Fierce Pharma

JANUARY 17, 2023

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

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Fierce Pharma

NOVEMBER 20, 2024

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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MedCity News

DECEMBER 2, 2024

Last year, Novartis discontinued its Huntington’s program after safety issues emerged in Phase 2 testing. Novartis is securing global rights to a PTC Therapeutics Huntington’s disease drug candidate that has encouraging Phase 2 data that will be discussed with the FDA to plan a pivotal study.

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Fierce Pharma

JUNE 22, 2023

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

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MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

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MedCity News

JULY 6, 2023

While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks. Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval.

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MedCity News

JUNE 11, 2023

With animal testing requirements finally removed, the pharma industry and its constituents can hope for faster innovation. Human tissues, coupled with AI that can deal with terabytes of data will blow mice models out of the water.

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Fierce Pharma

MAY 17, 2024

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

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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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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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World of DTC Marketing

DECEMBER 29, 2020

All vaccines go through clinical trials to test safety and effectiveness. Let’s also remember that pharma is going to make a LOT of money on these vaccines. The post How did pharma develop a vaccine so quickly? With so many exposures, the trials took a shorter time to see if the vaccine worked.

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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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Fierce Pharma

JANUARY 24, 2024

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

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Fierce Pharma

AUGUST 20, 2024

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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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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World of DTC Marketing

OCTOBER 20, 2020

J&J’s refusal to release any information regarding a COVID-19 vaccination trial that J&J paused earlier this month comes on the heels of a recent and widely-touted joint pledge of prudence and caution on vaccine trial safety by nine drug companies, including J&J, working on COVID 19 vaccines. Pharma still has not learned.

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World of DTC Marketing

AUGUST 12, 2022

Such warnings “constitute the pharma response in literally every instance since 1906,” the first drug regulation agency was created, said Dr. Aaron Kesselheim. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million.

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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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European Pharmaceutical Review

APRIL 4, 2025

Further findings highlighted other major concerns around AI: Reputational risk for companies when building, choosing or using AI technologies (37 percent) Safety (17 percent). Embracing digital innovation in pharma – what will it take?

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World of DTC Marketing

NOVEMBER 27, 2020

SUMMARY: Business by press release has made pharma executives a lot of money but we still haven’t seen any over reviewed data on COVID 19 vaccines. Pharma companies have also been capitalizing on the pandemic and positive press releases more broadly. It seems that we were premature to think that pharma is earning trust back.

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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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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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pharmaphorum

MAY 1, 2024

China's Jacobio Pharma is preparing to file its KRAS inhibitor glecirasib for approval, saying it could offer a safety advantage over current drugs in the class

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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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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? This guide breaks down the best practices for landing page optimization , helping pharma marketers maximize engagement while maintaining regulatory compliance.

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Fierce Pharma

APRIL 19, 2024

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

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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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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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Fierce Pharma

JULY 7, 2023

AstraZeneca and Daiichi Sankyo's TROP2 antibody-drug conjugate returned a concerning safety message. AstraZeneca and Daiichi Sankyo delivered a concerning safety message for their TROP2 antibody-drug conjugate. Moderna reportedly plans to invest up to $1 billion in China.

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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? Compliance and Regulatory Considerations Pharma marketing is heavily regulated, and PPC is no exception. PPC does just that. Simple: visibility.

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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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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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Pharma Marketing Network

NOVEMBER 15, 2024

Digital advertising is no longer just a nice addition; it’s a must-have for every successful pharma marketing strategy. But for pharma, it’s not just about being visible; it’s about being impactful and compliant. For example, an ad for Humira should clearly outline potential benefits and direct users to full safety information.

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Fierce Pharma

OCTOBER 26, 2023

With concerns growing over the burden Leqembi could impose on healthcare infrastructure, Eisai and Biogen have trotted out data for an under-the-skin version of the Alzheimer’s disease drug that ma | Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi.

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Pharma Marketing Network

MARCH 19, 2025

But how can pharma brands create meaningful connections in a digital landscape crowded with content? Unlike traditional consumer marketing, pharma marketing requires a strategic approach that balances compliance, education, and innovation. Pharma marketers must strike a balance between compliance and engagement.

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World of DTC Marketing

FEBRUARY 9, 2021

6ix: Safety information needs context. 9ine: “Why aren’t pharma websites updated?” In the top pharma product websites that we showed groups, they really disliked the website’s overall appearance and described it as “cold and unappealing.” First impressions are 94% design-related.

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