World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. 6ix: Safety information needs context. 7even: Real patient stories. 9ine: “Why aren’t pharma websites updated?” First impressions are 94% design-related. 10en: eMail communications.

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World of DTC Marketing

FEBRUARY 4, 2021

The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. COVID Dashboards.

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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.

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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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pharmaphorum

OCTOBER 26, 2022

When people think about pharma, they often think about “big” pharma: large, faceless corporations. And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. million rare disease patients in the U.S. Caring for a global community.

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World of DTC Marketing

OCTOBER 29, 2020

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. I just finished an analysis of a pharma clients website using their analytics. Who could blame them when the safety information sounds like a medical journal? For some reason, the FDA still requires fair balance on website home pages.

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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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World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. Patients should be scared. 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.

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MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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FDA Leads Safety Patients 100

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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Pharma Food and Drug Administration Government Medicine 105

Pharma Marketing Network

MARCH 25, 2022

Although the caregiver is seen as an extension of the patient and their role is not strictly defined, they are informal members of the front-line care team. 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? Sunny White.

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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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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

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Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

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Patients Food and Drug Administration FDA Safety 52

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.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

Pharma Marketing Network

SEPTEMBER 15, 2021

Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. In recent years the European Union has updated their requirements for Medical Device reporting following the FDA in the United States mainly with the EU Medical Device Regulation.

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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

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Physically threatening and emotionally significant for patients, such exacerbations can be fatal.

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FDA Food and Drug Administration Medical Patients 52

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. What is an effective solution?

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Government Pharma Ethics Training 87

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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Patients Food and Drug Administration FDA Safety 52

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

PM360

OCTOBER 13, 2023

Doctor Docs: Targeting Trust Between Pharma and HCPs A new study shows the crucial link in pharma marketers’ digital engagement strategy with HCPs is in jeopardy—trust. and France regarding pharma-provided digital platforms. One participant summed up these perceptions by stating “It’s a pharmaceutical site, you know.

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Healthcare Healthcare Doctors Pharma 59

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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World of DTC Marketing

JANUARY 8, 2021

Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine.

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Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). It is claimed to be the longest follow-up of any gene therapy programme for SCD.

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Food and Drug Administration FDA Prescription Food 52

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.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 83

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 96

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. ” Patients want to understand how the drug works and the potential side effects before starting therapy.

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Marketing Prescription Side effects Doctors 285

Pharma Leaders

APRIL 19, 2023

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). The Phase III trials were designed to assess the efficacy and safety of Xphozah. The company stated that the all the three Phase III clinical trials met their primary as well as the important secondary endpoints.

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World of DTC Marketing

NOVEMBER 10, 2020

Pharma CEOs still are more concerned about their company’s stock price than patents. Biogen shot up when an initial review of their Alzheimer’s drug was positive, but then analysts torpedoed the company when another FDA panel said there wasn’t enough data. It’s a never-ending cycle. It’s sad, really.

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World of DTC Marketing

DECEMBER 23, 2020

DTC marketers who believe that DTC is essentially the same as before the pandemic are failing to recognize significant shifts in patient behavior regarding prescription drugs. In an era of a pandemic, are psoriasis patients really going to ask for a drug that may compromise their immune system? What are other patients saying about it?

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European Pharmaceutical Review

NOVEMBER 8, 2022

There are also several pending bills that seek to lower drug costs by means other than price regulations, including: 1) deterring the delay in FDA approval of drug applications caused by sham ‘Citizen Petitions’. Citizen Petitions before the FDA. 562 would permit the FDA to deny the petition if either of these factors were satisfied.

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Food and Drug Administration Pharma Prescription Manufacturing 52

Pharma Marketing Network

APRIL 1, 2023

Pharma-Mkting.com is a leading resource for professionals in the pharmaceutical and medical device industries. With a focus on marketing and digital health, Pharma-Mkting.com provides a wealth of information, resources, and insights to help these industries succeed in an increasingly competitive market.

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Pharma Medical Pharmaceutical Marketing 52

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 75

Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. OA affects millions of people in the United States and most of these people have limited options to manage their symptoms.” According to the U.S.

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