MedCity News

SEPTEMBER 27, 2024

Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics.

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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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Fierce Pharma

MAY 17, 2023

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

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Fierce Pharma

JANUARY 24, 2024

. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, it's adjusted the wording of a proposed boxed warning.

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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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Fierce Pharma

JANUARY 22, 2024

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. |

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European Pharmaceutical Review

JANUARY 7, 2025

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines.

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MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. 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.

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Fierce Pharma

DECEMBER 22, 2023

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of (..)

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MedCity News

NOVEMBER 7, 2022

The FDA placed a clinical hold on Verve Therapeutics’ application to begin human testing of its gene-editing therapy for an inherited form of high cholesterol. No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K.

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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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Fierce Pharma

DECEMBER 9, 2023

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. |

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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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World of DTC Marketing

DECEMBER 29, 2020

All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Let’s also remember that pharma is going to make a LOT of money on these vaccines. That’s a hell of an incentive.

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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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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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Fierce Pharma

NOVEMBER 29, 2023

The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.

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Fierce Pharma

JANUARY 6, 2024

A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.

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MedCity News

NOVEMBER 30, 2022

While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.

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Pharma Marketing Network

MARCH 8, 2025

Introduction A well-optimized landing page can be the difference between a successful pharma marketing campaign and wasted ad spend. What makes a pharma landing page effective? It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies.

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Fierce Pharma

JANUARY 25, 2024

But questions remained unanswered.

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MedCity News

JULY 6, 2022

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

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Fierce Pharma

SEPTEMBER 11, 2024

Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming.

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Fierce Pharma

JUNE 27, 2023

Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.

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Pharma Marketing Network

MARCH 27, 2025

What once was a cautious, slow-moving experiment has now become a vital component of modern pharma marketing strategies. The increasing integration of platforms like LinkedIn, X (formerly Twitter), YouTube, and even TikTok has dramatically shifted how pharma brands engage with healthcare professionals (HCPs), patients, and caregivers.

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MedCity News

JUNE 1, 2023

Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced. 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.

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World of DTC Marketing

JUNE 24, 2021

Pharma TV ads drive people online to search for more information. Safety pages on Pharma product websites continue to have high utility. As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business. This is normal, and the FDA should take note.

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Pharma Marketing Network

MARCH 24, 2025

In a world where innovation, regulation, and consumer behavior shift rapidly, keeping up with pharma news is not just helpfulits essential. For pharma marketing executives and their teams, staying current helps maintain competitive advantage, ensures compliance, and unlocks opportunities for smarter, faster campaign decisions.

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World of DTC Marketing

FEBRUARY 9, 2021

6ix: Safety information needs context. They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues. 9ine: “Why aren’t pharma websites updated?” First impressions are 94% design-related. 7even: Real patient stories.

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Pharma Marketing Network

NOVEMBER 15, 2024

In today’s digital-first world, Pay Per Click (PPC) advertising has become an essential strategy for pharma marketing executives. Why PPC Matters in Pharma Marketing Why invest in PPC? Example: If promoting Jardiance for diabetes management, focus on unique selling points like proven efficacy and FDA approval.

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MedCity News

MARCH 22, 2023

In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals. 89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial.

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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

MARCH 5, 2025

With millions of healthcare professionals (HCPs) and patients turning to Google for medical information, paid search ads present a huge opportunity for pharma brands to boost engagement and conversions. So, how can pharma marketing teams maximize the impact of their Google Ads while staying compliant?

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Pharma Marketing Network

MARCH 18, 2025

However, pay per click advertising (PPC) presents a powerful and targeted solution for pharma marketers looking to engage HCPs efficiently. But how can pharma marketing teams maximize the impact of PPC campaigns while ensuring compliance and generating high-value leads?

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Fierce Pharma

AUGUST 15, 2024

So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels. | So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.

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Pharma Marketing Network

DECEMBER 31, 2024

Table of Contents Sr# Headings 1 Introduction: The Pharma Marketing Challenge 2 Building a Winning Pharma Marketing Strategy 3 The Role of Branded Drug Campaigns 4 Innovating for Future Success Introduction: The Pharma Marketing Challenge Marketing pharmaceuticals is no small feat.

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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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