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

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. Related Articles: Imcivree (setmelanotide) FDA Approval History.

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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. Our median cycle time is industry leading at 16 days in the U.S.,

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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

AUGUST 21, 2020

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments.

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Agency IQ

SEPTEMBER 15, 2023

The change, if adopted by FDA, will have huge implications for consumer options and will challenge the FDA to execute a clear communications rollout. Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs.

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The Pharma Data

JULY 29, 2021

With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. ” All biological products are approved only after they meet the FDA’s rigorous approval standards.

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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. Also, they help to explain how microbes in the gut can influence distant organ systems.

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FDA Law Blog: Biosimilars

JUNE 13, 2024

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R.

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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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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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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals.

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Philip Won , of Hyman, Phelps & McNamara, P.C.

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KIF1A

JULY 1, 2023

This activity may be regulated by the K-loop, which is known to be important for KIF1A’s long-range movement. Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning.

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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.”. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We We are pleased to work with U.S.

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The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. indications. Approximately 460,000 patients have been treated in the U.S.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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The Pharma Data

SEPTEMBER 7, 2020

The personalised cancer treatment has received conditional approval in the US. US regulators have approved Genentech’s Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Historically, the available drugs and U.S.

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FDA Law Blog: Biosimilars

MAY 15, 2023

By Riëtte van Laack — For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. AAFCO develops model regulations, that serve as model for the states.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

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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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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

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The Pharma Data

JANUARY 27, 2021

Our objective is to work with Bruker and our clinical partners to deliver an effective and high throughput assay protocol, that can be applied in the clinical setting, with the required sensitivity and specificity and CE/FDA approvals to provide a useful additional diagnostic tool in the fight against the coronavirus.

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Broad Institute

JULY 26, 2022

Learn more Drug Repurposing Hub A curated and annotated collection of FDA-approved drugs, clinical trial drugs, and pre-clinical tool compounds. Learn more Genotype-Tissue Expression (GTEx) A comprehensive public resource to study tissue-specific gene expression and regulation.

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Pharmaceutical Development Group

AUGUST 9, 2021

Since 1982, when the Federal Drug Administration (FDA) approved the first recombinant biotechnology drug, insulin, for human use, biotechnology, particularly biologic entities and biological processes, has provided key inputs for the development of pharmaceutical goods.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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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: Biosimilars

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , 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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The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. Key Takeaway RWD and RWE play an important role in rare diseases, where capturing relevant data to support drug development is challenging.

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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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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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