaphorum
APRIL 4, 2024
Healthcare system Providence has spun out a new company, Praia Health, focused on a platform to build and sustain connections between patients and health providers. The new company starts life with $20 million in Series A funding and a mission to develop the Praia Health Identity and Engagement Platform, which was launched within Providence’s digital innovation group (DIG) incubator in 2022 and already handles around 3.5 million user accounts.
MedCity News
APRIL 5, 2024
Biolinq raked in $58 million in capital this week. The company is developing a wearable patch that uses electrochemical sensors to measure a person’s glucose levels from the intradermal space just beneath the surface of their skin. The post Biolinq Snags $58M for ‘Smallest Biosensor in the World’ appeared first on MedCity News.
Fierce Pharma
APRIL 1, 2024
Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway with an asthma resc | Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway for an asthma rescue inhaler.
European Pharmaceutical Review
APRIL 5, 2024
Interim data from a Phase I/II clinical trial suggest that mRNA-3927, an investigational mRNA therapy from Moderna, could be a promising treatment for propionic acidaemia. A 70 percent reduction in the risk of metabolic decompensation events was reported by eight participants in the 12-month pretreatment period, according to the trial results published in Nature. “We are excited to share the first published clinical data utilising an mRNA therapy for intracellular protein replacement,̶
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 Technology
APRIL 1, 2024
Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.
MedCity News
APRIL 2, 2024
Interest in using GLP-1 drugs to reduce obesity combined with a desire by physicians to become less dependent on insurance-based reimbursement after the recent Change Healthcare cyberattack is building. The post How to Help Physicians Generate More Revenue and Make Their Patients Healthier appeared first on MedCity News.
Fierce Pharma
APRIL 1, 2024
Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. | Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. The two most influential proxy advisory firms are rallying investors to vote against the 2024 pay proposal for Soriot at the company’s annual general meeting this month.
European Pharmaceutical Review
APRIL 2, 2024
Revised versions of two widely used European Pharmacopoeia (EP) monographs now allow the use of recombinant factor C (rFC) for testing of pharmaceutical waters. The revised monographs – Water for injections (0169) and Purified water (0008) – mean that users can select the rFC test described in Ph. Eur. 2.6.32 directly when testing pharmaceutical waters.
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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.
pharmaphorum
APRIL 2, 2024
Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category. The deal, which has a top-end value of $900 million including $90 million in near-term payments, focuses on STRO-003, a preclinical-stage ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).
MedCity News
APRIL 4, 2024
Quantum Health CEO Zane Burke and Imagine360 CEO Jeff Bak highlighted the significance of the partnership, what it means for their respective businesses, and the industry at large, in response to emailed questions. The post Ardent Health Opts for New Employee Benefits and Employee Experience with Quantum Health and Imagine360 appeared first on MedCity News.
Fierce Pharma
APRIL 4, 2024
Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. | Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.
European Pharmaceutical Review
APRIL 2, 2024
Animal welfare is a crucial consideration in the adoption of alternative methods like recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR) for bacterial endotoxin testing (BET). These methods aim to impede animal suffering by reducing dependence on horseshoe crab blood. At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products.
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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.
pharmaphorum
APRIL 5, 2024
Our regular round-up of financings in the biotech sector is headed by rumours of a $150 to $200 million initial public offering (IPO) for Aardvark Therapeutics, an emerging player in the weight-loss category, alongside a trio of big private rounds.
MedCity News
APRIL 2, 2024
America’s Health Insurance Plans, the Better Medicare Alliance and the Association for Community Affiliated Plans all came out against CMS’ final 2025 Medicare Advantage and Part D rate announcement. The post Insurer Advocacy Orgs Slam Final MA, Part D Rate Announcement appeared first on MedCity News.
Fierce Pharma
APRIL 2, 2024
After years of struggling with hurdles such as generic competition and significantly lower-than-expected sales of its top meds, Acorda Therapeutics is hanging up the gloves with a $185 million deal | Merz Therapeutics, in a "stalking horse bid," agreed to pick up Acorda's Parkinson's disease med Inbrija and multiple sclerosis drug Amprya ahead of a court auction.
European Pharmaceutical Review
APRIL 4, 2024
A new £17.9 million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials. UK Health Minister Andrew Stephenson commented on the news, stating that the investment “reaffirms the UK’s position as a global leader in clinical research”.
Advertiser: ZoomInfo
In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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