Wed.Aug 07, 2024

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Novo shares tumble on lower-than-expected obesity drug sales

Bio Pharma Dive

Quarterly revenue from Ozempic and Wegovy missed Wall Street estimates by about 9%, concerning some analysts and causing a stock sell-off costing the Danish drugmaker tens of billions in market value.

Sales 281
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The Starting Point of Schizophrenia May Have Been Found in Brain Scans

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists think they may have found locations in the brain where schizophrenia first emerges, potentially making the neurological disorder’s onset easier to diagnose from a standard MRI brain scan.

Scientist 242
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Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

Bio Pharma Dive

Executives at Amgen had few updates on their drug MariTide, but defended what they see as the once-monthly shot’s competitive profile.

Drugs 311
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August 7, 2024: How to Investigate Whether Buprenorphine Prevents Suicidal Behavior, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Greg Simon and Susan Shortreed of the Kaiser Permanente Washington Health Research Institute (KPWHRI) will present “Does Starting Buprenorphine Prevent Suicidal Behavior? What Trial Should We Emulate?” The Grand Rounds session will be held on Friday, August 9, 2024, at 1:00 pm eastern. Simon is a senior investigator at KPWHRI and a research professor of psychiatry and behavioral sciences at the University of Washington.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Madrigal’s MASH drug launch gets off to a fast start

Bio Pharma Dive

U.S. sales of the medicine, Rezdiffra, were more than triple analysts’ expectations, encouraging Madrigal to market it in Europe without a partner.

Sales 204
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Need for systemic reform to address India’s low organ donation rates: Dr. Rahul Pandit

AuroBlog - Aurous Healthcare Clinical Trials blog

India continues to face significant challenges in boosting its organ donation rates, currently languishing at just over one per million population. Despite widespread public support, the country struggles to increase its organ donation rates, due in part to a combination of legal misconceptions, lack of awareness within the medical community, and cultural barriers.

More Trending

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Novartis' IgAN ambition takes shape with expanded FDA nod for Fabhalta

Fierce Pharma

The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line. | The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line.

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Amgen reports 45.9% decline in net income to $746m in Q2 2024

Pharmaceutical Technology

Amgen has reported a 45.9% decrease in net income to $746m in Q2 2024 compared to $1.3bn in the same period of the previous year.

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mRNA technologies: Looking beyond COVID vaccines

pharmaphorum

Explore the innovative applications of mRNA technologies beyond COVID-19 vaccines. Learn about the potential and future developments in this groundbreaking field.

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Hepatitis B market is ripe for treatment development, says Aligos CEO

Pharmaceutical Technology

As WHO reports a high HBV burden, Aligos Therapeutics’ CEO highlighted the potential for pharma to address unmet needs.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Novo Nordisk pulls its FDA heart failure submission for Wegovy, will reapply early next year

Fierce Pharma

Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. | Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025.

Drugs 126
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Novo Nordisk’s Wegovy sales weaken as Eli Lilly’s Zepbound exerts pressure

Pharmaceutical Technology

Shares in Novo Nordisk slid as supply bottlenecks and a more crowded weight loss treatment space depress Wegovy sales.

Sales 130
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Amgen's marketing efforts help boost Tepezza sales

Fierce Pharma

Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable? | Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable? In the second quarter, Tepezza generated $479 million in sales for an increase of 8% year over year and 13% sequentially.

Sales 125
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IDRx raises $120m to fund gastric tumour trials for lead TKI therapy

Pharmaceutical Technology

The company plans to use the Series B proceeds to finance Phase I and pivotal trials for IDRX-42, licenced from Merck KGaA.

Trials 130
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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

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BioMarin keeps but scales down Roctavian gene therapy ops

pharmaphorum

BioMarin Pharma has decided not to divest its haemophilia A gene therapy Roctavian but is reining back its ambitions for the business, for now

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Precigen cuts workforce by 20% to focus on gene therapy for benign tumours

Pharmaceutical Technology

Precigen also plans to raise $30m to focus on advancing its recurrent respiratory papillomatosis (RRP) candidate PRGN-2012.

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Pharmacosmos picks up G1 Therapeutics, FDA-approved drug Cosela in merger worth $405M

Fierce Pharma

In a deal worth approximately $405 million, Danish drugmaker Pharmacosmos has agreed to acquire G1 Therapeutics and the latter company's flagship product Cosela. | The companies will team up to expand the reach of G1's Cosela, which is used to reduce bone marrow damage associated with certain chemotherapy regimens.

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FDA approves Servier’s VORANIGO for IDH-mutant Grade 2 glioma

Pharmaceutical Technology

The US FDA has approved Servier's VORANIGO for Grade 2 astrocytoma or oligodendroglioma harbouring IDH1 and IDH2 mutations.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AI in the medical devices sector: Fostering innovation while navigating evolving regulations

pharmaphorum

Explore how artificial intelligence and machine learning are revolutionising the medical devices sector. Learn about the innovative technologies and how companies are navigating evolving regulations in this rapidly advancing field.

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Daiichi Sankyo and MSD expand collaboration on ADC development

Pharmaceutical Technology

Daiichi Sankyo and MSD broadened their partnership for the development and commercialisation of three ADCs.

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After 2023 snub, Amneal clinches approval for extended-release Parkinson's disease med Crexont

Fierce Pharma

As multiple drugmakers race to bring novel, levodopa-based Parkinson’s disease treatments to the market, New Jersey’s Amneal has taken home the gold in the U.S. | Late Wednesday, the FDA granted approval to Amneal’s Crexont—formerly known as IPX203—which is an oral, extended-release formulation of the common Parkinson’s disease (PD) drugs carbidopa/levodopa (CD/LD).

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Genentech and Sangamo to develop neurodegenerative disease therapies

Pharmaceutical Technology

Sangamo Therapeutics has signed an agreement with Genentech for the development of genomic medicines to treat neurodegenerative diseases.

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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.

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Wegovy slowdown rattles Novo Nordisk investors

pharmaphorum

Weaker sales of obesity drug Wegovy cause a dip in Novo Nordisk's share price, but CEO says volume growth is strong and will accelerate in second half

Sales 111
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England's NICE clears Vertex, CRISPR's Casgevy in beta thalassemia after passing on sickle cell use

Fierce Pharma

On the rocky road to ensuring access to gene therapy Casgevy in the U.K., Vertex and CRISPR Therapeutics are making inroads by securing a thumbs up from England’s National Institute for Health and | The cost-effectiveness regulator recommended government funding for the groundbreaking gene-editing therapy in one of its two approved indications.

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Janssen’s psoriasis drug shows promise for childhood diabetes

Pharma Times

Type 1 diabetes accounts for approximately 10% of diabetes cases in the UK

Drugs 110
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With Wegovy supplies back on tap, Novo Nordisk's obesity med doubles US prescriptions from start of year

Fierce Pharma

With supplies of its star obesity med Wegovy now largely unfettered, Novo Nordisk is dialing up its sales expectations for the remainder of the year—and teasing the potential for net price declines | With supplies of its star obesity med Wegovy now largely unfettered, Novo Nordisk is dialing up its sales expectations for the remainder of the year—and teasing the potential for net price declines on the immensely popular GLP-1.

Sales 108
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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

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MRC and MND Association award £3.9m to KCL and UCL for ALS/FTD research

Pharma Times

Researchers aim to explore and investigate axonal dysfunction in neurodegeneration

Research 110
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Levicept says non-opioid drug cuts arthritis pain in phase 2

pharmaphorum

A non-opioid drug for pain developed by UK biotech Levicept, with a new mechanism of action, has shown it can reduce pain associated with osteoarthritis in a phase 2 trial.Neurotrophin-3 (NT-3) inhibitor LEVI-04 hit all its primary and secondary objectives in the trial, which enrolled 510 patients with moderate-to-severe osteoarthritis of the knee, raising the hope it could become a non-addictive option for patients needing chronic pain relief.

Drugs 105
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Pharma Pulse 8/7/24: Struggling AI Startups Look for a Bailout from Big Tech, Strategic Market Access Ensures the Right Treatments at the Right Time & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Marketing 104
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After sharp declines, Merck KGaA and analysts share optimism about potential CDMO rebound

Fierce Pharma

Despite a rocky start to the year for Merck KGaA’s contract development and manufacturing group, the German company is finding some reason to be optimistic about its recent performance. | After a rocky start to the year, Merck KGaA’s CDMO and process solutions units appear to be nearing a comeback.

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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.