XTalks

JUNE 4, 2024

Oren Cohen, MD, FIDSA CMO & President of Clinical Pharmacology Fortrea Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, market access solutions and other enabling services.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

MAY 28, 2024

Phase III trials: In these advanced stages, focused on confirming efficacy and monitoring side effects in larger populations, DHTs may support market authorization and label claims. This approach can speed up development and improve data quality, potentially leading to more effective and personalized therapies.

Clinical Development 116

Clinical Development Development Clinical Trials Clinical Trials 116

Pharmaceutical Technology

MARCH 3, 2023

Bristol Myers Squibb has secured complete marketing authorisation from the European Commission (EC) for Reblozyl (luspatercept) to treat anaemia in adult patients with non-transfusion dependent (NTD) beta-thalassemia. The post Bristol Myers Squibb secures EC marketing approval for anemia therapy appeared first on Pharmaceutical Technology.

Marketing 147

Marketing Clinical Development Development 147

Pharmaceutical Technology

OCTOBER 21, 2022

Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers.

Development 278

Development Production Licensing Licensing 278

Pharmaceutical Technology

AUGUST 16, 2022

Gilead Sciences has entered an agreement with Everest Medicines to acquire complete rights to develop and market Trodelvy (sacituzumab govitecan) in Greater China, Singapore, South Korea, Philippines, Vietnam, Thailand, Indonesia, Mongolia and Malaysia.

Medicine 255

Medicine Marketing Development Clinical Development 255

Pharmaceutical Technology

JUNE 28, 2022

Astellas and Sutro will expedite the development of iADCs for three different biological targets. Sutro will oversee the research and preclinical research to detect candidate compounds and subsequently Astellas will carry out the clinical development. Furthermore, the company is entitled to get up to $422.5m

Development 264

Development Antibody Immune Response Production 264

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. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.

Development 264

Development Gene Expression Licensing Licensing 264

XTalks

OCTOBER 4, 2023

Health economics and outcomes research (HEOR) and market access strategies play a critical role in ensuring that newly approved therapies are made available to patients. Professionals in these roles are facing new challenges when it comes to negotiating coverage for many of the new, innovative treatments that are coming to market.

Marketing 105

Marketing Development Drugs Gene Therapy 105

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).

Marketing 147

Marketing Trials Development Protein 147

BioSpace

MAY 19, 2024

While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData.

Marketing 102

Marketing Clinical Development Development 102

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

XTalks

NOVEMBER 26, 2024

A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025. Patient advocacy groups, including the Amyloidosis Support Groups led by Muriel Finkel, highlight the transformative impact of Attruby on the lives of those with ATTR-CM.

Genetic Disease 105

Genetic Disease Genetics Protein Clinical Development 105

Pharmaceutical Technology

JUNE 12, 2023

In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development. Currently, Jazz Pharmaceuticals’s nabiximols is the only cannabinoid approved for pain, receiving approval in Israel, in August 2010.

Drugs 358

Drugs Development Clinical Development Sales 358

Pharmaceutical Technology

JUNE 19, 2023

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.

Gene Therapy 246

Gene Therapy Gene Production Pharma Companies 246

Pharmaceutical Technology

AUGUST 9, 2022

In the clinical development programme, 1,944 epilepsy patients received cenobamate treatment. In December last year, Endo subsidiary Endo Ventures and SK Biopharmaceuticals entered a licencing agreement under which Endo Ventures received exclusive rights for marketing cenobamate in Canada.

Life Science 246

Life Science Clinical Development Trials Marketing 246

pharmaphorum

MAY 3, 2022

Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019. The class as a whole is, however, trying to break into a low-cost generic market, and almost inevitably is facing pushback from payers.

Marketing 97

Marketing Drugs Sales Pharma Companies 97

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

MAY 30, 2023

Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut. which is the licensee of lebrikizumab, recently reported favourable outcomes for lebrikizumab through a novel secondary analysis of the Phase III clinical development programme.

Drugs 264

Drugs Sales Antibody Dermatology 264

Pharmaceutical Technology

APRIL 21, 2023

Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinical development. Enveda Biosciences intends to use the additional financing to advance several candidates derived from its drug discovery platform to clinical development in 2023 and 2024.

Clinical Development 147

Clinical Development Development Drugs Medicine 147

XTalks

NOVEMBER 21, 2024

Additionally, over a 176-week period, weekly injections of tirzepatide (marketed as Zepbound and Mounjaro) using pooled doses of 5 mg, 10 mg and 15 mg, significantly reduced the risk of disease progression to type 2 diabetes by 94 percent compared with placebo in adult prediabetes patients who were obese or overweight.

Sales 105

Sales Insulin Drugs Trials 105

Pharmaceutical Technology

NOVEMBER 30, 2022

While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development.

Development 246

Development Clinical Trials Clinical Trials Trials 246

pharmaphorum

JANUARY 31, 2022

Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The Japanese group says it hopes to complete clinical development of the vaccine and bring it to market in Japan before the end of the year.

Marketing 96

Marketing Vaccine Vaccination Antibody 96

World of DTC Marketing

NOVEMBER 19, 2021

government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinical development. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.

Vaccine 44

Vaccine Vaccination Allergies Production 44

Pharmaceutical Technology

AUGUST 18, 2022

After more than a decade of research and clinical development, and through the perseverance of clinicians, patients and their families, the approval of Zynteglo marks a watershed moment for the field of gene therapy.”. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Gene Therapy 246

Gene Therapy Gene Genotype In-Vivo 246

Pharma Mirror

JANUARY 30, 2022

Ben Beckley, Global Lead at EmerGENE explores the market challenges holding back Cell and Gene Therapy (C&GT) from taking its place as an established treatment area. Some 3,366 treatments are currently in preclinical and clinical development[1]. Some 3,366 treatments are currently in preclinical and clinical development[1].

Gene Therapy 130

Gene Therapy Gene Clinical Development Marketing 130

Pharmaceutical Technology

AUGUST 21, 2022

Currently, the company is working with various regulatory agencies to explore the potential to further advance ASC10’s clinical development. In preclinical studies, ASC10-A showed to possess robust cellular antiviral activity against wildtype SARS-CoV-2 virus as well as Omicron and Delta variants.

In-Vivo 162

In-Vivo RNA Clinical Development Drugs 162

pharmaphorum

JULY 8, 2022

The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. billion, according to the report.

Drugs 131

Drugs Clinical Development Marketing Genomics 131

Outsourcing Pharma

SEPTEMBER 29, 2023

Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.

Marketing 90

Marketing Drugs Clinical Development Development 90

Intouch Solutions

MAY 1, 2023

Both McKinsey (2014) and Deloitte (2022) emphasize that market access strategy and execution – a life sciences company’s ability to demonstrate clinical and economic evidence, negotiate with healthcare access stakeholders, and enable affordable and timely product fulfillment for appropriate patients – are critical to a drug’s success or failure.

Marketing 75

Marketing Life Science Production Clinical Trials 75

XTalks

JANUARY 7, 2025

These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. The deal was valued at approximately $25 billion and strengthened Abbotts presence in the cardiovascular devices market.

Life Science 105

Life Science Manufacturing Production Clinical Development 105

BioPharma Reporter

AUGUST 6, 2024

Experience with severe mental health disorders in close friends and family gave Sam Clark the drive to found Terran Biosciences to explore new approaches to therapeutics in neuropsychiatry.

Marketing 117

Marketing Clinical Development Development 117

Pharmaceutical Technology

APRIL 17, 2023

NKGen CEO Paul Song said: “The team at Graf fully understands and appreciates our novel NK cell therapy platform technology and our overall mission to help patients in real clinical need, especially those with neurodegenerative diseases. “We We believe that the business combination represents a key step in our overall growth strategy. “We

Gene Therapy 246

Gene Therapy Gene Clinical Development Development 246

Pharmaceutical Technology

FEBRUARY 14, 2023

Under the deal, Corbus Pharmaceuticals will have exclusive rights to develop and commercialise CRB-701 in Canada, Australia, the UK, the EU (including the European Free Trade Area), and the US, while CSPC will retain SYS6002’s rights in the remaining markets. According to the agreement, CSPC will receive a $7.5m

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Pharma Mirror

JULY 23, 2021

The initial phase of the expansion will see the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites and associated investments to support early-phase clinical development as well as late-stage and commercial tech transfers.

Manufacturing 130

Manufacturing Gene Therapy Clinical Development Gene 130

Pharmaceutical Technology

AUGUST 17, 2022

VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology. In the last 20 years, this is the biggest buzz in the vaccine market for Lyme disease,” said Yale School of Medicine associate professor Sukanya Narasimhan, PhD, about the Phase III VLA15 trial.

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Vaccine Vaccination Bacteria Protein 299

Pharmaceutical Technology

SEPTEMBER 22, 2022

Under the deal, GSK will obtain an exclusive licence for the development and marketing of tebipenem pivoxil HBr in all countries. Since 2009, Meiji has marketed tebipenem HBr in Japan. Known as Orapenem, it is marketed for the treatment of paediatric infections limited to pneumonia, otitis media and sinusitis.

Bacteria 147

Bacteria Marketing Trials Clinical Development 147

Pharmaceutical Technology

SEPTEMBER 13, 2022

This approach will support its manufacturer partners throughout the pharmaceutical development and marketing processes. This latest development will progress various AmerisourceBergen’s strategic imperatives and bolster its position to gain substantial growth prospects in the biopharma market.

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Manufacturing Compliance Marketing Clinical Development 130