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

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Food and Drug Administration in 2017.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 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

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

Drug Discovery World

JULY 2, 2024

OECD data places Switzerland second in the world for biotechnology R&D intensity 1 , and in 2021, the country had the seventh largest share of the global biotech market 2. In 2005, Glycart was acquired by the Roche Group and integrated in Roche Pharma Research and Early Development (pRED). References [link] [link].

Science 147

Science Drugs Clinical Trials Licensing 147

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

NOVEMBER 18, 2021

KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions. KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC. In theU.S.,

FDA Approval 52

FDA Approval FDA Therapies Treatment 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM is indicated for the treatment of Alzheimer’s disease.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 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

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 52

Trials Clinical Trials FDA Approval Animal Testing 52

The Pharma Data

DECEMBER 9, 2020

Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients,” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. .

FDA Approval 52

FDA Approval Clinical Development Vaccine Therapies 52

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 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

The Pharma Data

JANUARY 15, 2021

–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu ( fam-trastuzumab deruxtecan -nxki) has been approved in the U.S. Regular approval by the U.S. Enhertu is the first antibody drug conjugate to receive approval in the U.S. In the U.S.,

Treatment 52

Treatment Trials Disease Therapies 52

The Pharma Data

DECEMBER 8, 2020

Phase 3 TETON study planned in 2021 for Tyvaso® in patients with idiopathic pulmonary fibrosis. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. , INDICATION.

FDA 40

FDA Treatment FDA Approval Drugs 40

The Pharma Data

MAY 7, 2021

FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., The information contained in this release is as of May 7, 2021. anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. president and chief executive officer of Passage Bio. “We

Disease 40

Disease FDA Treatment Clinical Trials 40

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. Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases. ROCKVILLE, Md.

Clinical Development 52

Clinical Development Disease FDA Approval Treatment 52

The Pharma Data

DECEMBER 18, 2020

(FibroGen) are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to assist with the completion of labelling discussions. The NDA remains under regulatory review, with the FDA having set a new action date of 20 March 2021. The Lancet 2020; 395(10225):709–33.

Disease 52

Disease FDA FDA Approval Science 52

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 52

FDA Hospitals Clinical Development FDA Approval 52

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.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

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.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited.

Treatment 130

Treatment Virus Therapies Clinical Trials 130

The Pharma Data

SEPTEMBER 11, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Jardiance ® (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. vice president, Product Development, Lilly.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

The Pharma Data

JANUARY 24, 2021

– January 25, 2021) – PharmaDrug Inc. Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. About PharmaDrug Inc.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

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 52

Therapies Production Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 30, 2020

Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders. ” Abbreviations used: CGRP – calcitonin gene-related peptide.

Small Molecule 40

Small Molecule Licensing Licensing Clinical Trials 40

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 52

RNA Protein Expression Therapies Disease 52

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 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders. LONDON and BOSTON, Jan.

Science 40

Science Virus FDA Approval Treatment 40

The Pharma Data

DECEMBER 29, 2020

The benefit was driven by results starting one week post-treatment, when the risk of death or receiving mechanical ventilation was reduced by approximately half with antibody cocktail treatment, based on a post-hoc analysis. Senior Vice President and Head of Global Clinical Development at Regeneron. In the U.S.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4.

DNA 147

DNA Clinical Trials RNA Treatment 147

The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. P6: Neuromuscular Disorders and Clinical Trials. Spinal Muscular Atrophy (SMA).

Clinical Trials 52

Clinical Trials Trials Disease Nurses 52

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Updates from the clinical pipeline include: Dupixent ® (dupilumab). Regeneron Pharmaceuticals, Inc. Business Highlights.

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

DECEMBER 5, 2020

Among all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ?6 “As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment.” TARRYTOWN, N.Y. ,

Production 40

Production Trials Treatment Pharmaceuticals 40

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