2012, FDA Approval, Regulations and Trials

Microscopic innovations in women’s health

Drug Discovery World

SEPTEMBER 28, 2023

Ongoing impactful trials are investigating the potential for microbiome-based diagnostic tests for endometriosis 5 and PCOS 6 using blood, faecal, vaginal, and/or endometrial samples. For example, one clinical trial is using PCR to assess microbiota composition before and after a series of interventions for PCOS 7.

Clinical Trials

Clinical Trials Regulations Trials Drug Development

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

FDA Approval

FDA Approval FDA Treatment Pharmaceutical Companies

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. That PTE application was submitted to the PTO on July 26, 2012. That did not happen.

FDA

FDA Production FDA Approval Compliance

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s analysis of the draft guidance here. ]

FDA

FDA Science Production FDA Approval

Another Milestone in the Cystic Fibrosis Journey

NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. About 30,000 Americans have CF.

Clinical Trials

Clinical Trials Small Molecule Disease Therapies

AbbVie to Present Analysis Evaluating Continuous RINVOQ® (upadacitinib) Treatment in Psoriatic Arthritis for More Than One Year at EULAR 2021 Virtual Congress

The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. 1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. The approved dose for RINVOQ is 15 mg. NORTH CHICAGO, Ill.

Treatment

Treatment Therapies Clinical Trials Disease

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). AMG 451 / KHK4083.

Biosimilars

Biosimilars Production Treatment FDA

AstraZeneca’s COVID-19 Vaccine Authorised for Emergency Supply in the UK

The Pharma Data

DECEMBER 30, 2020

This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”.

Vaccine

Vaccine Clinical Trials Virus Government

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

FDA Science Regulations Production

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. All rights reserved.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Trials

Beyond Steel Tanks

Codon

MARCH 24, 2024

by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial. In response to this hysteria, regulation was aggressively tightened. . “It was about 6 p.m.

Engineering

Engineering Vaccine Production RNA

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. CARMIEL, Israel and BOSTON , Dec. About Fabry Disease.

Clinical Trials

Clinical Trials Disease Treatment Trials

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA Approval

FDA Approval Pharmacy FDA Drugs

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA

FDA Regulations Production Government

Third Circuit Affirms Mass Dismissal In Throwback Decision

Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. It turns out that our first post ended up describing the second worst case of the year. It also turns out the we were prescient, because the Louisiana Supreme Court ended up reversing the trial verdict for a number of the reasons we flagged.

Doctors

Doctors Packaging FDA FDA Approval

Drug Discovery Digest

Microscopic innovations in women’s health

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

Trending Sources

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Another Milestone in the Cystic Fibrosis Journey

AbbVie to Present Analysis Evaluating Continuous RINVOQ® (upadacitinib) Treatment in Psoriatic Arthritis for More Than One Year at EULAR 2021 Virtual Congress

Amgen Reports Second Quarter 2021 Financial Results

AstraZeneca’s COVID-19 Vaccine Authorised for Emergency Supply in the UK

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Janssen Presents Results from Phase 3 ACIS

Beyond Steel Tanks

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Logical Contradiction Doctrine: Buckman for Textualists

Third Circuit Affirms Mass Dismissal In Throwback Decision

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