Pharmaceutical Technology

APRIL 13, 2023

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Denali is also expected to receive potential development and commercial milestone payments upon achieving certain milestones, along with royalties based on the future net sales of the drug.

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Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. The potential Phase II trial in Parkinson’s disease will recruit between 75 and 100 patients, said Kelleher-Andersson.

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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.

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Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. The post Potentially game-changing schizophrenia drug enters Phase I trials appeared first on Drug Discovery World (DDW).

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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.

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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%.

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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.

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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.

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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.

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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.

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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.

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Pharmaceutical Technology

MAY 16, 2024

Uniquity is planning Phase II trials in COPD and asthma with TSLP-targeting drug solrikitug that it licensed from MSD

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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.

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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.

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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 […]

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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.

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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.

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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 […]

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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.

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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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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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

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

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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.

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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.

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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 (..)

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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 (..)

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Drug Discovery World

JULY 1, 2024

. “Pharma represents one of the biggest industries in the world, and there is immense potential to make the drug development process more efficient. ” Advancements in AI are creating more candidate drugs than the industry can progress.

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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, (..)

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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.

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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.

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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, (..)

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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.

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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 → (..)

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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, (..)

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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, (..)

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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).

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