Fierce Pharma

APRIL 12, 2023

Moderna nabs a win in Arbutus patent case as appeals court upholds prior invalidation zbecker Wed, 04/12/2023 - 11:16

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Pharmaceutical Technology

APRIL 12, 2023

Clinical-stage biotechnology firm LyGenesis has formed a joint research collaboration with Imagine Pharma to develop new cell therapies for type 1 diabetes (T1D). The companies will develop new cell therapies for patients with T1D, using LyGenesis’ allogeneic cell therapy platform and Imagine Pharma’s Type 1 Diabetes Activated Islet Progenitor Cells (T1D AIPCs).

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Pharma Leads Patients Pharmaceutical 98

Fierce Pharma

APRIL 12, 2023

AACR: AstraZeneca offers first look at Imfinzi's resectable lung cancer showing, fueling a key debate aliu Wed, 04/12/2023 - 15:37

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MedCity News

APRIL 12, 2023

Patients with opioid use disorder are more likely to stick with their treatment plan when offered buprenorphine via telemedicine, according to a new study. The study involved 1,378 patients, and their 180-day treatment retention rate was 56.4%.

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Patients 98

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Fierce Pharma

APRIL 12, 2023

Takeda gets FDA expansion of HyQvia to treat kids with primary immunodeficiency kdunleavy Wed, 04/12/2023 - 09:28

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FDA 219

MedCity News

APRIL 12, 2023

A joint report by the American Heart Association and Hello Heart found that women die from heart attacks at twice the rate of men and that women are seven times more likely to be misdiagnosed when having a heart attack. In response to the findings, Hello Heart launched a campaign Wednesday to help women understand heart attack symptoms.

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MedCity News

APRIL 12, 2023

By investing in Medicaid member engagement, health plans can strengthen their ability to reach members for Medicaid redetermination while taking actions that yield better outcomes and improved financial performance.

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Fierce Pharma

APRIL 12, 2023

Takeda hit with another pay-for-delay lawsuit, this time on gout drug Colcrys esagonowsky Wed, 04/12/2023 - 09:59

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PharmaVoice

APRIL 12, 2023

Pharma’s missing the mark when it comes to recruiting Black patients, and Ricki Fairley, CEO of The Black Breast Cancer Alliance, reveals what’s needed.

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European Pharmaceutical Review

APRIL 12, 2023

Patients treated with blood pressure-lowering drugs can experience greater improvements from changing medication compared to doubling the dose of their current medication, a study from Sweden has shown. Researchers aimed to investigate whether there is an optimal blood pressure drug for each individual, and therefore a potential for personalised blood pressure treatment.

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Side effects Medical Patients Leads 91

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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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MedCity News

APRIL 12, 2023

Home-based clinical training could enhance skills that are relevant for nurses no matter the care setting. Given the intimate nature of home care, it can be very instructive for understanding the need for a holistic approach to patient care, as well as promoting an empathetic touch.

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Copyright Clearance Center

APRIL 12, 2023

The post The Great Global Work From Home Experiment and How it Changed the Way We Work Forever appeared first on Copyright Clearance Center.

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MedCity News

APRIL 12, 2023

A federal jury found three former Outcome Health executives guilty of 47 counts of fraud. The convictions come after a 10-week trial that investigated the former leaders’ role in a billion-dollar scheme in which the company lied to its customers about how many physicians’ offices their advertisements would appear in.

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Physicians 83

European Pharmaceutical Review

APRIL 12, 2023

In November 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport was awarded to Boehringer Ingelheim’s investigational BI 907828 in de-differentiated liposarcoma (DDLPS), a rare and aggressive oncology indication for which there has been no new first-line treatment in over forty years. In this Q&A, Dr Christoph Zehendner, Medical Director for Boehringer Ingelheim UK and Ireland speaks to EPR about the significance of the Innovation Passport and Innovative

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Medicine Patients Medical Recruitment 85

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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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MedCity News

APRIL 12, 2023

Function Oncology goes beyond next-generation sequencing with a CRISPR-based technology that identifies targets for a patient’s cancer regardless of whether or not they are mutated. Now out of stealth, the company will present data validating its approach during the American Association for Cancer Research annual meeting.

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Biopharma Pharma 82

European Pharmaceutical Review

APRIL 12, 2023

Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ). [the aim of the collaboration is] to advance the next generation of Aβ immunotherapies for the treatment of Alzheimer’s disease” “This decision is an important next step of our collaboration with Denali… that aims to advance the next generation of Aβ immunotherapies for the treatment of Alzheimer’s disease,” stated Dominic Walsh, Head of the Neurodegenerative Research Unit a

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Transportation Engineering Safety Sales 80

MedCity News

APRIL 12, 2023

About 58% of health plans had at least one outcomes-based contract for prescription drugs in 2022, an Avalere Health survey found. More than 35% had more than 10 outcomes-based contracts in 2022.

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Prescription 72

PharmaTimes

APRIL 12, 2023

The trial will monitor patients across Europe for 24 months as they are treated with tildrakizumab

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Patients 95

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PharmaTech

APRIL 12, 2023

Michalle Adkins, director of Life Sciences Consulting at Emerson, discusses the structure of manufacturing organizations and how novel technologies may play a role in operations.

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Manufacturing Consulting 88

PharmaTimes

APRIL 12, 2023

Partnership will develop technology to screen and diagnose Lyme disease and diabetes

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Pharmaceutical Technology

APRIL 12, 2023

Pharming Group has conducted the first commercial shipments of oral selective PI3Kδ inhibitor Joenja (leniolisib) to patients diagnosed with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in the US. Joenja marks the first and only treatment approved in the country for the rare and progressive primary immunodeficiency in both adults and paediatric patients aged 12 years and above.

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Food and Drug Administration Patients FDA Food 59

PharmExec

APRIL 12, 2023

After the pandemic forced fundamenta­l­­­­ changes in the ways pharma and key opinion leaders worked together, both groups are using what they learned for a more seamless connection.

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Pharma 52

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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.

Specialization

Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). The TFDA has accepted the application for EUA to use the drug for the treatment of Covid-19 patients. Taiwan Shionogi will work with the regulator to secure the EUA for ensitrelvir in Taiwan as soon as possible.

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Food and Drug Administration Food FDA Patients 59

Legacy MEDSearch

APRIL 12, 2023

Abyrx, Inc. ( [link] ), a leading biomaterial sciences company with a focus on therapeutic technologies for use during surgical procedures, today announced its receipt of additional United States Food and Drug Administration (FDA) clearances for the company’s MONTAGE® Settable, Resorbable Bone Putty as both a bone void filler and cranial bone cement.

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FDA Food and Drug Administration Recruitment Manufacturing 52

Pharmaceutical Technology

APRIL 12, 2023

Foundation Medicine has announced it will supply a tissue-based test as a companion diagnostic for Bristol Myers Squibb’s (BMS) recently acquired ROS1/TRK inhibitor repotrectinib. FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. It is intended to provide tumour mutation profiling that allows oncologists to identify appropriate patients for treatment with targeted therapies like repotrectinib.

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Medicine Patients Leads 52

Referral MD

APRIL 12, 2023

As a healthcare content creator, I’ve spent quite a bit of time exploring the ins and outs of the healthcare industry. Over the years, I’ve deeply appreciated how technology has impacted the medical field. One observation that I find particularly intriguing is the power of referral management software—unbeknownst to many; it’s radically improving operational efficiency in doctors’ offices across the globe.

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Management Patients Physicians Doctors 52

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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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Pharmaceutical Technology

APRIL 12, 2023

On 30 March 2023, a US District Court judge issued a final judgment ruling that struck down a portion of the Affordable Care Act’s (ACA’s) requirement for most private insurance plans to cover many preventive services. The ruling only applies to services recommended by the US Preventive Services Taskforce (USPSTF) after 23 March 2010, when the ACA was enacted.

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Pharma Leaders

APRIL 12, 2023

Biotechnology company ImmuneBridge has raised $12m seed financing to advance new natural killer (NK) cell-based immunotherapies. Co-led by global investors Insight Partners and M Ventures, the financing round has also seen participation from Gaingels and One Way Ventures. ImmuneBridge is developing allogeneic NK cell-based immunotherapies to treat solid tumours and hematologic malignancies.

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Engineering Manufacturing Medicine Management 52

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. HyQvia is a liquid medicine containing recombinant human hyaluronidase and immunoglobulins (Ig).

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Food and Drug Administration FDA Prospecting Food 52

Pharma Leaders

APRIL 12, 2023

Sumitomo Pharma Oncology has received FDA’s Orphan Drug designation for its TP-1287 candidate to treat Ewing sarcoma, a rare cancer that typically occurs in children or teenagers. TP-1287 is an oral CDK9 protein inhibitor, which has been shown to inhibit tumor growth in preclinical models of blood cancers and several tumor types. The drug candidate is being evaluated in a phase 1 study in patients with advanced metastatic or progressive solid tumors who are either resistant to or can’t tolerate

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Pharma Patients 52

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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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