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 52

FDA Approval Hormones Production Drugs 52

Delveinsight

AUGUST 2, 2020

The dynamics of the cancer cachexia market is expected to gain momentum as several companies are testing the waters, advancing cancer cachexia pipeline. The Cancer cachexia market will comprise the upcoming therapies in the pipeline as well as the present treatment regimes, including Nutritional counselling or Appetite stimulants, Cytokine?

Marketing 94

Marketing Pharma Companies Development Hormones 94

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

Drugs 98

Drugs Antibody Pharma Companies Development 98

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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Drug Discovery World

OCTOBER 4, 2022

Erhardt adds that despite the ever-increasing number of people with AD, there has been an erosion of market value (from $4.2 billion in 2013 to less than $3 billion in 2018) due to loss of patent protection for the five FDA approved pharmacologic treatments available for AD, none of which slow or stop the damage from the disease. .

Development 52

Development In-Vivo Compound Screening Clinical Development 52

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.

Licensing 52

Licensing Licensing Drugs Gene 52

XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

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.

Drugs 52

Drugs Containment Development Sales 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 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].

FDA Approval 52

FDA Approval Dermatology Genetics Development 52

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

The FDA grants Orphan Drug designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.

Gene Therapy 40

Gene Therapy Drugs Clinical Trials Clinical Trials 40

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. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain. LONDON and BOSTON, Jan.

Life Science 40

Life Science Development Sales Drugs 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.

Drugs 94

Drugs Medicine Regulation Licensing 94

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.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . For more information about the Lilly data being presented at this year’s virtual Fall Clinical Dermatology meeting, please visit [link]. INDIANAPOLIS , Oct.

Dermatology 52

Dermatology Development Medicine Clinical Trials 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.” Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

DECEMBER 10, 2020

BNT162b2 has been authorized or approved for emergency use in several countries around the world including the U.K., 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. Bahrain, and Canada. Posted: December 2020.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JULY 26, 2022

The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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. Emergency Use Authorization .

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Vaccination Vaccine Protein Immune Response 111

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).

Sales 52

Sales Production Manufacturing Antibody 52

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.

Antibody 52

Antibody Trials Production Clinical Trials 52

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.

Antibody 40

Antibody Production Trials Medicine 40

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 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.,

Antibody 40

Antibody Trials Production Clinical Trials 40

Pfizer

JULY 19, 2022

Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. Emergency Use Authorization. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

JULY 8, 2022

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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. Emergency Use Authorization. INTERCHANGEABILITY.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Drug Discovery World

SEPTEMBER 16, 2022

W here globally is innovation occurring and what factors – industry, regulatory, and academia – are helping developers get their products to market? The UK stands as one of the key markets for cell and gene therapies. Unsurprisingly, the US is currently the biggest market in the world for cell and gene therapies.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 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. You should not place undue reliance on any forward-looking statements.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

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. FDA and an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency. Posted: November 2020.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

Pfizer

DECEMBER 8, 2022

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus. . 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.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

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 Clinical Trials Trials Protein 52

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). Please check your email to download the Report.

Gene Therapy 246

Gene Therapy Manufacturing Gene FDA Approval 246