Drug Discovery World

FEBRUARY 19, 2024

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year. antibody-drug conjugate [ADC] pipelines in some oncology settings).

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Drug Discovery World

JANUARY 25, 2024

There were no new market launches due to continued low valuations and investor appetite, however, two European listings on Nasdaq signals a gradual recovery. Major licensing and M&A deals demonstrate the ongoing quality and attractiveness of UK science.

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Drug Discovery World

JANUARY 3, 2023

Janssen has submitted a marketing authorisation application (MAA) seeking approval of talquetamab in Europe for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). . The post Janssen seeks European approval for multiple myeloma drug appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8% for the US market 2.

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Drug Discovery World

MARCH 17, 2023

The drug has been accepted for the treatment of chronic HDV infection in adult patients with evidence of significant fibrosis, whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contra-indication.

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BioPharma Drive: Drug Pricing

AUGUST 1, 2023

Some on Wall Street believe the New York-based biotechnology company is now less likely to get acquired after agreeing to sell partial rights to its only marketed product.

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Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company. I am a pharmacist by training and continued with a PhD in Clinical Pharmacology.

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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.

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Drug Discovery World

SEPTEMBER 7, 2022

The concept of Artificial Intelligence (AI) never fails to stimulate and in drug discovery the possibilities it presents, the potential it holds, are always thought-provoking, says DDW Publishing Director Lu Rahman. . We are well aware of the time and cost involved in developing a new drug.

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Drug Discovery World

OCTOBER 16, 2023

The United Kingdom has established itself as a hub for drug discovery expertise worldwide. There is a range of reasons why this area has become focal point for drug discovery, one of which is the fact that it encompasses the University of Oxford and the University of Cambridge, two of the oldest and most prestigious universities in the world.

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Drug Discovery World

MARCH 7, 2024

The combined entity will operate as Akari Therapeutics, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX. The merged pipeline features an antibody-drug conjugate (ADC) toolkit with novel payload and linker technologies.

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DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. UCSD, with its world-renowned Center for Microbiome Innovation , provides expertise in microbial genomics and drug discovery platforms.

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Drug Discovery World

JULY 12, 2024

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Asklepios BioPharmaceutical’s (AskBio) AB-1005 which is being developed for moderate Parkinson’s disease.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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Drug Discovery World

MAY 9, 2024

We look forward to working closely with the team at Accelerated Bio to enable the development of a next-generation cell line for biomanufacturing from their unique stem cell source.” Accelerated Bio out-licenses its commercial grade hTSC platform for drug discovery, therapy development, biomanufacturing and toxicology.

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Drug Patent Watch

JANUARY 21, 2021

This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights….

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Drug Discovery World

FEBRUARY 5, 2024

However, two-thirds (68%) of patients are comfortable receiving medicines before they’re licensed through their country’s healthcare system. Patients need to be backed by knowledge and resources, and knowing where they can get access to medicines – even before they are on the market – is vital for people with undiagnosed or rare diseases.”

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Drug Discovery World

JANUARY 19, 2023

The products, tools, talent and licensed technology will enable us to grow our NGS platform and unlock new market opportunities for IDT.” The post Key acquisition for next generation sequencing research assays appeared first on Drug Discovery World (DDW).

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Drug Discovery World

FEBRUARY 1, 2024

GSK’s Omjjara (momelotinib) has been granted marketing authorisation in Great Britain for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

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BioPharma Drive: Drug Pricing

FEBRUARY 14, 2024

The biotech is planning to dissolve less than four years after launching with plans to license drugs and market them in China and other Asian countries.

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Drug Discovery World

OCTOBER 7, 2022

The MHRA has granted marketing authorisation for Eli Lilly’s baricitinib (Olumiant), the first licensed JAK inhibitor for the treatment of severe alopecia areata in adult patients. . This is an important authorisation for patients as previously there has never been a licensed oral therapy for adults with severe alopecia areata.” .

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Drug Discovery World

SEPTEMBER 26, 2022

DDW Editor Reece Armstrong explores the rise of drug repurposing and the benefits and disadvantages it brings to drug discovery and development. . Drug repurposing, the act of finding new clinical targets for both approved and unapproved drugs, has emerged as a viable alternative to traditional drug discovery approaches. .

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. LOS ANGELES , Jan. 7, 2021 /PRNewswire/ — ImaginAb Inc. , No other terms were disclosed.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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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.

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Drug Discovery World

JULY 18, 2024

The report suggests the UK can build on the success of GW Pharmaceuticals, whose multiple sclerosis treatment product nabiximols was the first natural cannabis plant derivative to gain market approval in any country. The government should provide clear guidance that outlines the processes for developing botanical medicines in the UK.

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Drug Discovery World

AUGUST 31, 2023

The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP). The goal of ILAP is to accelerate the time to market facilitating patient access to medicines in the UK.

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The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 Juyou Bio-Technology Co.,

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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).

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Drug Discovery World

JUNE 17, 2024

Drug discovery and biotech took the top two spots for sector activity – hugely promising and hopefully the sign of a much more positive backdrop that will frame many of the discussions companies will be having with investors. So how can early-stage drug discovery companies improve their chances of success?

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. But like cockroaches, some pieces of legislation are resilient and never seem to die.

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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.

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Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Starting with the drug. Pharmacokinetics: How the body handles drugs. Providing a broad view.

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Drug Discovery World

JULY 24, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Janssen’s Talvey (talquetamab). The post CHMP recommendation for bispecific antibody talquetamab appeared first on Drug Discovery World (DDW).

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The Pharma Data

MAY 7, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

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Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

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