FDA Law Blog: Biosimilars

AUGUST 7, 2024

On July 30, brand name drug sponsor Novartis asked the District Court for a Temporary Restraining Order ( here and here ) enjoining FDA’s approval of a generic version of its ENTRESTO (sacubitril and valsartan) with certain dosing and indication information carved-out or modified.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. For more information on Kite, please visit www.kitepharma.com.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. Important Safety Information. BOSTON, Nov.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. For more information, see “Selected Safety Information” below. Selected Safety Information for Verquvo WARNING: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment.

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The Pharma Data

FEBRUARY 24, 2022

See the prescribing information for additional information on risks associated with Jardiance. The FDA granted the approval of Jardiance to Boehringer Ingelheim. Related Information. FDA takes steps to spark development of heart failure drugs Heart Health for Women. ###. Source link: [link].

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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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.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Specifically, Vanda alleges that FDA communications to certain generic competitors regarding dissolution rates, impurities, and micronization revealed Vanda’s confidential manufacturing information and caused economic injury to the company. FOOD AND DRUG ADMINISTRATION FOIA – FDA Presentation Pending 1:2023cv02325 (D.D.C.)

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Drug Target Review

MARCH 12, 2024

Bile acids are crucial signalling molecules that aid the regulation of the immune system and have essential metabolic functions, like controlling lipid and glucose metabolism. microbeMAAST: a taxonomically informed mass spectrometry search tool for microbial metabolomics data. Biochemical Pharmacology. Nature Microbiology.

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Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval. Spanogle, Ph.D.

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. The FDA granted approval of the IGA in GalSafe pigs to Revivicor Inc. SILVER SPRING, Md. ,

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

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The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects. [3]

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

MAY 13, 2021

Regulator seeks views on reclassification of pain medication ( MHRA 1 , 2 ). Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection ( FDA ). Medtech. Government, Regulatory & Legal.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

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DrugBank

MAY 6, 2024

A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.

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The Pharma Data

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.” For additional information, see Makena Information on FDA.gov. Source link: [link]

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Drug Target Review

OCTOBER 17, 2024

This year we completed investigational new drug (IND) enabling studies of ONC-841, which is an antagonist of Siglec-10, and received US Food and Drug Administration (FDA) approval for first-in-human study (FIH) in patients with solid tumours. The first patient has been dosed in the last quarter.

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The Pharma Data

MAY 17, 2021

. In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package insert for situations such as drug repurposing and de-escalation of therapy.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. They all as for the same type of information: U.S. An authorization letter from an appropriate representative of Boston Scientific Corporation would satisfy this Requirement for Information.

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The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML.

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Advarra

JANUARY 23, 2024

Researcher Considerations for IRB Review of Study Changes Modification or amendment information should include sufficient detail for IRB assessment. The more information researchers provide in the IRB submission, the easier it is for the IRB to consider implications for the research, researcher, and current and future research participants.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s analysis of the draft guidance here. ]

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Why This Guidance Now?

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

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FDA Law Blog: Biosimilars

MARCH 12, 2024

In fact, federal law and regulation appear to require AbbVie to list these patents.” No matter how Congress and FTC frame it, it is FDA that’s to blame for the listing confusion when it has had more than 20 years to respond to questions about whether these types of patents should have been listable in the first place.

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Pharmaceutical Development Group

AUGUST 9, 2021

Offshoring, sophisticated information technology, climate change, and a fresh approach to sales and marketing are all opportunities that the pharmaceutical sector may use. This condition of things is due to several variables. The pharmaceutical sector has certain distinct characteristics that influence product development.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C. Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Even more definitively, FDA wrote: Thus, when the BPCI Act was passed by Congress in 2009 and signed into law on March 23, 2010, the statutory term “strength” in section 505(j)(2)(A)(iii) of the FD&C Act had an existing, well-established administrative meaning that reflected both the total drug content (e.g.,

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The Pharma Data

NOVEMBER 20, 2020

The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments.

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