Category Regulatory

Lutikizumab Showed Positive Results in a Phase 2 Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase 3

AbbVie (NYSE: ABBV) today announced Phase 2 results showing adults with moderate to severe hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg every other week or 300 mg weekly achieved higher response rates…

Read MoreLutikizumab Showed Positive Results in a Phase 2 Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase 3

COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment in people with type 2 diabetes

 Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly…

Read MoreCOMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment in people with type 2 diabetes

AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure

Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as NAN-101)…

Read MoreAskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure

AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced today the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF),…

Read MoreAskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint

Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors. Global Phase…

Read MoreMerck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline

Resalis Therapeutics Raises €10 Million Series A to Complete First Clinical Trial for RES-010 in Obesity

Resalis Therapeutics today announced the closing of a €10 million ($11 million) Series A financing round led by Sunstone Life Science Ventures with participation from existing investors including Claris Ventures and angel investors. The proceeds will be used to initiate and…

Read MoreResalis Therapeutics Raises €10 Million Series A to Complete First Clinical Trial for RES-010 in Obesity

AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced today the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF),…

Read MoreAskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint

Wainua granted first-ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN.1 Wainua is the only approved medicine for the treatment of ATTRv-PN that can be…

Read MoreWainua granted first-ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”)today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1…

Read MorePADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy,…

Read MoreMerck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 genome-edited cell therapy, for the treatment of sickle cell disease (SCD) in patients 12 years and older…

Read MoreVertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease