The Pharma Data

JANUARY 10, 2021

Chief Executive Officer of MorphoSys, will present at the 39 th Annual J.P. EST. Live audio of the presentation can be accessed from the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

Drug Hunter

APRIL 20, 2023

The molecule was the first allosteric TYK2 inhibitor to enter clinical trials, is the first JAK-family kinase inhibitor approved for psoriasis, and is also the first approved drug targeting a pseudokinase domain. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: LP0200 has completed a Ph.

Small Molecule 130

Small Molecule Clinical Trials Trials Licensing 130

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. chief executive officer of Gamida Cell. About Omidubicel.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. About Ridgeback Biotherapeutics.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

OCTOBER 26, 2020

(Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. AR-711 (COVID-19). AR-201 (RSV infection).

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Essentially, FDA was now asking for 18 months of data following treatment.

Therapies 119

Therapies FDA FDA Approval Treatment 119

The Pharma Data

JANUARY 27, 2021

Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients,” said Martin Welschof, Ph.D, (Nasdaq: CASI), a U.S. CEO of BioInvent. CET ( 11:30 a.m.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based based sites.

Licensing 52

Licensing Licensing Pharmacy FDA 52

Drug Target Review

FEBRUARY 1, 2024

Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous. This can present challenges when attempting to recruit an enriched patient population for clinical trials. We were able to license a molecule from a multi-national pharmaceutical company.

Therapies 105

Therapies Drug Development Disease Clinical Development 105

The Pharma Data

NOVEMBER 5, 2020

There was a handful of positive clinical trial news reported today. The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). Here’s a look. Janssen’s Tremfya. Pfizer’s Xeljanz.

Clinical Trials 40

Clinical Trials Trials Hospitals Pharmaceutical Companies 40

The Pharma Data

NOVEMBER 10, 2020

The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. STOCKHOLM , Nov. About AlzeCure Pharma AB (publ).

Pharmaceutical Companies 40

Pharmaceutical Companies Disease Treatment Pharmaceuticals 40

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

DECEMBER 13, 2020

A webcast of the conference call will be available under “News and Presentations” in the Investors & Media section of Relay Therapeutics’ website at [link]. RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. About Relay Therapeutics.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

Licensing 52

Licensing Licensing Pharmaceutical Companies Treatment 52

The Pharma Data

NOVEMBER 22, 2021

The streamlined findings from the companies’ vital Phase 3 trial show that a two- cure series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per cure) was 100 effective against COVID-19, measured seven days through over four months after the alternate cure. We look forward to participating these data with the FDA and other controllers.”.

Vaccine 52

Vaccine Trials Clinical Trials FDA 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Eur J Neurol. 2020;27(S1).

Trials 52

Trials Treatment Disease Therapies 52

SugarCone Biotech

JUNE 10, 2024

However, in clinical trials, activating anti-4-1BB antibodies such as urelumab (BMS) and utomilumab (Pfizer) showed dose-limiting liver toxicities and minimal therapeutic activity. The NIMBY problem I think the “Cancer Immunity Cycle” as originally presented by Chen and Mellman ( 10.1016/j.immuni.2013.07.012

Immune Response 88

Immune Response Production Regulations Clinical Trials 88

The Pharma Data

APRIL 20, 2023

These data will be presented at the American Academy of Neurology (AAN) Annual Meeting held in Boston and virtually on April 22-27, 2023. Annual rate of brain volume change (ABVC) in the core Phase III trials for continuous Kesimpta was -0.34%/year and in the switch group, -0.42%/year ( P =0.115).

Treatment 40

Treatment Trials Disease Licensing 40

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s Source link: [link].

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

OCTOBER 27, 2021

Kymriah was preliminarily granted orphan medicinal product designation by the European Commission (EC) forFL.However, Kymriah would have the occasion to present an important treatment option for those cases with r/ r FL in need of potentially definitive issues, If approved in this implicit third suggestion.

FDA 52

FDA Treatment Trials FDA Approval 52

The Pharma Data

OCTOBER 15, 2020

Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. N axitamab In a poster presentation, Dr. Mora presented data from the Company’s pivotal 201 multicenter study. About Y-mAbs.

Licensing 52

Licensing Licensing Production Treatment 52

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

OCTOBER 22, 2020

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate. “W Additional details on the INTERLINK-1 clinical trial can be found here. . MARSEILLE, France, Oct. The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma.

Clinical Trials 40

Clinical Trials Trials Cell Biology Production 40

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Normality sensing licenses local T cells for innate-like tissue surveillance.

Therapies 105

Therapies Engineering Molecular Biology Science 105

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

The Pharma Data

NOVEMBER 23, 2020

(NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today announced that on November 23, 2020 , the NYSE American LLC (“NYSE American”), the Company’s current listing exchange, notified (..)

Compliance 52

Compliance Licensing Licensing Clinical Trials 52

The Pharma Data

JANUARY 19, 2021

The event will feature a presentation by renowned lymphoma expert Mats Jerkeman, MD, Lund University, who will discuss the current treatment landscape, and unmet medical need for patients with relapsed or refractory Non-Hodgkin’s Lymphoma for whom current treatment options are very limited. LUND, Sweden , Jan. Eastern Time ( 5:30 p.m.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

The Pharma Data

SEPTEMBER 16, 2020

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations.

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Clinical Trials Therapies 40

The Pharma Data

JULY 22, 2021

ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. A replay of the webcast will be archived on the Arvinas website following the presentation.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 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. Almirall S.A.’s About Atopic Dermatitis.

Trials 40

Trials Clinical Trials Small Molecule Disease 40

PPD

MAY 7, 2024

However, it also presents challenges and uncertainties, particularly in relation to the Population, Intervention, Comparator(s) and Outcomes (PICO) framework underpinning the new Joint Clinical Assessments (JCAs). Despite these challenges, the new EU HTA regulation presents significant opportunities.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. Lilly plans to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year.

Disease 52

Disease Treatment Pharmacokinetics Trials 52

The Pharma Data

JANUARY 27, 2021

The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees. The Company is in late-stage clinical development and has been working toward establishing commercial readiness.

Clinical Trials 52

Clinical Trials Trials Therapies Production 52

The Pharma Data

JANUARY 31, 2021

Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. This press release features multimedia.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

Olympian Clinical Research

JANUARY 5, 2022

Relaxation techniques are able to ground you back to the present if you are experiencing overwhelming feelings of stress or uncertainty about the future. Speaking with a licensed therapist can help you manage these overwhelming feelings and help you improve your overall quality of life. Use Relaxation Techniques. Meditation.

Clinical Trials 52

Clinical Trials Clinical Research Disease Licensing 52