AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 16, 2023

At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

Pharma Companies 188

Pharma Companies Licensing Licensing Manufacturing 188

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

DECEMBER 19, 2022

Innate is also eligible to receive a total of up to $1.43bn (€1.35bn) in preclinical, clinical, regulatory and commercial milestone payments and royalty payments on net sales in the future. As per the deal, Sanofi will hold an option to include up to two further ANKET targets.

Development 264

Development Engineer Clinical Trials Clinical Trials 264

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021. targeting ADC.

Clinical Trials 162

Clinical Trials Clinical Trials Licensing Licensing 162

Pharmaceutical Technology

MAY 1, 2023

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Nicox granted exclusive license to Ocumension to develop and commercialise Zerviate in China and most of the Southeast Asian markets.

Licensing 162

Licensing Licensing Sales Packaging 162

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

Licensing 111

Licensing Licensing FDA Approval Clinical Trials 111

Pharmaceutical Technology

MAY 15, 2023

Sanofi announced data from a real-world clinical trial that demonstrated its RSV antibody nirsevimab delivered an 83% reduction in hospitalisations in infants with respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD). Nirsevimab is being jointly developed between Sanofi and AstraZeneca.

Antibody 245

Antibody Vaccine Vaccination Trials 245

pharmaphorum

JUNE 23, 2021

GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. billion takeover of Tesaro in 2019. £1 mRNA ambitions.

Sales 100

Sales Vaccine Vaccination Drugs 100

pharmaphorum

OCTOBER 27, 2021

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.

Licensing 143

Licensing Licensing Manufacturing Clinical Trials 143

Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. The programmes include P-BCMA-ALLO1, an allogeneic CAR-T to treat multiple myeloma and P-CD19CD20-ALLO1, an allogeneic dual CAR-T to treat B-cell malignancies.

Development 147

Development Clinical Trials Clinical Trials Gene Therapy 147

Pharmaceutical Technology

MARCH 30, 2023

Laboratoires Théa’s sister company, Théa Open Innovation (TOI), has signed a licensing agreement with Galimedix Therapeutics for GAL-101. It is currently ready to enter Phase II/III clinical trials. GAL-101 binds to a specific motif from Aβ that is exposed only in the misfolded Aβ monomer form and can be targeted.

Clinical Trials 130

Clinical Trials Clinical Trials Licensing Licensing 130

Pharmaceutical Technology

NOVEMBER 10, 2022

Additionally, Royalty Pharma is entitled to receive further payments of up to $160m subject to meeting some clinical, regulatory and sales milestones. The rights to development, regulatory and sales milestone payments of $400m due from Amgen will be retained by Arrowhead. In 2016, it was licensed by the company to Amgen.

RNA 130

RNA Sales Clinical Trials Clinical Trials 130

XTalks

APRIL 3, 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.

Trials 59

Trials Clinical Trials Clinical Trials Genetics 59

XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. billion in revenue by 2024.

Genetics 116

Genetics Hormones Trials Drugs 116

Pharmaceutical Technology

MARCH 31, 2023

Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection. in sales-related milestone payments, along with tiered royalties on sales across all indications. Additionally, GSK will pay up to $242.5m

Sales 130

Sales FDA Approval Clinical Trials Clinical Trials 130

Pharmaceutical Technology

OCTOBER 18, 2022

Gilead holds an option for licensing MGD024 as a possible therapy to treat specific blood cancers, including myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.

Antibody 130

Antibody Development Sales Clinical Trials 130

pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . TALi is also in line for royalties on sales.

Licensing 64

Licensing Licensing Sales FDA Approval 64

Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

Clinical Trials 130

Clinical Trials Clinical Trials Insulin Medicine 130

Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

Development 130

Development Clinical Trials Clinical Trials Regulation 130

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. According to the agreement, CSPC will receive a $7.5m

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Pharmaceutical Technology

MARCH 23, 2023

The drug is currently licensed in combination with chemotherapy for patients with classical Hodgkin lymphoma, both as frontline therapy and for those at risk of progressing or having progressed following stem cell transplantation. Seagen generated almost $2 billion in revenue in 2022, an increase approaching 25% from 2021.

Licensing 147

Licensing Licensing Sales Trials 147

pharmaphorum

MARCH 19, 2021

Under the clinical trial supervision of the Royal College of Surgeons, Ireland, 40 subjects, 16 of which were independently confirmed as COVID19 positive with PCR tests, provided breath samples that were tested on the Microtox BT nano-optofluidic chip surface. It has licensed in a patented breathalyser, the analysts noted.

Contamination 145

Contamination Clinical Trials Clinical Trials Protein 145

Pharmaceutical Technology

JUNE 21, 2023

Coya Therapeutics has expanded its patent estate for COYA 301 by entering a licensing agreement with UNeMed, the University of Nebraska Medical Center’s technology transfer office. UNeMed will receive payments on reaching milestones and will also be entitled to tiered low-single-digit royalties on net sales.

In-Vivo 130

In-Vivo Immune Response Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MAY 19, 2023

Alimera Sciences has exclusive global rights to Yutiq excluding Southeast Asia, Hong Kong, Macau, China and South Korea, where the therapy was previously licensed to Ocumension Therapeutics. EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028.

Clinical Trials 130

Clinical Trials Clinical Trials Licensing Licensing 130

Pharmaceutical Technology

FEBRUARY 22, 2023

Spanish pharmaceutical firm Ferrer and Swiss biotechnology firm Asceneuron have signed a licensing agreement for the latter’s O-GlcNAcase inhibitor, ASN90, to treat progressive supranuclear palsy (PSP). Additionally, Asceneuron is eligible for tiered double-digit royalties on ASN90’s global net sales.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JANUARY 31, 2023

Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF).

Clinical Trials 130

Clinical Trials Clinical Trials Licensing Licensing 130

XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.

Development 242

Development Bioequivalency Generic Drugs Production 242

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Redx is also eligible to receive up to $360m in additional payments, dependent on development, regulatory and commercial milestones, as well as tiered royalties on any future sales.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MAY 31, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company’s pipeline products include Busulipo which is under Phase II clinical trials and Nefecon for IgA Nephritis which is under Phase II clinical trials.

Clinical Trials 100

Clinical Trials Clinical Trials Production Drugs 100

pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.

Licensing 52

Licensing Licensing FDA Approval Trials 52

pharmaphorum

AUGUST 10, 2021

Seagen said that the antibody in its ADC may be superior to trastuzumab, as it has a higher affinity for HER2 and gets into cells more effectively, although that will have to be put to the test in head-to-head clinical trials. While the licensing deal with Seagen tops up its finances, the scale well below the $6.9

Licensing 52

Licensing Licensing Antibody Sales 52

pharmaphorum

AUGUST 4, 2020

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinical trial.

Drugs 109

Drugs Clinical Trials Clinical Trials Trials 109

pharmaphorum

MAY 4, 2021

There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA. The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial.

Licensing 52

Licensing Licensing Dermatology Antibody 52

pharmaphorum

NOVEMBER 10, 2021

The drug was the first in the oral CGRP inhibitor class to get an prevention indication approved by the FDA in May, and that has helped accelerate its rollout, bringing in $336 million in US sales for Biohaven so far this year. The post Pfizer strikes $1.2bn licensing deal for Biohaven migraine drug appeared first on.

Licensing 52

Licensing Licensing Drugs Sales 52

The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

Licensing 52

Licensing Licensing Development Clinical Trials 52