The Pharma Data

AUGUST 3, 2021

Breakthrough results in the treatment of a type of heart failure, which is extremely difficult to manage Strong progress in mental health pipeline Good business performance in all areas, despite ongoing impact of COVID-19. Our strong R&D pipeline has made further, decisive progress in the first half of 2021.

Research 52

Research Treatment Clinical Trials Production 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

JANUARY 13, 2021

13, 2021 (GLOBE NEWSWIRE) — Harpoon Therapeutics, Inc. NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma.

Treatment 52

Treatment FDA Clinical Trials Trials 52

The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021.

International 52

International Disease Clinical Trials Trials 52

The Pharma Data

SEPTEMBER 8, 2021

Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma. Summary of Presentations. All times noted are Central European Summer Time (CEST).

Research 52

Research Immune Response Treatment Trials 52

The Pharma Data

MARCH 8, 2021

Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a single agent.

Trials 52

Trials Clinical Trials Pharmacokinetics Research Laboratories 52

The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021. vice president of Alzheimer’s disease development unit, Eli Lilly and Company.

Disease 40

Disease International Research Therapies 40

The Pharma Data

APRIL 4, 2022

The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development, Roche.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

The Pharma Data

APRIL 6, 2021

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. and China for marginal zone lymphoma (MZL) based on clinical data of MZL patients enrolled in the CHRONOS-1 study.

Research 52

Research Small Molecule Treatment Clinical Trials 52

The Pharma Data

APRIL 16, 2021

Opdivo in combination with Cabometyx was generally well tolerated, with a low rate of treatment-related discontinuations. The combination of Opdivo and Cabometyx was well tolerated, with safety reflective of the known profiles of both medicines and a low rate of treatment-related adverse events (TRAEs) leading to discontinuation.

Treatment 52

Treatment Trials Clinical Trials Immune Response 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. The Annual General Meeting will be held on April 29, 2021 in Lund, Sweden. LUND, Sweden , Dec. Chairman of the Nomination Committee.

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. 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

The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.

Therapies 52

Therapies Clinical Trials Treatment FDA 52

The Pharma Data

JANUARY 17, 2021

Company Expects to Report Initial Clinical Data in 2021. 17, 2021 /PRNewswire/ — Sirnaomics, Inc. , 17, 2021 /PRNewswire/ — Sirnaomics, Inc. , ” The Company expects to report initial clinical data from the trial in 2021. . GAITHERSBURG, Md. and SUZHOU BIOBAY, China , Jan. GAITHERSBURG, Md.

Treatment 52

Treatment Trials FDA Approval RNA 52

The Pharma Data

NOVEMBER 11, 2021

Wegovy was launched in the US in June 2021 following approval by the U.S. In September 2021, Wegovy was approved by the UK Medicines and Health products Regulations Agency (MHRA). mg injection is approved for the treatment of adults with obesity or overweight in the US and UK, as an adjunct to diet and exercise.

Treatment 52

Treatment Disease Clinical Trials Trials 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

Treatment 52

Treatment FDA Vaccine Trials 52

The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the novel combination of the cancer treatments copanlisib and rituximab. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL). Fields, M.D.,

Treatment 52

Treatment Therapies Trials Clinical Development 52

The Pharma Data

JANUARY 19, 2021

19, 2021 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc. The offering is expected to close on January 22, 2021, subject to customary closing conditions. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19.

Small Molecule 40

Small Molecule Clinical Development Treatment Disease 40

The Pharma Data

MARCH 29, 2022

Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer. Food and Drug Administration approved Opdivo in combination with chemotherapy for the treatment of adult patients with resectable (tumors ? CT, in New Orleans, Louisiana. Based on the results of CheckMate -816, the U.S.

Treatment 52

Treatment Clinical Trials Trials Immune Response 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. Accessed April 2021].

Biosimilars 40

Biosimilars Clinical Development Production Government 40

The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

OCTOBER 27, 2021

– This Clinical Study is the First from Merck and Gilead’s Collaboration to Develop Potential Long-Acting HIV Treatment Options –. Joan Butterton, vice chairman, global clinical development, contagious conditions, Merck Research Laboratories. There’s presently no cure for HIV or AIDS.

Treatment 52

Treatment Clinical Trials Clinical Development Trials 52

The Pharma Data

JANUARY 15, 2021

–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS

Treatment 52

Treatment Trials Disease Therapies 52

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

JANUARY 20, 2021

20, 2021 (GLOBE NEWSWIRE) — CytomX Therapeutics, Inc. The offering is expected to close on or about January 25, 2021, subject to satisfaction of customary closing conditions. The Company is developing a novel class of investigational antibody therapeutics, based on our Probody ® technology platform, for the treatment of cancer.

Clinical Development 40

Clinical Development Therapies Drugs Science 40

The Pharma Data

JANUARY 14, 2021

15, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX) (NASDAQ – CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021 , which will take place between 1pm and 5pm CET. STOCKHOLM , Jan.

Clinical Trials 40

Clinical Trials Disease Hospitals International 40

The Pharma Data

MARCH 17, 2021

In one analysis, the PRO data indicated that most patients (approximately 70-75%) in both arms reported being bothered “a little bit” or “not at all” by treatment-related side effects. With the exception of diarrhea, the addition of Verzenio to ET did not result in any clinically meaningful differences in the PROs.

Trials 52

Trials Therapies Treatment Disease 52

The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). 4 The FDA is expected to make a decision on approval by 23 October 2021.

Treatment 52

Treatment FDA Therapies Clinical Trials 52

The Pharma Data

JULY 12, 2021

The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Source link: [link].

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Leading Biosciences , Inc. (“LBS”), Food and Drug Administration (FDA) has granted Fast Track Designation to LB1148 for the treatment of postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery. . Generally, treatment with LB1148 was well tolerated.

FDA 40

FDA Treatment Trials Clinical Trials 40

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. ” About SPR206.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

The Pharma Data

JANUARY 18, 2021

18, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 2:30 PM ET. for the treatment of post-herpetic neuralgia. SAN DIEGO, Jan.

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

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). At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. About Molnupiravir.

Trials 69

Trials Virus RNA Research Laboratories 69

The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Patient enrollment is expected to begin in early 2021. Commenting on the announcement, Daniel Gruskin, M.D., LogicBio is headquartered in Lexington, Mass.

FDA 40

FDA Treatment Clinical Trials Clinical Development 40