pharmaphorum

JANUARY 16, 2023

Last year, IQVIA predicted that 2022 would be the crunch year for Alzheimer’s therapies: it is with a sense of déjà vu that the exact same prediction is contemplated for 2023. Innovators are looking to combine multiple techs into one platform – for example, Grail Dx’s multicancer early detection platform aims for full FDA approval in 2023.

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FDA Healthcare Healthcare Medicine 85

pharmaphorum

JANUARY 4, 2023

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

Pharmacology 59

Pharmacology Marketing Pharma Competition 59

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

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

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?

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Marketing Food and Drug Administration Medicine Prescription 103

pharmaphorum

DECEMBER 22, 2022

The FDA and EMA have formally started their review of the drug, which analysts have suggested could become a $3 billion blockbuster for Pfizer if it reaches the market for UC and other immuno-inflammatory diseases. “We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy.”

Pharmacology 52

Pharmacology Safety Patients Marketing 52

European Pharmaceutical Review

JULY 18, 2024

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. 2022; 7(93) Maecker et al. She also heads three of Ipsen’s specialised functions that support the entire pipeline from discovery through to lifecycle management. References Fu et al.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59

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. In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%.

Pharma 95

Pharma Manufacturing Medicine Marketing 95

European Pharmaceutical Review

APRIL 13, 2023

The US Food and Drug Administration (FDA) has decided to fast-track psilocybin for depression, with full support from President Biden’s administration. Pharmacological Reviews. World Health Organization; 2022 [cited 2023Mar]. Additionally, several US and Canadian states have legalised or decriminalised magic mushrooms.

Medicine 131

Medicine Food and Drug Administration Doctors Medical 131

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. 2022 Alzheimer’s Association International Conference.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

Clarivate

OCTOBER 7, 2024

Back in December 2022, President Biden signed a new law stating that novel medicines no longer needed to be tested on animals to receive U.S. Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Clinical Pharmacology and Therapeutics, 104(6), pp. Theranostics, 13(3), pp. Passini, E.,

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.

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Food and Drug Administration FDA Medicine Patients 122