World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. Does this mean DTC won’t work?

Clinical Trials 187

Clinical Trials Clinical Trials Trials Drugs 187

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 289

FDA Approval Clinical Trials Clinical Trials Trials 289

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

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.

FDA Approval 246

FDA Approval Clinical Trials Clinical Trials Antibody 246

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

MARCH 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. The post US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica appeared first on Pharmaceutical Technology.

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 12, 2023

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.​

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FDA Approval Drugs Medicine Clinical Trials 245

XTalks

NOVEMBER 7, 2024

Galderma’s doxycycline drug Oracea (doxycycline 40 mg capsules) is the current standard-of-care treatment for rosacea. Emrosi’s approval was based on data from a pair of Phase III clinical trials for the treatment of rosacea. Other studies suggest that Helicobacter pylori bacteria infections may also cause rosacea.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

XTalks

APRIL 1, 2025

XTALKS WEBINAR: Keys to Success in Clinical Trials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinical trials and accelerate their path to drug approval.

FDA Approval 59

FDA Approval RNA Clinical Trials Clinical Trials 59

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

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

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

JANUARY 29, 2025

The FDA has approved Novo Nordisks Ozempic (semaglutide) for reducing the risk of kidney failure, progression of kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). The approval marks Ozempic as the first GLP-1 receptor agonist (GLP-1 RA) authorized in a kidney disease indication.

FDA Approval 66

FDA Approval Trials Clinical Trials Clinical Trials 66

Pharmaceutical Technology

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Asthma control improvement and safety profile were consistent with previous clinical trials.

FDA Approval 147

FDA Approval Antibody Clinical Trials Clinical Trials 147

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

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.

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Drugs FDA Approval Clinical Trials Clinical Trials 239

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

XTalks

FEBRUARY 19, 2025

Deciphera leverages its proprietary switch-control kinase inhibitor platform targeting kinase activation to develop orally administered drug candidates, reflecting its commitment to innovative treatments for conditions with limited therapeutic options. In 2024, Deciphera was acquired by ONO Pharmaceutical for $2.4

FDA Approval 59

FDA Approval Drugs Trials Clinical Trials 59

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Drugs 246

Drugs FDA Approval Development Marketing 246

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.

FDA Approval 246

FDA Approval Pharmacy Marketing Drugs 246

Pharmaceutical Technology

AUGUST 29, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte ’s Pemazyre (pemigatinib) to treat adults with relapsed or refractory (r/r) myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. One subject among those with EMD only attained a CR.

FDA Approval 147

FDA Approval Clinical Trials Clinical Trials Trials 147

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105

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.

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Clinical Trials Clinical Trials Trials Clinical Research 147

XTalks

JANUARY 22, 2025

From blockbuster anticoagulants like Eliquis (apixaban) and Xarelto (rivaroxaban) to life-saving treatments such as Entresto (sacubitril/valsartan) and Brilinta (ticagrelor), each of these drugs has made a significant impact in the cardiovascular space. Partnered with Pfizer, the drug continues to show strong market performance.

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Sales FDA Approval Drugs Marketing 104

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

JANUARY 2, 2025

Anteris approach has shown promising results in clinical trials, demonstrating better hemodynamics and exercise capacity compared to traditional three-piece valves. With US Food and Drug Administration (FDA) approval for an early feasibility study (EFS), Anteris has treated 15 patients across multiple heart valve centers in the US.

FDA Approval 110

FDA Approval Marketing Clinical Trials Clinical Trials 110

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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Clinical Trials Clinical Trials FDA Approval Trials 234

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Agent drug-coated balloon. The balloons outer surface is coated with the drug paclitaxel, a safe and effective measure to prevent the arteries from narrowing again.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

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

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

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 115

FDA Approval Insulin Drugs Hormones 115

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

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

Pharmaceutical Technology

AUGUST 25, 2022

The US Food and Drug Administration (FDA) has gra nted approval for AbbVie and Janssen Biotech’s Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD) in paediatric patients aged one year and above. Imbruvica is indicated for such patients following failure of one or more lines of systemic therapy.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Protein 130