Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease.

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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). Cystic Fibrosis Foundation News Release, July 18, 2017. About 30,000 Americans have CF.

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Drug Target Review

JULY 5, 2024

Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 545:54-59 (2017).

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. Labcompare.

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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. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab).

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Agency IQ

SEPTEMBER 15, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 11, 2023 6:44 PM CDT Regulatory background: User fees and over-the-counter (OTC) drug reform Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Without sufficient resources, the FDA is unable to do so. Read AgencyIQ analysis here.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The result was the addition of Section 503A to the FD&C Act.

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Vial

JUNE 12, 2024

PROs, included in clinical trials as primary or secondary endpoints , are increasingly recognized by regulators, clinicians, and patients as valuable tools. Role of PROs in drug approvals A recent review sought to comprehensively characterize the inclusion of PROs and regulatory considerations in FDA-approved novel oncology drugs.

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The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Daratumumab already is approved for the treatment of multiple myeloma. Scientists at Charité, University Medicine Berlin , have been able to use daratumumab to successfully treat two female patients who have systemic lupus erythematosus.

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Europe and Japan.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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Agency IQ

MAY 17, 2024

The bill is effectively a successor to the RACE for Children Act of 2017, which became law as part of the FDA Reauthorization Act of 2017 (FDARA). However, the FDA then approved another amifampridine product, Ruzurgi, in 2019 for the treatment of LEMS in pediatric patients. DORIS MATSUI (D-Calif.)

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

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Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. 2.2017 were used given 74 percent enrollment in 2017.

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The Pharma Data

NOVEMBER 4, 2020

Securities and Exchange Commission Regulation G. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. Use of Non-GAAP Adjusted Financial Information. 500 mg/dL) hypertriglyceridemia.

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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. ERLEADA ® received U.S. 2 To date, more than 10,000 patients worldwide have been treated with ERLEADA ®.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on April 28, 2011 and by the European Commission on September 7, 2011. FDA on February 8, 2018. [vi] vi] Since its first approval in the U.S. 2 ERLEADA ® received U.S.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. 2017 Oct;9(10):249-262. 3 In August 2019 , RINVOQ received U.S. Arthritis Care & Research. 2015;10;1-25. Ajeganova S. and Huizinga T. Ther Adv Musculoskelet Dis.

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The Pharma Data

APRIL 26, 2021

New approvals. billion, zero coupon bond issued in March 2017 at maturity. Exjade/Jadenu. Top 20 products total. R&D update – key developments from the first quarter. Entresto. . These treasury share transactions resulted in an equity decrease of USD 1.7 billion and a net cash outflow of USD 1.9 billion compared to USD 24.5

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Agency IQ

MAY 3, 2024

With the new LDT final rule, FDA works to clarify what emergency response will look like going forward The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations. In the U.S. IVDs are defined at 21 CFR 809.3(a), The rule amends 21 CFR 809.3(a)

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Drug & Device Law

DECEMBER 21, 2023

255 (2017) ( 2017+1 ). FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. 21, 2017), in 2017 ), or Bausch v. Superior Court of California , 582 U.S. But here we are. 4th 210 (5th Cir. Novartis , 407 P.3d 3d 18 (Cal.

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Eye on FDA

OCTOBER 28, 2021

Recently it was reported that the President Biden appears ready to nominate former FDA Commissioner Robert Califf to boomerang back and head the agency for a second time. If so, he returns to very different circumstances than when he left FDA in January 2017 after an 11-month stay. 1) It begins with communication and lots of it.

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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.

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Drug & Device Law

DECEMBER 29, 2023

The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. Hrymoc was tried in late 2017. That makes Hrymoc a one-off exception from a general exclusion of §510(k) evidence.

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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. Cartridge Co. ,

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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.

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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. On occasion, states have attempted to prohibit sale and/or use of non-abortion-related FDA-approved products, but with one exception, these efforts have not resulted in litigation.

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Drug & Device Law

MARCH 2, 2023

The Supreme Court pretty much put the kibosh on this in 2017 in its Bristol-Myers Squibb decision. The application of specific personal jurisdiction remained a bit unclear , so the Supreme Court weighed in on the “related to” requirement in Ford v.

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Drug & Device Law

MARCH 19, 2024

Plaintiff did not allege that the design of the clips deviated from the FDA approved design. Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA. The court answered that question affirmatively for plaintiff’s design defect and manufacturing defect claims.

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Drug & Device Law

FEBRUARY 14, 2024

In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss. (Has any SCOTUS dictum visited more mischief? Lastly, the OPLA (bless it) bars punitive damages against FDA-approved products. 2024 Ohio Misc.

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Drug & Device Law

SEPTEMBER 9, 2022

After opportunity for notice and comment, the FDA promulgated literally hundreds of regulations classifying device types. Despite that classification, the statute allowed it to be cleared even before approval based on its equivalence to a device on the market in 1976, when MDA device regulation began. 2017); Kaiser v.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. She sued in 2017 with a bunch of the typical claims for medical device cases.

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Drug & Device Law

SEPTEMBER 12, 2022

As with practically all post- Albrecht successful preemption cases, the drug had an extensive FDA regulatory history regarding the risk at issue (suicide) and related risks (chiefly depression and suicidal ideation). Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R.

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Drug & Device Law

APRIL 17, 2023

Allegations that FDA-approved drug warnings are inadequate justify taking judicial notice of those warnings on a motion to dismiss. What such agency approved warnings say “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” quoting Fed.

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