Pharmaceutical Technology

JANUARY 19, 2023

Deuruxolitinib’s safety and efficacy was assessed in moderate to severe Alopecia Areata adult patients in the THRIVE-AA Phase III clinical programme. Sun Pharma stated that it will follow Concert’s plan to seek approval from the US Food and Drug Administration (FDA) for its new drug application in the first half of the year.

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PM360

OCTOBER 28, 2022

Promising AI Use Cases in Pharma. Although we’re still at the beginning of the AI revolution in pharma, promising use-cases have already been identified: Drug discovery: In drug discovery , AI models are predicting the 3D structure of target proteins at an unprecedented scale.

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Pharmaceutical Technology

FEBRUARY 24, 2023

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. You can compare timelines.

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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Marketing Pharma Food and Drug Administration Media 52

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary. We need a 21st-century approach that puts patient safety first. In other words, money over safety. Patients should be scared.

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European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. The post Data integrity considerations in Pharma and Life Sciences appeared first on European Pharmaceutical Review. How can this be mitigated?

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Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. In 2021, they accounted for 0.2%

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

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Marketing Pharma Food and Drug Administration Media 40

Impetus Digital

NOVEMBER 14, 2022

It is no secret that Pharma (still) has a major diversity problem. We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. This is a good start but is not enough to solve this problem on its own.

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European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder.

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Food and Drug Administration FDA Competition Pharma 116

pharmaphorum

NOVEMBER 3, 2022

Food and Drug Administration’s (FDA) draft guidance, “ Digital Health Technologies for Remote Data Acquisition in Clinical Investigations ”. We see how digital measures of adherence ensure that sample size calculations hold and drug developers can accurately evaluate the safety and efficacy of new molecules.

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Pharma Leaders

MAY 1, 2023

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. The FDA also did not request for new preclinical or Phase III clinical trials for assessing efficacy or safety.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). Thus, LY03010 could be more convenient to administer and improve patient compliance by optimising the initial dosing regimen, while ensuring efficacy and safety.

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Competition Food and Drug Administration Pharma Food 98

Clarify Health

NOVEMBER 9, 2022

Pharma companies have accelerated to address diversity, ethnicity, and inclusion (DE&I) in their clinical trials. Deloitte research recently discovered it delivers three key advantages: Safety and effectiveness: Clinical trial participants must reflect the patient population likely to use a new drug. Current FDA guidance.

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Pharma Food and Drug Administration Medicine Patients 40

European Pharmaceutical Review

NOVEMBER 6, 2023

IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced.

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Food and Drug Administration Safety Food Patients 76

Pharmaceutical Technology

MAY 7, 2023

Formosa Pharmaceuticals along with AimMax Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for APP13007, a new formulation to treat inflammation and pain after ocular surgery. Both trials enrolled 151 subjects in a corneal endothelial cell safety substudy.

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Food and Drug Administration FDA Safety Food 52

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 85

Clarify Health

NOVEMBER 9, 2022

Pharma companies have accelerated to address diversity, ethnicity, and inclusion (DE&I) in their clinical trials. Deloitte research recently discovered it delivers three key advantages: Safety and effectiveness: Clinical trial participants must reflect the patient population likely to use a new drug.

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Pharma Food and Drug Administration Patients Medicine 40

Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Manufacturing FDA Safety Pharma 59

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. appeared first on Pharma Marketing Network. The post Why Is FDA Issuing Fewer Marketing Violation Letters?

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Pharmaceutical Technology

MAY 3, 2023

Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for spesolimab (SPEVIGO) to prevent generalised pustular psoriasis (GPP) flares. Safety data were found to be consistent with earlier clinical trials.

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Food and Drug Administration Food Safety Medical 52

Pharmaceutical Technology

NOVEMBER 17, 2022

China’s National Medical Products Administration (NMPA) has granted approval for Ascletis Pharma ’s Investigational New Drug (IND) application for its therapy ASC61 to treat advanced solid tumours. In preclinical studies, the small molecule inhibitor demonstrated good pharmacokinetic and safety profiles in animal models.

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pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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FDA Food and Drug Administration Patients Food 112

Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

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Food and Drug Administration FDA Safety Food 52

World of DTC Marketing

NOVEMBER 1, 2020

Pharma companies have made a LOT of money off our bloated and ineffective healthcare system, and they should be all be banding together to educate the public on the truth around COVID, like the importance of wearing masks. Then there are political moves that aren’t supported by science.

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Pharmaceutical Technology

MARCH 22, 2023

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. He adds that in the early 2000s there were no set standards for RFID in the pharma industry, so the compatibility between systems was not guaranteed.

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Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Valeo Pharma and Veru have signed a commercial services agreement in Canada for sabizabulin as a treatment for Covid-19. Due to clear clinical efficacy without any safety concerns, the Independent Data Monitoring Committee stopped the trial. The proportion of mortality by day 60 was the trial’s primary endpoint.

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Food and Drug Administration Food Pharma Safety 52

Pharma Leaders

JUNE 27, 2023

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Based on the safety and efficacy findings from the Phase III BENEGENE-2 study, the company made these filings.

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PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA). Example: Top Pharma Company Using NLP to Explore Drug Label Data.

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Food and Drug Administration Competition Safety Pharmacology 98

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. He is currently a CMC consultant with an interest in impurities and safety‑based limits. Internet] US Food and Drug Administration.

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Food and Drug Administration FDA Safety Food 77

Pharma Leaders

MARCH 21, 2023

The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC). In the Phase II dose-expansion phase, PBP1510 at the RP2D along with gemcitabine will be administered for assessing the efficacy and safety of PBP1510.

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Food and Drug Administration Safety FDA Food 52

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances. References.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the US, members of the public can request, through a Citizen Petition, that the US Food and Drug Administration (FDA) “take or refrain from taking” various administrative actions, including denying approval of generic and biosimilar drug applications. Citizen Petitions before the FDA.

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European Pharmaceutical Review

AUGUST 30, 2022

He called for strategies to improve diversity across the pharma industry, saying these must be considered where trial populations vastly differ from the disease demographics to ensure that all population subgroups are well represented in clinical research, especially within the field of oncology. Initiatives are already underway.

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Pharma Leaders

JUNE 7, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

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Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) granted Eli Lilly’s Lartruvo (olaratumab) accelerated approval in 2016 for soft tissue sarcoma (STS). If the Australian pharma company can demonstrate a renewed potential for the drug, Lilly could receive up to $255m in commercial and regulatory milestone payments.

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