The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.”

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

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Trials Clinical Trials Clinical Trials Medicine 40

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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pharmaphorum

DECEMBER 21, 2021

BeiGene was also the developer of Novartis’ PD-1 inhibitor tislelizumab , which was filed for FDA approval in September as a second-line treatment for oesophageal cancer. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55

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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. today announced that the U.S. A decision on U.S. Actemra/RoActemra is not U.S. Roche also partnered with Gilead Sciences, Inc.,

FDA Approval 52

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Drug Discovery World

MARCH 7, 2023

She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

Antibody 52

Antibody Trials Production Clinical Trials 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Delveinsight

AUGUST 2, 2020

Helsinn Group , a Swiss pharma player, is evaluating Anamorelin, an orally active selective ghrelin receptor agonist against Cancer cachexia, The company is conducting Phase III trial to test the efficacy and safety of anamorelin for the treatment of weight loss and anorexia in patients with advanced NSCLC with cachexia.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

Genetics 52

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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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Licensing Licensing Drugs Gene 52

The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. In September 2020, the U.S.

Medicine 52

Medicine Trials Allergies FDA Approval 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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Drug Discovery World

OCTOBER 4, 2022

million from the National Institute on Aging of the National Institutes of Health, the company plans to begin a Phase Ia clinical trial evaluating its lead tau self- association small molecule inhibitor OLX-07010. . Diseases such as PSP and FTD have no licensed and available treatments. With its recent award of $3.35

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pharmaphorum

SEPTEMBER 8, 2022

Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 Clarity announced in August that its phase 1/2a trial in paediatric patients with high-risk neuroblastoma would continue recruiting across five clinical sites in the US.

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XTalks

NOVEMBER 28, 2023

Featuring Ilsun Hong, VP and Product Evaluation Team Leader, and Thomas Newcomer, VP and Head of US Market Access at Samsung Bioepis, the discussion revolves around key developments, challenges and future trends in biosimilars. Read on to learn more about Samsung Bioepis’ pivotal role in the biosimilar industry from these two experts.

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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. About the Phase 2/3 Study.

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Vaccination Vaccine Clinical Trials Clinical Trials 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.

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Gene Therapy Drugs Clinical Trials Clinical Trials 40

The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. 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.

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Production Antibody Manufacturing Trials 52

The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. 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. Nuance Pharma .

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RNA Antibody Life Science Protein 52

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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FDA Approval Dermatology Genetics Development 52

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

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

NOVEMBER 20, 2020

18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. About the Study.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. Submission for Emergency Use Authorization (EUA) to the U.S.

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Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Production Trials Medicine 40

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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Drugs Medicine Regulation Licensing 94

The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

Dermatology 52

Dermatology Development Medicine Clinical Trials 52

The Pharma Data

NOVEMBER 5, 2020

REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. 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). and non-GAAP diluted EPS (1) was $8.36 .

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Pfizer

JULY 26, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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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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Clinical Trials Clinical Trials Trials In-Vitro 52

Pfizer

JULY 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

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Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.

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XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Sales Manufacturing FDA Approval Life Science 98

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). Increases of ALT ?5x

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Trials Development Dermatology Clinical Trials 52

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies. billion in funding. . “The

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Gene Therapy Gene Manufacturing Medicine 52