Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA 40

FDA Pharmacy Drugs Production 40

Drug Target Review

JUNE 21, 2023

4 For the treatment of rare genetic disorders especially, drugs with genetically supported targets are more than twice as likely to be approved 5 , thereby indicating genetics and genomics can empower companies to develop better drugs. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Epub 2015 Nov 12.

Disease 112

Disease Clinical Trials Therapies Science 112

The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

FDA Approval 40

FDA Approval FDA DNA Therapies 40

The Pharma Data

MARCH 15, 2022

To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.

FDA Approval 52

FDA Approval FDA Production Drug Development 52

Dark Matter Blog

AUGUST 27, 2020

In addition to the early work of Matt Disney at the Scripps Research Institute and others in the academic community showing that this was even possible, a number of pharmaceutical companies have made important advances towards drugging RNA structures to discover new therapeutics.

Small Molecule 52

Small Molecule RNA Clinical Trials Drugs 52

Metabolite Tales Blog

MAY 12, 2023

Now >20% of all commercialised medicines in the pharmaceutical industry contain a fluorine atom [2]. In 2021, almost one third of FDA approved drugs contained at least one fluorine. References [1] Metabolic and Pharmaceutical Aspects of Fluorinated Compounds. Benjamin M. Airaksinen. Blackaby, Alastair J.

Drugs 52

Drugs Small Molecule FDA Approval Metabolic Stability 52

Agency IQ

JANUARY 19, 2024

Similarly, only one product in 2023 was recommended for approval under “ exceptional circumstances ” – Loargys. This approval type has always been uncommon – before the pandemic, this pathway was used just eight times between 2015 and 2019. [ See AgencyIQ’s analysis of this approval type from 2015-2021 here.]

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. Source link.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Clinical Trials 40

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. Migraine is both widespread and disabling. New Haven, CT.

Clinical Trials 40

Clinical Trials Treatment FDA Trials 40

Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), “between 2008 and 2015, amphetamine-related hospitalizations more than tripled, increasing from 55,447 instances to 206,180.

FDA 40

FDA Treatment Production Trials 40

The Pharma Data

AUGUST 11, 2020

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

AUGUST 11, 2020

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Treatment 52

Treatment Trials Therapies Clinical Trials 52

Agency IQ

SEPTEMBER 29, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

FDA Approval 52

FDA Approval FDA Production Treatment 52

The Pharma Data

FEBRUARY 8, 2021

The recruitment period for the study spanned from December 2015 to July 2017. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. About the Janssen Pharmaceutical Companies of Johnson & Johnson. ERLEADA ® received U.S.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3210 Accelerated Approval : FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA 40

FDA Science Regulations Production 40

New Drug Approvals

APRIL 9, 2025

1] Gepotidacin was approved for medical use in the United States in March 2025. [1] “FDA approval” Reuters. ^ “GSK’s investigational antibiotic granted FDA priority review for urinary tract infections” PMLiVE. World Health Organization (2015). 60 (3): 19181923. doi : 10.1128/aac.02820-15.

FDA 62

FDA FDA Approval Clinical Trials Treatment 62

New Drug Approvals

APRIL 5, 2025

Society and culture Legal status Treosulfan was authorized for medical use in the European Union in June 2019, [9] and approved for medical use in the United States in January 2025. [11] Retrieved 2 January 2023. ^ “Trecondi (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)” Therapeutic Goods Administration (TGA).

FDA 62

FDA FDA Approval Production Treatment 62

The Pharma Data

OCTOBER 14, 2020

Although Regeneron Pharmaceuticals has been in the news lately for its antibody cocktail against COVID-19 that was used to treat President Trump, it’s not the only arrow in the company’s quiver. Food and Drug Administration (FDA) approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.

FDA 40

FDA Treatment FDA Approval Virus 40

Drug & Device Law

FEBRUARY 22, 2024

Instead of highlighting the cognitive dissonance of the possibility that both of these theories of liability could be viable, we could be touting the creativity of the plaintiff lawyers trying different approaches to force pharmaceutical companies to play an unfun version of Simon Says.

FDA Approval 52

FDA Approval Clinical Trials Trials FDA 52

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.

Production 52

Production FDA Approval FDA Compliance 52

Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. Longbons T.,

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. 4th 851 (6th Cir.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

OCTOBER 13, 2023

Ortho-McNeil-Janssen Pharmaceuticals, Inc. , 2015), and the Supreme Court’s opinion in Mutual Pharmaceutical Co. It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is just a claim that the defendant should have proposed to the FDA a different warning than what the FDA approved.

FDA Approval 59

FDA Approval FDA Marketing Science 59

Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 2015)), Booker v. 604 (2011), and Mutual Pharmaceutical Co. It is fair to say that Bexis co-founded this blog (in 2006!) Federal preemption involving OTC drugs is the subject of today’s musings. 379r(a)(1).

Drugs 105

Drugs Regulations Production FDA Approval 105

Drug & Device Law

AUGUST 31, 2023

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. b)(2) not to make such a change without first obtaining FDA approval.” Ortho-McNeil-Janssen Pharmaceuticals, Inc. , Ortho-McNeil-Janssen Pharmaceuticals, Inc. , Bartlett , 570 U.S. 3d 281 (6th Cir.

FDA Approval 59

FDA Approval FDA Production Pharmaceuticals 59

Drug & Device Law

MARCH 16, 2023

2015), Tersigni v. It quoted from Bartlett on impossibility preemption and the rejection of the argument that it “could be avoided because [the] pharmaceutical company could comply with seemingly irreconcilable state and federal laws by ceasing production of the drug altogether.” Wyeth , 619 F.3d 3d 632 (6th Cir. Wyeth , 85 A.3d

FDA Approval 59

FDA Approval FDA Testimonials Production 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , Luitpold Pharmaceuticals, Inc. , Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. 2d 898, 909-10 (W.D.

Production 59

Production FDA Approval Vaccine FDA 59

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

JANUARY 9, 2023

Bayer Healthcare Pharmaceuticals Inc. 2022 WL 17348351, at *4. “[F]or certain categories of drugs” – including this one – “the monograph system replaces the individualized NDA approval process with a rulemaking process.” Here’s a link to the official statement on the FDA’s website. 2022 WL 16951538 (S.D.N.Y.

Regulations 59

Regulations FDA Nurses FDA Approval 59

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. 660, 664 (1962).

FDA Approval 116

FDA Approval FDA Drugs Regulations 116

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 127

FDA Approval Pharmacy FDA Drugs 127