The Premier Consulting Blog

JANUARY 14, 2025

Research and Development Projects Project Pragmatica An initiative to advance evidence generation for approved products Introduce functional efficiencies and enhance patient centricity by integrating aspects of clinical trials with real-world routine clinical practice through appropriate use of pragmatic design elements.

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Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Therapeutics There are no FDA-approved therapies built upon Cas12, but the enzyme is currently being used in multiple clinical trials.

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New Drug Approvals

JULY 10, 2025

. ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). October 2022). PMID 36251573. ^ “Sebetralstat Orphan Drug Designations and Approvals” U.S. Food and Drug Administration (FDA).

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New Drug Approvals

APRIL 18, 2025

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).

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New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 21 December 2022. 24 August 2022. FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release).

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FDA Law Blog: Drug Discovery

JUNE 18, 2025

As described in a 2022 FDA analysis , the median time-to-approval from submission for RTOR applications was 3.3 As an extreme example, FDA approved a supplement for Adcetris (brentuximab vedotin) for a new indication 11 days following application submission. requirement for new REMS, advisory committee, etc.).

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Crown Bioscience

JUNE 6, 2024

This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

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Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. 2022; 131(5): 311- 324. Tang et al.,

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Poster at ISSX/MDO 2022 Seattle meeting. [6] Br J Pharmacol.

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. 2] Iversen et al., 131(5): 311- 324.

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Eye on FDA

JANUARY 16, 2023

By contrast in 2021 there were only 10 (see blue bars below in the chart tracking meetings from 2017 – 2022). Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. But conversely, in 2022 the number of NMEs plummeted. Pre-pandemic numbers were consistently higher.

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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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The Pharma Data

FEBRUARY 24, 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. The DURYSTA data presentations coincide with the two-year anniversary of 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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Fierce BioTech

OCTOBER 5, 2023

Discover Strategies for Combatting Disruptions in Gene Therapy Development Cell and gene therapy development has exploded, with Q4 2022 showing more FDA approvals than over the past five years combined.[1] 1] How can sponsors keep pace with this rapidly growing market and avoid costly delays that can threaten critical timelines?

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New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1 December 2022. J Med Chem.

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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. About Biogen.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ? That’s important, because PTE applications for U.S. Patent Nos. Patent Nos.

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. In 2022, SEED Biosciences received its very first and prestigious New Product Award. He was awarded with the Ignite Award at SLAS 2019.

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. By contrast, in 2023, the number of recommendations for approval was over three times the number of negative outcomes.

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. In 2022, SEED Biosciences received its very first and prestigious New Product Award. He was awarded with the Ignite Award at SLAS 2019.

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New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending ( Motion to Dismiss Denied-in Part/Granted-in-Part ) 1:2023cv02884 (D.D.C.)

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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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. Two PTE applications were submitted to FDA ( See FDA Docket Nos. Patent Nos.

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The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The transaction is expected to be modestly dilutive to Sanofi’s EPS in 2022. Transaction Terms.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

The NADA applicant requested reconsideration, but FDA refused to set the testing phase at the INAD opening and instead used the date that a major health or environmental effects test on the drug was initiated. Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014.

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Policy Prescription

OCTOBER 3, 2023

In the summer of 2022, a policy debate in the Senate HELP committee ensued with Sens. Of course, India is the largest supplier of FDA-approved generic drugs sold in U.S. but negotiate higher prices in foreign markets. Consider how this international drug price dynamic may affect the politics of the issue. Many people in the U.S.,

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The Pharma Data

APRIL 15, 2022

In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. New GSK reaffirms its full-year 2022 guidance, the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**, and long-term sales ambition.

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. FDA Expedited Programs.

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The Pharma Data

NOVEMBER 3, 2020

mg, effective January 1, 2022. Prior to the January 1, 2022 effective date of the newly issued Category I CPT code, payments to physicians are expected to continue with the service reported using CPT code 0356T. DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery.

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Broad Institute

JULY 26, 2022

Resources, services, and tools By Maria Nemchuk July 26, 2022 Breadcrumb Home Resources, services, and tools Key scientific datasets and computational tools developed by our scientists and their collaborators. Learn more ENCODE Integrated, annotated encyclopedia of functional and regulatory elements in the genome.

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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. o) define children. [2]

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Alta Sciences

APRIL 17, 2024

According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. According to an article published in Frontiers in Pharmacology , as of October 2023, there were 15 FDA-approved ADCs on the market, and more than one hundred in clinical development in the U.S.A.,

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New Drug Approvals

DECEMBER 24, 2023

December 2022). S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. .; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634.

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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] July 2022). 1] It is taken by mouth. [1] 401 (10383): 1159–1171.

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