The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Licensing 52

Licensing Licensing Therapies Science 52

Drug Discovery World

AUGUST 1, 2023

Partnerships Earlier this year cell-engineering company MaxCyte signed a strategic platform license (SPL) with biotechnology company Catamaran Bio. In return MaxCyte will receive platform licensing fees and program-related revenue.

Licensing 130

Licensing Licensing Drugs Engineering 130

Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

Clinical Trials 130

Clinical Trials Trials Therapies Licensing 130

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). There have been challenges in gene therapy development.

Therapies 98

Therapies FDA Trials Clinical Trials 98

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Licensing 52

Licensing Licensing Therapies Engineering 52

Drug Discovery World

JUNE 1, 2023

In May 2023, Japanese drug-maker Eisai entered into a joint development agreement with Chinese drug-developer Bliss Biopharmaceutical for BB-1701, an ADC with option rights for a strategic collaboration 6. This appears to be supported by the number of Chinese collaborations, approvals and expansions in 2023 alone.

Marketing 245

Marketing FDA Approval Licensing Licensing 245

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Drug Discovery World

OCTOBER 6, 2023

FDA acceptance advances investigational gene therapy The US Food and Drug Administration (FDA) has accepted Rocket Pharmaceuticals’ Biologics License Application (BLA) and granted Priority Review for RP-L201 (marnetegragene autotemcel).

Drugs 130

Drugs DNA Licensing Licensing 130

Drug Discovery World

JULY 26, 2023

The Phase I clinical trial, sponsored and managed by Cancer Research UK’s Centre for Drug Development, tested whether an IgE antibody could be used to treat cancer. The drug, MOv18 IgE, was developed by researchers at King’s College London.

Clinical Trials 130

Clinical Trials Immune Response Trials Drugs 130

Drug Discovery World

NOVEMBER 25, 2022

Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. Gene therapy could ‘transform prognosis’ for AADC deficiency patients . FDA approves first disease-modifying therapy for T1D . The top stories: .

FDA Approval 130

FDA Approval FDA Drugs Therapies 130

ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development. Repurposing is one such method. CBRN MCMs).

Therapies 40

Therapies Licensing Licensing FDA Approval 40

Drug Discovery World

SEPTEMBER 8, 2023

Antibody development drives high-value biotech deals The development of antibodies and associated technologies continues to drive high-value deals, according to a recent report in Nature.

Drugs 130

Drugs Licensing Licensing Government 130

The Pharma Data

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. ,

Therapies 52

Therapies Disease Licensing Licensing 52

The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. .

Therapies 52

Therapies Virus Licensing Licensing 52

Drug Discovery World

MAY 3, 2023

Michael Pehl, Chief Executive Officer of Adcendo, said: “2022 was a pivotal year for Adcendo with the expansion of our team, uPARAP ADC Development Candidate Nomination and the recent linker/payload license agreement with Duality Biologics.

Licensing 130

Licensing Licensing Clinical Development Therapies 130

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding. Northern Ireland “Northern Ireland is a medtech super-hub,” says Saleko.

Drugs 190

Drugs Science Therapies Targeted Protein Degradation 190

The Pharma Data

JANUARY 12, 2021

Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. Also in December, the company partnered with Atara Biotherapeutics to develop off-the-shelf T-cell immunotherapies for high mesothelin-expressing tumors. Photo courtesy of Bayer.

Therapies 52

Therapies Licensing Licensing Pharmaceuticals 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Therapies 59

Therapies Engineering Production FDA 59

Drug Discovery World

MAY 6, 2024

Even before this, however, Amsterdam was established as an important centre for drug development. The company is now investigating a promising gene therapy for Huntingdon’s disease in a Phase I/II trial, with patients already showing signs of preserved neurological function. The CDD will sponsor and manage KWF-supported trials.

Drugs 148

Drugs Science Molecular Biology Clinical Trials 148

Drug Discovery World

SEPTEMBER 26, 2022

Perhaps the biggest benefit drug repurposing brings is its potential to get treatments to patients faster than traditional means of drug discovery. A report by the medical charity LifeArc 1 puts the timeframe for a therapy brought to market through repurposing methods at anywhere from one to three years.

Pharmaceutical Companies 130

Pharmaceutical Companies Drugs Pharmaceuticals Clinical Trials 130

Drug Discovery World

MARCH 22, 2023

It will combine the use of novel Huntington’s disease drug targets from Aitia’s Gemini Digital Twins with UCB’s expertise in drug research and preclinical model systems in neurodegeneration, with the aim to accelerate the discovery of new therapies for people living with Huntington’s disease.

Targeted Protein Degradation 130

Targeted Protein Degradation Small Molecule Drugs Licensing 130

Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Greater insight into the entire biopharmaceutical lifecycle can improve the availability of effective therapies worldwide.

Production 246

Production Engineering Pharmaceutical Companies Clinical Trials 246

Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

Science 59

Science Drugs Compliance Drug Development 59

Drug Discovery World

NOVEMBER 29, 2022

The curriculum and assessment structure is based on what the students will need to thrive in the drug development sector, with all scientific topics taught with the drug in mind first. Pharmacokinetics: How the body handles drugs. Pharmacodynamics: How drugs exert their effects on the body. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Conversations in Drug Development Trends

OCTOBER 26, 2022

That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities. Certain licensing must be obtained. Raters and therapists are not the same. More guidance on safety considerations can be found, here.

Trials 97

Trials Clinical Trials Licensing Licensing 97

The Pharma Data

DECEMBER 29, 2020

a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. Its drug development pipeline includes thymus, pancreas, and kidney regeneration.

Therapies 52

Therapies FDA Disease Trials 52

Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.

Licensing 52

Licensing Licensing Small Molecule Therapies 52

Drug Discovery World

OCTOBER 4, 2022

“Recent reports suggest global market value is forecasted to grow to $25-$40 billion before the end of this decade, driven primarily by the introduction of disease-modifying therapies with accompanying biomarkers for early diagnosis, coupled with the demographic rise in the number of patients.” .

Disease 130

Disease Small Molecule Compound Screening Clinical Development 130

The Pharma Data

DECEMBER 22, 2020

Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy. Outside of Japan , Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. , ” About Rakuten Medical, Inc.

Clinical Trials 52

Clinical Trials Therapies Trials Production 52

The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. Noria) and PSMA Therapeutics Inc.

Small Molecule 52

Small Molecule Licensing Licensing Therapies 52

Crown Bioscience

MAY 4, 2021

Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids. Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

Drug Discovery World

AUGUST 5, 2022

Ian Hollingsworth, Associate Director of product development at Boyds, the global drug development consultancy, explains the benefits to the drug development lifecycle of building strong partnerships with external consultants, and when and how to get the best from them. Why sponsors use external consultants.

Drug Development 130

Drug Development Drugs Pharma Companies International 130

Drug Target Review

MAY 17, 2024

Lerociclib may provide MYC-driven HCC patients with a safe and more effective alternative to current therapies, which are far from curative. This underscores our strategy to focus on a specific patient population with the right drugs – a key aspect of our pipeline strategy and platform capabilities.

Disease 52

Disease Licensing Licensing Treatment 52

Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

RNA 64

RNA Cell Biology Clinical Development DNA 64

LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

Clinical Research 45

Clinical Research Disease Research Clinical Trials 45

Drug Discovery World

JANUARY 2, 2024

She believes we might start to see a combination of vaccines with other immunotherapies or classical therapies out there, and that this will become more and more prevalent because of the nature of cancer. Tony Hickson, Chief Business Officer of Cancer Research Horizons, was on hand to comment on the announcement.

Research 148

Research Vaccine Science Trials 148