Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Vomiting and diarrhoea are the most common side effects observed in the trial.

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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.

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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

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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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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). However, other studies found that the relapse in symptoms occurs in patients independent of Paxlovid use.

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Food and Drug Administration FDA Side effects Safety 59

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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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.

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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.

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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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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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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.

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Food and Drug Administration Side effects Safety Food 93

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

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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

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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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.

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World of DTC Marketing

DECEMBER 23, 2020

DTC marketers who believe that DTC is essentially the same as before the pandemic are failing to recognize significant shifts in patient behavior regarding prescription drugs. Any discussion around DTC should acknowledge the following: 1ne: DTC is more effective for some health categories than others. What are the side effects?

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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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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.

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Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication.

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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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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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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. Some 48% of patients on Briumvi also suffered with infusion reactions.

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Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months.

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pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

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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. Due to this, adjunctive treatments are used as part of a patient’s treatment regimen.

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Legacy MEDSearch

JUNE 28, 2023

2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 ”, states board-certified cosmetic dermatologist, Roy G.

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pharmaphorum

OCTOBER 27, 2022

The phase 3 clinical programme, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs.

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World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. 6ix: Safety information needs context. In clinical trials, how many people experienced a listed side effect? 7even: Real patient stories. First impressions are 94% design-related.

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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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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). Understanding patient sub-group exceptions for competitive or for label development purposes.

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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). Hope for patients with recurrent CDI. Further clinical study data for Rebyota.

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Pharmaceutical Technology

JULY 28, 2022

Cobitolimod, an agent being developed for patients with moderate to severely active UC, has both a novel MOA and a route of administration that is unique among marketed agents. Obefazimod also demonstrated efficacy in patients who had previously been exposed to biologics or JAK inhibitors.

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PM360

OCTOBER 13, 2023

HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Only 15% of prescribers think the drugs come at reasonable cost to patients or have decent insurance coverage eligibility. Three quarters of U.S.

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pharmaphorum

SEPTEMBER 29, 2022

The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the top-line results are being disclosed. of patients, respectively.

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Side effects FDA Safety Patients 101

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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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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pharmaphorum

AUGUST 11, 2022

The system did not only spend money and resources trying to address issues caused by those treatments, but patients also wasted time looking for answers; precious time that could have been spent receiving proper and effective treatment. billion in the United States alone.

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