Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

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The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015. About BioLineRx BioLineRx Ltd.

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DrugBank

AUGUST 15, 2024

This drug, approved by the FDA in 2015, targets a protein that regulates cholesterol levels in the blood, offering a novel therapeutic approach for patients who do not respond adequately to statins. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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Drug Development Clinical Trials Drugs Therapies 101

Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. The April 2024 multi-day workshop showcased presentations and panels from various regulators, trade groups, academics and patient advocates.

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New Drug Approvals

SEPTEMBER 29, 2024

At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). 2013 Jan 1;36(4):665-77. Cortexyme’s approach is based on the theory that P. J Alzheimers Dis.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain. That would leave 19% of staff affected by furloughs.

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Codon

APRIL 19, 2023

In 2013, a Fusarium fungus — called Tropical Race 4 — was identified in Mozambique. This gene is regulated, in turn, by a small arsenal of other proteins from the MaMADS family. ( Most countries probably won’t regulate plants that are engineered with Tropic’s technology. Yes, I know. In 2016, the U.S.

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Codon

APRIL 19, 2023

In 2013, a Fusarium fungus — called Tropical Race 4 — was identified in Mozambique. This gene is regulated, in turn, by a small arsenal of other proteins from the MaMADS family. ( Most countries probably won’t regulate plants that are engineered with Tropic’s technology. Yes, I know. In 2016, the U.S.

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Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

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Agency IQ

MARCH 7, 2024

DAVID GREENBERG of Sanofi provided perspective based on an industry questionnaire , saying the transition will require industry to “re-activate or re-submit more than 300 TIV licenses, submit nearly 1500 variations, and update quality data in 174 countries.”

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

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The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Securities and Exchange Commission Regulation G. Licensing and royalty revenue. million and $8.9 million and $5.7 million and $1.1 million and $346.5 million and $227.6

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure. Biotechnology Journal (2013).

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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BioPharma Drive: Drug Pricing

JUNE 9, 2025

Originally designed to regulate blood sugar in type 2 diabetes, GLP-1 receptor agonists have evolved into groundbreaking treatments for obesity, cardiovascular disease and even neurodegenerative conditions.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. PNAS (2013).

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Nature Methods (2013).

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Armstrong , 2013 WL 4853333, at *20-21 (E.D. 10, 2013) (free speech considerations precluded negligent misrepresentation suit over contents of a book); E.S.S. Palli , 2013 WL 1867072, at *4 (Conn. Brown , 348 F.3d

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. 2013), we focused on the court’s endorsement of the “off-label protocol” for RU-486 (mifepristone), which was approved as an abortifacient, as “standard of care.” 472 (2013). (See

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2013); Heisner v.

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BMG Labtech

FEBRUARY 24, 2025

Protein nitration is one example that takes place on tyrosine residues which can have important consequences for the regulation of biological processes. 2013 Mar 19;110(12):E1102-11. Epub 2013 Mar 4. 3 in this blog adapted from this reference under license CC-BY 4.0. Nitration of Hsp90 induces cell death. 1215177110.

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