PharmExec

JULY 2, 2024

The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.

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Pharmaceutical Technology

APRIL 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.

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Pharmaceutical Technology

MAY 11, 2023

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. The trials assessed the frequency of agitation symptoms in Alzheimer’s dementia patients, based on the Cohen-Mansfield agitation inventory (CMAI) total score.

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Food and Drug Administration FDA Pharmacology Safety 59

Pharma Leaders

APRIL 17, 2023

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. FDA is a validation of the quality of the NV354 pre-clinical program and another important milestone for Abliva.

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pharmaphorum

OCTOBER 25, 2022

Interim results from the phase 2b study in patients aged 45 to 55 years with presbyopia showed that the drug did not achieve a statistically significant dose response three months after starting treatment, missing its primary endpoint. It is estimated that more than 80% of adults over the age of 45 develop the condition.

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European Pharmaceutical Review

AUGUST 23, 2022

The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019. Patients’ symptoms were monitored for PTSD and hepatitis C virus between two clinical visits over eight to 12 weeks. MDMA-assisted therapy successful in PTSD patients.

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Food and Drug Administration Pharmacology Prospecting Medical 94

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. Companies are testing the use of digital platforms along with pharmacological treatments.

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PM360

NOVEMBER 29, 2022

Food and Drug Administration (FDA) or European Medicines Agency (EMA). Understanding patient sub-group exceptions for competitive or for label development purposes. International sources: The focus for many labeling teams is on major sources such as FDA and EMA. Extracting contra-indications to understand competitive coverage.

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Food and Drug Administration Competition Safety Pharmacology 98

Pharmaceutical Technology

APRIL 26, 2023

Patients will receive the digital therapy through their mobile phone applications over a 12-week period, and its efficacy will be evaluated based on the difference in the number of monthly migraine days. According to the company, patients often do not achieve full remission with a solely pharmacotherapeutic approach.

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Food and Drug Administration Pharmacology Food Patients 52

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. More approvals, in larger patient population conditions will elevate the ongoing discussion of how to pay for these therapies.

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Infuse Medical

DECEMBER 17, 2024

Companies in 3D medical animation such as Infuse Med are adept in converting complicated medical jargon into understandable images appealing to patients, doctors, and other stakeholders. Check out some case studies where 3D medical animation simplified communication between healthcare professionals and their patients.

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Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. Recruitment in the European study is expected to end this summer. said Prof.

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European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs. Internet] [link].

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Legacy MEDSearch

OCTOBER 13, 2022

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. “Pain is variable from patient to patient and over time. Keith Grossman, Chairman and CEO of Nevro.

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Medgadget

MAY 2, 2023

The system uses the patient’s EEG data to calculate a value for the amygdala-derived-EFP biomarker, and meanwhile the patient tries various mental strategies that may help to reduce the value. These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution.

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Impetus Digital

AUGUST 2, 2024

From the drug discovery phase to patient care, AI has the potential to enhance almost every stage of the product life cycle. Among others, ML algorithms can predict trial outcomes, write protocols, optimize eligibility criteria, identify and recruit the most suitable candidates for trials, monitor patient health remotely, and analyze data.

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pharmaphorum

JANUARY 4, 2023

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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Pharmaceutical Technology

DECEMBER 16, 2022

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. The company now expects to complete its submission for a BLA with the FDA by the end of the year.

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pharmaphorum

JANUARY 3, 2023

With the results of the GEMSTONE-304 study, sugemalimab becomes the latest immuno-oncology agent to show improvements in survival outcomes in first-line ESCC, contributing to the transformation in pharmacological treatment for the aggressive cancer. The post CStone gets a win for sugemalimab in oesophageal cancer appeared first on.

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Pharmaceutical Technology

AUGUST 16, 2022

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling.

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Food and Drug Administration Pharmacology Food Safety 52

pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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Pharmacology FDA Marketing Pharma 52

pharmaphorum

DECEMBER 22, 2022

The FDA and EMA have formally started their review of the drug, which analysts have suggested could become a $3 billion blockbuster for Pfizer if it reaches the market for UC and other immuno-inflammatory diseases. In ELEVATE UC 12, etrasimod achieved a 25% clinical remission rate after 12 weeks, compared to 15% for a matched placebo group.

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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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European Pharmaceutical Review

JULY 18, 2024

1 As they can be highly targeted in their action, they could become the treatment of choice for clinicians and patients due to the reduced risk of side effects. This class also seem to be better tolerated across patients. Ultimately, this means that we do not yet know how to translate the potential of an ADC into a real patient impact.

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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. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

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Food and Drug Administration Safety Patients Leads 97

Evolve Your Success

OCTOBER 24, 2023

It might need to be something that allows it to be moved, bent, put over the patient, maneuvered through a hospital or a doctor’s office, or what have you to provide either additional functionality, transport, or whatever the case may be. They understand the American and European requirements of the FDA and the EU. It runs the gamut.

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pharmaphorum

DECEMBER 20, 2022

Earlier this year, Madrigal reported positive results in another phase 3 trial of resmetirom called MAESTRO-NAFLD-1, including some patients with NASH, and said a filing in the lead indication of non-cirrhotic NASH with liver fibrosis hinged on a positive readout in MAESTRO-NASH.

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European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

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Food and Drug Administration Manufacturing Engineering Pharmacology 97

Pharmaceutical Technology

MAY 15, 2023

Pyridine derivatives contain one nitrogen atom in a six-membered aromatic ring and are the most extensively used heterocycles in the field of drug design, due to their promising effect on pharmacological activity, which has led to the discovery of numerous broad-spectrum therapeutic agents.

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Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Ethical conduct helps maintain the company’s integrity and foster trust with HCPs and patients.

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Sales Pharmaceutical Ethics Pharmaceutical Sales 52

Contrarian Sales Techniques

DECEMBER 5, 2023

As treatments become more tailored to individual patients, sales reps must understand complex scientific concepts and communicate them effectively. You need to comprehend and convey how these products can truly make a difference in patients' lives. Another game-changer has been the shift towards personalized medicine.

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Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma.

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Food and Drug Administration FDA Medicine Patients 122

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. Press Release by: Theranica.

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Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. But these treatments have their own limits.

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pharmaphorum

JANUARY 12, 2023

The Attorney General of Alabama has threatened to use an obscure law passed in 2006 to prosecute women who terminate a pregnancy using pharmacological means, shortly after the FDA made access to the drugs easier.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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