The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information. INDICATION.

Clinical Trials

The Pharma Data

MAY 7, 2021

The information contained in this release is as of May 7, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer Disclosure Notice.

Licensing

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. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

Research

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S. 7 Following the emergence of the SARS-CoV-2 variant of concern, Omicron (B.1.1.529), Actemra/RoActemra is not U.S.

Treatment

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. 2021 [cited 16 December 2021]. Sci Rep 9, 18911 (2019).

Drugs

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

The Pharma Data

OCTOBER 25, 2020

FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

FDA

The Pharma Data

JANUARY 7, 2021

07, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. The offering is expected to close on or about January 12, 2021, subject to customary closing conditions. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. ROCKVILLE, Md. and CHESTERBROOK, Pa., per share (the “Public Offering Price”).

Clinical Development

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. 4] , [5] , [6].

Treatment

The Pharma Data

JANUARY 17, 2021

Company Expects to Report Initial Clinical Data in 2021. 17, 2021 /PRNewswire/ — Sirnaomics, Inc. , ” The Company expects to report initial clinical data from the trial in 2021. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.

Treatment

The Pharma Data

JULY 6, 2021

AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. billion in clinical development, regulatory and commercial launch-related milestone payments.

Disease

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

Trials

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

Clinical Trials

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).

Vaccine

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine

The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. BioAge is on the cusp of taking pilot therapies BGE-117 and BGE-175 into clinical trials, targeting the first half of 2021.

RNA

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. WAKEFIELD, Mass., Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials

The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021.

Therapies

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

Drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

Drugs

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

Hospitals

The Pharma Data

NOVEMBER 30, 2020

Biohaven launched NURTECä ODT (rimegepant), our lead CGRP receptor antagonist oral small molecule for the acute treatment of migraine in March of this year in the USA , and have submitted an sNDA for the preventive treatment of migraine with an expected PDUFA in the second quarter of 2021. GPCR – G protein-coupled receptors.

Small Molecule

The Pharma Data

JUNE 28, 2021

Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. Lilly intends to submit the full registration package to regulatory authorities by the end of 2021. mg once weekly for four weeks, then increased the dose to 0.5

Clinical Trials

The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

Vaccine

The Pharma Data

DECEMBER 29, 2020

” The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. The FDA also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.

Clinical Trials

The Pharma Data

JANUARY 18, 2021

His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the discovery that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. LONDON and BOSTON, Jan.

Science

The Pharma Data

OCTOBER 30, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

Hospitals

The Pharma Data

NOVEMBER 20, 2020

In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. Posted: November 2020.

Vaccine

The Pharma Data

NOVEMBER 9, 2020

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. billion doses in 2021. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. The FDA has set an action date of July 7, 2021.

Disease

The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production

The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Virus

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. These recent studies evaluated patients with seasonal allergic rhinitis (SAR) and the common cold. billion, compared with retail sales of $0.5

Science

The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

Science

The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Research

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., Outside the U.S.,

FDA Approval