The Pharma Data

NOVEMBER 29, 2020

29 , 2020 /PRNewswire/ — Gannex, a wholly owned company of Ascletis Pharma Inc. Prior to joining Gannex, Dr. Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. The clinical trial application of ASC09F has been approved. SHANGHAI , Nov.

Clinical Development 40

Clinical Development Disease Clinical Trials Therapies 40

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

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. 19-21, 2020. 20, 2020 , from 2:25 p.m. – 21, 2020 , from 2:25 p.m. – 20, 2020, at?11:00

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. source Link.

Biosimilars 52

Biosimilars Clinical Development Production Government 52

The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — BioInvent International AB ‘s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

DECEMBER 21, 2020

22, 2020 07:13 UTC. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,

Vaccine 52

Vaccine Trials Clinical Trials Clinical Development 52

The Pharma Data

OCTOBER 27, 2020

27, 2020 /PRNewswire/ — Mirati Therapeutics, Inc. The offering is expected to close on or about October 30, 2020 , subject to customary closing conditions. Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. SAN DIEGO , Oct.

Small Molecule 52

Small Molecule Immune Response Clinical Development Clinical Trials 52

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

The Pharma Data

NOVEMBER 14, 2020

15, 2020– Gilead Sciences, Inc. Nasdaq: GILD) and Novo Nordisk A/S (NASDAQ Copenhagen: NOVO B) today announced results from a Phase 2 proof-of-concept trial. The results were presented at The Liver Meeting Digital Experience (TLMdX), November 13–16, 2020 (Late Breaker #L02). FOSTER CITY, Calif. &

Trials 52

Trials Science Treatment Disease 52

The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S.

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

LifeSciVC

JANUARY 16, 2024

In lean times such as 2023, we saw a shift towards several “hot” areas driven by massive commercial potential, clinically (± commercially) validated mechanisms, and exits that encouraged further investing, even at the early stage. Additional trials (e.g.,

Small Molecule 137

Small Molecule Trials Therapies Disease 137

The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 10, 2020

The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments. About NCT03763149 Trial. . SAN FRANCISCO , U.S. and SUZHOU, China , Nov.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

Clinical Trials 52

Clinical Trials Trials Immune Response Vaccine 52

The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

Clinical Trials 52

Clinical Trials Trials Disease Hospitals 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate’s pediatric program.

Vaccine 52

Vaccine Disease Trials Protein Expression 52

The Pharma Data

OCTOBER 28, 2020

SIGNAL Phase 2 trial data continue to support cognitive benefit and reduced brain atrophy with pepinemab treatment in Huntington’s disease. Data provide strong rationale for continued development in Huntington’s and other slowly progressive neurodegenerative diseases, including Alzheimer’s. ROCHESTER, N.Y.,

Clinical Trials 40

Clinical Trials Treatment Disease Clinical Development 40

The Pharma Data

DECEMBER 14, 2020

15, 2020 /PRNewswire/ — Alume Biosciences, Inc. This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. LA JOLLA, Calif. ,

Clinical Trials 52

Clinical Trials Trials Clinical Development Pharmaceuticals 52

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer.

Trials 52

Trials Treatment Disease Pharmaceuticals 52

The Pharma Data

DECEMBER 21, 2020

22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. , SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

NOVEMBER 30, 2020

Kunwar Shailubhai will host a conference call on Wednesday, 2 December 2020 at 4:15 p.m. Dr. Shailubhai will provide updates on the Company’s proposed move from AIM to the Standard Segment of the Main Market of the London Stock Exchange, ongoing clinical trials, as well as other recent developments in Tiziana Life Sciences.

Science 40

Science Clinical Trials Disease Clinical Development 40

The Pharma Data

DECEMBER 13, 2020

As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

Clinical Development 40

Clinical Development Clinical Trials Therapies Trials 40

The Pharma Data

NOVEMBER 11, 2020

Expect to initiate INZ-701 Phase 1/2 clinical trials for ENPP1 and ABCC6 deficiencies in first half of 2021. 12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. H1 2021: Initiation of Phase 1/2 clinical trial. H1 2021: Initiation of Phase 1/2 clinical trial.

Clinical Trials 40

Clinical Trials Trials Disease FDA 40

The Pharma Data

DECEMBER 14, 2020

14, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases (“the Company”), today announced the pricing of an underwritten public offering of 6,320,000 shares of common stock at a public offering price of $43.50 NEW YORK, Dec.

Clinical Trials 40

Clinical Trials Clinical Development Production Trials 40

The Pharma Data

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

Production 40

Production FDA Trials FDA Approval 40

The Pharma Data

OCTOBER 22, 2020

The closing of the offering is expected to occur on or about October 27, 2020, subject to the satisfaction of customary closing conditions. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.

Clinical Trials 40

Clinical Trials Pharmaceutical Companies Clinical Development Pharmaceuticals 40

The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. All patients in the trial received a HER2 test, and the results were centrally confirmed. 6 More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.6

Trials 52

Trials Treatment Disease Therapies 52

The Pharma Data

JANUARY 10, 2021

001- 38475), including the Company’s Annual Report on Form 20-F filed with the SEC on April 16, 2020. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the SEC on April 16, 2020. All statements other than statements of historical fact are forward-looking statements.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Treatment 52

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Sandoz Global Communications.

Biosimilars 40

Biosimilars Clinical Development Production Government 40

The Pharma Data

OCTOBER 29, 2020

Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe. Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5%

Clinical Trials 40

Clinical Trials Trials International Biosimilars 40

The Pharma Data

OCTOBER 21, 2020

22, 2020 /PRNewswire/ — Synlogic, Inc. 22-25, 2020. 22-25, 2020. Title: Development of a Synthetic Biotic, SYNB8802, for the Treatment of Enteric Hyperoxaluria Poster #: PO0650. CAMBRIDGE, Mass. ,

Clinical Trials 40

Clinical Trials Engineering Clinical Development Treatment 40

Vial

APRIL 10, 2024

With over 1,100 CROs worldwide as of 2020, choosing the appropriate partner often requires evaluating the advantages and disadvantages of large global CROs versus mid/small ones. Still in its early stages, Vial was established in 2020 and has quickly emerged as a leading CRO.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D.,

Trials 52

Trials Treatment Therapies Clinical Trials 52