Category Regulatory

Imfinzi plus transarterial chemoembolisation and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolisation

Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to TACE alone in patients with hepatocellular…

Read MoreImfinzi plus transarterial chemoembolisation and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolisation

Voydeya granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy

Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). It is indicated in Japan in combination with C5 inhibitor therapy when patients have had an insufficient response to such C5 inhibitors.1 Voydeya is a first-in-class, oral, Factor…

Read MoreVoydeya granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy

Biotech companies to increase R&D spend but highlight complexity of clinical trials – ICON

ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, today launched its “Optimising biotech funding” whitepaper. This provides an overview of the current state of play for biotech companies and the research and development (R&D) strategies they can…

Read MoreBiotech companies to increase R&D spend but highlight complexity of clinical trials – ICON

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