World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.” SUMMARY: DTC marketing is not the reason why prescription drugs cost so much.

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Marketing Prescription Side effects Doctors 285

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

FDA 91

FDA Side effects Sales Safety 91

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. points in patients receiving difelikefalin versus 2.4

Food and Drug Administration 80

Food and Drug Administration FDA Side effects Medicine 80

Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). In response to the approval news, some pointed concerns about long-term safety.

Food and Drug Administration 59

Food and Drug Administration FDA Side effects Safety 59

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

pharmaphorum

SEPTEMBER 7, 2022

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year. The safety data has one element, however, that might be expected to stimulate discussion at the advisory committee meeting.

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FDA Safety Side effects Marketing 52

Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company. According to the U.S.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Food 52

pharmaphorum

JANUARY 20, 2023

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. Final results from CLARITY-AD are also due in the first half of this year.

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FDA Safety Side effects Marketing 64

Pharma Leaders

APRIL 19, 2023

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). Diarrhea was the most common side effect using Xphozah in clinical trials. The Phase III trials were designed to assess the efficacy and safety of Xphozah.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Food 52

European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. 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

Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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Side effects Food and Drug Administration Safety Physicians 64

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

FDA 52

FDA Side effects Prescription Patients 52

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

pharmaphorum

AUGUST 31, 2022

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 The FDA said in a statement that the BA.4 The post FDA clears bivalent Omicron shots from Pfizer, Moderna appeared first on.

FDA 59

FDA Side effects Manufacturing Insurance 59

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

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FDA Side effects Biopharma Prospecting 66

Legacy MEDSearch

DECEMBER 12, 2022

Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio ®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older.

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Side effects Insurance FDA Pharmacology 98

World of DTC Marketing

FEBRUARY 4, 2021

The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

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Pharma Food and Drug Administration Side effects Safety 180

Contrarian Sales Techniques

FEBRUARY 25, 2023

This includes potential side effects or adverse reactions to medications. Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public. This is before a drug can be approved for public use.

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Side effects Medical sales reps Insurance Pharmacology 52

World of DTC Marketing

DECEMBER 23, 2020

What are the side effects? The FDA can be myopic when researching how consumers view and react to DTC. They’re going to go online where they can read the safety warnings that too often than not scare them because they lack context. That belief is out the window. Today people go online to learn more about the drug.

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Prescription Doctors Side effects Marketing 249

European Pharmaceutical Review

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products. Data that facilitated the line extension of Comirnaty ® for Covid-19.

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Food and Drug Administration Patients Side effects Medicine 86

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

Marketing 52

Marketing Side effects Safety Specialization 52

Legacy MEDSearch

JUNE 28, 2023

3,6 It stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH, without serious side effects. Port wine stains affect 1 in every 300 infants, and over time usually get darker and thicker, making early onset treatment critical for optimal results. Geronemus, M.D.,

Medical 52

Medical FDA Recruitment Side effects 52

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.

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Food and Drug Administration Competition Safety Pharmacology 98

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. 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.

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Management Side effects Patients Safety 73

pharmaphorum

JULY 7, 2022

New data on Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD) has gone a long way towards building confidence in its efficacy – but have introduced a concern about its safety. In the case of Pfizer’s candidate, that clinical hold occurred after cases of myocarditis were seen that have been linked to the gene therapy.

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Safety Side effects FDA Patients 59

Pharmaceutical Technology

NOVEMBER 14, 2022

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. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson.

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Side effects Patients Manufacturing Safety 144

Pharmaceutical Technology

JUNE 16, 2023

This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial.

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Food and Drug Administration Side effects Safety Recruitment 52

World of DTC Marketing

FEBRUARY 9, 2021

6ix: Safety information needs context. In clinical trials, how many people experienced a listed side effect? They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues. First impressions are 94% design-related.

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Pharma Side effects Medical FDA 180

European Pharmaceutical Review

DECEMBER 1, 2022

Rebyota, the first faecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people 18 years and older after being given antibiotics for recurrent CDI, has been approved by the US Food and Drug Administration (FDA). Further clinical study data for Rebyota.

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Food and Drug Administration Side effects Food Safety 88

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

pharmaphorum

OCTOBER 27, 2022

An FDA advisory panel yesterday voted 13 to 3 to recommend approval of daprodustat to treat anaemia caused by chronic kidney disease (CKD) in adult patients on dialysis, but by 11 to five against approval for patients not on dialysis.

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Side effects FDA Patients Sales 73

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.

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Patients Food and Drug Administration Side effects Food 76

pharmaphorum

SEPTEMBER 29, 2022

Lecanemab has also been filed via this route with the FDA, with a decision due by 6 January. Aside from dubious efficacy data, Aduhelm has also been held back by the risk of side effects – known as amyloid-related imaging abnormalities (ARIA) – that were also more common with lecanemab than placebo in Clarity AD, seen in 21.3%

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Side effects FDA Safety Patients 100

Pharmaceutical Technology

JULY 28, 2022

While data from the Phase III trial is not yet available, the Phase IIb CONDUCT trial (NCT03178669) assessed the efficacy and safety of cobitolimod in patients with moderately to severely active UC and demonstrated promising results and a strong safety profile.

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Food and Drug Administration Safety Side effects Marketing 98

pharmaphorum

DECEMBER 12, 2022

As Roche heads towards an FDA verdict on its CD20xCD3 bispecific Lunsumio for lymphoma before the end of this year, rivals from Regeneron and AbbVie are starting to nip at its heels, with new clinical results reported at the American Society of Haematology meeting.

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Side effects Safety FDA Patients 52

pharmaphorum

NOVEMBER 4, 2022

Galapagos is in the roll-out phase for its first commercial products – JAK1 inhibitor Jyseleca (filgotinib) for rheumatoid arthritis – which has been approved in Europe and Japan but fell foul of FDA concerns about the class’s safety and was rejected in the US. Jyseleca has made €60.5

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Side effects Safety FDA Sales 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.” There are no FDA-approved medications to treat sarcopenia.

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Food and Drug Administration Side effects Pharmaceutical Leads 107