BioPharma Drive: Drug Pricing

JULY 18, 2025

While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles. The FDA expanded Elevidys’ approval the next year, allowing a substantially larger group of patients to receive it, including those whose disease had eroded their ability to walk.

Therapies

The Pharma Data

JUNE 11, 2025

With this approval, MAVYRET becomes the first and only DAA treatment approved to treat both acute and chronic hepatitis C virus (HCV) infections in patients as young as three years old, with or without compensated cirrhosis, using an eight-week regimen. No one should die of hepatitis C.” Global and U.S.

FDA Approval

Twist Bioscience

APRIL 3, 2025

Human Comprehensive Exome Human Core Exome Human Methylome Panel Human RefSeq Panel Mitochondrial Panel Mouse Exome Panel Respiratory Virus Research Panel Comprehensive Viral Research Panel Twist's Whole Exome Library Preparation Workflow.

RNA

The Pharma Data

JUNE 9, 2025

Temporary Recommendations: Strengthened Global Coordination and National Action The revised temporary recommendations, applicable until at least 20 August 2025, target all WHO Member States experiencing mpox virus (MPXV) transmission. Collaborative Surveillance Strengthening disease surveillance remains a central pillar of the response.

Vaccine

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

Vaccine

New Drug Approvals

JULY 18, 2025

3] It was discovered for the treatment of hepatitis C [4] and has since been investigated for use against other viral diseases such as AIDS and COVID-19 , [2] [5] for which it was granted conditional approval in China. [6] It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV). Swallow, S.;

RNA

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 You can unsubscribe at anytime. © 2025 TechTarget, Inc.

Vaccine

The Pharma Data

SEPTEMBER 3, 2020

Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Source link.

Vaccine

The Pharma Data

SEPTEMBER 30, 2021

That’s how easy it’s for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, are reporting in iScience the event of an intranasal subunit vaccine that gives durable local immunity against inhaled pathogens. Breathe in, exhale.

Vaccine

The Pharma Data

MARCH 8, 2021

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

Trials

Drug Target Review

SEPTEMBER 8, 2023

However, recent insights indicate that it also operates beyond the nucleus, orchestrating initial events at the cell surface that trigger the activation of T cells. Remarkably, these findings propose that the presence of a cytoplasmic version of RARα is indispensable for T cells to initiate their defence against diseases.

Regulations

The Pharma Data

APRIL 26, 2022

NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. No vaccine-related serious adverse events (SAEs) were observed. About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. The study is being conducted at U.S.

Vaccine

The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% There was a 1.08 REGN-COV2 was well tolerated in the trial. high dose, 1.6% low dose; 2.3%

Virus

The Pharma Data

SEPTEMBER 5, 2021

Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses. In clinical trials, Vaxzevria demonstrated 100% efficacy against severe disease and hospitalisation after two doses. To date, AstraZeneca and its partners have supplied more than 1.1

Vaccine

The Pharma Data

JULY 28, 2021

Incidence of very rare thromboembolic events was far lower than in people diagnosed with COVID-19 infection. 1 Follow-up time was not sufficient to report rates after two doses of Vaxzevria , though other studies have shown rates of rare blood clotting events to be lower after a second dose.

Vaccine

The Pharma Data

JUNE 25, 2021

Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% 100) against moderate or severe disease. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.

Vaccine

Drug Target Review

DECEMBER 5, 2024

2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. Signal Transduct Target Ther. 2024;9(1):78.

Therapies

The Pharma Data

JANUARY 8, 2021

While speaking at a virtual event hosted by Oddo BHF, a financial service group, Bancel said the “nightmare scenario” that the vaccine will not work is now in the past. FRIDAY, Jan. 8, 2021 — Moderna CEO Stéphane Bancel said the company’s COVID-19 vaccine may prevent infection for years, CBS News reported Thursday.

Vaccine

The Pharma Data

DECEMBER 3, 2020

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

Vaccine

The Pharma Data

JANUARY 31, 2021

No serious adverse events related to the vaccine candidates studied were reported. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. . CHENGDU, China , Feb. For more information, visit www.dynavax.com.

Clinical Trials

The Pharma Data

DECEMBER 11, 2020

11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. Centers for Disease Control and Prevention. FRIDAY, Dec. regulators. Short answer: Yes.

Vaccine

The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. Have chronic kidney disease. Have immunosuppressive disease. cardiovascular disease, OR. chronic obstructive pulmonary disease/other chronic respiratory disease. sickle cell disease, OR. Have diabetes.

Hospitals

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. Data from the event-driven trial could support global authorization and approval, including in the U.S. GAITHERSBURG, Md., 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. and globally.”.

Vaccine

The Pharma Data

JUNE 26, 2021

The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. In June 2020, the two companies built upon the existing agreement to pursue novel mRNA vaccines to broadly address current and future infectious diseases.

Clinical Trials

The Pharma Data

NOVEMBER 23, 2020

. Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. AstraZeneca.

Vaccine

The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. and Roche will develop, manufacture and distribute it outside the U.S.

Hospitals

The Pharma Data

DECEMBER 28, 2020

Moleculin recently announced that the FDA had allowed its request for Investigational New Drug (IND) status for Annamycin, allowing Moleculin to begin a Phase 1B /2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease. .

FDA

The Pharma Data

OCTOBER 15, 2020

15, 2020 — A single pick-up hockey game in Tampa Bay in June wound up becoming a COVID-19 superspreader event, with one player infecting as many as 15 other people on the ice, Florida public health officials report. Centers for Disease Control and Prevention. THURSDAY, Oct. The other two sick people were not tested for COVID.

Virus

The Pharma Data

JANUARY 31, 2021

” Dr. Richard Hatchett , Chief Executive Officer of CEPI, commented: “To end the acute phase of this pandemic, and to control the virus in the longer term, the world needs multiple safe and effective vaccines which can be deployed in a range of populations and countries. . EMERYVILLE, Calif. and CHENGDU, China , Feb.

Vaccine

Alta Sciences

JANUARY 11, 2024

It is estimated that there are over 6,000 monogenic diseases, affecting over 350 million people worldwide; for these diseases, cell and gene therapy may provide hope for a cure. There are three primary vectors employed in gene therapy: adeno-associated virus (AAV), adenovirus, or lentivirus vectors.

Therapies

The Pharma Data

JANUARY 31, 2021

Nasdaq: VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that it is entering a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS).

Immune Response

The Pharma Data

JANUARY 29, 2021

Pascal Soriot, Chief Executive Officer, said: “Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations.

Vaccine

The Pharma Data

JANUARY 29, 2021

Pascal Soriot, Chief Executive Officer, said: “Today’s approval underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations.

Vaccine

The Pharma Data

DECEMBER 30, 2020

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. The overall reported rates of serious adverse events were 0.7% in the vaccine group and 0.8%

Vaccine

The Pharma Data

NOVEMBER 10, 2020

The Quebec City-based vaccine developer said that an interim analysis from the phase 1 study also showed no severe adverse events, and generally mild-to-moderate and brief reactogenicity events. Based on the promising phase 1 data, the company plans to proceed with a phase 2/3 clinical trial. “We Martin Berman-Gorvine.

Immune Response

The Pharma Data

JANUARY 3, 2021

InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs, such as TLC19 for the treatment of Coronavirus disease 2019 (COVID-19) as well as other programs for severe acute and chronic pulmonary diseases. Cautionary Note on Forward-Looking Statements. Source link.

Clinical Trials

The Pharma Data

NOVEMBER 16, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Vaccine