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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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

JANUARY 2, 2023

South Korean biotechnology company Alteogen has signed an exclusive license agreement with Swiss company Sandoz to develop and market biosimilar products that are enabled by the former’s Hybrozyme technology. Additionally, the company will have an option to license Alteogen’s Hybrozyme technology for two more products.

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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

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. .

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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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XTalks

DECEMBER 4, 2024

Jupiter Neurosciences, a clinical-stage pharma company specializing in neuroinflammation, made its public market debut with an initial public offering (IPO) on the Nasdaq Capital Market under the symbol “JUNS.” ” The company priced 2,750,000 shares of common stock at $4.00

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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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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.

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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

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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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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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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Pharmaceutical Technology

JULY 4, 2022

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement.

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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

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease.

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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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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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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 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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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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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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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Druggist

NOVEMBER 10, 2020

Today I will list Calpol alternative products, including other brands and forms of liquid paracetamol and alternative drugs. Although the intention is to find Calpol alternative products for toddlers and children, I included a few products, which have a minimum age restriction of 12 years and above. Calpol alternative products.

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Druggist

DECEMBER 17, 2020

Without a doubt, codeine-containing products are one of the most commonly sold medicines in the UK. Most codeine products are combination products of codeine and another drug. Restrictions on the supply of codeine-containing products. Codeine over the counter: UK list of products. Prescription-only codeine.

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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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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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Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The decentralized procedure applies to all products without a prior marketing authorization in the EU that are not required to use the centralized procedure.

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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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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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Pharmaceutical Technology

AUGUST 10, 2022

Furthermore, Cerevance will simultaneously out-license a discovery-stage programme to Merck under the partnership. Cerevance will also potentially receive royalty payments on sales of approved products resulting from the partnership. “We

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Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891).

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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. Many claims may or may not accurately reflect what these products offer, “It’s the wild west.”.

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Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. Because the products would already have been tested within the exporting country, the testing would be duplicative and (to many people’s minds) unnecessary.

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). Patients should be scared. In other words, money over safety.

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