pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

Pharmacology 52

Pharmacology FDA Marketing Pharma 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

APRIL 13, 2023

Psychedelic research: evaluating the fast-evolving regulatory roadmap Psychedelics: the position in Europe The EMA’s recent letter confirms that as of 17 February 2023 in the EU, 6 there were: 11 ongoing clinical trials in EU with psilocybin for a range of central nervous system conditions four ongoing trials with MDMA one trial with LSD.

Medicine 131

Medicine Food and Drug Administration Doctors Medical 131

pharmaphorum

DECEMBER 22, 2022

Regulators in the US and EU have started a review of Pfizer’s S1P receptor modulator etrasimod for people living with moderately-to-severely active ulcerative colitis (UC), with decisions expected in the first halves of 2023 and 2024, respectively.

Pharmacology 52

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Pharmaceutical Technology

MARCH 17, 2023

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. But creating a combined product is tricky from a regulatory perspective, says Sørensen.

Prescription 111

Prescription Pharmacology Pharma Medical 111

Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. Looking back at 2023 , AI for drug discovery saw both wins and losses.

Pharma 95

Pharma Manufacturing Medicine Marketing 95

European Pharmaceutical Review

JULY 18, 2024

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. 2023; 3 Tsuchikama et al. She also heads three of Ipsen’s specialised functions that support the entire pipeline from discovery through to lifecycle management. 2023;15(1) Shastry et al.

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Pharmaceutical Technology

DECEMBER 16, 2022

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. The company now expects to complete its submission for a BLA with the FDA by the end of the year.

Pharmacology 105

Pharmacology Pharma Pharmaceutical Manufacturing 105

European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Engineering Pharmacology 97

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. They became integral to physiological and pharmacological research during the 19th century and started to be systematically used for drug development during the 20th century. Food and Drug Administration, 2023). Theranostics, 13(3), pp.

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. 2023 AD/PD Conference. References Hendrix S.

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Food and Drug Administration Safety Patients Leads 97

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.

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Pharmacology Side effects FDA Safety 59