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. The submission is planned to be completed in the first half of this year.

Licensing 130

Licensing Licensing Sales Medicine 130

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.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

OCTOBER 7, 2022

A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. Additionally, the company granted Sanofi an exclusive right of first negotiation (ROFN) to attain international rights to market teplizumab for T1D indications for a one-time payment of $20m.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

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.

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

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).

Marketing 130

Marketing Antibody Licensing Licensing 130

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.

Marketing 130

Marketing Licensing Licensing Production 130

Pharmaceutical Technology

JUNE 5, 2023

Pint-Pharma will obtain and maintain all marketing authorisations and will commercialise BESREMi in the region. In 2019, the European Medicines Agency approved the therapy, which has also been licensed in Japan, Taiwan and South Korea. It holds orphan drug designation in the US to treat PV.

Marketing 130

Marketing Licensing Licensing Sales 130

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.

Development 130

Development Marketing Licensing Licensing 130

Pharmaceutical Technology

MARCH 31, 2023

On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV. GSK owns a majority stake in ViiV Healthcare.

Medicine 130

Medicine Manufacturing Pharma Companies Licensing 130

Pharmaceutical Technology

AUGUST 8, 2022

A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo. In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer.

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

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. Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction.

Medicine 290

Medicine Production Generic Drugs Regulation 290

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).

Marketing 97

Marketing Research Trials Clinical Trials 97

pharmaphorum

NOVEMBER 16, 2022

The 2022 edition of the Access to Medicine Index (ATMI) – which places the top 20 pharma companies for their efforts to improve delivery of medicines to lower income countries – sees GSK retain the number one position, newly joined by Johnson & Johnson in second and AstraZeneca in third. Jayasree Iyer.

Medicine 105

Medicine Production Pharma Companies Licensing 105

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.

Marketing 109

Marketing Regulation Production Medicine 109

pharmaphorum

MAY 17, 2021

Experts from Vynamic discuss their vision for a future where patients are at the heart of medicine reimbursement in Europe – and provide actionable steps for achieving this. This article appears in full in our digital magazine Deep Dive: Market Access 2021. Read below for a sneak-peak: The reimbursement landscape in Europe is complex.

Medicine 93

Medicine Life Science Marketing Clinical Trials 93

pharmaphorum

FEBRUARY 3, 2022

India’s Dr Reddy’s Laboratories has joined the growing list of pharma companies that are looking to tap into the market for medical cannabis, buying German developer Nimbus Health for an undisclosed sum. The two drugs were developed by medical cannabis pioneer GW Pharma, which was acquired by Jazz last year.

Licensing 119

Licensing Licensing Marketing Medicine 119

Pharmaceutical Technology

MAY 25, 2023

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK. percentage points (96% CI, −0.3

Vaccination 195

Vaccination Vaccine Immune Response Bacteria 195

pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

Marketing 98

Marketing Antibody Medicine FDA Approval 98

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).

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

pharmaphorum

NOVEMBER 16, 2021

In the second of a two-part series, Leela Barham argues that whilst international comparisons of uptake are useful, there could be more to gain from looking at more medicines and their uptake in England rather than looking at a small set of medicines and their uptake internationally. Consistently focus on innovative medicines.

Medicine 96

Medicine Branding Gene Therapy Life Science 96

Pharmaceutical Technology

JANUARY 5, 2023

Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.

Gene Therapy 237

Gene Therapy Gene Development Engineer 237

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The post physIQ licenses virtual trial tech to Janssen in multi-year deal appeared first on. No financial details were disclosed.

Licensing 72

Licensing Licensing Trials Clinical Trials 72

Drug Patent Watch

FEBRUARY 3, 2021

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve….

Licensing 98

Licensing Licensing Medicine Marketing 98

Pharmaceutical Technology

DECEMBER 26, 2022

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Till date, the company has signed a total of 12 ADC licensing deals, worth more than $5bn.

Antibody 130

Antibody Development Drugs Licensing 130

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.

Development 242

Development Bioequivalency Generic Drugs Production 242

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.

Licensing 52

Licensing Licensing Pharma Companies Manufacturing 52

pharmaphorum

JANUARY 12, 2021

With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. The promise of faster market access .

Marketing 82

Marketing Medicine Branding Development 82

Pharmaceutical Technology

FEBRUARY 9, 2023

ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics. ReviR combines computational and high throughput drug discovery technologies to deliver advanced medicines to patients.

Development 241

Development RNA Gene Therapy Genetics 241

pharmaphorum

OCTOBER 27, 2021

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.

Licensing 143

Licensing Licensing Manufacturing Clinical Trials 143

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.

Production 230

Production Packaging Packaging Development 230

Outsourcing Pharma

JANUARY 29, 2024

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

Life Science 98

Life Science Licensing Licensing Medicine 98

Pharmaceutical Technology

FEBRUARY 26, 2023

Coupled with this, the harsh conditions of the biotech market affected some companies. These safety concerns froze research, says Dr. Sarah McGill, associate professor of medicine at the University of North Carolina School of Medicine, Chapel Hill. “It It will take some time for research to thaw,” she adds.

Bacteria 278

Bacteria Trials Research Medicine 278

STAT News

MARCH 24, 2023

The revision of the EU pharmaceutical legislation will set up a framework for the use of human medicines, from production, to clinical trials, to marketing authorization.

Licensing 98

Licensing Licensing Clinical Trials Clinical Trials 98

Delveinsight

AUGUST 23, 2021

The present treatment approach in the Von Hippel-Lindau therapy market revolves around controlling and preservation of functional parenchyma to avoid the morbidity associated with renal or adrenal loss. by 2030 Owing to Increasing Prevalence and Emerging Therapieswth of the VHL disease pipeline market and influx of key pharma companies.

Marketing 98

Marketing Clinical Trials Clinical Trials Trials 98

STAT News

JANUARY 11, 2023

… Merck plans to take legal action against several pharmaceutical companies in China after noticing that some manufacturers were supplying Covid-19 drugs to some provinces and cities saying the medicines were authorized by Merck , Reuters reports.

Gene Therapy 98

Gene Therapy Licensing Licensing Gene 98

Pharmaceutical Technology

JUNE 2, 2023

The patent offers protection until 2037 and completes the intellectual property (IP) coverage for ALS across all important geographic areas where the therapy can be marketed, including the US, South Africa, and Eurasia. The US Food and Drug Administration and the European Medicines Agency granted orphan drug designation to masitinib.

Compliance 130

Compliance Licensing Licensing Drugs 130