Camargo

JULY 27, 2021

How and When to Incorporate PK Design into Your Gene Therapy Development Plan. While most gene therapy clinical studies are ongoing, a number of products are in advanced clinical development, and several are approved by FDA. PK Planning for Gene Therapy Development Programs. Route of Administration Considerations.

Gene Therapy 238

Gene Therapy Gene Gene Editing Genetics 238

pharmaphorum

APRIL 19, 2022

The funding will be used to continue the clinical development of lead oligonucleotide PGN-EDO51 for DMD, as well as two other oligo drugs PGN-EDODM1 for myotonic dystrophy type 1 (DM1) and PGN-EDO53, another DMD candidate. Once there, they disrupt the expression of RNA coding for disease-associated proteins.

Protein 105

Protein RNA Sales Production 105

The Pharma Data

JUNE 7, 2023

a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas’ LNP technology will support Bayer’s in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver.

Gene Therapy 40

Gene Therapy Gene Gene Editing In-Vivo 40

pharmaphorum

NOVEMBER 18, 2021

The two companies have been working together since 2019 to develop multiple RNA interference (RNAi) candidates for disorders such as non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases. billion in cash. If approved, it could become a $500 million-a-year product, according to the company.

Gene Silencing 52

Gene Silencing RNA Protein Gene 52

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 58

Vaccination Vaccine Production Clinical Development 58

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. Both Pfizer and Moderna vaccines use synthetic messenger RNA to activate the immune system against the virus.

Vaccination 76

Vaccination Vaccine RNA Clinical Trials 76

The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” . CHENGDU, China , Feb. S-Trimer is intended to be adjuvanted.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development.

Vaccination 58

Vaccination Vaccine RNA Immune Response 58

pharmaphorum

FEBRUARY 19, 2021

billion cumulative doses of its NVX-CoV2373 recombinant protein-based vaccine candidate, which is yet to be approved by regulators. It can be stored at standard refrigerator temperatures and does not require the ultra-cool supply chain required to maintain stability of RNA vaccines from Pfizer/BioNTech and Moderna.

Vaccination 79

Vaccination Vaccine Manufacturing RNA 79

Roots Analysis

OCTOBER 30, 2023

In the past few years, Next Generation RNA therapeutics have emerged as one of the key therapeutic modalities in the modern healthcare industry. These RNA based therapeutics play a crucial role in protein production and regulation of gene functions.

RNA 40

RNA Vaccination Vaccine Development 40

The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Sigilon Therapeutics

RNA 52

RNA Antibody Life Science Protein 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

pharmaphorum

NOVEMBER 9, 2020

The vaccine is based on a strand of messenger RNA – a short segment of genetical material that codes for the “Spike” protein found on the surface of the coronavirus. Around 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.

Vaccination 98

Vaccination Vaccine Clinical Trials Clinical Trials 98

pharmaphorum

OCTOBER 16, 2020

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month. Russia approves second shot.

Trials 98

Trials Vaccination Vaccine Antibody 98

The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Drug Discovery World

MARCH 7, 2023

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. Dr Janette Thomas, CEO, Five Alarm Bio Five Alarm Bio is an anti-ageing therapeutics company, which completed a seed investment round in early 2023.

Life Science 98

Life Science DNA Clinical Development Development 98

The Pharma Data

OCTOBER 28, 2020

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., 29, 2020 06:00 UTC. CAMBRIDGE, Mass.–( About Moderna.

Vaccination 40

Vaccination Vaccine Manufacturing Clinical Trials 40

pharmaphorum

NOVEMBER 23, 2021

GlaxoSmithKline has joined the ranks of drugmakers trying to develop new drugs for non-alcoholic steatohepatitis (NASH) – a condition with no approved therapies and a lengthy list of failed drug candidates – via a deal with Arrowhead Pharmaceuticals.

Sales 52

Sales Drugs Trials RNA 52

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding.

Drugs 75

Drugs Life Science Gene Therapy Genome 75

The Pharma Data

OCTOBER 19, 2020

. “Innovation in cancer treatment is realized through collaboration, and the physicians and researchers at Emory’s Winship Cancer Institute have consistently shown their commitment to developing novel cancer therapies using this collaborative approach,” said Chadi Nabhan , M.D., Ramalingam , M.D.,

Life Science 52

Life Science Clinical Trials Clinical Trials RNA 52

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Drug Discovery World

OCTOBER 4, 2022

As it stands, there are currently 19 gene therapies approved for clinical use, alongside 18 RNA therapies and 59 non-genetically modified cell therapies, according to the Q2 report by the American Society of Cell & Gene Therapy. million by Horizon Europe which will go towards its goal of developing bioprocessing technologies. .

Gene Therapy 52

Gene Therapy Drugs Gene Manufacturing 52

Drug Discovery World

DECEMBER 26, 2023

Neuroscience was also a key area for the year for the audience, with a number of ground-breaking developments, including a new potential treatment for schizophrenia and positive results for psychedelics as an antidepressant. Variant of the month, EG.5 5 or ‘Eris’ was found in more than 50 countries.

Development 64

Development Clinical Trials Clinical Trials Drugs 64

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Ali Madani, PhD, Founder and CEO, Profluent Bio, on: ‘Protein engineering with large language models’.

Protein 59

Protein Antibody Engineer Scientist 59

The Pharma Data

JULY 18, 2021

That’s why we set out to develop a conjugate vaccine that includes pneumococcal serotypes that pose the greatest threat and elicits a strong immune response to each serotype covered,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

Development 52

Development Protein Manufacturing Medicine 52

Drug Discovery World

NOVEMBER 30, 2023

Lightcast is developing a novel, programmable microfluidic platform that allows precise and highly flexible control of individual microdroplets using software-generated light patterns. This presentation covered three primary drivers for a protein expression model: speed, cost and sustainability. “It

Antibody 59

Antibody Protein Engineer In-Vivo 59

XTalks

OCTOBER 26, 2023

She has 23 years of experience working with clients to move vaccine candidates through the clinical development pipeline, including regulatory submission. The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

Drug Discovery World

MAY 30, 2023

From antibody-drug conjugates and RNA, to CRISPR and CAR-T therapy, DDW asked the drug discovery industry what the most important development in oncology over the last five years has been. At PhoreMost, we have been particularly excited about the emergence of targeted protein degradation (TPD) as a new therapeutic modality.

Research 52

Research Drugs Protein RNA 52

Drug Discovery World

FEBRUARY 28, 2023

With only 10% of these conditions indicated for an approved therapy, there is a sizable opportunity for scientists and companies to develop treatments for patients with no other options to turn to. Therefore, the risk for off-target insertional mutagenesis is greatly reduced.

Genetics 52

Genetics Genetic Analysis Vaccination Vaccine 52

Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4. As such CTCs and ctDNA can provide complementary information.

Medicine 59

Medicine DNA Genome Genomics 59

pharmaphorum

NOVEMBER 4, 2022

Pfizer’s gIRV encodes the haemagglutinin – the surface protein of the influenza virus that plays a role in the initiation of infection – of four different influenza strains and is recommended for the Northern Hemisphere 2022/23 by the World Health Organization. Both were based on BioNTech’s proprietary mRNA platform technology.

Vaccination 52

Vaccination Vaccine Immune Response RNA 52

The Pharma Data

OCTOBER 14, 2020

is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA.

Protein 52

Protein RNA Production Genetics 52

Drug Discovery World

OCTOBER 17, 2023

BN : Our bodies consist of an incredibly complex network of about 35 trillion cells divided into as many as 300 cell types that fulfil distinct roles in development, homeostasis, and disease. This limits its efficacy in later stages of drug development or in the discovery and characterisation of biomarkers.

Gene Expression 52

Gene Expression Drugs Protein Gene 52