Fri.Oct 07, 2022

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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Merck’s Lagevrio ‘no better than placebo’ in COVID hospitalisations

pharmaphorum

A UK study has found that Merck & Co’s oral COVID-19 therapy Lagevrio was unable to reduce hospitalisations compared to placebo in patients at higher risk from the virus, adding fuel to assertions in some quarters that its authorisation was premature. The 25,000-subject PANORAMIC trial conducted by researchers at Oxford University looked at the addition of a five-day course of Lagevrio (molnupiravir) to standard care in people aged over 50, or adults aged 18 and over with conditions th

Patients 119
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Pediatric mental health startup launches with $26M and a vow to scale Mass General’s proven care model

MedCity News

InStride Health — a virtual care provider for pediatric patients with moderate to severe anxiety and OCD — recently launched with $26 million in funding. The startup delivers insurance-covered pediatric mental health treatment using a care model developed by two of its co-founders, who are Mass General Brigham clinicians.

Insurance 109
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Frontiers Health Steering Committee spotlight – Fredrik Debong

pharmaphorum

As we enter October and the Frontiers Health 2022 conference in Milan, we’re shining a spotlight on some of the Steering Committee members who have helped make the event what it is. Here we talk to Fredrik Debong, who cofounded MySugr in 2012 and sold it to Roche Diabetes Care five years later in an eight- to nine-figure deal. A cooling off in digital health investment.

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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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Betting the House on Orphan Drugs

Pharmaceutical Commerce

While all drug development efforts are fraught with peril, a growing number of biopharma companies—large and small—are staking a claim in the rare disease treatment space, chasing odds that could yield clinical and financial rewards.

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Star ratings for Medicare Advantage, Part D see sharp drop for 2023, CMS shows

MedCity News

There are 260 MA plans with Part D coverage that received four stars or more for 2023, a share of about 51%. This is a steep decline from 2022, when there were 322 plans with four stars or more, accounting for about 68% of plans.

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BioMarin layoffs to save $50M a year; cash will go to pipeline, gene therapy launch prep

MedCity News

BioMarin Pharmaceutical said the layoffs will improve efficiency across the company as it prepares for the potential U.S. launch of Roctavian, a gene therapy for severe hemophilia A. The one-time treatment was approved in Europe in August.

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NICE recommends first oral S1P receptor modulator for ulcerative colitis

European Pharmaceutical Review

The National Institute of Health and Care Excellence (NICE) has recommended Bristol Myers Squibb’s Zeposia ® (ozanimod) for use in England and Wales to treat moderate to severe ulcerative colitis (UC) cases in adults who are intolerant of, or unresponsive to biologics or conventional therapies. UC is an Inflammatory Bowel Disease (IBD) that makes immune system attack the gastrointestinal (GI) tract.

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Aurobindo Pharma-Openings for Freshers in Quality Control-Apply Now

Pharma Pathway

Aurobindo Pharma-Openings for Freshers in Quality Control-Apply Now. Job Description. Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. Greetings from Aurobindo !!!

Pharma 87
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TauRx sees path to FDA filing for tau-targeting Alzheimer’s drug

pharmaphorum

TauRx Pharma’s effort to bring a tau-targeting drug for Alzheimer’s disease (AD) to market has been a marathon, with a number of setbacks over the years, but the company reckons it may finally be getting closer to the finishing line. The phase 3 LUCIDITY trial of tau aggregation inhibitor hydromethylthionine mesylate (HMTM, formerly known as LMTM or LMTX) showed improvements in cognition in patients compared to their performance and baseline, and also seemed to reduce brain atrophy t

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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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OPTIMA announce AstraZeneca and Mutabor as official partners

PharmaTimes

The companies will aim to improve treatment for patients with prostate, breast and lung cancer

Patients 117
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OSD contract manufacturing market valued at $54.7 billion by 2030

European Pharmaceutical Review

A market report has projected that the global oral solid dosage (OSD) contract manufacturing market is expected to be worth $54.7 billion by 2030, displaying a compound annual growth rate (CAGR) of 6.0 percent. Data showed that worldwide, oral solids are the most popular mode of drug delivery due to being highly cost-effective and offering simple manufacturing processes.

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Alembic Pharmaceuticals Ltd- Opening for B.Pharm/ D.Pharm/ MBA/ Science Graduate Freshers-Apply Now

Pharma Pathway

Alembic Pharmaceuticals Ltd- Opening for B.Pharm/ D.Pharm/ MBA/ Science Graduate Freshers-Apply Now. Job Description. Alembic Pharmaceuticals Ltd. is one of the leading API & Formulations manufacturing and marketing pharmaceutical Company. We continue to enjoy leadership positions in antibiotics, anti -infective, anti -cough and also have significant worldwide presence in specialty therapeutic area such as cardiology, neurology, diabetology, etc.

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Is the launch environment really more competitive now?

pharmaphorum

It’s often stated – mostly without reference to data – that the environment for innovative launches is more competitive now than it ever has been. Is this true? IQVIA has the long term market data, from World Reviews back to 1978, to investigate, and analysed nearly 30 years of launches into leading therapy classes, from multiple eras in the development of the pharmaceutical industry.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Ziphius vaccines and UZ Ghent establish vaccine collaboration

PharmaTimes

First EU public-private collaboration for production of saRNA-based vaccines

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National Book Award 2022 Finalists Announced

Copyright Clearance Center

The post National Book Award 2022 Finalists Announced appeared first on Copyright Clearance Center.

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Are you a bad boss?

PharmaVoice

Pharma execs share their tips for being a better leader.

Pharma 105
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Surrozen and Boehringer partner to develop therapy for retinal diseases

Pharmaceutical Technology

Surrozen and Boehringer Ingelheim have entered a partnership and licence agreement for researching and developing SZN-413 to treat retinal diseases. The collaboration will merge the SWAP technology of Surrozen for Wnt signalling modulation with the research and development capabilities of Boehringer for developing a first-in-class eye disease treatment.

Sales 59
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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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The Talent Sourcing Process

Rep-Lite

The medical and pharmaceutical industries can be very tough. Medical sales and pharmaceutical sales can be challenging to bring up and maintain. To do so, one needs to have good talent in the company. This entails having great sales reps working for your business. Medical sales reps and pharmaceutical sales reps are vital to a business in these fields.

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B2B Sales Enablement: A Quick Guide for Hybrid Sales Teams

Spotio

Sales teams should be able to access knowledge, tools, and processes whenever — and wherever — they need them. Field sales reps, who may be out of the office meeting with clients, need access to product information and resources that they can pull up on their mobile devices or laptops. Inside sales reps who are working the phones need easy access to call scripts and customer contact information.

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The Talent Sourcing Process

Rep-Lite

The medical and pharmaceutical industries can be very tough. Medical sales and pharmaceutical sales can be challenging to bring up and maintain. To do so, one needs to have good talent in the company. This entails having great sales reps working for your business. Medical sales reps and pharmaceutical sales reps are vital to a business in these fields.

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Delix Therapeutics and Pfizer UK Recognized as Global Champions of Greater Equity for Women in the Workplace by Healthcare Businesswomen’s Association

Pharma Marketing Network

Fairfield, N.J. (20 September, 2022)—To showcase the impactful commitment and outcomes of equitable practices for women in the workplace, the Healthcare Businesswomen’s Association (HBA) recognizes Delix Therapeutics and Pfizer UK Ltd., for game-changing initiatives working to close the gender gap in the healthcare and life science industries. The awards will be presented on Thursday, 3 November, in conjunction with HBA’s Annual Conference in Philadelphia.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Business optimism declines in September 2022: Poll

Pharmaceutical Technology

Business optimism decreased in September 2022 compared to August 2022, according to an ongoing poll by Verdict, amidst businesses expressing concerns about rising inflation and its impact on the overall economy. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.

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TPD Assay Development & Screening Summit

pharmaphorum

Uniting Technical Personnel to Expand Assay Capabilities for Next Generation Protein Degraders. Bringing together technical expertise sharing case studies with actionable insights, the Inaugural TPD Assay Development & Screening Summit has been established as the first and only industry-dedicated conference to support in-house assay development and screening strategies to find new targets, uncover novel ligands, drive down costs and progress from early discovery to drug candidate with scal

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Encube Ethicals- Openings for Officer/ Sr. Officer/ Jr. Engineer in Production Department -Apply Now

Pharma Pathway

Encube Ethicals- Openings for Officer/ Sr. Officer/ Jr. Engineer in Production Department -Apply Now. Job Description. Greetings from Encube Ethicals Pvt. Ltd !!! Openings for Multiple Positions in Production Department @ Encube Ethicals Pvt. Ltd. Department: Production. Designation: Officer/ Sr. Officer/ Jr. Engineer. Education: B.Pharm/ Diploma. Experience: 01 to 06 years.

Ethics 52
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1st Molecular Glue Drug Development Summit

pharmaphorum

Built with biopharmaceutical industry insights, this in-person meeting will bring together KOLs to delve deep into the key remaining challenges when it comes to identifying, designing and developing the next generation of molecular glues and truly unlock the widespread therapeutic potential of this promising therapy. This forum will deliver exclusive data from the movers and shakers in the molecular glue space, from the likes of C4 Therapeutics , Monte Rosa Therapeutics, Amgen, Proxygen, Pin

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Cold Chain Tech Continues to Evolve

Pharmaceutical Commerce

The pandemic, which stressed all participants in the pharma cold chain, has not stopped innovation in industry practices, as exploration of the main drivers shows.

Pharma 52
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Monkeypox Treatment and Prevention: Stopping the Latest Outbreak

Pharmacy Times

There is not yet an FDA-approved treatment available for monkeypox, but existing antiviral agents have been found to be effective in vitro and in animal studies.

FDA 62
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Global Logistics: A Cold Chain Blueprint

Pharmaceutical Commerce

The growing pipeline of cold chain products holds tremendous promise for patients, but can result in failed shipments if not properly planned for.

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Psychedelic Medicine May Be an Effective Treatment for Alcoholism

Pharmacy Times

New research suggests that MDMA may offer promising benefits to patients with certain unmet psychological treatment needs.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.