BioPharma Drive: Drug Pricing

JULY 10, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Since the drug’s U.S.

Drugs

The Pharma Data

JUNE 11, 2025

Food and Drug Administration (FDA) approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), the company’s oral, pangenotypic direct-acting antiviral (DAA) therapy. Tackling a Silent Global Epidemic HCV is a highly infectious bloodborne virus that primarily affects the liver. No one should die of hepatitis C.” Global and U.S.

FDA Approval

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime.

Vaccine

Codon

JULY 10, 2025

The event hosts will provide snacks and drinks, and the winning teams will get signed copies of our DNA books and free hats. Register here Issue 07 also features: Leech Therapy. The tools for delivering gene therapies into cells have improved radically since the use of retroviruses in the early 1990s. Please RSVP to join.

Engineering

New Drug Approvals

JULY 18, 2025

It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV). 11] It is believed to work by inhibiting the RNA-dependent RNA polymerase (RdRp) enzyme in the SARS-CoV-2 virus. [12] 2024, 67, 4376−4418 Azvudine (1). Azvudine (1) is an antiviral manufactured by China-based Genuine Biotech.

RNA

BioPharma Drive: Drug Pricing

JULY 22, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Vicebio specializes in a vaccine technology it dubs “molecular clamp.”

Vaccine

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

Therapies

DrugBank

JANUARY 29, 2025

Gene Therapy Gene therapy operates on the principle of modulating the DNA blueprint of cells to induce a therapeutic response. Gene therapy trials explore using lentiviral vectors to deliver a functional copy of the HBB gene to hematopoietic stem cells, the progenitors of all blood cells.

Therapies

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. However, there are significant challenges associated with the successful development of these complex, leading-edge therapies. what is the altascientist?

Therapies

Drug Target Review

SEPTEMBER 25, 2024

Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades. The reactivation of oncogenic signalling upstream or downstream of the driving oncogene is a well-studied source of resistance to targeted cancer therapies.

Small Molecule

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. Our stock price is volatile and may be affected by a number of events.

Therapies

The Pharma Data

JANUARY 3, 2021

(Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that U.S. GM1 is a rare and often life-threatening CNS disorder with no approved disease-modifying therapies available. About PBGM01. About Passage Bio.

Therapies

The Pharma Data

JANUARY 27, 2021

. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We

Therapies

The Pharma Data

OCTOBER 21, 2020

In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days.

Clinical Development

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 combined dose groups; 6.5% placebo; p=0.024). REGN-COV2 was well tolerated in the trial.

Virus

The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. 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. , who require oxygen therapy due to COVID-19, OR.

Hospitals

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

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

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. The candidate vaccines were given in two doses, three weeks apart. About Dynavax.

Clinical Trials

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

NOVEMBER 22, 2020

There were no serious adverse safety events. They use mRNA that codes for the spike protein in the SARS-CoV-2 virus, which is embedded in a nanolipid particle—basically a minuscule fat molecule. When injected into the body, cells churn out the spike protein, which causes the body’s immune system to recognize the virus.

Vaccine

The Pharma Data

OCTOBER 6, 2021

A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. About Pfizer: Breakthroughs That Change Patients’ Lives.

Vaccine

The Pharma Data

OCTOBER 26, 2020

Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. SAN JOSE, Calif. , AR-711 (COVID-19).

Pharmaceuticals

The Pharma Data

JANUARY 29, 2021

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.

Vaccine

The Pharma Data

JANUARY 29, 2021

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.

Vaccine

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. About CpG 1018.

Vaccine

BioPharma Drive: Drug Pricing

JULY 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Seven of these CAR-T therapies are available in the U.S., You can unsubscribe at anytime.

Therapies

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

NOVEMBER 23, 2020

No serious safety events related to the vaccine have been confirmed. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. AZD1222 was well tolerated across both dosing regimens. AstraZeneca.

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

SEPTEMBER 7, 2020

If your anxiety persists, there are lots of self-help books on the best therapies, such as cognitive behavioural therapy (CBT), which is also provided on the NHS. CBT is a talking therapy which helps people deal with overwhelming problems by breaking them down into smaller chunks. Who is most at risk?

Virus

The Pharma Data

MARCH 1, 2022

We look forward to discussing this further with FDA over the coming months so that we can make this investigational new therapy available to people living with multidrug-resistant HIV as soon as possible,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

FDA

The Pharma Data

SEPTEMBER 12, 2020

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Pfizer: Breakthroughs That Change Patients’ Lives.

Vaccine

The Pharma Data

AUGUST 21, 2020

As the pharma community continue to research and develop hundreds of potential therapies to combat the Covid-19 pandemic, very few initiatives are yet to cross the finishing line into the commercial market. REGN -COV2 could be a critical line of defense against the Covid-19 pandemic.”.

Vaccine

The Pharma Data

JANUARY 24, 2021

These statements reflect management’s beliefs with respect to future events and are based on information currently available to management. This marks the third US clinical site that has obtained both study level and site IRB approval through a central IRB. Additional information is available at www.theralase.com and www.sedar.com.

Pharmaceutical Companies

The Pharma Data

JANUARY 31, 2021

Convergent has exclusive rights to technology related to next generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued U.S. The key component of Convergent’s PRRT prostate cancer therapy is its proprietary drug, CONV 01-?, in the proprietary dual PRRT therapy.

Small Molecule