The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Production Research Doctors 52

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

Development 242

Development Bioequivalency Generic Drugs Production 242

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

Development 161

Development Production Immune Response Licensing 161

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

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Sosei Group Forward-looking statements.

Licensing 40

Licensing Licensing Production Development 40

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Increases of ALT ?5x

Licensing 40

Licensing Licensing FDA Approval Development 40

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.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Malaria Vaccine Phase II Trial.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

pharmaphorum

APRIL 27, 2021

On Wednesday (28 April), the focus will shift to Keytruda and Tecentriq as first-line treatments for UC patients unable to be treated with cisplatin-containing chemotherapy – which got the go-ahead in 2017 and 2018, respectively.

Drugs 63

Drugs Trials FDA Approval Marketing 63

Delveinsight

JANUARY 5, 2021

Recent results from Phase III clinical studies support the duo’s regulatory submission for somatrogon. The US FDA has accepted the initial Biologics License Application submission for the therapy with the target action date for an FDA decision is October 2021. SCONE Medical Solutions Inc.

Hormones 52

Hormones FDA Approval Trials Drugs 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. About the Phase 2/3 Study.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

AUGUST 4, 2023

GSK’s Jemperli (dostarlimab) has been approved in the US plus chemotherapy as the first new frontline treatment option in decades for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). As a clinician, I celebrate the practice-changing potential of adding Jemperli to chemotherapy for patients.”

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Licensing 52

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. There are five categories, each containing five cannabis scientists.

Medicine 52

Medicine Scientist Production Regulation 52

The Pharma Data

NOVEMBER 20, 2020

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. The information contained in this release is as of November 20, 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

RPD designation is granted by the FDA to encourage treatments for serious or life-threatening diseases primarily affecting children 18 years of age and younger and fewer than 200,000 people in the United States.

Gene Therapy 40

Gene Therapy Drugs Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 8, 2020

Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. To learn more, visit www.modernatx.com.

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. The information contained in this release is as of December 10, 2020. About the Phase 2/3 Study.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

NOVEMBER 9, 2020

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. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.

Packaging 52

Packaging Packaging Drugs Containment 52

The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. Sairiyo is currently focused on advancing the clinical development of Cepharanthine to treat rare cancer diseases. PharmaDrug Inc.

Drugs 52

Drugs Containment Development Sales 52

FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Production 59

Production Drugs FDA Approval Compliance 59

The Pharma Data

OCTOBER 30, 2020

If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. Department of Health and Human Services under OT number: HHSO100201700020C. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccination 52

Vaccination Vaccine FDA Approval Containment 52

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.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

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

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

JANUARY 21, 2021

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Hypersensitivity Reactions: Hypersensitivity reactions, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens.

FDA Approval 52

FDA Approval RNA Drugs Containment 52

The Pharma Data

OCTOBER 28, 2020

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Based on this finding, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

Pfizer

JULY 19, 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.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

JULY 8, 2022

The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. The information contained in this release is as of July 8, 2022. Emergency Use Authorization. INTERCHANGEABILITY.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

DECEMBER 5, 2020

Founded and led for 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.

Antibody 40

Antibody Production Trials Medicine 40