The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. About Eisai Co.,

Disease 40

Disease Treatment Therapies FDA 40

The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. Financial terms of the new agreement are not disclosed.

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

OCTOBER 18, 2020

Guselkumab is currently approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 2 There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA. The focus is on cancer.

Treatment 40

Treatment Clinical Development Therapies Production 40

The Pharma Data

DECEMBER 18, 2020

Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia. AstraZeneca in CVRM Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. Am J Kidney Dis. 2006 May; 47(5): S1-S132. .

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases.

Clinical Development 52

Clinical Development Clinical Trials Clinical Supply Trials 52

The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. There are no therapies approved by the FDA for the treatment of neuronopathic Gaucher disease. Founder and Chief Executive Officer of Prevail.

Disease 40

Disease FDA Treatment Therapies 40

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. based Rinri Therapeutics.

Small Molecule 52

Small Molecule Engineering Clinical Development Pharmaceuticals 52

The Pharma Data

MARCH 1, 2022

“There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases,” said Tom Hudson, M.D., It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies.

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017.

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

APRIL 4, 2022

FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. The most common adverse event observed with Dupixent, in Part A and Part B, was injection site reactions.

FDA 52

FDA Treatment Disease FDA Approval 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). About CEPI.

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

MARCH 27, 2023

With limited treatment options currently available, there is an urgent unmet medical need for new therapies and earlier, accurate diagnosis across the different types of this systemic, progressive and fatal condition.” Eugene Schneider, M.D., Eugene Schneider, M.D.,

Trials 40

Trials Disease Treatment Science 40

The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . Chief Clinical Officer, Neurology Business Group, Eisai. aggregates (protofibrils).

Clinical Trials 52

Clinical Trials Treatment Clinical Development Disease 52

The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. acousia Therapeutics – Jonas Dyhrfjeld-Johnsen joined Germany-based Acousia in the new role of chief development officer. Schijns, a former professor at N.C.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. About IDHENTIFY.

Trials 52

Trials FDA Approval Therapies Treatment 52

The Pharma Data

APRIL 1, 2021

In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. If approved, Tecartus would become the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (?18 Tecartus is an autologous, anti-CD19 CAR T cell therapy.

Treatment 52

Treatment Virus Therapies FDA 52

The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. “The 2017) Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. NEW YORK and LONDON, Nov. Shailubhai, K.,

Clinical Trials 40

Clinical Trials Science Disease Trials 40

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. Demetrios Braddock, M.D.,

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

JULY 21, 2021

Positive top-line results have already been reported for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and covers six serotypes that are prevalent in North America and Europe. About VLA15.

Vaccine 52

Vaccine Disease Trials Protein Expression 52

The Pharma Data

JANUARY 3, 2021

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

The Pharma Data

NOVEMBER 1, 2020

This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease.” Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world.

Clinical Trials 52

Clinical Trials Trials Medical Schools Hospitals 52

Broad Institute

OCTOBER 11, 2023

But immunotherapy was not yet widely used and had not been applied clinically to Merkel cell carcinoma, so she received traditional chemotherapy and radiation therapy, suffering life-threatening complications along the way. His mother had a presentation of the disease that suggested her immune system was already on the job.

Research 137

Research Immune Response Clinical Trials Therapies 137

Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. 2017 Jan;155(1):234–47. 2017 Jul 6;21(1):14–7. Toxicol Sci.

Drugs 112

Drugs FDA Disease Animal Testing 112

The Pharma Data

JUNE 30, 2021

Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. Food and Drug Administration (FDA) whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency. “The View the full release here: [link].

Therapies 52

Therapies Treatment Virus Vaccine 52

The Pharma Data

NOVEMBER 11, 2020

Separately, Fast Track Designation facilitates the potential expedited development and review of a drug for the treatment of a serious or life-threatening disease and that has demonstrated the potential to address unmet medical needs. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D.,

Clinical Trials 40

Clinical Trials Trials Disease FDA 40

Agency IQ

SEPTEMBER 15, 2023

In 2017, the FDA expanded the restrictions , which include behind-the-counter sale requiring photo identification with a per-month individual purchase quota, to products containing ephedrine and phenylpropanolamine — effectively narrowing the decongestant drugs approved for over-the-counter sale.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

Disease 112

Disease Clinical Trials Therapies Science 112

The Pharma Data

APRIL 8, 2021

FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

Drug Development 52

Drug Development Disease Therapies Engineering 52

Agency IQ

AUGUST 16, 2024

As opposed to the linear dose-response relationships of chemotherapies, the wide therapeutic indexes of many of these newer therapies means that doses can be increased without simultaneously increasing toxicities. intermediate or surrogate) endpoints and clinical outcome endpoints (e.g.,

Production 40

Production FDA Science Clinical Trials 40

The Pharma Data

SEPTEMBER 2, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. From the success of our first-in-class B-cell MS therapy OCREVUS, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of ENSPRYNG.”.

Clinical Trials 52

Clinical Trials Disease Treatment Therapies 52

The Pharma Data

OCTOBER 28, 2020

There are no currently approved therapies for Angelman syndrome; however, several symptoms of this disorder can be reversed in adult animal models of Angelman syndrome suggesting that improvement of symptoms can potentially be achieved at any age. Angelman syndrome is often misdiagnosed as autism or cerebral palsy. About Ultragenyx.

Protein Expression 40

Protein Expression Therapies Treatment Production 40

The Pharma Data

NOVEMBER 15, 2020

This prestigious group of professionals will help lead the Company as it prepares for potential commercialization of its investigational cell therapy, MultiStem ®. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. She earned a BA from Durham University, U.K.,

Clinical Trials 40

Clinical Trials Trials Production Therapies 40

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

NOVEMBER 8, 2020

R&D pipeline continues to drive future value through innovation and differentiated therapies including expected upcoming approval of Tirbanibulin. In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. Financial highlights (€ million). .

Licensing 52

Licensing Licensing Production Treatment 52