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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The Pharma Data

SEPTEMBER 10, 2021

This is the first marketing authorization globally for abrocitinib-. This is the first marketing authorization globally for abrocitinib-. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. This is the first marketing authorization worldwide for this treatment. “We

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Drug Target Review

SEPTEMBER 5, 2024

This was very challenging for me and at that moment I decided to get experience from later stage products and therefore took on the role as Global Product Director for late-stage marketed cardiovascular products. I experienced challenges in cultural differences working with US, UK, Japan, and China.

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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 Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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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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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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Drug Discovery World

JULY 28, 2023

The top stories: Partnership could enhance antibody discovery for cancer research Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. New eBook: Breakthroughs accelerating therapeutic antibodies The latest eBook by DDW is out now.

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Drug Discovery World

JULY 12, 2024

The UK MHRA Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market, facilitating patient access.

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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

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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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

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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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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability. Biogen Inc.

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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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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

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 programme was licensed from Bayer Healthcare and is a fifth generation neutrophil elastase inhibitor (NEI) targeting the inflammatory aspects of AATD, a rare condition.

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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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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. KAROLINE MATHYS is the head of the new sector.

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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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The Pharma Data

DECEMBER 20, 2020

Collaboration Strengthens Peijia’s Position for Competing in a Largely Untapped Market and Supports Global Expansion of HighLife’s Technology. Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential.

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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 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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SCIENMAG: Medicine & Health

JUNE 9, 2023

Virginia Tech Intellectual Properties (VTIP) with LINK + LICENSE + LAUNCH’s Proof-of-Concept Program has provided the springboard for faculty to bring their research to market. Over the past four years, the program has funded 24 Virginia Tech research projects. Credit: Photo by Luke Hayes for Virginia Tech.

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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

JANUARY 17, 2021

But that number doesn’t quite reflect the company’s likely market valuation , which is expected to be between $9 billion and $12 billion. Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments.

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The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA).

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Drug Discovery World

MARCH 17, 2023

The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203.

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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.

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Drug Discovery World

MAY 29, 2024

Timing is critical, but regardless of the market cycle, big pharma and biotechs are inherently co-dependent, a dynamic that is central to the health of the drug industry. The pharma counterparts in search and evaluation (S&E) are doing the same, as they want to spend their time wisely. The entire team from Good moved to Bonum.

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Drug Discovery World

MAY 31, 2023

Eisai has submitted a marketing authorisation application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. The investigational therapy has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

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Drug Discovery World

JULY 2, 2024

OECD data places Switzerland second in the world for biotechnology R&D intensity 1 , and in 2021, the country had the seventh largest share of the global biotech market 2. A study conducted by IQVIA and published in the 2023 Swiss Biotech Report recently showed that 20% of European biotech companies are now headquartered in Switzerland 3.

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Drug Discovery World

AUGUST 14, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted HTL0039732 an Innovation Passport, the first step in its Innovative and Licensing Access Pathway (ILAP), which aims to improve patient access to new medicines by reducing the time to market.

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

3582 went nowhere; and many additional unsuccessful attempts to get a similar bill passed followed over the years. 3) A covenant not to sue on any claim that the ANDA product or biosimilar biological product infringes a United States patent.

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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).

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FDA Law Blog: Biosimilars

JUNE 12, 2024

While that’s not to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market impact, or to show that some of the promises of significant savings for large numbers of consumers have been realized.

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