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.

FDA 82

FDA Side effects Biopharma Marketing 82

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects.

Side effects 187

Side effects FDA Patients Doctors 187

World of DTC Marketing

AUGUST 10, 2022

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. While there is a segment that sees the drug as a “quick fix” to lose weight, others are skeptical and want to know more about side effects and costs.

Marketing 252

Marketing Media Side effects Pharma 252

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.

FDA 52

FDA Side effects Competition Patients 52

Legacy MEDSearch

DECEMBER 12, 2022

Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct a targeted Coverage with Evidence program with the goal of providing its members with affordable treatment for episodic and chronic migraine.

Side effects 98

Side effects Insurance FDA Pharmacology 98

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. The first AdCom was critical of the study’s robustness.

FDA 98

FDA Food and Drug Administration Physicians Side effects 98

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.

Food and Drug Administration 95

Food and Drug Administration Side effects Safety Food 95

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 87

Food and Drug Administration Side effects Medicine Food 87

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

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.

Side effects 91

Side effects Food and Drug Administration Patients Management 91

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

Pharma 181

Pharma Doctors Side effects Prescription 181

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.

Side effects 79

Side effects Safety Biopharma Recruitment 79

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.”

Food and Drug Administration 107

Food and Drug Administration Side effects Pharmaceutical Leads 107

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.

Government 130

Government Side effects Media Pharma 130

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.

Side effects 52

Side effects Leads Safety Medical 52

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.

Side effects 144

Side effects Patients Manufacturing Safety 144

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.

Management 73

Management Side effects Patients Safety 73

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.

Patients 76

Patients Food and Drug Administration Side effects Food 76

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.

Side effects 100

Side effects Patients Leads Safety 100

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.

Safety 59

Safety Side effects FDA Patients 59

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 95

Food and Drug Administration Side effects Leads Patients 95

pharmaphorum

OCTOBER 1, 2022

The dive came despite Intercept’s despite assertions that it remains on track to resubmit the FXR agonist in its lead indication of fibrosis due to NASH by year end. It will now do so on the strength of the phase 3 REGENERATE study, which involved patients with liver fibrosis due to NASH, a less severely affected population.

Side effects 59

Side effects FDA Prospecting Pharma 59

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 94

Food and Drug Administration Side effects Leads Patients 94

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.

Patients 98

Patients Recruitment Pharmacology Side effects 98

pharmaphorum

OCTOBER 13, 2022

BeiGene is looking increasingly like it will become the leading challenger to AbbVie and Johnson & Johnson’s market-leading BTK inhibitor Imbruvica for cancer, after besting its rival in a clinical trial showdown.

Side effects 52

Side effects Sales Marketing Competition 52

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.

Side effects 82

Side effects Medical Prescription Patients 82

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.

Side effects 82

Side effects Marketing Pharma Medicine 82

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).

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

Legacy MEDSearch

OCTOBER 25, 2023

Dr. Andrea Synowiec, a neurologist and headache specialist who serves as System Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania is the lead author of the study. We designed Nerivio with exactly these requirements in mind.”

Side effects 52

Side effects Recruitment Networking Management 52

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

pharmaphorum

DECEMBER 12, 2022

. “This is exciting news because existing treatments fail to improve platelet counts for as many as 30% of adults with chronic ITP,” commented said Catherine Broome of Georgetown Lombardi Cancer Centre in Washington DC, the trial’s lead investigator.

Side effects 52

Side effects Sales Competition Patients 52

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.

Manufacturing 52

Manufacturing FDA Side effects Marketing 52

pharmaphorum

OCTOBER 10, 2022

Immutep claimed fast-track status from the FDA for efti last week as a combination therapy alongside Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) for previously-untreated non-small cell lung cancer (NSCLC), based on the results of the phase 2 TACTI-002 study. month mPFS with Keytruda plus chemo, with fewer side effects.

Side effects 59

Side effects Sales Marketing FDA 59

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 60

Consulting Side effects Manufacturing Safety 60

European Pharmaceutical Review

NOVEMBER 4, 2022

based treatment concomitant with reductions in traditionally unavoidable and problematic side effects. Type A Meeting Between FDA and Athenex Discusses Oral Paclitaxel Plus Encequidar for Metastatic Breast Cancer [Internet]. FDA Feedback Leads to Discontinuation of Tesetaxel Development in Solid Tumors [Internet].

Food and Drug Administration 84

Food and Drug Administration FDA Pharmaceutical Patients 84

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). For example, in the U.S.,

Networking 59

Networking Consulting Safety Side effects 59

Silver Line CRM

NOVEMBER 20, 2020

Whether it’s a desperately needed vaccine for a contagious disease, new research on side effects or success of treatments, or a life-saving treatment using new technology, pharmaceutical marketers must be ready for whatever new developments arise. What pages on your site do they engage with?

Marketing 52

Marketing Pharma Side effects Training 52