Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.

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Bio Pharma Dive

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 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. ” The post Renaissance Pharma licenses Hu14.18

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Pharmaceutical Technology

JANUARY 23, 2023

Takeda has signed an exclusive licence agreement with HUTCHMED (China) and its subsidiary HUTCHMED to develop and market the latter’s fruquintinib. The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018.

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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. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

MARCH 17, 2023

Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health.

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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. This promotes podocyte stability in the kidneys. Lupkynis has also received orphan drug designation in Switzerland.

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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).

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Pharmaceutical Technology

MAY 8, 2023

Under the terms of the license and commercialisation deal, Dr. Reddy’s will get licence for the development and commercialisation of toripalimab in India, Panama, Peru, Colombia, South Africa, Brazil, Argentina, Chile, Uruguay, and Mexico. Junshi Biosciences may get an aggregate of up to $728.3m

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Fossil Remedies

OCTOBER 16, 2022

In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. To launch the best PCD pharma franchise company, you will have to acquire the necessary licenses from authorities. Wholesale Drug License.

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Camargo

DECEMBER 15, 2020

Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. How big is the addressable market, and what do I know about it?

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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. GlobalData’s Pharma Intelligence Center shows 19 autologous CAR-T cell products in Phase I, and nine products in Phase II, globally.

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Pharmaceutical Technology

JUNE 5, 2023

PharmaEssentia may be entitled to receive certain milestone payments along with royalties based on sales of the product. Pint-Pharma will obtain and maintain all marketing authorisations and will commercialise BESREMi in the region. It holds orphan drug designation in the US to treat PV.

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Fossil Remedies

JANUARY 19, 2022

But do we know which PCD products should we pick so that the maximum profitability is ensured? This blog is an attempt to clarify the concepts about choosing the best products. Points to consider while choosing products. Always pick products that you are comfortable with. Legally identified products. Perhaps no.

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Pharmaceutical Technology

MAY 31, 2023

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. The investigational product candidate has concluded Phase III development as a treatment option for Barth syndrome.

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BioPharma Reporter

JULY 6, 2022

Touchlight has agreed to a non-exclusive patent license for Pfizer to utilize its enzymatic doggybone DNA (dbDNA).

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pharmaphorum

OCTOBER 28, 2022

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.

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Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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pharmaphorum

MAY 17, 2021

UK biotech Arecor Therapeutics has announced plans to float on the London stock market, to fund plans to develop novel formulations of insulins and other biological drugs with enhanced properties. Arecor has four active licensing agreement in place with partners including Hikma and Inhibrx.

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XTalks

JANUARY 29, 2021

Oncology products monopolise the list of best-selling drugs. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products.

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Approximately only 20 % of the drugs that enter phase I are approved for marketing. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA).

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Fierce Pharma

APRIL 4, 2024

. | Teva has unveiled a fresh in-licensing accord with Spain’s mAbxience to chip in on an investigational biosimilar spanning multiple oncology indications.

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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. on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product.

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Pharmaceutical Technology

MAY 1, 2023

Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). It has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US.

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Roots Analysis

AUGUST 7, 2023

Moreover, cell based biomanufacturing imposes inherent limitations on the effective production of biologics. Given the growing demand for biologic products, cell free expression has become a key focus area for stakeholders in the biopharmaceutical industry. Interestingly, most of these kits are used for cell-free protein expression.

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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.

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Pharmaceutical Technology

AUGUST 1, 2022

The human health product candidates of GreenLight are currently in the pre-clinical stage. In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide.

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pharmaphorum

NOVEMBER 22, 2022

Germany’s Merck KGaA has said it needs to double the productivity of its R&D operations, with the aim of launching a new product every 18 months on average, to boost its pharma business. The post Merck pledges revamp of R&D to drive productivity appeared first on.

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Fierce Pharma

JUNE 12, 2023

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement. Following a deal with Amgen, J&J has granted Alvotech and Teva a license to launch their Stelara biosimilar no later than Feb.

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Pharmaceutical Technology

JULY 18, 2022

Quoin Pharmaceuticals and Endo International subsidiary Endo Ventures have signed a licence and distribution agreement and a supply agreement to develop, register, supply, market and distribute the former’s QRX003 exclusively in Canada. A lead product of Quoin, QRX003 is a topical lotion intended to treat Netherton Syndrome.

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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pharmaphorum

APRIL 14, 2022

billion product at peak. It was one of Genmab’s lead in-house development projects prior to the AbbVie partnership , which also includes two other named antibodies and a drug discovery collaboration, and the project the Danish biotech has held up as being key to its ambition to start selling its own products.

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pharmaphorum

DECEMBER 7, 2021

billion in milestones depending on sales levels if the antisense-based drug reaches the market. Onpattro and Tegsedi are also being developed for ATTR-cardiomyopathy, so eplontersen may well have to jostle for market share in an increasingly crowded market if its gets approved.

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Outsourcing Pharma

JANUARY 29, 2024

The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license.

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pharmaphorum

SEPTEMBER 26, 2022

In May, the Delaware court sided with Hospira and ruled that three patents Astellas is relying on for Lexiscan market exclusivity in the US – 8,106,183; 8, 524,883; and RE47301 – are not infringed by Hospira’s generic, which was submitted for FDA approval in 2018. It was first launched in the US in 2008.

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pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . Akili is one of a group of companies that were founded by PureTech, which retains a stake.

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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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