Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 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.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 18, 2021

In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. About Sandoz.

Biosimilars 40

Biosimilars Government Production Pharmaceuticals 40

FDA Law Blog: Biosimilars

JULY 24, 2023

Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

FDA 52

FDA Regulations Clinical Trials Production 52

The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . The collaboration aims to help alleviate supply and logistical constraints in the African Union member states .

Government 52

Government Production Biosimilars Treatment 52

The Pharma Data

JULY 27, 2021

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

JANUARY 26, 2021

Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr.

Hospitals 40

Hospitals Laboratories Pharmaceuticals Production 40

The Pharma Data

MAY 15, 2023

In total, 4 out of 10 members of the new Sandoz Board of Directors will be female, resulting in an above average 40% female-to-male ratio for this important governance body. “I Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

Science 40

Science Doctors Government Compliance 40

The Pharma Data

SEPTEMBER 17, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims.

Therapies 52

Therapies Production Government Biosimilars 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% This extension does not include potential pediatric exclusivity. About IBRANCE® (palbociclib) 125 mg tablets and capsules. 2,3 In the U.S.,

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

Production 52

Production Government Regulations Marketing 52

The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

Production 52

Production Government Marketing Regulations 52

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Clinical Trials Government 40

The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. The increase in U.S.

Production 52

Production Marketing Research Government 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

FDA 115

FDA Production Regulations Marketing 115

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the FDA has appropriated funding through January 19.

FDA 40

FDA Science Regulations Production 40

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

Clinical Trials 52

Clinical Trials Drug Development Trials Biosimilars 52

FDA Law Blog: Biosimilars

MARCH 22, 2023

When an ambiguous law or regulation is presented to a court, it is the court’s job to decide what it means, no matter how ambiguous or inartful the provision may be. That commentary does not typically focus on the stakes for a defendant that believes it was right, goes to trial and loses.

Government 59

Government Trials Regulations 59

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the U.S.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. The positive CHMP opinion is based on data from the VIALE-A and M14-358 trials and represents the third positive CHMP opinion for an extension of indications for Venclyxto. Humira net revenues were $3.907 billion , an increase of 6.9 percent on a reported basis, or 12.6

FDA 40

FDA Production Treatment International 40

The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021.

Production 52

Production Clinical Trials Trials Government 52

The Pharma Data

JULY 8, 2021

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Source link: [link].

Disease 52

Disease Government Clinical Trials Research 52

The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., Chief Executive Officer of Alexion. ” Third Quarter 2020 Financial Highlights.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recorded a $4.7

Production 52

Production International Clinical Trials Small Molecule 52

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

International 40

International Regulations Production Marketing 40

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

MAY 14, 2021

Pfizer publishes clinical trial diversity data from past decade, showing there’s much work to be done ( Endpoints ). Lupin Pursues India Approval For Lucentis Biosimilar, COVID-19 Opportunities ( Scrip ). Lupin Pursues India Approval For Lucentis Biosimilar, COVID-19 Opportunities ( Scrip ).

FDA 52

FDA Therapies Vaccine Biosimilars 52

Agency IQ

JULY 28, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 27, 2023 11:49 AM CDT Big-picture things to watch in Q3 A rush of things for FDA to do as we approach the end of the fiscal year: The government operates on a Fiscal Year that begins on October 1 each year and ends on September 30. government by October 1.

FDA 40

FDA Science Biosimilars Regulations 40

The Pharma Data

MAY 3, 2021

Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ).

Vaccine 52

Vaccine Biosimilars FDA Regulations 52

Drug Discovery World

JULY 26, 2024

This, coupled with looming patent expirations, the impact of new drug pricing regulations, and tighter universal regulation of medical devices presents a complex environment for both large and small life science companies. Conversely, Trump champions free market competition and biosimilars. A new direction for the UK?

Science 130

Science Government Biosimilars Marketing 130

The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). Government, Regulatory & Legal.

Trials 52

Trials Vaccine FDA Biosimilars 52