Food and Drug Administration, Leads, Safety and Side effects

BMS strikes $14bn deal for Karuna Therapeutics

European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile.

Food and Drug Administration

Food and Drug Administration Side effects Safety Food

Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration

Food and Drug Administration Side effects Pharmaceutical Leads

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

Food and Drug Administration

Food and Drug Administration Side effects Recruitment Safety

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration

Food and Drug Administration FDA Side effects Prospecting

ANeuroTech shares plans for major depressive disorder pivotal programme

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). While the drug is marketed in other countries, it is not registered in the US.

Food and Drug Administration

Food and Drug Administration Side effects Safety Recruitment

The internet enables misinformation on COVID

World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. The major concerns for hesitancy included worries over side effects and that the vaccine is too new. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness.

Food and Drug Administration

Food and Drug Administration Government Safety Side effects

Three-dose vaccine prevents HIV patients getting hepatitis B

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B.

Patients

Patients Food and Drug Administration Side effects Food

Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration

Food and Drug Administration Side effects Leads Patients

Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration

Food and Drug Administration Side effects Leads Patients

Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

Patients

Patients Food and Drug Administration Side effects Safety

Psilocybin-assisted therapy reduces depressive symptoms in cancer patients

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumour,” commented Manish Agrawal, MD, of Sunstone Therapies and lead author of the study.

Food and Drug Administration

Food and Drug Administration Patients Side effects Safety

FDA grants approval for CSL’s haemophilia B gene therapy

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. The trial is designed to analyse the safety and efficacy of Hemgenix.

Food and Drug Administration

Food and Drug Administration FDA Side effects Food

Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

Food and Drug Administration

Food and Drug Administration Safety Patients Leads

US FDA clears Transcenta’s IND for Rett syndrome treatment

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. The transgene regulation technology can be tuned to provide a desired transgene expression level in a narrow range.

FDA

FDA Food and Drug Administration Side effects Safety

Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. The CAR T cells need to persist in the blood to expand and elicit maximal effect, and there is a correlation between expansion and persistence and response.

Manufacturing

Manufacturing Food and Drug Administration Patients Pharma

Pharma coming to moral crossroads

World of DTC Marketing

SEPTEMBER 28, 2020

Will it lead to an early approval with limited testing or will J&J ensure the vaccine goes thru thorough testing? So the question becomes could the current administration try and approve a COVID-19 vaccine without complete testing in order to try and win votes from a public who is scared of COVID? OK, NOW WHAT?

Food and Drug Administration

Food and Drug Administration Pharma Side effects Food

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

Food and Drug Administration

Food and Drug Administration Pharmaceutical Food Side effects

Pharma Rep Focus

BMS strikes $14bn deal for Karuna Therapeutics

Developing a first-in-class small molecule drug for inflammatory disease

Trending Sources

How using AI in clinical trials accelerates drug development

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

ANeuroTech shares plans for major depressive disorder pivotal programme

The internet enables misinformation on COVID

Three-dose vaccine prevents HIV patients getting hepatitis B

Developing a new treatment paradigm for chronic kidney disease

Developing a new treatment paradigm for IgAN

Novel oral chemotherapeutic holds potential for stomach cancer patients

Psilocybin-assisted therapy reduces depressive symptoms in cancer patients

FDA grants approval for CSL’s haemophilia B gene therapy

Paving the way for anti-Abeta active immunotherapy

US FDA clears Transcenta’s IND for Rett syndrome treatment

Developing point-of-care CAR T manufacturing

Pharma coming to moral crossroads

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

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