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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Side effects Patients Manufacturing Safety 144

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.

Management 101

Management Side effects Patients Safety 101

Pharmaceutical Technology

JUNE 5, 2023

Results unveiled at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting indicate that some patients with locally advanced rectal cancer can be treated with chemotherapy alone and may not need radiation therapy before surgery. Additionally, the patients had to be candidates for surgery. In the FOLFOX group, 9.1%

Patients 52

Patients Side effects Medicine 52

pharmaphorum

OCTOBER 19, 2022

At the moment the main treatment strategy is to restrict phe in the diet, a lifetime commitment that often requires nutritional supplements to prevent deficiencies and, often, the method is unable to control levels of the amino acid effectively on its own.

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Side effects Patients Sales Engineering 98

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. Side effects from treatment were similar to those associated with autologous stem cell transplants.

Safety 114

Safety Side effects Patients Medicine 114

European Pharmaceutical Review

APRIL 20, 2023

This is according to results from a preliminary study, of which the abstract will be presented at the American Academy of Neurology’s 75th Annual Meeting held between April 22-27 2023. Results from a Phase III study evaluating migraine patients given 10mg, 30mg and 60mg of atogepant were published in 2021.

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Side effects Safety Medical Pharmaceutical 98

European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose. Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor.

Food and Drug Administration 104

Food and Drug Administration Side effects Medicine Food 104

European Pharmaceutical Review

APRIL 6, 2023

For breast cancer patients, the treatment is approved for those who have inherited faults in their BRCA1 or BRCA2 genes, after surgery and chemotherapy and are HER2-negative and at high-risk. Following this recommendation, 300 BRCA-positive HER2-negative high-risk early breast cancer patients will now be eligible to be treated with olaparib.

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Side effects Medicine Patients Pharmaceutical 98

European Pharmaceutical Review

MARCH 14, 2024

HTL0048149 began first-in-human clinical trials in 2023, according to an announcement by Sosei in July 2023. Sosei Heptares will receive an upfront payment of €25 million. The small molecule treatment HTL0048149 is a first-in-class GPR52 agonist with a novel mechanism of action.

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Side effects Sales Pharmaceutical Patients 97

pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. “We look forward to working closely with US regulators to advance vamorolone towards approval,” he added.

FDA 98

FDA Side effects Biopharma Marketing 98

European Pharmaceutical Review

OCTOBER 12, 2022

A Phase III trial evaluating TauRx Therapeutics’ oral drug hydromethylthionine mesylate (HMTM), a tau aggression inhibitor, showed the medication continued to improve cognition over a pre-treatment baseline in patients with early Alzheimer’s for the first time. The safety data from the trial was consistent with earlier trial data.

Side effects 98

Side effects Safety Patients Sales 98

European Pharmaceutical Review

OCTOBER 17, 2024

Additionally, EURneffy could alleviate the risk of accidental needle-related side effects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors. Derived from IQVIA Claims Data, 2023.

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Food and Drug Administration Medicine Consulting Food 121

pharmaphorum

JULY 18, 2022

That is down to the company’s ADC technology platform, which means that the cytotoxic payload that circulates systemically after administration is lower than the already-marketed ADCs and should therefore limit side effects, according to the biotech.

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Side effects Physicians FDA Marketing 59

European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. 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 98

Food and Drug Administration Side effects Safety Food 98

PM360

MAY 21, 2024

Navigating the complex healthcare system can be a stressful experience for patients, from obtaining a diagnosis to finding the right specialty care or treatment. To help alleviate some of the challenges patients face, it’s crucial to meet them with personalized resources that fit their needs at different stages throughout their journey.

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Patients Prescription Side effects Doctors 52

European Pharmaceutical Review

JANUARY 11, 2024

The current medications (opioid and non-opioid) often force the patients to make an unfortunate choice between efficacy and debilitating side effects, leading to a cycling through multiple different therapies and suboptimal treatment response. The present unmet needs within chronic pain are not met with opioid therapies.

Medicine 102

Medicine Pharmacology Management Side effects 102

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

Clarify Health

OCTOBER 3, 2023

Today, there are some noticeable shifts for the better happening on the digital front, largely driven by healthcare consumerism and the demand that healthcare meet patients where they are – on their phones, in their homes, and outside the hospital. Collecting data outside of a care setting can offer valuable insights into day-to-day health.

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Healthcare Healthcare Patients Side effects 59

PM360

AUGUST 24, 2023

healthcare system but we haven’t seen widespread acceptance by doctors and patients. As we found in our latest physician survey, physicians are actively seeking more information on key topics such as patient affordability, patient eligibility, clinical results, formulary coverage, and more.

Marketing 97

Marketing Physicians Electronics Patients 97

LEVO Health

JUNE 14, 2024

The healthcare industry – along with the rest of the modern world – is witnessing a transformative shift with the integration of artificial intelligence (AI), reshaping the way providers interact with and care for patients. Enhanced Diagnostic Accuracy AI algorithms are increasingly used to assist in the accurate diagnosis of diseases.

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Healthcare Healthcare Patients Healthcare Provider 52

European Pharmaceutical Review

OCTOBER 19, 2023

Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Side effects Doctors 105

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. The study included 92 adult patients with confirmed CDI. After treatment, patients were followed up at intervals of 72 hours, three weeks, eight weeks, three months and six months. percent compared to 61.54

Safety 111

Safety Patients Side effects Management 111

PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5

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Prescription Medical Patients Side effects 105

European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

Patients 52

Patients Food and Drug Administration Side effects Food 52

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. The TLR9 agonist is currently being investigated in the Phase III CONCLUDE trial (NCT04985968), with an expected study completion date of August 2023.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects Marketing 98

PM360

JULY 13, 2023

Here are twelve of the best examples of programs, strategies, solutions, technology, and more that companies have developed or are using to keep patients on their prescribed therapies. But outdated manual processes are complex and leave many patients out. But outdated manual processes are complex and leave many patients out.

Education 89

Education Medical Patients Media 89

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. Looking back at 2023 , AI for drug discovery saw both wins and losses. In theory, this will allow for highly tailored, personalized therapy plans with superior efficacy and minimal side effects.

Pharma 92

Pharma Manufacturing Medicine Marketing 92

pharmaphorum

SEPTEMBER 16, 2022

UK-based George Medicines is running a phase 3 trial of GMRx2 – a low-dose formulation of established blood pressure drugs telmisartan, amlodipine, and indapamide – involving 1,500 patients across seven countries. By 2030, it is projected that over 215 million Africans will have hypertension.

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Side effects Medicine Healthcare Provider Patients 52

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). Up to fifty percent of IgAN patients progress to end-stage renal disease, requiring dialysis or transplant.

Food and Drug Administration 98

Food and Drug Administration Patients Leads Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

This month, new data from Novo Nordisk has revealed that semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD). Up to fifty percent of IgAN patients progress to end-stage renal disease, requiring dialysis or transplant.

Food and Drug Administration 98

Food and Drug Administration Patients Leads Side effects 98

Pharmaceutical Technology

JANUARY 22, 2023

More therapies to meet unmet needs GlobalData predicts that at least 35 US regulatory decisions on drugs for rare diseases are on the horizon for 2023. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. point reduction in the placebo arm.

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FDA Safety Pharmaceutical Patients 126

Pharmaceutical Technology

FEBRUARY 26, 2023

In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. Rebyota is a faecal microbiota-based treatment for patients with recurrent CDI that is administered through an enema. But since the immunity of cancer patients is suppressed by treatments like chemotherapy, the risks here are much greater, she explains.

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Safety FDA Medicine Side effects 111

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

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.

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Consulting Manufacturing Side effects Safety 74

Pharmaceutical Technology

APRIL 21, 2023

The company will make a $20m upfront payment, which includes $6m paid at closing and an additional $4m payment in the fiscal year 2023. Our core mission of helping patients in need remains strong and steadfast, and we look forward to developing this asset and our pipeline for patients around the world.”

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Food and Drug Administration Side effects Distribution Sales 52

Pharmaceutical Technology

APRIL 14, 2023

NASH is a form of nonalcoholic fatty liver disease (NAFLD), where patients develop excess fat in their liver. Alongside increased liver fat, NASH patients suffer from liver inflammation and damage that can eventually lead to fibrosis. Madrigal expects to file an NDA for the drug in H1 2023, based on a February 2023 company update.

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Side effects Patients Leads Pharmaceutical 52

Pharmaceutical Technology

JUNE 5, 2023

It has also been approved in the US to treat symptomatic New York Heart Association class II-III obstructive HCM in adult patients, improving their functional capacity and symptoms. The treatments currently used to try to manage symptoms are associated with side effects and are often ineffective.

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Side effects Medicine Management Patients 52