Pharmaceutical Technology

JULY 28, 2022

Melinta Therapeutics has signed a licence agreement with Cidara Therapeutics to facilitate a strategic collaboration for marketing the latter’s rezafungin in the US. According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway.

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Licensing Licensing Clinical Trials Clinical Trials 147

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. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinical trial. .

Development 264

Development Gene Expression Licensing Licensing 264

XTalks

JANUARY 22, 2025

IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

Pharmaceutical Technology

OCTOBER 21, 2022

On concluding this trial, Roche will gain the right to develop and market the licenced products across various indications, contingent on approval. Roche also holds an option for licensing second arenaviral cancer immunotherapy. According to the agreement, Roche will make $25m in upfront payment to Hookipa. .

Development 278

Development Production Licensing Licensing 278

XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

Trials 59

Trials Clinical Trials Clinical Trials Insulin 59

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.

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Licensing Licensing FDA Approval Clinical Trials 111

Pharmaceutical Technology

DECEMBER 19, 2022

On choosing the candidate, the company will oversee the complete development, production and marketing. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.

Development 264

Development Engineer Clinical Trials Clinical Trials 264

Pharmaceutical Technology

SEPTEMBER 13, 2022

Trodelvy has already received regulatory approval for previously treated triple-negative breast cancer (TNBC) across the eight major markets (8MM – US, France, Germany, Italy, Spain, UK, Japan and China). month OS benefit compared to SOC chemotherapy in the DESTINY-Breast04 trial.

HR 162

HR Marketing Hormones FDA Approval 162

Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

Marketing 130

Marketing Antibody Licensing Licensing 130

XTalks

MARCH 19, 2025

Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism.

Trials 59

Trials Hormones Engineer Licensing 59

Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Logistics expertise.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Licensing 130

Pharmaceutical Technology

JANUARY 25, 2023

After a tumultuous year that weathered the continued impact of a bear market , many in biotech are looking for signs of improvement in 2023. A game of musical chairs Lyne compares the current situation to a game of musical chairs, where the status of each company essentially depends on where they were positioned when the market shifted.

Marketing 173

Marketing Life Science Pharma Companies Licensing 173

Pharmaceutical Technology

MAY 3, 2023

Aurinia Pharmaceuticals has received marketing authorisation from the Swiss Agency for Therapeutic Products (Swissmedic) for Lupkynis (voclosporin), along with a background immunosuppressive therapy. The regulatory authorisation is based on the Phase III AURORA 1 study and the AURORA 2 continuation trial.

Marketing 130

Marketing Licensing Licensing Production 130

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 72

Licensing Licensing Trials Clinical Trials 72

Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. None of these products are in a registrational trial, and as such, GlobalData does not anticipate their entry into the AML market earlier than 2028.

Marketing 130

Marketing Gene Editing Production Sales 130

Pharmaceutical Technology

JULY 21, 2022

In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca. According to data from the PROVENT clinical trial, AZD7442 demonstrated a statistically significant decline in symptomatic Covid-19 development risk.

Antibody 264

Antibody Compliance Clinical Trials Clinical Trials 264

Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. Competition in an increasingly heated market.

Vaccination 162

Vaccination Vaccine Marketing Bacteria 162

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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Marketing Research Trials Clinical Trials 97

Worldwide Clinical Trials

OCTOBER 19, 2022

As evidence emerges about their potential for PTSD, depression, cancer-related distress and more, the market for psychedelics could swell from $2 billion in 2020 to $10.75 Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

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. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.

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Trials Drugs Clinical Trials Clinical Trials 136

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. Zerviate, 0.24% was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine, which is marketed under undeb Emadine brand name.

Licensing 162

Licensing Licensing Sales Packaging 162

Cloudbyz

NOVEMBER 22, 2024

The Everest Group PEAK Matrix® is an industry-standard evaluation that ranks service providers on two essential dimensions: market impact and vision & capability. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

SEPTEMBER 19, 2022

The regulatory agency carried out the review of the Biologics License Application (BLA) for the therapy under the Priority Review approach. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

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. Seagen has three marketed ADCs as well as two novel ones, one of which, disitamab vedotin, is HER2-directed.

Clinical Trials 162

Clinical Trials Clinical Trials Licensing Licensing 162

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

Pharmaceutical Technology

JUNE 1, 2023

Sanofi has announced that its anti-CD40L antibody frexalimab demonstrated significantly reduced disease activity in a Phase II trial of patients with relapsing multiple sclerosis (RMS). Following these positive results, Sanofi plans to initiate further RMS trials next year. The agreement involved milestone payments upto $500 million.

Trials 162

Trials Antibody Marketing Development 162

pharmaphorum

JANUARY 25, 2021

GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. Immutep said a collaboration with GSK remains in place and GSK2831781 continues to be under exclusive license with GSK.

Drug Trials 103

Drug Trials Trials Drugs Licensing 103

World of DTC Marketing

MAY 24, 2022

DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. And the COVID-19 pandemic has likely given the market an added boost, Torous adds.

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Licensing Licensing Scientist Production 252

pharmaphorum

DECEMBER 7, 2020

Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.

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Marketing Regulation Production Medicine 109

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

Clinical Trials 103

Clinical Trials Clinical Trials Trials Compliance 103

pharmaphorum

FEBRUARY 21, 2022

In contrast, up to 55% of all patients with breast cancer have tumours with a HER2-low score, as defined in the DESTINY-Breast04 trial, and approval in this group could unlock $3 billion in additional sales for Enhertu, according to analysts at Credit Suisse. billion upfront to license rights to Enhertu in a deal that could be worth up to $6.9

Trials 132

Trials Sales Hormones Drugs 132

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. Over 2,400 patients have continued in the 72-week open-label extension trial.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

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). The market potential of the CUD and NDD indications alone could top 2 billion euros ($2.12

Licensing 59

Licensing Licensing Trials Clinical Trials 59