Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. To get an approved NDA or Biologics License Application (BLA) you must conduct all phases of clinical studies. A: This does not usually happen. of this guidance. of this guidance.

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Packaging FDA Trials Regulations 52

PPD

JULY 9, 2024

How the flex hub model saves one developer time and money As an example of the value that our flex hub model brings to biotech and pharmaceutical developers, here is a brief look at one long-term partnership in place since 2013.

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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Agency IQ

MARCH 25, 2024

As explained in a 2013 Government Accountability Office report, the intent of the CPG was to “identify those circumstances under which the agency believed establishments with retail pharmacy licenses were engaged in ‘manufacturing, distributing, and promoting unapproved new drugs’ in a manner outside the traditional pharmacy practice of compounding.”

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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. as well as Champions Oncology Inc.,

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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New Drug Approvals

SEPTEMBER 29, 2024

In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). In January 2023, Quince put out word that it had sold Cortexyme’s legacy small molecule protease inhibitor portfolio to Lighthouse Pharmaceuticals, a company co-founded by a former Cortexyme CEO ( press release ).

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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. Many studies have also employed a follow-up session for the participant to discuss their experience with the practitioner.

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Agency IQ

JANUARY 26, 2024

Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates. And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.” Enter the beyond-use date.

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New Drug Approvals

JULY 10, 2023

Possible CGRP involvement in migraine has been the basis for the development and clinical testing of a number of compounds, including for example, advanced clinical candidates rimegepant (BHV-3000) and zavegepant (BHV-3500), which are developed by Biohaven Pharmaceutical Holding Company Ltd., New Haven, CT. Click here to purchase.

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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.

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The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Licensing and royalty revenue.

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Codon

JUNE 30, 2024

Biotech startups were incorporated, pharmaceutical firms partnered with universities, and even oil companies initiated research programs to create engineered organisms. At that time, their case became entwined with a similar case filed by a pharmaceutical manufacturer called Upjohn Company regarding a patent for a purified strain of fungus.

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Agency IQ

JUNE 16, 2023

2) Update delivery timing and methods to require community water systems that serve 10,000 or more persons to provide reports biannually; and allow electronic delivery methods consistent with the “Safe Drinking Water Act–Consumer Confidence Report Rule Delivery Options” issued by the EPA on January 3, 2013.

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New Drug Approvals

APRIL 21, 2025

2013 Jun 11;110(24):9992-7. Epub 2013 May 28 PATENT [link] Chemical Synthesis Methyl 3-(3-bromopropoxy)-4-fluorobenzoate (Compound 2) To a solution of methyl 4-fluoro-3-hydroxybenzoate 1 (3.0 June 2013). June 2013). It is taken by mouth. [1] 1] The most common adverse reactions include diarrhea and upper abdominal pain.

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FDA Law Blog: Biosimilars

MARCH 31, 2025

2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. In Actavis , the FTC argued that pharmaceutical settlements should be subject to a presumption of anticompetitive effect. Supreme Court declined to hold, in FTC v. Actavis, Inc., The latest iteration of proposed Section 27 in S.

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FDA Law Blog: Biosimilars

APRIL 2, 2025

2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. In Actavis , the FTC argued that pharmaceutical settlements should be subject to a presumption of anticompetitive effect. Supreme Court declined to hold, in FTC v. Actavis, Inc., The latest iteration of proposed Section 27 in S.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2024

2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. In particular, the Supreme Court has weighed in fairly definitively in its 2013 decision in FTC v. Supreme Court declined to hold, in FTC v. Actavis, Inc., As we noted in our prior post, S. A lot has happened since then of course.

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Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. If a permanent freeze goes into effect, researchers estimate there could be 8.7

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. Forest Pharmaceuticals, Inc.

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Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , 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. April 15, 2013); Tofolowsky v. May 3, 2013) (all quoting §19(a)). Tosh , 929 F.

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Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , 2013); Massa v. 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.

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Drug & Device Law

OCTOBER 27, 2022

2022), is neither a medical-device nor a pharmaceutical case. 2013); Heisner v. In support of that proposition, the defendants pointed the agency’s declaration that it “believe[d] that photographic identification, a valid driver’s license, validated biometric means, or other means can be useful in establishing the donor’s identity.”

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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 2d 891 (W.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 692, 694 (5th Cir.

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Drug & Device Law

MARCH 7, 2022

Francis , 2013 WL 5603848, at *2 (D.N.J. It does not give him license to evade the less rigid ? 2013 WL 5603848, at *2 (citing Malleus v. It does not, however, give a plaintiff “license to evade the less rigid ? 2013 WL 12226936, at *6 (D. 13, 2013); Moore v. Sun Pharmaceuticals Industries, Ltd.

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