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

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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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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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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pharmaphorum

NOVEMBER 28, 2023

FDA launches wide probe into CAR-T therapy safety Phil.Taylor Tue, 28/11/2023 - 18:27 Bookmark this

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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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PharmaTech

FEBRUARY 21, 2024

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

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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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Fierce Pharma

JANUARY 25, 2024

But questions remained unanswered.

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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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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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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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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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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days.

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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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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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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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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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MedCity News

JUNE 22, 2022

The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity. .

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review. Like Stelara, the most serious known side effect of Wezlana is infection.

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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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pharmaphorum

JUNE 27, 2022

The safety of Astellas’ gene therapy portfolio has been thrust into the spotlight once again, after the FDA placed a clinical hold on a trial of its Pompe disease candidate AT845. The post Another Astellas gene therapy hits a safety hurdle appeared first on.

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PharmaVoice

JANUARY 30, 2024

Despite a recent safety warning from the FDA, companies such as BMS and J&J stress that the benefits of their cancer therapies still outweigh the risks.

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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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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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PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. home health visits). the patient population, product being studied, therapeutic area, and trial phase.

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MedCity News

NOVEMBER 18, 2022

The group complains that the FDA never studied the safety of the drugs under the labeled conditions of use. .

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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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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. The post First-in-class phosphate absorption inhibitor approved by FDA appeared first on European Pharmaceutical Review. XPHOZAH is expected to be available to eligible patients in the US in November 2023.

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PharmExec

MARCH 8, 2024

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

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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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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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European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The FDA is expected to decide on approval of Xolair for patients with food allergies in the first quarter of 2024.

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Pharma Marketing Network

MAY 3, 2023

In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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Pharmaceutical Commerce

NOVEMBER 1, 2023

The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.

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