Drug Discovery World

MARCH 24, 2023

dendritic cells, monocytes) triggers a broad immune response that includes significant increases in cytotoxic CD8 plus T cells armed with chemo-induced tumour antigens to target cancer. This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month

Trials 52

Trials Immune Response HR Clinical Development 52

The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Product Type-Specific Analysis.

Development 161

Development Production Immune Response Licensing 161

Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1.

Drugs 59

Drugs Life Science Gene Editing Gene 59

pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

Drug Discovery World

OCTOBER 27, 2023

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

pharmaphorum

DECEMBER 1, 2021

BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead drug plinabulin as a treatment for low white blood cell counts caused by cancer chemotherapy. of patients taking plinabulin plus pegfilgrastim and 13.6% of the pegfilgrastim-only arm.

Drugs 52

Drugs Immune Response Trials Licensing 52

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody 52

Antibody Licensing Licensing Development 52

Drug Discovery World

APRIL 20, 2023

Dr Paula Moran, Dr Kiri Granger, Dr J Mark Treherne , and Dr Jenny Barnett explore the effects of long Covid-19 symptoms and what the opportunities are for drug developers working to treat post-Covid-19 cognitive impairment. New therapeutics of course depend on an understanding of biological mechanisms.

Development 98

Development Drugs Clinical Trials Clinical Trials 98

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. What Is a Surrogate Endpoint?

Trials 98

Trials Gene Hormones Clinical Trials 98

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

Drug Discovery World

NOVEMBER 8, 2022

Merck has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing collaboration and license agreement with Moderna. . KEYNOTE-942 is an ongoing randomised, open-label Phase II trial that enrolled 157 patients with high-risk melanoma.

Vaccination 52

Vaccination Vaccine Development Immune Response 52

The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.

Immune Response 52

Immune Response In-Vivo Genetic Analysis Research 52

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccination 110

Vaccination Vaccine Immune Response Trials 110

The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Co-Founder and Chief Executive Officer at Biond.

Immune Response 52

Immune Response Clinical Trials Clinical Trials Development 52

XTalks

JUNE 21, 2024

Dr. Bryan began his career at Schering-Plough, engaging in formulation and drug delivery. Unlike traditional therapies that act on the immune cascade after it has been initiated, Revolo’s treatments act at the very beginning of the immune response.

Development 52

Development Immune Response Regulation Drugs 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

OCTOBER 26, 2020

Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. The approval marks the first drug approved by the U.S. Days after the U.S.

Antibody 52

Antibody Vaccination Vaccine Manufacturing 52

pharmaphorum

FEBRUARY 8, 2022

With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in a phase 1/2 trial of its Pompe disease candidate AT845 hasn’t found any cause for concern. Shares in the drugmaker rose just over 1% after the FORTIS data was announced.

Gene Therapy 52

Gene Therapy Gene Immune Response Licensing 52

Delveinsight

JANUARY 21, 2021

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The new research provides a scientific rationale to advance clinical studies of the drug combination in patients with AML. billion in total for three drugs.

Research 52

Research Protein Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 7, 2021

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients. Information of this kind can make or break a cancer trial, giving guidance about whether a tumour is growing or has become swollen because of an incursion by T-cells.

Doctors 53

Doctors Doctor Immune Response Pharma Companies 53

XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. Researchers estimate that the incidence of CIDP in the US ranges from 0.8

FDA Approval 40

FDA Approval Immune Response Trials Drug Delivery 40

The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. adult participants from the Phase 1 trial of the two-dose series. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. In the U.S.,

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) are starting to pick up. The NDA was built on data from the Phase III VICTORIA trial. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). Here’s a look.

Manufacturing 52

Manufacturing Immune Response Allergies Drugs 52

The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. 1-4 The U.S. Almirall S.A.’s

Dermatology 40

Dermatology Trials Bioavailability Medicine 40

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. About the Phase 2/3 Study.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

pharmaphorum

AUGUST 27, 2020

The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials. Regulatory pressures, lengthy drug development times, and the fact that drug prices have become politicised have raised risks and cut revenue projections, leading to the biotech sector falling out of fashion.

Vaccination 101

Vaccination Vaccine Life Science Clinical Trials 101

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S.,

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 52