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

Drug Discovery World

AUGUST 2, 2023

Renaissance Pharma has announced its first development programme focused on Hu14.18, a humanised anti-GD2 monoclonal antibody (mAb), licensed from St Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastoma. A novel Phase II trial incorporating Hu14.18 and three-year event-free (EFS) of 73.7%.

Licensing 98

Licensing Licensing Antibody Trials 98

Pharma Times

DECEMBER 21, 2021

The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.

Trials 119

Trials Licensing Licensing Drugs 119

Bio Pharma Dive

DECEMBER 14, 2021

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

Gene Therapy 317

Gene Therapy Licensing Licensing Gene 317

Pharmaceutical Technology

JULY 28, 2022

The collaboration comes after Cidara filed a New Drug Application (NDA) for rezafungin to treat candidemia and invasive candidiasis. Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review.

Licensing 147

Licensing Licensing Clinical Trials Clinical Trials 147

Bio Pharma Dive

FEBRUARY 10, 2022

The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

Licensing 338

Licensing Licensing Drugs Trials 338

Pharmaceutical Commerce

FEBRUARY 20, 2024

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

Licensing 99

Licensing Licensing Trials Drugs 99

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 22, 2023

The Central Drugs Standard Control Organisation (CDSCO) has said that a joint investigation team of its East Zone office and the State Licensing Authority (SLA) of Sikkim have declared the samples of Glenmark Pharmaceuticals’ blood pressure-lowering drug Telma 40 failed in the quality tests in February, 2023, as spurious.

Drugs 167

Drugs Licensing Licensing Clinical Trials 167

Pharmaceutical Technology

OCTOBER 4, 2022

An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.

Licensing 147

Licensing Licensing Manufacturing Medicine 147

Pharmaceutical Technology

APRIL 3, 2023

Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.

Development 246

Development Drugs Clinical Development Licensing 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 30, 2023

Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]

Cosmetics 162

Cosmetics Drugs Licensing Licensing 162

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.

Drugs 144

Drugs Licensing Licensing Manufacturing 144

pharmaphorum

JANUARY 9, 2023

Swiss biotech Stalicla has continued to diversify its pipeline from a focus on autism therapies with a deal to license Novartis’ mavoglurant, in clinical trials for cocaine use disorder (CUD) as well as neurodevelopmental disorders (NDD). STP-2 was licensed from Evgen Pharma in October last year.

Licensing 58

Licensing Licensing Trials Clinical Trials 58

Pharmaceutical Technology

MAY 18, 2023

The trial, a six-week study, will assess the change in the Hamilton Depression Rating Scale score, says Houghtaling. The company currently aims to study the drug in a group of 160 subjects, which will be evenly split between those on the drug and on placebo, says Houghtaling. Rob Houghtaling, Sr.

Trials 130

Trials Licensing Licensing Development 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

Regulation 145

Regulation Drugs Licensing Licensing 145

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The poll of 114 triallists by clinical data specialist ERT found 82% of them found organisations aery using “virtual trial” approaches.

Licensing 71

Licensing Licensing Trials Clinical Trials 71

BioTech 365

JANUARY 19, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ex-Gilead execs bag $80M to trial drug licensed from Merck KGaA.Ex-Gilead

Licensing 40

Licensing Licensing Trials Drugs 40

pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. Jazz acquired rights to Sativex when it completed its $7.2 billion takeover of Sativex’ developer GW Pharma earlier this year.

Trials 136

Trials Drugs Clinical Trials Clinical Trials 136

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). The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CRB-701.

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Fierce Pharma

APRIL 25, 2024

A depression drug candidate that Neurocrine licensed from Takeda succeeded in a phase 2 trial. Novartis has started cutting ties with Chinese contractors amid a potential threat from the BIOSECURE Act. Novartis has started cutting ties with Chinese contractors amid a potential threat from the BIOSECURE Act.

Licensing 77

Licensing Licensing Trials Drugs 77

BioTech 365

JANUARY 27, 2022

Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-Specific Revenue Forecasts – ResearchAndMarkets.com Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

Drug Discovery World

NOVEMBER 24, 2023

Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s widespread support for the project. “We The Clamp2 trial group showed a 2.5-fold fold boost in neutralising ‘titres’ and it was 2.1 in the Novavax group.

Clinical Trials 110

Clinical Trials Clinical Trials Engineer Vaccination 110

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. Under the terms of the agreement, POINT will complete the study and, if positive, Lantheus will take responsibility for submitting the drug for approval.

Licensing 52

Licensing Licensing FDA Approval Trials 52

pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

Licensing 63

Licensing Licensing Development Drugs 63

BioTech 365

JANUARY 27, 2022

Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

OCTOBER 14, 2021

Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following FDA Acceptance of Investigational New Drug Application for Phase 1 Clinical Trial in Non-Hodgkin’s Lymphoma Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following FDA Acceptance of Investigational New Drug Application for Phase … Continue reading → (..)

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

BioTech 365

JUNE 9, 2021

World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Regulation Licensing 40

Fierce Pharma

AUGUST 3, 2023

Bristol Myers Squibb and BeiGene have settled their Abraxane feud by terminating their three-drug licensing deal altogether. Bristol Myers Squibb and BeiGene decided to terminate their three-drug licensing deal. Sumitomo Pharma's Otsuka-partnered schizophrenia candidate ulotaront failed in two phase 3 trials.

Trials 52

Trials Licensing Licensing Drugs 52

BioTech 365

JUNE 9, 2021

Global Osteoarthritis and Osteoarthritis Pain Market 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com Global Osteoarthritis and Osteoarthritis Pain Market 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Regulation Licensing 40

pharmaphorum

JULY 8, 2022

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. In the EU, loncastuximab tesirine has orphan drug designation for the treatment of DLBCL, a form of non-Hodgkin lymphoma (NHL).

Licensing 52

Licensing Licensing Sales Marketing 52

pharmaphorum

OCTOBER 27, 2020

US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. Moreover, as an orally-active drug merimepodib could also have found a role outside the hospital setting.

Drug Trials 98

Drug Trials Trials Drugs Contract Manufacturing 98

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 6, 2022

The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].

Cosmetics 125

Cosmetics Licensing Licensing Drugs 125

Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the FDA’s current thinking on the use of single-arm trials?

Production 190

Production Trials Development Clinical Trials 190

Drug Discovery World

JANUARY 16, 2024

The Jenner Institute at the University of Oxford is conducting the study using Bacille Calmette-Guérin (BCG), the current licensed vaccine against TB. The post Clinical trial will test novel inhaled TB vaccine appeared first on Drug Discovery World (DDW).

Clinical Trials 59

Clinical Trials Clinical Trials Vaccination Vaccine 59

pharmaphorum

NOVEMBER 10, 2021

Pfizer has bolstered its central nervous system (CNS) drugs portfolio with a $1.2 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.

Licensing 52

Licensing Licensing Drugs Sales 52