Fierce Pharma

APRIL 15, 2024

After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.

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MedCity News

APRIL 15, 2024

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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Fierce Pharma

APRIL 11, 2024

As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

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Biopharma Pharma 302

Dominic Tyer

APRIL 11, 2024

Online changes pose some pressing questions for the industry and demand a new approach to websites and data

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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

Distribution

PharmaTech

APRIL 12, 2024

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

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pharmaphorum

APRIL 9, 2024

Great Ormond Street Hospital is applying for the license to a gene therapy for rare disease ADA-SCID that was abandoned by a biotech developer on commercial grounds.

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Pharmaceutical Commerce

APRIL 10, 2024

If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.

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Patients Manufacturing 103

MedCity News

APRIL 10, 2024

Nurse managers being too busy to train and support their team members is one of the biggest reasons nurses are exiting the healthcare industry, according to a new report. The post Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem appeared first on MedCity News.

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PharmaTech

APRIL 11, 2024

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

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FDA 105

pharmaphorum

APRIL 10, 2024

The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.

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Manufacturing 130

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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.

Safety

Fierce Pharma

APRIL 11, 2024

The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea. | The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea.

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Government 268

Copyright Clearance Center

APRIL 10, 2024

A spate of recent lawsuits is shining light on how some generative AI (GenAI) companies are using copyrighted materials, without permission, as a core part of their products. Among the most recent examples is the New York Times Company’s’ lawsuit against OpenAI, which alleges a variety of copyright-related claims.

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MedCity News

APRIL 11, 2024

Following an extensive investigative report from the New York Times, the AHA is calling for the Labor Department to probe into the business practices of data analytics firm MultiPlan. The report revealed that MultiPlan works with major payers to negotiate reduced reimbursements for out-of-network medical providers — and this that practice ends up costing patients and employers.

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ALULA

APRIL 9, 2024

It’s been somewhat of an annual tradition for me to attend the Women in Leadership panel at the American Manufacturing Summit and share the highlights. This year’s panel discussion brought together five senior leaders: Joy Malinowski from Constellation Brands, Elena Bernado from Hello Fresh, Susanne Lauda from AGCO, Donna Deyo from Paccar, and Angela Reamer from Monin.

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Manufacturing 98

Advertiser: ZoomInfo

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

Competition

pharmaphorum

APRIL 15, 2024

Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.

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Healthcare Healthcare 82

Fierce Pharma

APRIL 12, 2024

After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey. | After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey.

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FDA 255

European Pharmaceutical Review

APRIL 11, 2024

The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. 1 That’s more than the automotive sector, which released 46.4 megatonnes in the same year, and the increased demand and complexity of medicines since then will only have swollen this figure. 1 Every major pharmaceutical manufact

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Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 92

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

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Safety FDA Leads Biopharma 93

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.

FDA

PharmaVoice

APRIL 10, 2024

TAE Life Sciences is bringing radiation-based cancer therapy to clinical trials globally in the coming years.

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pharmaphorum

APRIL 15, 2024

Roche’s CD20xCD3 bispecific antibody Columvi has improved survival when used as a second-line therapy for diffuse large B-cell lymphoma (DLBCL) in a phase 3 trial, setting up regulatory filings for earlier use of the drug in the treatment pathway.

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Fierce Pharma

APRIL 12, 2024

History is repeating for AstraZeneca CEO Pascal Soriot, who successfully dodged an executive pay revolt at the company’s annual meeting Thursday, echoing a similar situation that played out in 2021 | Out of more than 1.18 billion votes cast by AstraZeneca shareholders at the company's annual meeting this week, 64.43% of investors voted in favor of an updated pay policy that could see CEO Pascal Soriot earn upward of 18.7 million pounds sterling ($23.5 million) for his performance this year.

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European Pharmaceutical Review

APRIL 15, 2024

Researchers investigating environmental microbial contamination found “no seasonal climatic influences were observed” in bacteria and fungi counts present in Grade D (ISO 8) Brazilian pharmaceutical cleanrooms. Samples were obtained via surface and air monitoring over a one-year period. While microbial levels were predicted to be higher during rainy periods compared to dry spells, “no statistically significant differences in bacteria and fungi counts were found between months or seasonal period

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Pharmaceutical Pharmaceutical products Distribution Training 75

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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

MedCity News

APRIL 9, 2024

Pelago’s new contingency management program rewards patients for engaging in treatment, such as completing a survey, completing app check-ins, attending appointments and completing cognitive behavioral therapy exercises. The post Pelago Unveils Contingency Management Program To Support Those With Substance Use Disorder appeared first on MedCity News.

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Management Patients 114

PharmaVoice

APRIL 15, 2024

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

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Patients 96

pharmaphorum

APRIL 11, 2024

The European Parliament has voted through reforms to legislation regulating the pharma sector, which the industry claims could compromise competitiveness and patient care.

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Pharma Competition Patients 94

Fierce Pharma

APRIL 10, 2024

New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. | New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions.

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FDA 265

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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.

Management

European Pharmaceutical Review

APRIL 15, 2024

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.

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MedCity News

APRIL 11, 2024

Grow Therapy’s $88 million Series C funding round was led by Sequoia Capital. The financing will help the company invest in its team, improve its product and expand its footprint. The post Grow Therapy Secures $88M To Expand Mental Health Services appeared first on MedCity News.

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Pharmaceutical Technology

APRIL 12, 2024

Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.

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Manufacturing 98

pharmaphorum

APRIL 11, 2024

Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.

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FDA 107

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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.

Patients