The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 months (95 percent CI, 6.9 – NE). [7].

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5].

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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. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Sigilon Therapeutics

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The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.

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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.” Casirivimab and imdevimab injection is not FDA approved for any use.

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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.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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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. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc.

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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.

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The Pharma Data

NOVEMBER 20, 2020

BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Source: Pfizer Inc. . Posted: November 2020. Source link.

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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The Pharma Data

NOVEMBER 9, 2020

BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Source: Pfizer, inc. Posted: November 2020. Source link.

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The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” said David Weinreich, M.D.,

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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.,

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

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The Pharma Data

MAY 31, 2022

if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The target action date for the FDA decision is September 30, 2022. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S.,

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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Regulatory filings around the world are also planned in 2022.

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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. In millions).

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The Pharma Data

DECEMBER 10, 2020

BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Source: Pfizer Inc. . Posted: December 2020. Source link.

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The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Posted: November 2020. Source link.

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

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The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

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The Pharma Data

MARCH 4, 2021

This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s).

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BioPharma Drive: Drug Pricing

JUNE 9, 2025

From pioneering treatments for rare pediatric diseases to exploring natural killer cells for Alzheimers and developing FDA-approved digital therapeutics for fibromyalgia, each episode reveals the scientific ingenuity and personal determination behind medical advances. 3 Digital Behavioral Therapy for Fibromyalgia Ep.

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New Drug Approvals

APRIL 8, 2025

Vimseltinib 1628606-05-2 DCC-3014 2/14/2025 FDA APPROVED, Romvimza 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one C 23 H 25 N 7 O 2 , 431.5 Food and Drug Administration (FDA) granted the application for vimseltinib priority review designation. [2] October 2022).

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Drug Target Review

MARCH 20, 2025

Regulatory approval and market introduction Anthos Therapeutics is actively pursuing the clinical development of abelacimab. “This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted.

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New Drug Approvals

MAY 11, 2025

11] History Omaveloxolone is a second generation member of the synthetic oleanane triterpenoid compounds and in clinical development by Reata Pharmaceuticals. Jump up to: a b c d e f g h i j k l m n o p q “FDA approves first treatment for Friedreich’s ataxia” U.S. Food and Drug Administration (FDA).

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