Sat.Dec 30, 2023 - Fri.Jan 05, 2024

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Goldman Sachs Closes $650M Fund to Invest in ‘Golden Era’ of Biotech Innovation

MedCity News

Goldman Sachs’s new fund—its first dedicated to life sciences—will focus on early- to mid-stage therapeutics companies with multiple assets. Genetic medicine, cell therapy, immunotherapy, and artificial intelligence are among the areas of investment interest for the firm.

Medicine 119
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Millions of doses of Pfizer's Paxlovid will go to waste in UK, EU as COVID demand plummets

Fierce Pharma

On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.

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Eli Lilly Announces New Telehealth, Home Delivery Option for Popular Weight Loss Drug

Pharmaceutical Commerce

LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.

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Collaboration to develop novel AI-designed oncology therapy

European Pharmaceutical Review

Under a new licensing agreement, Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group, gains the global rights to develop and commercialise a novel, small molecule KAT6A inhibitor. This treatment has potential for hormone sensitive cancers such as breast cancer, and other oncology indications. The therapeutic is designed using the artificial intelligence (AI)-platform from Insilico Medicine, the biotech company that is also part of this collaboration.

Medicine 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Making the Most of Real-World Data in Clinical Trials

MedCity News

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.

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Novo Nordisk, Eli Lilly's weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

Fierce Pharma

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. | Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

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MHRA authorisation is first endocrine therapy innovation in decades

European Pharmaceutical Review

Korserdu ® (elacestrant) is the first treatment indicated for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations. The endocrine therapy has been granted a marketing authorisation by the UK Medicines & Healthcare products Regulatory Agency (MHRA). This represents the first endocrine therapy innovation in nearly 20 years. The small molecule treatment is authorised for postmenopausal women, and men, with oestrogen receptor (ER)-positive, HER2-negative, locally advanced

Medicine 105
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Report: Improving Health Equity is a Top-10 Goal for Most Healthcare Execs in 2024

MedCity News

A recent Deloitte report found that improving health equity is a top-10 goal for 83% of life sciences and healthcare C-suite executives in 2024. The report also laid out factors that will likely influence health equity in 2024, including AI.

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Study finds no link between Novo Nordisk’s GLP-1 drugs and suicidal ideation

Fierce Pharma

Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medical records of patients shows no link between use of the GLP-1 drugs and an increase in suicidal though

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MHRA’s post-Brexit mutual recognition framework goes live

pharmaphorum

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the UK more quickly.

Medicine 102
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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.

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Biopharma dealmaking: predictions for 2024

European Pharmaceutical Review

The past 12 months has seen significant growth in global mergers and acquisitions (M&A) within the biopharma sector. This activity is expected to continue in 2024, with increasing need for biopharma to access innovation through collaboration and dealmaking to offset looming patent challenges. “In 2023, total life sciences deal value increased by 34 percent to $191 billion.

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19 Senators Urge HHS to Drop Appeal That Would Jeopardize Americans’ Access to Life-Saving Drugs

MedCity News

A bipartisan group of senators sent a letter to HHS asking it to rethink its appeal of a recent federal district court decision that limits the use of “copay accumulators” — which are programs insurers use to prevent medication copay assistance from counting toward patients’ deductibles or out-of-pocket maximums.

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JPM24, Day 2: BioNTech warns of COVID vaccine sales decline; Alnylam looks to become 'top-tier' biopharma player

Fierce Pharma

As the J.P. | As the J.P. Morgan Healthcare Conference rolled on in San Francisco, BioNTech, Alnylam and many other companies updated investors on their strategies heading into 2024.

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Expert analysis: the latest in HIV research and clinical trials 

Pharmaceutical Technology

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

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How to Stay Competitive in the Evolving State of Martech

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

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What New Year’s Resolutions and Organizational Change Have in Common

ALULA

Despite our best intentions, it’s widely known that over 75% of new year’s resolutions fail by the second week of February. While it’s hard enough to keep one’s own resolutions, advancing organizational change can be even more daunting. The very fundamentals of such work – securing effective sponsorship, supporting impacted employees, clearly articulating the finish line, etc. – are tricky to align and execute.

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Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

MedCity News

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.

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With trial win for oral thalassemia drug, Agios charts broader path than gene therapy rivals

Fierce Pharma

Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients. | Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients.

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AbbVie and Umoja to develop new CAR-T therapies for cancer

Pharmaceutical Technology

AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.

Biopharma 122
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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'Faster, Please': Key Challenges in Chemicals and Materials R&D

PharmExec

Companies must address myriad challenges to improve upon issues such as data quality and transparency, process efficiency, and artificial intelligence/machine learning preparedness.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from Kismet Health, the University of California at Berkeley’s life science startups, and the companies presenting at the Consumer Technology Association’s pitch contest at CES.

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JPM24, Day 3: Alkermes enters new phase after busy year

Fierce Pharma

As the J.P. Morgan Healthcare Conference moves into its third day, we're covering the latest developments here. | On Wednesday at the the J.P. Morgan Healthcare Conference, attendees will get a chance to hear from AbbVie, Amarin and several other pharmaceutical companies.

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Regulatory revision essential for bioprocess IIoT adoption

European Pharmaceutical Review

According to a paper recently published in the Biochemical Engineering Journal , challenges such as strict regulation and lack of industry awareness, limit the adoption of Industrial Internet of Things (IIoT) in bioprocessing and overall bioproduction. As a system that uses various technologies , such as data analytics and artificial intelligence (AI), to transfer data between each other autonomously in an industrial setting, IIoT “enables wide-scope data collection and utilisation, and reduces

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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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AstraZeneca Reaches Agreement to Acquire Cell Therapy Specialist Gracell Biotechnologies

Pharmaceutical Commerce

Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers.

Patients 105
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Aetna Better Health of Kentucky, Av?sis and MapHabit Launch Pilot Program for Vulnerable Patients

MedCity News

Aetna Better Health of Kentucky, Avēsis and MapHabit have teamed up to support 200 Kentucky children with autism or intellectual disabilities. The pilot program will help the patients with activities of daily living, such as oral hygiene.

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Novo Nordisk, Eli Lilly's obesity drugs will lead in new drug sales in 2024: Evaluate

Fierce Pharma

Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market wi | Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market with their dominance.

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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

A paper published in the European Journal of Pharmaceutics and Biopharmaceutics has reviewed the current application status of Quality by Design (QbD) within the framework of the ICH guidelines (ICH Q8(R2) – Q14 and ICH Q2(R2)). Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Magazine: Pharma’s path to Net Zero: Targeting Scope 3 emissions

Pharmaceutical Technology

In this issue: Pharma’s efforts to curb Scope 3 emissions, understanding European Pharmaceutical legislation, and looking back at the pharma industry’s performance in 2023.

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Trial Data Looks Promising for ‘IUD For Men’

MedCity News

Contraline released promising data from the clinical trial it’s conducting to test the efficacy of Adam, its male birth control product. The nonhormonal gel seems to be doing a good job of blocking the flow of sperm to the vas deferens, and no serious adverse events have been reported.

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JPM24, Day 1: Moderna touts $6.7B in '23 sales; Bluebird has cash on hand to last until early 2025

Fierce Pharma

As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. | As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. Plus, Moderna, bluebird and other companies updated investors on their businesses heading into 2024.

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Verona cuts $400m loan deal as it preps COPD drug for market

pharmaphorum

Verona Pharma has agreed a new $400 million debt facility with Oxford Finance and Hercules Capital designed to help the company navigate the possible approval and launch of ensifentrine, its therapy for chronic obstructive pulmonary disease (COPD). The Anglo-US company has already tapped $50 million of the funding and can take another $100 million if an ongoing review of ensifentrine by the US FDA results in regulatory approval.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.