Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success.

Clinical Trials 137

Clinical Trials Clinical Trials Trials Clinical Research 137

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). Nausea, headache, and nasopharyngitis are the most common adverse events observed in patients treated with Cibinqo in the trials.

FDA Approval 147

FDA Approval Trials Clinical Trials Clinical Trials 147

Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. mg tablet) to treat cardiovascular disease.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

Bio Pharma Dive

JUNE 8, 2021

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it.

FDA Approval 285

FDA Approval Clinical Trials Clinical Trials Trials 285

STAT News

SEPTEMBER 9, 2022

… Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, STAT writes, citing a new pilot study. million, on average, for Phase 2 clinical trials. million when these methods were used during both trial stages. But be safe. And the return was $20.4

Clinical Trials 98

Clinical Trials Clinical Trials FDA Approval Trials 98

XTalks

MAY 5, 2022

Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. The US Food and Drug Administration (FDA) has approved two classes of drugs for the treatment of ADHD: stimulants and nonstimulants.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JUNE 26, 2023

has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021.

FDA Approval 96

FDA Approval Drugs Sales In-Vitro 96

Pharmaceutical Technology

SEPTEMBER 5, 2022

The US Food and Drug Administration (FDA) has approved the expanded usage of Vertex Pharmaceuticals ’ Orkambi (lumacaftor/ivacaftor) to treat cystic fibrosis (CF) in children aged 12 months to under 24 months. It enrolled 46 children aged one to under two years with the F/F genotype. “The

FDA Approval 130

FDA Approval Genotype Clinical Trials Clinical Trials 130

XTalks

JANUARY 2, 2024

Chiesi Global Rare Diseases, a specialized division within the Chiesi Group dedicated to pioneering therapies for individuals affected by rare diseases, has received approval from the US Food and Drug Administration (FDA) for Filsuvez (birch triterpenes) topical gel. Specifically, 41.3 percent observed in the control gel arm.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration.

FDA Approval 130

FDA Approval Drugs Insulin Clinical Trials 130

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Trials peaked at 115 in 2018 before declining to 91 last year.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

Pharmaceutical Technology

MARCH 6, 2023

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. Last week, the company and Confo Therapeutics signed a global licence deal for CFTX-1554, the latter’s clinical-stage peripheral pain candidate.

FDA Approval 130

FDA Approval HR Hormones Clinical Trials 130

XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

Botox 98

Botox FDA Approval Cosmetics Clinical Trials 98

Drug Discovery World

AUGUST 11, 2023

The US Food and Drug Administration (FDA) has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Clinical Research 52

Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. The regulatory approval was supported by data from the GEM-1/2 and GEM-3 clinical trials.

FDA Approval 130

FDA Approval Gene Therapy Genetic Disease Gene 130

XTalks

AUGUST 18, 2023

Iveric Bio, a company of Astellas, has secured recent approval from the US Food and Drug Administration (FDA) for its innovative drug, Izervay (avacincaptad pegol intravitreal solution). Another New Treatment for Geographic Atrophy There is one other FDA-approved drug for geographic atrophy on the market.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MAY 1, 2023

Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

XTalks

MAY 2, 2022

Mycovia Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for Vivjoa (oteseconazole) for the treatment of recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection for permanently infertile or postmenopausal women. Live and On-Demand: Thursday, May 19, 2022, at 1pm EDT (10am PDT).

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

Drugs 246

Drugs FDA Approval Clinical Trials Clinical Trials 246

pharmaphorum

MAY 16, 2022

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. The drug is injected under the skin once a week and the dose can be adjusted to meet an individual’s blood sugar needs.

FDA Approval 111

FDA Approval Insulin Drugs Hormones 111

Drug Discovery World

FEBRUARY 19, 2024

The US Food and Drug Administration has approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of metastatic, unresectable melanoma. Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

FDA Approval 52

FDA Approval Contract Manufacturing Manufacturing Trials 52

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

Drugs 243

Drugs FDA Approval Clinical Trials Clinical Trials 243

Outsourcing Pharma

JANUARY 25, 2022

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

FDA Approval 95

FDA Approval Clinical Trials Clinical Trials Trials 95

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

Drugs 239

Drugs FDA Approval Clinical Trials Clinical Trials 239

XTalks

SEPTEMBER 14, 2022

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients.

Life Science 90

Life Science FDA Approval Insulin Drugs 90

Pharmaceutical Technology

JUNE 15, 2023

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours. The planned Phase I/II clinical trial in HNSCC will begin in the second half of 2023.

FDA Approval 130

FDA Approval Antibody Clinical Trials Clinical Trials 130

XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 The FDA approved 2.5

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

OCTOBER 4, 2022

The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

Medical Xpress

MAY 1, 2023

The Food and Drug Administration (FDA) in the U.S. has authorized the first approved drug for a rare form of motor neuron disease (MND) based on the results of a Phase 3 clinical trial completed at the University of Sheffield, the U.K. center for the international trial.

FDA Approval 86

FDA Approval Drugs Clinical Trials Clinical Trials 86