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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

This Assessment does not itself prescribe specific remedies for the ills it diagnoses; those are supposedly coming in the future Strategy document. The Assessment states that this prescribing is tantamount to doing direct harm, given the known and unknown risks and benefits of drugs in these contexts of use.

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IPC alert advises patients to monito possibility of mefenamic acid’s adverse effects: Meftal makers

Express Pharma

DRESS syndrome, mentioned in the IPC alert, is a very rare event that is previously documented in medical literature, both in India and globally. The post IPC alert advises patients to monito possibility of mefenamic acid’s adverse effects: Meftal makers appeared first on Express Pharma.

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

The gist of a briefing document published from FDA reviewers ahead of an expert advisory board meeting is that the vaccine is good to go. But there are still unanswered questions that can only be addressed once the shot is administered to the wider public. of participants.

Vaccines 111
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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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NICE says yes to BeiGene’s Brukinsa after Scottish nay

pharmaphorum

The final appraisal document from health technology assessment (HTA) agency NICE says that Brukinsa can be used to treat WM in adults who have had at least one prior treatment, and only if bendamustine plus rituximab therapy is also suitable.

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How authentication of drugs has become a fundamental pillar of patient safety

Express Pharma

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation.