Fri.Dec 16, 2022

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After prior rejection, Ferring finally nabs FDA nod for bladder cancer gene therapy

Fierce Pharma

After prior rejection, Ferring finally nabs FDA nod for bladder cancer gene therapy. esagonowsky. Fri, 12/16/2022 - 15:19.

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CSL closes on EU approval for haemophilia B gene therapy

pharmaphorum

CSL’s gene therapy for haemophilia B has been recommended for approval by the EMA’s human medicine committee, setting up a decision by the European Commission early next year. The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

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In surprise move, AbbVie bows out of top industry groups

Fierce Pharma

In surprise move, AbbVie bows out of top industry groups. zbecker. Fri, 12/16/2022 - 11:27.

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BehaVR and OxfordVR Merge, Secure $13M in Funding

MedCity News

BehaVR offers care for anxiety, mental wellness, pain management and maternal health, while OxfordVR is primarily focused on serious mental illness, such as PTSD, bipolar disorder and schizophrenia. Through the merger, OxfordVR’s products will join BehaVR’s platform, providing services for a whole range of mental health conditions.

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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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AZ wins patent fight with Viatris, gains more exclusivity for blockbuster Symbicort

Fierce Pharma

AZ wins patent fight with Viatris, gains more exclusivity for blockbuster Symbicort. kdunleavy. Fri, 12/16/2022 - 10:06.

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Medgadget Visits Healthcare? Expo Taiwan

Medgadget

This past week, Medgadget was an official media partner with the Healthcareᐩ Expo Taiwan. This four-day annual event brings together healthcare companies from all over Taiwan and the rest of the world. It is also an opportunity for tech companies not typically associated with healthcare, such as ASUS, Intel, and BenQ, to showcase what they’re doing in medicine and healthcare.

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Movano Health On Track to File First FDA Submission for its Smart Ring’s SpO2 and Heart Rate Data Following Successful Pivotal Hypoxia Trial

Legacy MEDSearch

Movano Health , a purpose-driven healthcare solutions company at the intersection of medical and consumer devices , today announces successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the University of California, San Francisco (UCSF) to assess the accuracy of its smart ring’s blood oxygen saturation (SpO 2 ) and heart rate data.

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Is Legislation to Safeguard Americans Against Superbugs a Boondoggle or Breakthrough?

MedCity News

The PASTEUR Act, as amended, would provide $6 billion in federal funding over several years to give drugmakers incentive to develop and manufacture lifesaving medications for the small but growing number of infections highly resistant to antibiotics.

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Three Reporting UX Strategies to Maximize Sales Force Success

PM360

Strategic reporting efforts are fundamental to support sales force efficiency and effectiveness. Biopharma companies that do not prioritize reporting strategy find even the strongest sales force will struggle. Commercial teams need properly designed reports with data presented in a way that is easy to access and interpret. Without it, the sales force will be ill-equipped to accurately identify key takeaways, resulting in a perceived lack of information needed to successfully do their jobs.

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Putting Patients First: Seeking To Solve Long-standing Challenges With Clinical Research Participation and Access

MedCity News

Clinical research as a care option is a means of connecting patients with clinical research as part of their ongoing health care, located where they receive that care, and offered by their trusted provider.

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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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Ten ways to ‘silent-night’ in peace

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional, and global life science communications to offer some little tips for enjoying a big business career. In this year-end column, he reflects on measures to ensure your festive break becomes that – festive, and a proper break – and that you’re not burning through precious off-time without any relaxation.

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Stanford Becomes 2nd California Health System to Grant Workers’ Big Raises This Month

MedCity News

Healthcare workers at Stanford Medical Center and Lucile Packard Children’s Hospital ratified a new agreement that increases their wages by 15% over the next three years. It’s been good month for nurses unions in Northern California — Kaiser Permanente nurses recently ratified a new contract that increased wages by 22.5% over four years and included provisions for improved staffing.

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Can pharma quit Twitter? Social strategy evolves as Musk changes the platform

PharmaVoice

A breakdown of how Twitter’s recent shifts are impacting pharma, and how the industry should navigate the platform in 2023.

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Value-Based Primary Care Must Also Integrate Specialty Care

MedCity News

The intentional use of specialty care coordination inside value-based, accountable primary care structures are necessary tools in the march to reward value and positive health outcomes over the volume of services rendered.

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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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WHO updates guidelines for treating drug-resistant tuberculosis

European Pharmaceutical Review

The World Health Organization (WHO) has released its updated consolidated guidelines on treatment for drug-resistant tuberculosis (DR-TB), which features major improvements in treatment options for people with multidrug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB), including a regimen that offer better patient outcomes. The 2022 updates include a new recommendation on the use of a novel all-oral six-month regimen made up of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM

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UK: Taylor & Francis Signs Accessible Publishing Charter

Copyright Clearance Center

The post UK: Taylor & Francis Signs Accessible Publishing Charter appeared first on Copyright Clearance Center.

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Alzheimer’s therapeutics market to reach $6.8 billion by 2032

European Pharmaceutical Review

According to a report by Future Market Insights (FMI), the global Alzheimer’s therapeutics market is expected to grow at a compound annual growth rate (CAGR) of 9.3 percent, and driven largely by collaboration of existing players, reach $6.8 billion by 2032. The report predicted the Alzheimer’s therapeutics market will reach $2.8 billion worldwide in 2022.

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The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’

pharmaphorum

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Further, with a pandemic treaty in development, there are reasons to believe that many countries and the WHO want to see a more equitable distribution of medical products for future pandemics. The world was caught unprepared for the global pandemic that struck in 2020.

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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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3 Healthcare Predictions for 2023: New Realities and Priorities for Health Plans

MedCity News

The health system will enter a new reality with the public health emergency lifted After […].

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A Year’s Worth of Publishing News

Copyright Clearance Center

The post A Year’s Worth of Publishing News appeared first on Copyright Clearance Center.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out new developments from Equiva Health, BehaVR, Juno Medical, Cabinet Medical and Override.

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Invest now to reduce manufacturing harms to environment, says pharma survey

Pharmaceutical Technology

The pharmaceutical industry must improve its environmental footprint by investing in technology and expertise, as well as through better design of new drugs early in their development, according to a GlobalData survey of the pharmaceutical industry. The report, Pharmaceutical Manufacturing ESG Survey – Towards a Sustainable Supply Chain (November 2022), reveals that most pharma industry insiders believe the sector is not doing enough to limit harm to the environment.

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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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Nurturing Manufacturing Agility

PharmaTech

Some manufacturers are developing smaller, more mobile drug manufacturing processes for point-of-use patient care.

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Pfizer and Anumana boost detection of cardiovascular disease

PharmaTimes

Partnership will support development of new algorithm and identify at risk patients

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Endometriosis market projected to grow at a CAGR of 10% between 2020 and 2030

Pharmaceutical Technology

The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% across the seven major markets (7MM: the US, 5EU [France, Germany, Italy, Spain and the UK], and Japan), according to GlobalData’s recently published Endometriosis: Global Drug Forecast and Market Analysis – Update. This growth is primarily due to market release of several gonadotropin-releasing hormone (GnRH) receptor antagonists, including Myovant’s Myfembree (r

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Ruta Kersyte: Curating insights from case law

Clarivate

A passion for the law doesn’t always have to lead to a position at a law firm or corporate legal department. For Ruta Kersyte, her legal training has led to a career at the intersection of trademarks, litigation and technology. Ruta earned her undergraduate and graduate degrees in European and business law. Deeply interested in trademarks and their global impact, she wanted to explore different career paths in the legal realm, leading to a position at Darts-ip as a trademark case law analyst in

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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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Sio Gene Therapies comes to the end of its rocky road

pharmaphorum

Sio Gene Therapies’ litany of clinical disappointments over the last few years has finally led to the demise of the biotech, formerly known as Axovant and one of the ‘vant’ companies originally founded by entrepreneur Vivek Ramaswamy. Sio’s board of directors has decided it is time to call it quits and abandon the business, after efforts launched earlier this year to try to find a new change in direction for the business came to nothing. “After evaluating the compan

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The role of T-cells in future SLE therapies

Pharmaceutical Technology

The rheumatology market is a rapidly growing and highly lucrative industry, but there are still major untapped opportunities for cellular therapies to enter this space, in particular the systemic lupus erythematosus (SLE) market. The example of rituximab, originally a cancer drug, now used for lupus, has shown the potential of adopting cancer medications for lupus.

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Second phase 3 trial extends Astellas’ lead in claudin 18.2 cancers

pharmaphorum

Astellas has confirmed it is out in front among developers of drugs targeting claudin 18.2, after a second phase 3 trial of zolbetuximab hit its objectives. The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer.

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CHMP issues positive opinion for CSL’s etranacogene dezaparvovec

PharmaTimes

Gene therapy involves adults with haemophilia B and brings renewed hope to patients across Europe

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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.