FDA Law Blog

JULY 21, 2022

In the July 2021 Executive Order on Promoting Competition in the American Economy , the White House noted that patent laws “have been misused to inhibit or delay—for years or even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” But President Biden wants that to change.

Generic Drugs 98

Generic Drugs Production Drugs Marketing 98

The Pharma Data

JANUARY 12, 2021

About the Regeneron Antibody Cocktail for COVID-19. About Regeneron. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. Regeneron expects to fulfill the entire 1.25 million targeted doses if the 1,200 mg dose is authorized.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

JULY 21, 2021

Leaders from these companies, organizations, and learning institutions have signed a pledge to co-develop programs focused on building trust in the health care system with communities of color and making measurable progress towards health equity. Enabling the next generation of Black and African American leaders.

Medicine 52

Medicine Clinical Trials Clinical Trials Trials 52

The Pharma Data

NOVEMBER 20, 2020

Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of the antibody cocktail for both the treatment and prevention of COVID-19, and we will share new results as available.”. About Regeneron. and Roche will develop, manufacture and distribute it outside the U.S.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 21, 2020

government allocation program. Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of REGEN-COV2 for both the treatment and prevention of COVID-19, and we will share new results as available.” Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

Cloudbyz

JUNE 1, 2023

Here are some key points about Salesforce Workflow Automation: Workflow Rules: These are the standard rules that an organization sets up to automate tasks like sending an email, updating a field, or assigning a new task when certain conditions are met. This feature is designed to save time and improve efficiency by reducing repetitive tasks.

Compliance 78

Compliance Development Branding Production 78

The Pharma Data

OCTOBER 25, 2020

More information about the symposium, which is available to registered attendees of the ASCAT meeting, can be found in the conference program. In addition, the report examines existing public policy efforts to address and alleviate the challenges faced by those living with SCD. 4 – 7.

Medicine 52

Medicine Development Containment FDA Approval 52

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. NAVIGATOR and the PATHFINDER clinical trial program Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE. Amgen will record sales in the U.S. Outside the U.S.,

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. 12-15 The program includes additional planned mechanistic and long-term safety trials. Tezepelumab granted Breakthrough Therapy Designation by US FDA.

Trials 40

Trials Production Sales Manufacturing 40

The Pharma Data

MAY 14, 2021

But in Claim Your Six Pack Abs I am going to show you how to go about getting that body anyway. I want to take a moment before I tell you what Claim Your Six Pack Abs is about to impress upon you what it is not. If you really want that body there is nothing stopping you from having it. Real people do possess those tight midsections!

Production 52

Production Containment Vaccination Vaccine 52

The Pharma Data

OCTOBER 29, 2020

Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials. About Alexion. This press release and further information about Alexion can be found at: www.alexion.com.

Sales 40

Sales Clinical Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 22, 2020

Emilio Emini, director of the TB & HIV program, the Bill & Melinda Gates Foundation. This grant will support ICRC’s work with experienced trial sites in sub-Saharan Africa to enroll, follow and retain the large number of women required for this research. About IMPOWER Clinical Trials Program.

Trials 52

Trials Clinical Trials Clinical Trials Production 52

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 previously $59.4

Vaccination 40

Vaccination Vaccine Production Sales 40

The Pharma Data

DECEMBER 30, 2020

But further confusing the issue was that about 1800 participants accidentally received a first dose that was only about half the intended dose. But in those participants, the efficacy was about 90%, while in the broader dosing regimen it was 62%. M&A. BioMarin Pharmaceutical’s Roctavian for hemophilia B.

Vaccination 52

Vaccination Vaccine Gene Therapy Trials 52

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.

Gene Therapy 246

Gene Therapy Gene Trials Bacteria 246

Pharmaceutical Technology

FEBRUARY 17, 2023

The non-binding draft guidance gives insight into the agency’s current outlook and recommendations for standard and expedited programs in oncology. In 2021, the FDA granted Amgen’s (NASDAQ:AMGN) non-small cell lung cancer (NSCLC) drug Lumakras (sotorasib) an expedited approval, making it the first FDA-approved KRAS inhibitor.

Clinical Trials 289

Clinical Trials Clinical Trials Trials Drugs 289

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. Centessa is exploring Serpin PC in a registrational program consisting of several trials, including the observational Phase II PRESent-5 clinical trial (NCT05605678).

Gene Therapy 147

Gene Therapy Gene FDA Approval Clinical Trials 147

XTalks

SEPTEMBER 14, 2020

An agreement had previously been reached between Ottawa and CanSino Biologics to launch a joint testing program in Canada. However, Hahn later retracted that statement, as that claim seriously overstated preliminary findings released by the Mayo Clinic about the benefit of convalescent plasma. Russia’s COVID-19 Vaccine.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92