pharmaphorum

DECEMBER 4, 2020

Under the agreement Valneva could receive up to $308 million in cash payments, after Pfizer paid $130 million up front for marketing rights to the vaccine if it succeeds in the clinic. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

Vaccination 117

Vaccination Vaccine Bacterium Protein 117

Roots Analysis

FEBRUARY 26, 2024

In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017. Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Contract Manufacturing 52

Pharmaceutical Technology

MARCH 23, 2023

Pfizer recently announced an agreement to acquire Seagen, a biotech company based in the US with four marketed oncology therapeutic agents and a rich pipeline. Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio.

Licensing 147

Licensing Licensing Sales Trials 147

Pharmaceutical Technology

FEBRUARY 24, 2023

ACE-1334 is under clinical development by Merck and currently in Phase I for Lung Disease. ACE-1334 overview ACE-1334 is under development for the treatment of pulmonary disease with fibrotic component and systemic sclerosis and its associated interstitial lung disease. It is developed based on protein engineering platform.

Production 100

Production Vaccination Vaccine Engineer 100

Pharmaceutical Technology

JUNE 10, 2023

RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. The drug candidate is an injectable neurotoxin, purified botulinum toxin type A that targets synaptosomal-associated protein 25. It is developed based on TransMTS peptide technology.

Development 130

Development Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JUNE 10, 2023

RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. The drug candidate is an injectable neurotoxin, purified botulinum toxin type A that targets synaptosomal-associated protein 25. It is developed based on TransMTS peptide technology.

Development 130

Development Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JUNE 5, 2023

BI-765063 is under clinical development by Boehringer Ingelheim International and currently in Phase I for Hypopharyngeal Cancer. It acts by targeting cells expressing SIRP-alpha (Signal Regulatory Protein alpha) and CD47. The drug candidate is a second generation check point inhibitor.

Production 100

Production Manufacturing Drugs Clinical Trials 100

Drug Discovery World

JULY 6, 2023

The first patient has been dosed in the clinical Phase I evaluation of the Sema3A monoclonal antibody, part of the Evotec-Bayer multi-target research collaboration in kidney diseases. Semaphorin-3A is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton.

Antibody 52

Antibody Trials Genetics Protein 52

pharmaphorum

JANUARY 13, 2022

Clinical trials will be needed to see if doing so can interrupt the neurodegeneration seen in Parkinson’s. Alpha-synuclein is a protein that gets misfolded and clumps together in the brains of patients with Parkinson’s and other diseases collectively known as synucleinopathies.

Antibody 98

Antibody Drugs Protein Licensing 98

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. The drug candidate targets DNA-dependent protein kinase (DNA-PK). It was also under development for small cell lung cancer, rectal cancer and chronic lymphocytic leukemia (CLL). It is a new chemical entity.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. The drug candidate targets DNA-dependent protein kinase (DNA-PK). It was also under development for small cell lung cancer, rectal cancer and chronic lymphocytic leukemia (CLL).

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Drug Discovery World

MAY 25, 2023

Broughton: new inhalation testing service The service is designed to help pharmaceutical companies bring orally inhaled and nasal drug products (OINDPs) to market efficiently. It is accessible, boosts developer productivity and aims to save up to 80% of the time and cost associated with traditional API management strategies.

Production 52

Production Reagent DNA Drugs 52

pharmaphorum

MAY 13, 2021

There are already several drugs on the market to treat Duchenne, notably from Sarepta Therapeutics which has three FDA-approved drugs that use “exon skipping” technology. These allow the body to produce a correct version of the misfolded dystrophin protein that is the root cause of DMD.

Gene Therapy 101

Gene Therapy Gene Trials Protein 101

pharmaphorum

JANUARY 5, 2022

Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market. Pfizer is paying $225 million upfront to its partner to get the ball rolling on the project, including $75 million in cash and $150 million in equity, offset by $25 million from BioNTech in return for an antigen technology that will be used to develop the shot.

Vaccination 104

Vaccination Vaccine Sales Clinical Development 104

pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

Vaccination 57

Vaccination Vaccine Production Clinical Development 57

The Pharma Data

AUGUST 10, 2020

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373. The candidate is built upon a stable, prefusion protein and includes Novavax’s Matrix?M M adjuvant.

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

Drug Discovery World

AUGUST 28, 2023

DS: Samsara’s autophagy inducing candidate SAM001 will be the first agent of its class to enter clinical trials. It is the method for removing unwanted debris, e.g., old proteins, and breaking them down so their constituent parts can be used again. What is autophagy? How does SAM001 work? PH: Autophagy is the cell’s recycling process.

Genetics 52

Genetics Protein Genetic Disease Clinical Trials 52

Pharmaceutical Technology

JULY 7, 2022

While just two gene therapy products have been approved by the FDA, a number of companies are nearing the market with therapies targeting rare diseases, including 14 candidates in Phase III plus three in the pre-registration phase, according to GlobalData. A new frontier in cancer research.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

XTalks

MARCH 28, 2024

Progressive muscle weakness in the disease is caused by genetic mutations in the dystrophin gene that lead to a lack of functional dystrophin protein. According to the FDA, life expectancy for those with DMD has increased over the years, with some patients surviving beyond 30 years.

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. Furthermore, atezolizumab is in Phase II clinical development by F.

Clinical Trials 95

Clinical Trials Clinical Trials Trials Antibody 95

pharmaphorum

APRIL 23, 2021

The alliance is based on Obsidian’s cytoDRIVE platform, which uses already approved small-molecule drugs alongside gene-editing medicines to control the expression of protein from a gene sequence. For example, adding a small-molecule might stabilise the medicine, allowing levels of the target protein to increase.

Gene Editing 52

Gene Editing Genetics Drugs Gene 52

pharmaphorum

SEPTEMBER 28, 2021

VLA15 targets the outer surface protein A (OspA) of the Borrelia burgdorferi bacteria that causes Lyme disease, a tick-borne infection that causes a characteristic rash that can be accompanied by flu-like symptoms and – in some cases – debilitating tiredness and aches that can last for years.

Vaccination 104

Vaccination Vaccine Bacteria Protein 104

pharmaphorum

SEPTEMBER 23, 2020

The Swiss biotech’s Nasdaq-listed shares were down almost 44% in pre-market trading today in the wake of the announcement. AC Immune’s chief executive Prof Andrea Pfeifer said the results were “surprising and disappointing”, given that tau protein has emerged as a promising target for AD therapy.

Protein 62

Protein Trials Drugs Clinical Development 62

The Pharma Data

MARCH 23, 2021

Berlin, March 23, 2021 – Bayer announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for larotrectinib, under the brand name Vitrakvi , for the treatment of Neurotrophic Tyrosine Receptor Kinase ( NTRK ) fusion-positive advanced or recurrent solid tumors.

Genome 52

Genome Genomics Gene Protein 52

Drug Discovery World

OCTOBER 4, 2022

New York-based Oligomerix is an emerging clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterised by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) to Alzheimer’s disease (AD).

Development 52

Development In-Vivo Compound Screening Clinical Development 52

pharmaphorum

JUNE 20, 2022

stake in French vaccines developer Valneva at a cost of €90.5 million (around $95 million) and rejigged the terms of their alliance to develop a shot for Lyme disease. The shot targets the outer surface protein A (OspA) of the Borrelia burgdorferi bacteria that causes Lyme disease. Pfizer has acquired an 8.1%

Vaccination 98

Vaccination Vaccine Licensing Licensing 98

pharmaphorum

SEPTEMBER 18, 2020

A key focus of the three-year agreement with Moderna is to use the LNP platform to deliver gene-editing therapies to lung cells, correcting the defect in the gene and allowing functional CFTR protein to be made. Vertex will be responsible for preclinical and clinical development as well as commercial activities should they reach the market.

Gene Editing 104

Gene Editing Gene Vaccination Vaccine 104

pharmaphorum

JANUARY 12, 2021

Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic “dark matter” – the portion of the human genome that is normally not expressed as protein. These sequences are usually silenced in healthy cells but are activated and presented on tumour cells.

Genome 80

Genome Genomics Licensing Licensing 80

pharmaphorum

SEPTEMBER 8, 2021

Rezurock is the first inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2) to be approved for marketing, and Kadmon’s only commercial product, with analysts suggesting it could make around $500 million in annual sales. KD033 is an anti-PD-L1/IL-15 fusion protein and is currently in a phase 1 trial.

Drugs 52

Drugs Sales Immune Response Marketing 52

pharmaphorum

FEBRUARY 19, 2021

RIPK1 or receptor-interacting serine/threonine-protein kinase 1 is a regulator of immune cells known as macrophages as well as inflammatory mediators called cytokines. Lilly will cover costs associated with bringing R552 to market, and has global rights to the drug, although Rigel has retained co-commercial rights in the US.

Clinical Development 52

Clinical Development Development Drugs Protein 52

pharmaphorum

APRIL 26, 2022

There’s only one vaccine candidate for tick-borne infection Lyme disease in clinical development – Valneva and Pfizer’s VLA15 – and it has just moved another step closer to being available.

Vaccination 67

Vaccination Vaccine Bacteria Trials 67

The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

Containment 52

Containment Clinical Development Development Protein 52

The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D.,

Containment 52

Containment Clinical Development Antibody Development 52

Drug Discovery World

AUGUST 12, 2022

VLA15 is the only Lyme disease vaccine candidate currently in clinical development. It works by targeting the outer surface protein A (OspA) of the bacteria that cause Lyme disease. Participants will receive three doses of VLA15 or a saline placebo, followed by a booster dose. . Official comments .

Vaccination 52

Vaccination Vaccine Trials Bacteria 52

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

Gene Therapy 52

Gene Therapy Engineer Gene Research Analyst 52

XTalks

SEPTEMBER 21, 2023

XTALKS WEBINAR: Clinical Trial Risk Identification, Management and Reporting from Clinical Development to Marketing Live and On-Demand: Friday, October 27, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to successfully develop and maintain the safety profile of medicinal products.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

pharmaphorum

NOVEMBER 17, 2020

There are 11 potential COVID vaccines in late-stage clinical development and since Pfizer’s announcement two more groups from Russia’s Gamaleya Research Institute and US biotech Moderna have published favourable efficacy results.

Vaccination 76

Vaccination Vaccine RNA Clinical Trials 76