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. Topic sponsors are not involved in the creation of editorial content.

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Food and Drug Administration FDA Side effects Food 105

World of DTC Marketing

FEBRUARY 22, 2021

This has abuse potential written all over it and could lead to more dangerous health problems. If I was the FDA is would not allow DTC for this product without clinical proof that it’s non-addictive and that it would only go to patients who REALLY need it after trying other things like losing weight. Americans average 6.8

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Pharma Doctors Side effects Prescription 181

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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Food and Drug Administration FDA Recruitment Side effects 98

pharmaphorum

OCTOBER 24, 2022

Tremelimumab has been approved by the FDA in the US for use in tandem with AZ’s PD-L1 inhibitor Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), the most common tumour type affecting the liver. The post AstraZeneca gets first FDA okay for CTLA4 drug tremelimumab appeared first on.

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FDA Side effects Patients Leads 77

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. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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FDA Food and Drug Administration Side effects Safety 83

World of DTC Marketing

JULY 22, 2020

Almost two billion dollars is a hell of an incentive but it could also lead to bad data and cutting corners. Whose is better at protecting us and which one has the least amount of side effects? Money can be a bad incentive to cut corners or hide data at a time when both the FDA and CDC are politicized.

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Government Side effects Media Pharma 130

European Pharmaceutical Review

OCTOBER 7, 2024

Data from this Phase II supported US Food and Drug Administration (FDA) approval: a 98 percent response rate and an 83 percent complete response rate. Overall, rates of serious side effects of cilta-cel were similar to those reported in previous clinical trials, according to findings from the real-word study.

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Food and Drug Administration Side effects FDA Patients 105

pharmaphorum

OCTOBER 27, 2022

Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so the review time will be cut from 10 to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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FDA Side effects Biopharma Marketing 81

Pharmaceutical Technology

NOVEMBER 14, 2022

Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure. The] main the main issue is that there aren't that many sites in the US where MSCs can be produced in sufficient quantities in FDA-certified labs,” says Gilkeson.

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Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

NOVEMBER 4, 2022

A new computer model has successfully simulated a clinical trial evaluating the efficacy of aducanumab and donanemab for Alzheimer’s disease (AD), establishing a gradual increase in dosage up to the maximum dose helps to minimise cognitive decline and limit side effects. .

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Food and Drug Administration Side effects Food Patients 105

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.

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Food and Drug Administration Patients Side effects Safety 116

European Pharmaceutical Review

NOVEMBER 3, 2023

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

Food and Drug Administration 104

Food and Drug Administration Side effects Medicine Food 104

pharmaphorum

OCTOBER 26, 2022

Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. Patients afflicted with psoriasis have a malfunctioning immune system that mistakenly attacks the body by overproducing skin cells, which leads to a build-up of scaly plaques. Side effects, front and centre.

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Side effects Food and Drug Administration Patients Management 90

European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

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Food and Drug Administration Side effects Safety Food 98

Pharma Marketing Network

OCTOBER 22, 2020

the ads can come from different sources and that can lead to run ins with the FDA. That needs to be established since it could lead to misbranding claims.”. So naming a drug “CureAll” might lead potential patients to believe that CureAll cures everything. What is the best way to solve for it?

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Side effects Leads Pharma FDA 104

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.

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Food and Drug Administration FDA Side effects Prospecting 52

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

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Food and Drug Administration Side effects Pharmaceutical Leads 115

European Pharmaceutical Review

OCTOBER 18, 2024

This new treatment could decrease long-term side effects including second cancers later in life and heart and lung conditions, according to the researchers. The goal of this study was to improve the cure rate while also minimising side effects and long-term toxicities—and that’s what makes this an unprecedented clinical trial.”

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Side effects Food and Drug Administration Food Patients 59

European Pharmaceutical Review

OCTOBER 21, 2022

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. A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017.

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Patients Food and Drug Administration Side effects Food 96

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

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Side effects Safety Biopharma Recruitment 78

pharmaphorum

OCTOBER 10, 2022

The FDA has approved use of GlaxoSmithKline’s Boostrix (Tdap) vaccine for use during the third trimester of pregnancy, for prevention of pertussis (whooping cough) in infants younger than two months old. This estimate was supported by updated statistical analyses of data published in observational studies, the FDA said.

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FDA Side effects Safety Sales 52

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). Imran joined Oncology US Medical Affairs in 2018 as the Therapeutic Area Lead, Lymphoma and Myeloid Malignances.

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Food and Drug Administration Food Medical Medicine 110

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. Analysts have suggested, however, that the profile of the two drugs is very similar, leading to questions about how successful Mirati will be differentiating Krazati from its rival.

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FDA Side effects Competition Patients 52

Pharmaceutical Technology

MARCH 7, 2023

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The Visionary trial has exclusively enrolled MS patients with chronic optic neuropathy, in which progression of MS leads to damage of the optic nerve. before the submission to the FDA.

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Side effects Patients Leads Safety 100

European Pharmaceutical Review

OCTOBER 19, 2023

Can you share an update on the clinical trial for your lead candidate? Like other cancer treatments, we must prove the effectiveness of radiopharmaceuticals through clinical trials, so they are more available and eventually implemented as a common standard of treatment to control tumours.

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Food and Drug Administration Manufacturing Side effects Doctors 105

pharmaphorum

SEPTEMBER 16, 2022

Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen. Regarding both common cold and headache, they are as well among the side effects reported for similar drugs.

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Management Side effects Patients Safety 72

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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Patients Recruitment Pharmacology Management 98

pharmaphorum

AUGUST 11, 2022

Some people are hyper-metabolisers, meaning a drug may move too fast through their system and not deliver the intended therapeutic effect; while others may metabolise a drug too slowly, triggering an adverse side effect or overdose.

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Side effects Medical Prescription Patients 81

pharmaphorum

AUGUST 5, 2022

SAR444245, meanwhile, is a long-acting IL-2 that blocks off part of the molecule that engages with alpha receptors, designed to maintain the anticancer efficacy of the molecule while preventing side effects. It is being tested in a wide range of solid tumours and lymphoma, alone and in combination with other drugs.

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Side effects Marketing Pharma Medicine 81

Legacy MEDSearch

JUNE 28, 2023

1 Early treatment of PWS during childhood leads to the best clinical response. 1 Early treatment of PWS during childhood leads to the best clinical response. 3,6 It stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH, without serious side effects.

Medical 52

Medical FDA Recruitment Side effects 52

pharmaphorum

AUGUST 8, 2022

Karuna Therapeutics has unveiled positive topline results from its phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium), in adults with schizophrenia. The post Karuna Therapeutics scores phase 3 win for schizophrenia therapy KarXT appeared first on.

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Side effects Leads Medical Safety 52

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 98

Food and Drug Administration Patients Leads Side effects 98

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).

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Food and Drug Administration Patients Leads Side effects 98

PM360

JULY 13, 2023

Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC). The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023.

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Patients Engineering Side effects Leads 98

pharmaphorum

JULY 7, 2022

Treatment with intravenous steroids resulted in a “partial resolution” of the inflammation at four months, and the side effect had no apparent effect on the heart’s ability to pump blood (systolic function), said Sarepta. Roche has exclusive rights to the therapy outside the US.

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Safety Side effects FDA Patients 59

Contrarian Sales Techniques

JULY 12, 2024

Generics, while FDA-approved, sometimes carried an invisible question mark. The Internal Struggle Dr. Reyes explained the rigorous testing generics go through to ensure they matched the brand name in effectiveness. What if there were unseen side effects? Reyes understood the concern. Were they truly the same?

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Doctors Side effects Medical Patients 52

European Pharmaceutical Review

NOVEMBER 5, 2024

According to Medincell, TEV-‘749 could be the first long-acting olanzapine medication with a favourable safety profile, because “other LAIs of olanzapine have been associated with a [US] FDA black box warning for PDSS that limits their use”.

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Side effects Medical Safety Medicine 52