The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

FDA Approval 52

FDA Approval FDA Molecular Biology Virus 52

Drug Discovery World

AUGUST 30, 2022

TPOXX is an FDA-approved antiviral drug for the treatment of smallpox. It limits viral spread in the body by inhibiting the work of the protein involved in the release of the enveloped virus. In total, 25 patients (all male) with confirmed monkeypox infection completed a course of tecovirimat therapy. Official comments.

Therapies 130

Therapies FDA Approval Vaccine Treatment 130

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are pleased to work with U.S. AUTHORIZED USE IN THE U.S.:

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–( This press release features multimedia.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

NOVEMBER 23, 2021

Approval is for Cytomegalovirus, a Type of Herpes Virus. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. The FDA, an agency within theU.S.

FDA Approval 52

FDA Approval Treatment FDA DNA 52

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

Vaccine 52

Vaccine Virus Clinical Trials Government 52

Drug Discovery World

NOVEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved Ixchiq, Valneva’s single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus (CHIKV). The vaccine is indicated in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

FDA Approval 148

FDA Approval Vaccine FDA Virus 148

The Pharma Data

SEPTEMBER 11, 2020

In broader pharmaceutical news, Takeda has revealed it has agreed to divest its non-core portfolio of prescription therapies to Cheplapharm in exchange for an upfront payment of $562 million, while Mylan has announced an agreement to acquire the intellectual property and commercialisation rights to Aspen’s thrombosis business for €641.9

FDA Approval 52

FDA Approval Vaccine Clinical Trials FDA 52

Drug Discovery World

MAY 29, 2024

Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. AAV purification The question of adeno-associated virus (AAV) vectors, according to Hummersone, is interesting for several reasons.

Therapies 274

Therapies Molecular Biology DNA Immune Response 274

The Pharma Data

FEBRUARY 23, 2022

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s TicoVac TM (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older, in the following U.S. Global President, Vaccines, Pfizer. “We

Vaccine 52

Vaccine FDA Approval Laboratories Virus 52

The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

Vaccine 52

Vaccine Trials FDA Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. Ricks , Lilly chairman and CEO.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

Therapies 40

Therapies Science FDA Production 40

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. Vaccines Working Group : Accelerates the evaluation of vaccine candidates. And ACTIV has indeed moved at unprecedented speed since its launch.

Clinical Trials 52

Clinical Trials Hospitals Vaccine Trials 52

Codon

MAY 18, 2023

A gene therapy for Duchenne muscular dystrophy is (probably) on the way. On May 12, the FDA said that “the clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD.” No more designing new flu vaccines each year? Read more in Nature.

DNA 52

DNA Engineering Therapies Virus 52

Codon

MAY 18, 2023

A gene therapy for Duchenne muscular dystrophy is (probably) on the way. On May 12, the FDA said that “the clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD.” No more designing new flu vaccines each year? Read more in Nature.

DNA 52

DNA Engineering Therapies Virus 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.

Licensing 40

Licensing Licensing Therapies Laboratories 40

Drug Discovery World

APRIL 27, 2023

Today, North Carolina ranks among the top three states in bioscience employment and has become a world leader in vaccine research and manufacturing 5. FUJIFILM Irvine Scientific recently announced plans to build a cell culture media manufacturing facility in RTP.

Small Molecule 130

Small Molecule Science Drugs FDA Approval 130

Drug Discovery World

JULY 8, 2024

While mRNA vaccines and RNA interference therapies have garnered much attention, a new class of RNA therapeutics known as aptamers is gaining momentum, particularly to address acute diseases. The most developed RNAi is small interfering ribonucleic acid (siRNA)-based therapies.

RNA 148

RNA Small Molecule Vaccine FDA Approval 148

Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

Therapies 130

Therapies Clinical Trials Production Trials 130

The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Test patients for latent TB before initiating Olumiant and during therapy. See the full Prescribing Information here.

Treatment 52

Treatment Clinical Trials Therapies Drugs 52

The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. . Casirivimab and imdevimab injection is not FDA approved for any use.

Government 52

Government Hospitals Virus Production 52

The Pharma Data

DECEMBER 30, 2020

That company’s breast cancer treatment Trodelvy, which was granted accelerated approval from the U.S. billion acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis. But the U.K.-based

Science 52

Science Pharmaceuticals Disease FDA Approval 52

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. vice president of immunology development at Lilly.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

SEPTEMBER 1, 2020

Presentation Topic: Disease Modifying Therapies – Risk Management. Presentation Topic: Disease Modifying Therapies – Mechanism of Action. Presentation Topic: Disease Modifying Therapies – Mechanism of Action. Treatment discontinuation and restart among patients with multiple sclerosis using disease-modifying therapies.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

JUNE 28, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ in these indications is 15 mg. Have recently received or are scheduled to receive a vaccine. In August 2019, RINVOQ received U.S.

FDA 52

FDA Treatment FDA Approval Vaccine 52

The Pharma Data

APRIL 1, 2021

at week 12 (p<0.001 for both doses), as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, which continued to improve through week 24; patients in the adalimumab group saw an improvement (5.7) The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. at week 12.

Doctors 52

Doctors Treatment Therapies FDA 52

The Pharma Data

APRIL 3, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Have recently received or are scheduled to receive a vaccine. In August 2019 , RINVOQ received U.S.

Treatment 52

Treatment FDA Drugs FDA Approval 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. “The Cell Therapy product sales increased 39% to $219 million for the second quarter 2021 compared to the same period in 2020.

Science 52

Science Production Treatment FDA 52

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

Production 130

Production Vaccine Immune Response Therapies 130

Agency IQ

JANUARY 19, 2024

Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. However, BeiGene announced that it is seeking approval in the U.S. Inaqovi (cedazuridine/decitabine; Otsuka Pharmaceuticals) is approved in the E.U.

Biosimilars 40

Biosimilars FDA Production Treatment 40