Tue.Sep 20, 2022

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Hope for lupus sufferers with Feinstein Institutes-led phase 2 trial

pharmaphorum

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., data from the phase 2 LILAC (Part A) clinical trial published this month shows that the experimental lupus therapy could reduce disease activity in the joints of patients, globa

Medicine 109
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Survey: 67% of employers to prioritize controlling healthcare costs over next 3 years

MedCity News

Employers expect healthcare costs to increase 6% next year, up from the 5% increase they are experiencing this year. Respondents don’t see this improving down the road either, with 71% saying they anticipate moderate to significant increases over the next three years.

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10 Ways to Attract New Patients from Key Local Employers

Healthcare Success

Help Providers Win New Patients from Large Local Businesses with These Tactics. Large or dominant employers in your local communities are excellent targets of opportunity for new patients and cases. Most healthcare providers have local businesses that are (or could be) a source of new business. Whether it’s a company that's conveniently located across the street, or a dominant employer in the community, your providers want their business—here’s how you can help them win it.

Patients 105
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Drug Solutions Podcast: Cell Therapy Development: Advances, Trends, and the Challenge of Retention

PharmaTech

Experts from Umoja Biopharma dive into cell therapy development in this episode of the Drug Solutions Podcast, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point.

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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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Consolidation Forces Pharma to Rethink Commercial Strategies: Q&A with Beghou Consulting’s Rohit Gupta

PharmExec

Rohit Gupta is vice president of analytics strategy and transformation at Beghou Consulting - he works with biopharma leaders on all facets of drug commercialization, from market sizing strategies, to launch planning, to business analytics.

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Merck HIV drug trials paused by FDA will resume under modified plan

MedCity News

A Merck HIV drug placed under multiple full and partial clinical holds last year is now clear to resume testing. As part of a modified plan, Merck will test a lower dose of its experimental drug, islatravir. The pharma giant is also dropping tests of the drug for HIV prevention.

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TCARE gains $17M in Series A funding for family caregiver support solution

MedCity News

The funding round was led by American Family Ventures and brings the company’s total funds to $20 million. With the money, TCARE will grow its team and work to expand its offerings for its existing clients.

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Green HPLC method enables antipsychotic determination

European Pharmaceutical Review

In a recent paper, researchers demonstrated the comparability of a green high performance liquid chromatography (HPLC) for the determination and screening of typical antipsychotic drugs both in bulk and pharmaceutical formulation. Antipsychotics are used to treat a variety of serious mental disorders including schizophrenia and bipolar disorder, in which manic states may require management with multiple drugs.

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OIG: Over 50,000 Medicare Part D beneficiaries experienced an opioid overdose in 2021

MedCity News

Over 1 million Medicare beneficiaries had a diagnosis for opioid use disorder in 2021. But despite this high number, only 18% received medication to treat their disorder.

Medical 98
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Amneal Pharmaceuticals-Walk-In Interview for Diploma / ITI/ B.Sc/ M.Sc/ B.Pharm/ M.Pharm Candidates On 25th Sept’ 2022

Pharma Pathway

Amneal Pharmaceuticals-Walk-In Interview for Diploma / ITI/ B.Sc/ M.Sc/ B.Pharm/ M.Pharm Candidates On 25th Sept’ 2022. Job Description. We are looking for Competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Ahmedabad SEZ Matoda Plant. Sterile Manufacturing (Injectable Unit / Parenteral Unit). Designation: Operator/ Officer/ Sr.

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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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Rocket Pharma stocks up on cardiac gene therapies with $53M Renovacor acquisition

MedCity News

Rocket Pharmaceuticals is acquiring Renovacor, a gene therapies developer whose lead program addresses a particular genetic mutation that leads to a type of heart failure. The all-stock deal gives Rocket the opportunity to expand its reach in genetically driven cardiac diseases.

Pharma 96
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EMA approves biosimilar interchangeability in EU

European Pharmaceutical Review

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. Interchanging biosimilars is an acceptable practise already used by many Member States. However, the current lack of certainty whether interchangeability is acceptable EU-wide has prompted this decision.

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Eugia Pharma -Walk-In Interviews for Production/ Warehouse / Quality Assurance/ Quality Control/ Microbiology On 24th Sept’ 2022

Pharma Pathway

Eugia Pharma -Walk-In Interviews for Production/ Warehouse / Quality Assurance/ Quality Control/ Microbiology On 24th Sept’ 2022. Job Description. Eugia Pharma Specialities Limited is Subsidiary of Aurobindo Pharma Limited, 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.

Pharma 86
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Zuranolone shows promise as episodic treatment for depression

European Pharmaceutical Review

New data supports the potential use of Biogen’s and Sage Therapeutics’ zuranolone as a potential episodic treatment for people with major depressive disorder (MDD). Zuranolone is an investigational oral 14-day treatment under clinical development for adult patients with MDD and postpartum depression. In the ongoing open-label, longitudinal SHORELINE Study in MDD, the median time to the first repeat treatment course for those patients who responded to the initial 14-day treatment course was

Safety 86
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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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Shilpa Biologicals Pvt. Ltd- (60+ Openings) Walk-In Interview for Production/ QA/ QC Analytical/ QC Micro/ R&D/ Analytical R&D On 25th Sept’ 2022

Pharma Pathway

Shilpa Biologicals Pvt. Ltd- (60+ Openings) Walk-In Interview for Production/ QA/ QC Analytical/ QC Micro/ R&D/ Analytical R&D On 25th Sept’ 2022. Job Description. Shilpa Biologicals Pvt. Ltd- Biopharma started its operations in 1987 at Raichur, Karnataka-India. The Commercial production in the AML was started in November 1989. Today Shilpa Medicare Limited is a global brand in Manufacturing and supplying of affordable API Formulation globally in different regulated markets.

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Peer Review, Still a Critical Step in Scholarly & Scientific Publishing

Copyright Clearance Center

The post Peer Review, Still a Critical Step in Scholarly & Scientific Publishing appeared first on Copyright Clearance Center.

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SMS Pharmaceuticals Ltd- Walk-Ins for  Production/ Quality Control/ IT Dept. On 24th Sept’ 2022

Pharma Pathway

SMS Pharmaceuticals Ltd- Walk-Ins for Production/ Quality Control/ IT Dept. On 24th Sept’ 2022. Job Description. Company Profile: . SMS Pharmaceuticals Ltd is one of the leading pharmaceutical manufacturing companies in India with world -class facilities, with a wide range of process equipment fully compliant with the cGMP and WHO Standards. Walk-Ins for Production/ Quality Control/ IT Dept.

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First bispecific antibody approved in EU to combat leading causes of vision loss

European Pharmaceutical Review

The European Commission has approved Roche’s Vabysmo ® (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME) – two of the leading causes of vision loss worldwide. “Many people with nAMD and DME struggle to keep up with the monthly eye injections and physician visits, often associated with current standards of care, and unfortunately their vision may suffer as a result of undertreatment,” explained

Leads 76
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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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Genfit agrees to acquire biopharma firm Versantis for $109m

Pharmaceutical Technology

Genfit has signed an exclusivity agreement for the acquisition of all the share capital and voting rights of Versantis, a Switzerland-based clinical-stage biotechnology firm, in a deal totalling $109m (Sfr105m). Versantis focuses on unmet liver ailment needs. Its key asset, VS-01, is a first-in-class liposomal-based treatment product candidate. This product is being analysed clinically as a first-line therapy for acute-on-chronic liver failure (ACLF) and urea cycle disorder (UCD).

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LEO Pharma receives positive CHMP opinion of Adtralza

PharmaTimes

Therapy is for the treatment of adolescents with moderate-to-severe atopic dermatitis

Pharma 92
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2022 Trends in Healthcare Sales

Scott’s Directories

The year 2022 has produced many new B2B marketing trends in the healthcare sector. Statistics from CB Insights reveal that more than 12,000 medical tech-related startups cater to the healthcare sector worldwide. The studies from CB Insights further showed that the number of tech startups catering to the healthcare sector is increasing significantly.

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OpSens Announces FDA Clearance for the SavvyWire™ for Use in Transcatheter Aortic Valve Replacement (TAVR) Procedures

Legacy MEDSearch

OpSens Inc. , a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, announced that it has received 510(k) regulatory clearance from the U.S. Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR.

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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.

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Structure is freeing!

Storyvine

Sitting in front of the camera is intimidating for most people. They don’t know what to say -– ­where to begin, how to end, and may uncomfortably ramble on. Storyvine templates provide structure to your video by breaking it down into “story beats” via prompts. This allows the filmer (aka Storymaker) to just focus on answering questions to create a clear and concise story.

Leads 52
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Data-crunching specialist CytoReason signs $110m Pfizer alliance

pharmaphorum

Three years after it started working with Pfizer, artificial intelligence-powered drug discovery specialist CytoReason has converted the relationship into a lucrative, wide-ranging contract. The big pharma company is making a $20 million investment in the Israeli startup along with funding that could reach $90 million over the next five years, in a return for options to license CytoReason’s AI platform and disease models.

Pharma 52
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EC grants approval for Roche’s Vabysmo to treat two retinal conditions

Pharmaceutical Technology

The European Commission (EC) has granted approval for Roche's Vabysmo (faricimab) to treat two retinal conditions, neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) associated visual impairment. . This latest approval is based on findings from four Phase III clinical trials in the two indications, which enrolled a total of 3,220 subjects.

Medical 52
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Scott Burrows, Florida Resilience Speaker

Scott Burrows

Why has resilience become so important? “Let me tell you something you already know. You, me, or nobody is gonna hit as hard as life. But it ain’t about how hard ya hit. It’s about how hard you can get hit and keep moving forward.

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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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Medopharm Pvt. Ltd-Walk-In Interview for Production On 23rd Sept’ 2022

Pharma Pathway

Medopharm Pvt. Ltd-Walk-In Interview for Production On 23rd Sept’ 2022. Job Description. Walk-In Interview for Production Department On 23rd Sept’ 2022 @ Medopharm Pvt. Ltd. Department: Production. Qualification: DME/ DEEE/ DECE. Experience : Freshers/ 01 years. Position: Trainee Operator. Location: Guduvanchery. Male & Female candidates preferable.

Pharma 52
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International Week of Happiness at Work

Star OUTiCO

As we start to return to normal after the sadness of the past 10 days, it’s a fitting time to celebrate International Week of Happiness at Work. We asked some of our Recruitment, Business Support, and HR team members what they love most about working at Star OUTiCO – here’s what they said…. For me, I love working with people that operate as team and support each other to achieve not only individual but common goals as well.

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Rui Laboratories Pvt. Ltd- Walk-In Interview for Quality Control/ R&D On 21st to 24th Sept’ 2022

Pharma Pathway

Rui Laboratories Pvt. Ltd- Walk-In Interview for Quality Control/ R&D On 21st to 24th Sept’ 2022. Job Description. Walk-In Interview for Quality Control/ R&D On 21st to 24th Sept’ 2022 @ Rui Laboratories Pvt. Ltd. Departments: Quality Control / R&D. Qualification: B.Sc/ M.Sc. Experience : 01 to 08 years. Location: Atchutapuram.

Pharma 52
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Why does your address raise your risk of heart attack? AI seeks answers

pharmaphorum

It’s well known that where you live can have a profound impact on your risk of heart attack or stroke, but the exact reasons behind that inequality can be hard to tease out. Now, a collaboration between drugmaker Novartis, Microsoft, and New York University (NYU) intends to use artificial intelligence (AI) to investigate the factors behind the observation that a person living in one neighbourhood can have a greater risk of heart disease and poorer outcomes than another living mere streets

Food 52
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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.