The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

FDA Approval 52

FDA Approval Therapies FDA Hospitals 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Small Molecule 102

Small Molecule Government FDA Approval Regulations 102

The Pharma Data

MAY 7, 2021

Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We For more than 170 years, we have worked to make a difference for all who rely on us.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Policy Prescription

OCTOBER 3, 2023

Second, governments in high-income foreign countries engage in some form of bargaining with drug companies on drug prices. Of course, India is the largest supplier of FDA-approved generic drugs sold in U.S. The theory covers four “stylized facts” of the international market in prescription drugs. First, drug prices in the U.S.

Pharmacy 84

Pharmacy International FDA Approval Government 84

Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Most FDA user fee amounts are published at a regular cadence.

FDA 40

FDA Government Drugs Production 40

The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. FDA approves expanded use for Chiesi’s sickle cell drug Ferriprox ( PMLive ).

Vaccine 52

Vaccine FDA Approval FDA Licensing 52

The Pharma Data

NOVEMBER 30, 2020

While the test could make it much easier for people to learn if they have Alzheimer disease, independent experts noted that information about the test’s accuracy have not been published and the test has not been approved by the U.S. government funded some of the research leading to the test, according to Eliezer Masliah, M.D.,

Disease 52

Disease FDA Approval Doctors Government 52

The Pharma Data

MAY 27, 2022

federal government spent an estimated $1.8 The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. . “Patients and the government are paying a lot for drugs that may not work.”

Clinical Trials 52

Clinical Trials Drugs FDA Government 52

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic. A decision on U.S. Actemra/RoActemra is not U.S.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

Compliance 52

Compliance FDA FDA Approval Drugs 52

Pharmaceutical Development Group

AUGUST 9, 2021

Since 1982, when the Federal Drug Administration (FDA) approved the first recombinant biotechnology drug, insulin, for human use, biotechnology, particularly biologic entities and biological processes, has provided key inputs for the development of pharmaceutical goods.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies FDA Approval Production 52

FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

Regulations 59

Regulations Pharmacy Licensing Licensing 59

FDA Law Blog: Biosimilars

APRIL 21, 2024

5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here ). Usually at this point in a post we would identify the date of approval of the relevant NDA.

FDA 59

FDA FDA Approval Production Marketing 59

The Pharma Data

NOVEMBER 16, 2020

DJSI World is a leading global index comprised of organizations that are corporate leaders in environmental, social and governance (ESG) practices, representing the top 10 percent of most sustainable companies in each industry. President and Chief Executive Officer of Regeneron.

FDA Approval 52

FDA Approval Science Disease Laboratories 52

The Pharma Data

DECEMBER 30, 2020

The Company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”. Source: AstraZeneca.

Vaccine 52

Vaccine Clinical Trials Trials Virus 52

The Pharma Data

NOVEMBER 16, 2020

The partnership brings NIH together with other HHS agencies and government partners and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Source: NIH.

Clinical Trials 52

Clinical Trials Vaccine Trials FDA Approval 52

The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca . Posted: January 2021. Source link.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: January 2021. Source link.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 17, 2021

As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective. The company is supported by funding from institutional investors, corporate partnerships and government grants. Surgery can also have a significant recurrence rate.

Treatment 52

Treatment Trials FDA Approval RNA 52

The Pharma Data

NOVEMBER 9, 2020

government. FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. billion from the U.S.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

JANUARY 12, 2021

The Swiss Federal Government has secured 7.5 Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine 52

Vaccine RNA Clinical Trials Science 52

The Pharma Data

NOVEMBER 16, 2020

government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an Emergency Use Authorization and/or similar global authorizations. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. government’s potential purchases of mRNA-1273.

Vaccine 52

Vaccine FDA Clinical Trials Pharmacy 52

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. million to 7.5

Vaccine 40

Vaccine RNA Clinical Trials Government 40

The Pharma Data

OCTOBER 25, 2020

SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020. The RALI-dx COVID-19 Severity Triage Test is expected to be used primarily in hospital emergency departments upon FDA approval. SQI intends to submit RALI- fast for EUA to FDA in late Q1 2021. intends to submit its EUA to FDA in early Q1 2021.

FDA 52

FDA Hospitals Clinical Development FDA Approval 52

The Pharma Data

OCTOBER 15, 2020

FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, ®, Impella LD®, and Impella 5.5®

Hospitals 52

Hospitals FDA Approval FDA Treatment 52

The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. For more than 170 years, we have worked to make a difference for all who rely on us.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

NOVEMBER 23, 2020

AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: November 2020. Source link.

Vaccine 52

Vaccine Virus Trials Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

The agreement also details the structure of shared governance of the joint collaboration. Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges. link] 1. About ImmunityBio.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

FDA 52

FDA Regulations Clinical Trials Drugs 52

The Pharma Data

JANUARY 13, 2021

A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

NOVEMBER 30, 2020

Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. Novavax was awarded $1.6 Source link.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

DrugBank

DECEMBER 18, 2024

For instance, consider Foundation Medicine's FoundationOne CDx , an FDA-approved comprehensive genomic profiling test for solid tumors. For payers, including insurance companies and government agencies, the widespread adoption of DTx can lead to significant long-term cost savings.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Treatment Therapies 52

The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .

Therapies 52

Therapies Clinical Trials Treatment Disease 52

The Pharma Data

NOVEMBER 16, 2020

government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine 52

Vaccine Clinical Trials FDA Disease 52

The Pharma Data

NOVEMBER 20, 2020

In some cases, governments may have regulatory pathways similar to an EUA. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. The companies will be ready to distribute the vaccine candidate within hours after authorization. Manufacturing and Delivery Capabilities. Source: Pfizer Inc. . Posted: November 2020. Source link.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52