Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 7:50 PM EDT | UPDATED JUN 26, 2023 12:41 PM EDT Note: This calendar also include some activities scheduled to take the last week of June, after this piece is published. Was supposed to be finalized as of June 24, 2022. The following PDUFA dates were obtained from publicly available sources.

FDA

The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. The financial impact of the vaccine on the full year consolidated financials for the fiscal year ending March 31, 2023 (Fiscal Year 2022) will depend on the specific distribution schedule.

Vaccine

Agency IQ

MARCH 7, 2024

BY AMANDA CONTI | MAR 6, 2024 8:46 PM CST AgencyIQ’s quick primer on the influenza virus and how annual vaccine strains are selected Influenza viruses have caused untold illness and death through human history. A key part of the influenza virus’ ability to infect humans is hemagglutinin (HA), a glycoprotein found on the surface of the virus.

Vaccine

Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

Biosimilars

The Pharma Data

MARCH 11, 2021

At Crop Science we’re targeting above-market growth from 2022. Bayer is also displaying its sense of responsibility during the COVID-19 crisis, applying its knowledge and resources to help in tackling the virus – in line with the company’s vision “Health for all, Hunger for none.”

Science

Codon

APRIL 2, 2023

Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Read A really simple way to isolate AAVs, which are a type of virus often used to deliver gene therapies into cells. from 2021 to 2022, up to $625 million. Ricciardi M.J. Science Translational Medicine. Gene Therapy.

DNA

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 1) The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022. Amgen (NASDAQ:AMGN) announced that the U.S.

FDA

The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.

Treatment

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Top-line results are expected in the first half of 2022.

Licensing

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Here are just a few: About 30,000 people know how to synthesize an influenza virus, at a cost of about $5,000.

Therapies

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Here are just a few: About 30,000 people know how to synthesize an influenza virus, at a cost of about $5,000.

Therapies

Codon

SEPTEMBER 29, 2024

The first model of life emerged sometime in 2022 or 2023. There was scFormer in 2022, scGPT in 2023, and plenty of others. At best, the corporations with the best models released weak versions to the public under non-commercial licenses. The pessimism of just a few years before was replaced with exuberant optimism.

Engineering

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. An update on Pfizer’s potential first-in-class maternal vaccine candidate for the prevention of respiratory syncytial virus (RSVpreF).

Vaccine

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

The Pharma Data

JUNE 24, 2021

government to purchase at not-for-profit price 200 million doses in 2021 and 300 million in the first half of 2022. The 300 million doses for 2022 will be delivered between January and end of June 2022. government also has the option for additional doses in 2022. government in Pfizer’s U.S. facilities.

Government

PLOS: DNA Science

SEPTEMBER 7, 2023

ChatGPT was released November 30, 2022, from OpenAI/Microsoft. Now, college tuition includes a fee to license an e-textbook for a limited time. Initially, I was concerned about my future as the chatbot near-instantaneously answered my queries on increasingly obscure terms from my field, genetics. The first E-books date from the 1990s.

DNA

The Pharma Data

MARCH 22, 2022

Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus.

Treatment

Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway.

Therapies

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA

The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. These are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. Free cash flow¹ of USD 1.6 Financials.

Production

Codon

MAY 11, 2023

It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. In one instance, “a user heard the words ‘I don’t have my driver’s license yet.’ This paper was submitted to the journal more than a year ago, in April 2022.

Vaccine

Codon

MAY 11, 2023

It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. In one instance, “a user heard the words ‘I don’t have my driver’s license yet.’ This paper was submitted to the journal more than a year ago, in April 2022.

Vaccine

Codon

APRIL 16, 2023

These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study. Read An RNA-based system to study hepatitis B virus replication and evaluate antivirals.

Engineering

The Pharma Data

MAY 4, 2021

Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) — In February 2021, Pfizer announced that the FDA approved the supplemental Biologics License Application (sBLA) for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).

Vaccine

Codon

JANUARY 21, 2024

A 2022 survey identified 284 human challenge trials that have been conducted since 1980. 2 AP: A news story in Nature about your organization, 1Day Sooner, discussed some recent challenge trials involving the hepatitis C virus. When we're doing a human challenge study, it is with a well-characterized virus or pathogen.

Vaccine

The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

Vaccine

Drug & Device Law

JULY 31, 2023

171, 212 (Fall 2022). Uber Technologies , 2022 Cal. March 22, 2022) (same); Shaff v. 2022), review denied (Cal. Uber , 2022 WL 2031868, at *2 (Cal. July 13, 2022) (similar language). 2022 WL 551701 (N.D. 3d , 2022 WL 16752071 (C.D. 1145, 1165 n.135 Meta Platforms, Inc. Lexis 9648, at *6 (Cal.

Production

Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991. billion by 2031.

Drugs

Codon

FEBRUARY 23, 2025

Because of PEPFAR’s effectiveness, the United Nations (UN) set an ambitious goal in 2022 to end HIV transmission and eliminate AIDS-related deaths by 2030. Experimenting with a retrovirus called murine leukemia virus , he found that zidovudine did, in fact, obstruct retrovirus replication by inhibiting reverse transcriptase.

Clinical Trials