Pharmaceutical Technology

NOVEMBER 14, 2022

Several other investigational therapies are expected to have material updates in 2023. 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 78

Management Side effects Patients Safety 78

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 74

Patients Food and Drug Administration Side effects Food 74

Pharmaceutical Technology

JULY 28, 2022

The TLR9 agonist is currently being investigated in the Phase III CONCLUDE trial (NCT04985968), with an expected study completion date of August 2023. Data from the QUASAR induction study demonstrated positive efficacy and safety results. Abivax is developing obefazimod, another agent with a first-in-class mechanism.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects Marketing 98

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 104

Food and Drug Administration Side effects Pharmaceutical Leads 104

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 58

Consulting Manufacturing Side effects Safety 58

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). cited 2024Mar]. Internet] Vera Therapeutics.

Food and Drug Administration 93

Food and Drug Administration Side effects Patients Leads 93

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). cited 2024Mar]. Internet] Vera Therapeutics.

Food and Drug Administration 93

Food and Drug Administration Side effects Patients Leads 93

pharmaphorum

SEPTEMBER 12, 2022

CodeBreak-200 will nevertheless likely serve as a confirmatory study for the approval of Lumakras (sotorasib) in this heavily pretreated patient population, which was granted by the FDA in May 2021. Overall, almost 83% of patients taking Amgen’s drug saw their tumours shrink or stabilise, versus 60% of those on chemo.

Side effects 52

Side effects FDA Patients Safety 52

PM360

AUGUST 9, 2022

This allows patients to complete the whole treatment process, from drug preparation and drug administration to treatment monitoring, side effect reporting, and communication, with one click on their device and smartphone. The FDA 510(k) submission is expected to take place in Quarter 3 2023. Orbita Outreach.

Prescription 105

Prescription Medical Side effects Patients 105

Pharmaceutical Technology

FEBRUARY 26, 2023

This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.

Safety 111

Safety FDA Medicine Side effects 111

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

pharmaphorum

AUGUST 5, 2022

The latest milestone payment has been triggered by FDA approval to start a phase 2 trial of the drug in schizophrenia, said Sosei Heptares this morning. Also covered by the pact is a dual M1/M4 agonist and a selective M1 agonist, which are scheduled to start clinical trials in 2023 and would trigger additional payments.

Side effects 52

Side effects Safety FDA 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 77

Food and Drug Administration Safety Patients Leads 77

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. FDA; 2022 [cited 2023 Mar]. After this incident CAR-related toxicity scales and guidelines were established to prevent adverse reactions.

Manufacturing 83

Manufacturing Food and Drug Administration Patients Pharma 83

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.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. 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. GlobalData is the parent company of Pharmaceutical Technology.

FDA 126

FDA Safety Pharmaceutical Patients 126