European Pharmaceutical Review

JUNE 28, 2024

Data integrity and AI: how pharma can build a data-driven future LabVantage Solutions explains that data integrity remains a core responsibility – and challenge – as pharmaceutical organisations seek to leverage AI and data lakes to grow, innovate and serve patients.

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MedCity News

JANUARY 2, 2024

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.

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Pharma Marketing Network

MARCH 25, 2022

5 While the CDC gathers information on these topics for public health planning, there are immediate needs that pharma can address. . What Can Pharma Do? Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Sunny White.

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MedCity News

SEPTEMBER 29, 2023

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The speciality drug channel participants, including speciality pharmacies, biopharma companies, and distributors, are transforming their operations with automated and secure data systems and next-generation analytics, which will improve data collection, partner performance and strategy effectiveness. Discover the top speciality pharmacies.

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European Pharmaceutical Review

SEPTEMBER 14, 2023

This includes its Macclesfield campus, the UK’s largest pharma manufacturing site. The pharma company’s sites in Macclesfield, Cambridge, Luton and Speke will be supplied by energy from the biomethane facility. Supply of the renewable gas is planned through a new 15-year partnership with Future Biogas.

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PM360

OCTOBER 8, 2024

The company is the only pure-bred pharmacovigilance specialist, providing comprehensive, independent pharmacovigilance services as well as advanced tools and technology-powered solutions that address companies’ most complex product safety needs. The business is supported by investment from Stanley Capital Partners.

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MedCity News

NOVEMBER 10, 2024

While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia.

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MedCity News

JULY 7, 2022

Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.

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MedCity News

AUGUST 7, 2023

Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.

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MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. This may best be achieved by large pharma companies, with their combined $200bn annual R&D budget, compared to smaller companies that are relying on external investment.

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Pharmaceutical Technology

SEPTEMBER 13, 2022

An international team of scientific, regulatory, and safety and compliance (GxP) specialists, PharmaLex is based in Germany. The company provides strategic assistance and regulatory support to biopharma firms across the lifecycle of the product.

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MedCity News

NOVEMBER 30, 2022

Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder.

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pharmaphorum

AUGUST 4, 2022

This is due to the specialist nature of roles and the growth and diversification of biopharma, which requires an increasingly sophisticated and skilled workforce. Furthermore, by simulating real-life scenarios, AR offers the chance for staff in the pharma industry to practice complex operations without the associated risks.

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MedCity News

OCTOBER 15, 2024

In addition to meeting the main safety and tolerability goal, MieraGTx Holdings’ gene therapy for Parkinson’s disease also showed signs of efficacy. The one-time treatment is intended to reprogram dysfunctional brain circuits.

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European Pharmaceutical Review

DECEMBER 12, 2023

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. As a biotech, what work does Innate Pharma do in the biopharma industry?

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MedCity News

MARCH 31, 2024

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

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MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

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Pharmaceutical Technology

MAY 23, 2023

The safety and effectiveness of the drug prophylaxis for acute HAE attacks are yet to be proved. In June 2022, BioCryst signed an exclusive partnership with Austrian company Pint Pharma to register and promote ORLADEYO across Latin America.

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MedCity News

APRIL 30, 2024

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. The post J.P.

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Clarivate

JUNE 29, 2023

These include: Assisting in molecule design with desired properties using predictive analytics, a hotbed of pharma dealmaking in recent years, including last year’s Sanofi-Exscientia collaboration , which featured a potential value of up to $5.2

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Clarivate

OCTOBER 25, 2021

The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle.

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Safety Biopharma Competition Management 110

Pharma Pathway

SEPTEMBER 20, 2022

Ltd- Biopharma started its operations in 1987 at Raichur, Karnataka-India. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue. Job Description. Shilpa Biologicals Pvt. Contact : 9809818187, 8099056599.

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Clarivate

OCTOBER 17, 2024

Audience members during the recent Clarivate webinar Emerging Deal Trends in Biotech and Pharma identified three of the biggest challenges they face when securing deals. Finding the right partners Selecting the right partners in pharma dealmaking is crucial to ensuring the success of a partnership.

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pharmaphorum

SEPTEMBER 28, 2022

It is being led by chief executive Bertrand Damour (pictured above), a biopharma entrepreneur who previously held the top job at Swiss biotech NBE-Therapeutics , another ADC specialist that was acquired by Boehringer Ingelheim for $1.4 It is expected to be ready for clinical testing within the next 18 months, according to a company statement.

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PM360

SEPTEMBER 28, 2022

Now, as the President of Accord BioPharma , the U.S. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon. specialty division of Intas Pharmaceuticals, Ltd.,

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MedCity News

FEBRUARY 20, 2024

The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug.

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Salesforce

JUNE 11, 2019

Biopharma companies have consistently had to reimagine themselves over the years to confront globalization, the entry of generics and biosimilars, and now the advent of precision medicine and value-based care. Simply put, it’s taking more time and money ($2B+) to get new drugs approved, and the peak sales per drug is declining.

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PM360

JUNE 24, 2024

It provides guidance and acts as a safety net for prescribers. In other words, ClaimsTM provides creators access to real-time approved brand claims, references, and safety during initial creative development and actively surveys draft materials throughout the project lifecycle to ensure they align with previously approved content.

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Healthcare Healthcare Patients Side effects 52

pharmaphorum

SEPTEMBER 28, 2022

In recent years, the biopharma market has become progressively complex. Payers must take into consideration not only the clinical efficacy of a drug, but also its safety profile, side effects, and cost-effectiveness, among other factors.

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PM360

OCTOBER 22, 2024

DANNY SIGURDSON CEO and Founder Courier Health To effectively engage patients and prescribers to improve overall adherence to prescribed medication regimens, biopharma companies first need the visibility and full context of where a patient stands in their treatment journey. The axiom “you can’t manage what you can’t measure” applies here.

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Clarivate

JUNE 17, 2024

That first approval was fraught with disappointment, however, as limited clinical benefit and safety concerns arising during the post-marketing period resulted in a withdrawal. After the first publication of an experimental ADC design 60 years ago, it took 20 years for clinical trials to begin and 40 years for the first regulatory approval.

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Pharma Marketing Safety Leads 52

MedCity News

JULY 20, 2023

Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent.

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MedCity News

APRIL 4, 2023

The Scorpion drugs could have safety advantages over approved Johnson & Johnson and Takeda therapies that address the same rare genetic signature.

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MedCity News

JUNE 1, 2023

But the decision keeps the spirit of an earlier coverage determination, which called for the gathering of more evidence about the safety and efficacy of these therapies. Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced.

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European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

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