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.

Safety 57

Safety Side effects FDA Patients 57

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). The company aims to run an interim analysis of the trial by mid-2024 at the very latest.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 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

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.

Management 74

Management Side effects Patients Safety 74

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 99

Food and Drug Administration Side effects Pharmaceutical Leads 99

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.

Patients 69

Patients Food and Drug Administration Side effects Food 69

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

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 89

Food and Drug Administration Side effects Leads Patients 89

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 88

Food and Drug Administration Side effects Leads Patients 88

pharmaphorum

AUGUST 11, 2022

Next, pharmacists review the participant’s genetic results – along with health data such as drug, lifestyle, and food interactions – to customize a “Medication Action Plan” that members’ physicians can access to determine which drugs should be prescribed to increase safety and efficacy.

Side effects 86

Side effects Medical Prescription Patients 86

Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine.

Side effects 52

Side effects Recruitment Networking Management 52

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

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 54

Consulting Side effects Manufacturing Safety 54

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

Medical 105

Medical Electronics Patients Healthcare 105

World of DTC Marketing

JULY 19, 2021

Concerns about safety, fear of unknown side effects, and misinformation about COVID-19 are some reasons why people may not accept the vaccine. The media stories about the FDA. DTC marketers need to be more forthcoming when it comes to drug trials and side effects. So how should DTC marketers view this?

Marketing 279

Marketing Side effects Media Safety 279

World of DTC Marketing

SEPTEMBER 27, 2021

The reasons for people refusing vaccines are both safety and side effect concerns, although politics plays a big part as well. The drug, which FDA advisors refused to approve, has more side effects than initially anticipated, and of course, the media is running with the story, which, in turn, leads to a lack of trust in the FDA.

Side effects 173

Side effects Marketing Media FDA 173

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. The trial is designed to analyse the safety and efficacy of Hemgenix.

Food and Drug Administration 105

Food and Drug Administration FDA Side effects Food 105

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumour,” commented Manish Agrawal, MD, of Sunstone Therapies and lead author of the study.

Food and Drug Administration 104

Food and Drug Administration Patients Side effects Safety 104

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

FDA 83

FDA Food and Drug Administration Side effects Safety 83

pharmaphorum

OCTOBER 10, 2022

The FDA has approved use of GlaxoSmithKline’s Boostrix (Tdap) vaccine for use during the third trimester of pregnancy, for prevention of pertussis (whooping cough) in infants younger than two months old. This estimate was supported by updated statistical analyses of data published in observational studies, the FDA said.

FDA 52

FDA Side effects Safety Sales 52

PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. What Other Developments Within Oncology Excite You? What Is Your Company Currently Working On?

Patients 98

Patients Engineering Side effects Leads 98

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

Food and Drug Administration 72

Food and Drug Administration Safety Patients Leads 72

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings. A Patient-Centric Month Leads to Results.

Patients 59

Patients Pharma Education Media 59

PM360

NOVEMBER 29, 2022

Researchers are diligently creating new methods for cell and gene editing as well as therapeutic delivery to increase safety, accessibility, and affordability. The advanced therapy industry has shown great promise in treating rare and genetic diseases, but have encountered roadblocks in safety, affordability, and accessibility.

Patients 111

Patients Safety Marketing Side effects 111

European Pharmaceutical Review

DECEMBER 27, 2023

4 Manufacturing of CAR T-cell therapies: an overview In addition, multi-disciplinary teams must be established for in-house CAR T-cell therapy programmes to ensure maximum success and safety. On the logistics side, the in-house process eliminates, in principle, the need for cryopreservation of the CAR T-cell products. 2021;3(S1):6–10.

Manufacturing 78

Manufacturing Food and Drug Administration Patients Pharma 78

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?

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. Along with these drugs comes the opportunity to raise awareness and funds for different rare diseases.

FDA 126

FDA Safety Pharmaceutical Patients 126

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Food Side effects 98