The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

Clinical Development 52

Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

JULY 8, 2021

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

SEPTEMBER 29, 2020

The FDA approval is based on data from a clinical development programme that included positive results from a pivotal phase 3 study. HES is a rare and under-diagnosed disorder which is characterised by persistent and market overproduction of eosinophils, a type of white blood cell.

FDA Approval 52

FDA Approval FDA Treatment Clinical Development 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 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. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

Drugs 52

Drugs FDA Approval Drug Development Pharmacokinetics 52

The Connected Lab

APRIL 8, 2020

The cost to develop a new prescription medicine that gains market approval has gone up 145% to $2.6 billion and takes an average of 10 years to develop 1. For patients suffering from an illness with no approved treatment, the wait can be unnerving. A Tough Road: Cost To Develop One New Drug Is $2.6

Pharma Companies 52

Pharma Companies Laboratories Drugs FDA Approval 52

Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.

Drug Development 52

Drug Development Treatment Drugs FDA Approval 52

The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

Clinical Development 52

Clinical Development Disease Treatment FDA Approval 52

The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology.

Clinical Trials 52

Clinical Trials FDA Approval Treatment Production 52

The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. In April 2020, Harpoon announced dosing of the first patient with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM).

Treatment 52

Treatment FDA Clinical Trials Drugs 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].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

DECEMBER 8, 2020

The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. . SciNeuro Pharmaceuticals .

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

DECEMBER 10, 2020

agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. Under the terms of a definitive agreement announced on August 24, 2020, ImmunityBio, Inc. and its affiliate NantKwest, Inc.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

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. in July 2019, who have recently initiated a Phase 1 study with their formulation.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

DECEMBER 15, 2020

is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix, Inc.

FDA Approval 40

FDA Approval Disease Therapies Clinical Development 40

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.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

NOVEMBER 30, 2020

It showcases our ability to advance strategically important candidates against specific disease targets through early development to become attractive partnering opportunities in parallel with the multi-target deals we have established. ” Abbreviations used: CGRP – calcitonin gene-related peptide. About Sosei Heptares.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

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.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

“We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application.” Protalix has licensed to Pfizer Inc.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JANUARY 18, 2021

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc.

Science 40

Science Virus Treatment Disease 40

The Pharma Data

NOVEMBER 20, 2020

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Source: Pfizer Inc. . Posted: November 2020. Source link.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

DECEMBER 11, 2020

To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the vaccine, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods of time with dry ice. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally.

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

APRIL 11, 2021

Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. Retevmo (marketed as Retsevmo ® outside the U.S.) was approved by the European Commission in February 2021. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50

Research 52

Research Treatment Therapies Trials 52

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. The CHPA presenters described “issues and misconceptions” with the FDA analysis. billion, compared with retail sales of $0.5

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell. Forward-Looking Statements.

Therapies 40

Therapies Clinical Trials Production Treatment 40

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.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

NOVEMBER 9, 2020

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Source: Pfizer, inc. Posted: November 2020. Source link.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

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.,

Virus 40

Virus Trials Clinical Trials Production 40

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. Patients treated with avacopan achieved both primary endpoints of clinical remission at 26 and 52 weeks.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

FDA Approval Treatment FDA RNA 52

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. Food and Drug Administration (FDA).

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

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.

FDA Approval 40

FDA Approval FDA Treatment Pharmaceutical Companies 40

The Pharma Data

MARCH 28, 2022

The FDA approval is based on the results from the SUSTAIN FORTE trial. We are pleased with the FDA approval for a higher 2.0 mg dose of Ozempic ® , which further supports our purpose of driving change in diabetes care” said Martin Lange, executive vice president, Development at Novo Nordisk. Ozempic ® 2.0

Treatment 52

Treatment FDA Approval Trials FDA 52

The Pharma Data

JULY 12, 2021

“With our longstanding expertise in innovative science in the cardiovascular space, today’s approval of finerenone marks an important milestone in Bayer’s commitment to improving the lives of patients with kidney and cardiovascular diseases.”. FDA has approved finerenone for marketing authorization in the U.S.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

DECEMBER 18, 2020

Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia. Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. . Source link.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

JULY 29, 2021

Our flagship HIV therapy, Biktarvy, saw continued growth and gains in market share, despite the ongoing impact of the pandemic,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. billion of cash, cash equivalents and marketable debt securities compared to $7.9 Non-GAAP diluted EPS increased 68% to $1.87

Science 52

Science Production Treatment FDA Approval 52