The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. TITUSVILLE, N.J. , cp-51575v4. REFERENCES.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. About Takeda Pharmaceutical Company Limited. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. ryoko.matsumoto@takeda.com . +81

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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.

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The Pharma Data

NOVEMBER 9, 2021

Johnson & Johnson and its Janssen Pharmaceutical Companies moment blazoned they will appeal the$ 572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s action against opioid manufacturers. The Company is confident it has strong grounds to appeal this decision.

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The Pharma Data

JANUARY 24, 2021

is a specialty pharmaceutical company focused on the development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. Persons”, as such term is defined in Regulations under the U.S. Toronto, Ontario–(Newsfile Corp.

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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.

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Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval. Light and Sound Progress in biology has long been driven by light.

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The Pharma Data

DECEMBER 8, 2020

OSAKA, Japan–( BUSINESS WIRE )– As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade.

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The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced financial results for the first half of fiscal year 2020 (period ended September 30, 2020). 29, 2020 06:19 UTC. Press release ). Press release ). Press release ).

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Codon

MARCH 24, 2024

In response to this hysteria, regulation was aggressively tightened. To make matters worse, many companies struggled with engineering problems on the path to scale. Between the technical uncertainty and the horrendous PR, pharmaceutical companies had little interest in adopting molecular farming technologies.

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Approximately 4,500 people in the U.S. Janssen Biotech, Inc.

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The Pharma Data

NOVEMBER 4, 2020

Securities and Exchange Commission Regulation G. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in the future. Use of Non-GAAP Adjusted Financial Information. About Amarin.

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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. About the Janssen Pharmaceutical Companies of Johnson & Johnson. 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. About the Janssen Pharmaceutical Companies of Johnson & Johnson. 2 ERLEADA ® received U.S. To date, more than 10,000 patients worldwide have been treated with ERLEADA ®.

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The Pharma Data

NOVEMBER 23, 2021

Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. It’s a type of herpes contagion.

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Drug Patent Watch

DECEMBER 19, 2024

As companies invest billions in research and development, protecting their innovations through strategic patent management has become more important than ever. This comprehensive guide will explore how pharmaceutical companies can leverage their drug patent portfolios to maximize value, maintain market dominance, and drive innovation.

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Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. We were hardly alone.

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 727 F.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F. That’s why Buckman Co. 1, 6 (D.D.C.

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Drug & Device Law

AUGUST 28, 2023

It has generally been assumed that such plaintiffs, while free to seek an advisory opinion from the FDA, may not collaterally attack FDA decisions in other litigation. FDA , 727 F. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. E.g. , Estee Lauder, Inc. 1, 6 (D.D.C.

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Drug & Device Law

MARCH 15, 2023

The Azurity case was a beef between a specialty pharmaceutical company that sold an FDA premarket approval drug and a drug compounding company that sold a competing drug that had not been given FDA premarket approval. That last point was a shot at the premarket approval drug.

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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

NOVEMBER 15, 2022

Mensing, Mutual Pharmaceutical Company v. The AERs were also too infrequent (no more than 20 cases over seven years) to be considered occurring at a greater frequency than at the time of FDA approval. Plaintiff also premised her failure to warn claims on a failure to report adverse events to the FDA.

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Drug & Device Law

JUNE 29, 2022

We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Rather, a pharmaceutical company sued a compounder for fraudulently stealing business from it. The FDA approved the plaintiff’s 5 mg solution, and the only other FDA approved ephedrine solutions came in the 50 mg concentration.

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