Clinical Development, Containment, FDA Approval and Genetics

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

Clinical Development

Clinical Development Vaccination Vaccine Development

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

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.,

FDA Approval

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J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval

FDA Approval Gene Hormones Licensing

Janssen submits EMA filing for bladder cancer treatment

Drug Discovery World

SEPTEMBER 14, 2023

This submission, and Janssen’s ongoing study of erdafitinib, reinforces our commitment to deliver much-needed targeted therapies in the areas of high unmet need, including for devastating diseases like metastatic UC,” said Kiran Patel, Vice President, Clinical Development, Solid Tumours, Janssen Research & Development, LLC.

Containment

Containment Genetics FDA Approval Marketing

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

APRIL 24, 2023

Approximately 72 percent of rare diseases are genetic, and around 70 percent of rare genetic diseases emerge in childhood. Out of over 7,000 rare diseases, only 5 percent (or less) of rare diseases are thought to have approved treatment options, known as “orphan” therapies.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

Production

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Bristol Myers Squibb Provides Update on Phase 3 IDHENTIFY Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia

The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada. IDHIFA is also approved in Australia and Canada.

Trials

Trials FDA Approval Development Clinical Trials

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

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

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Passage Bio’s PBKR03 Receives Orphan Drug and Rare Pediatric Disease Designations from FDA for Treatment of Krabbe Disease

The Pharma Data

OCTOBER 27, 2020

NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. PHILADELPHIA, Oct. 28, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc. More information is available at www.passagebio.com. F orward -Looking Statements.

Gene Therapy

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Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

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

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Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

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

Antibody Trials Production Clinical Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

Antibody

Antibody Trials Production Clinical Trials

Regeneron Reports Third Quarter 2020 Financial and Operating Results

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.

Sales

Sales Production Manufacturing Antibody

What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

Vaccination

Vaccination Vaccine RNA Manufacturing

GBT Presents Data at 15th Annual Scientific Conference on Sickle Cell and Thalassemia

The Pharma Data

OCTOBER 25, 2020

FDA approval. SCD is one of the most prevalent genetic rare diseases in Europe, and despite a clinical understanding of SCD, estimated life expectancy for those affected by the disease is significantly lower than the European average, indicating an urgent need to improve the quality of care for these patients.

Medicine

Medicine Development Containment FDA Approval

Clinical Research Informer

Novavax Announces COVID-19 Vaccine Clinical Development Progress

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

Trending Sources

J&J’s Akeega Approved as First Combo Treatment for BRCA-Positive Prostate Cancer

Janssen submits EMA filing for bladder cancer treatment

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

Bristol Myers Squibb Provides Update on Phase 3 IDHENTIFY Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Passage Bio’s PBKR03 Receives Orphan Drug and Rare Pediatric Disease Designations from FDA for Treatment of Krabbe Disease

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Regeneron Reports Third Quarter 2020 Financial and Operating Results

What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

GBT Presents Data at 15th Annual Scientific Conference on Sickle Cell and Thalassemia

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