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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FDA Safety Medicine 218

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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Safety Medicine FDA 293

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

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Safety FDA Leads Biopharma 121

Fierce Pharma

JANUARY 25, 2024

But questions remained unanswered.

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Safety FDA Medicine Patients 249

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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FDA Safety Pharmaceutical Marketing 213

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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FDA Manufacturing Safety 205

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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Safety FDA Patients Biopharma 109

MedCity News

JULY 6, 2023

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

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Safety FDA Biopharma Pharma 104

Fierce Pharma

MARCH 4, 2024

. | After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

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Safety FDA 230

World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. Drug companies know how to play the system. Can we make sense of this?

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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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Side effects Safety FDA 215

Fierce Pharma

SEPTEMBER 19, 2023

Gaining FDA approval last month for its geographic atro | Astellas reported results of a phase 3 trial that assessed Izervay’s effectiveness and safety over a 24-month period.

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Safety FDA 237

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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FDA Safety Healthcare Healthcare 125

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

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FDA Food and Drug Administration Patients Biopharma 207

MedCity News

NOVEMBER 10, 2024

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. 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.

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FDA Engineering Safety Biopharma 124

pharmaphorum

MARCH 10, 2024

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug.

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FDA Safety 124

World of DTC Marketing

JUNE 24, 2021

Safety pages on Pharma product websites continue to have high utility. If the FDA understood consumer behavior like marketers instead of scientists, they would understand how DTC works. More importantly, the FDA needs to work with online sites to eliminate health misinformation. This is normal, and the FDA should take note.

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FDA Doctors Prescription Pharma 165

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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FDA Safety Marketing Biopharma 113

Fierce Pharma

JULY 13, 2023

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still working out the logistics of testing and reimbursement.

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Doctors Safety FDA 196

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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Food and Drug Administration FDA Medical Food 105

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 post FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades appeared first on MedCity News.

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FDA Safety Pharma Biopharma 122

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.

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Safety Food and Drug Administration Prospecting Food 98

World of DTC Marketing

OCTOBER 29, 2020

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. While the product safety information page is among the top five pages visited what alarmed me was that time on the page was measured in seconds not minutes for most online visitors. It doesn’t happen, and the FDA should know this by now.

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Side effects Safety FDA Pharma 181

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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FDA Patients Safety Biopharma 113

PharmaTech

SEPTEMBER 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

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Safety Patients Consulting FDA 98

Pharmaceutical Technology

MAY 3, 2024

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

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FDA Safety 105

pharmaphorum

JUNE 11, 2024

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval.

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FDA Safety 115

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

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Patients FDA Doctors Physicians 200

European Pharmaceutical Review

MARCH 27, 2024

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. However, due to the importance of pyrogen testing for the safety of pharmaceutical products , the report stated that this will help to drive market growth.

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Safety Marketing Food and Drug Administration Pharmaceutical 94

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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FDA Safety Biopharma Pharma 119

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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Safety Leads FDA Biopharma 116

Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). Furthermore, the favourable pharmacokinetic, safety and tolerability profile of REL-1017 was in line with data reported in prior Phase I trials.

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Food and Drug Administration FDA Safety Food 119

World of DTC Marketing

JANUARY 8, 2021

Can the FDA really control the quality of vaccine orders this big? However, in vaccines, cut corners could compromise patient safety. I wonder why the FDA has not hired or dispatched more safety inspectors to plants making Covid-19 doses. Supply Issues? Right now, the biggest challenge is just getting vaccinated.

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Government Safety FDA Pharma 266

European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. The safety profile of donanemab was initially reported from the TRAILBLAZER-ALZ trial in the New England Journal of Medicine.

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FDA Food and Drug Administration Safety Medicine 98

World of DTC Marketing

NOVEMBER 10, 2020

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. When a vaccine is available, you can also bet that people will form long lines to get vaccinated even though there is skepticism about vaccine safety.

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Media Retail FDA Safety 286

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. FDA’s draft guidance refers to psychedelics as “classic psychedelics”. These should be submitted latest 23 Aug 2023 to be considered.

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Food and Drug Administration FDA Safety Food 98

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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FDA Food and Drug Administration Biopharma Food 128