FDA Approved Oncology Drugs 2023
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.
Metabolism of 2022 FDA approved small molecule drugs PART 1
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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Metabolism of 2022 FDA approved small molecule drugs PART 2
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.
Metabolism of 2023 FDA Approved Small Molecules – PART 1
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.
Repurposing FDA-approved drugs may help combat COVID-19
The Pharma Data
FEBRUARY 25, 2022
Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Commun Biol 5, 169, 2022. ” Other authors on the paper include Sydney A.
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When the Going Gets Tough – FDA AdComms in 2022
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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Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland
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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Allergan, an AbbVie Company, to Present Data from its Leading Portfolio of Eye Care Treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting
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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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
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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Discover Strategies for Combatting Disruptions in Gene Therapy Development
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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Olutasidenib
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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2023 IS the Year for OTC Naloxone!
FDA Law Blog: Biosimilars
MARCH 29, 2023
While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.
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“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace
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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Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease
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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Phase2/3 Interim Data Assessing the Safety, Tolerability and Clinical Issues of Veklury ® (Remdesivir) in Pediatric Cases With COVID-19 Presented at CROI 2022
The Pharma Data
FEBRUARY 12, 2022
This data will be presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022) taking place from February 12-16. Veklury was approved by the FDA on October 22, 2020 for grown-ups and pediatric cases 12 times of age and aged and importing at least 40 kg for the treatment of COVID-19 taking hospitalization.
Optimising CRIPSR gene editing of hard-to-transfect cells
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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FDA approves first over-the-counter naloxone nasal spray
The Pharma Data
MARCH 31, 2023
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. “The FDA remains committed to addressing the evolving complexities of the overdose crisis.
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Predicting Drug Development in 2023
EG Life Sciences
FEBRUARY 15, 2023
The year 2022 reflected a transformative path for the drug development industry. It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022.
Optimising CRISPR gene editing of hard-to-transfect cells
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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Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
The Pharma Data
OCTOBER 9, 2021
FDA is anticipated in late 2022. “As With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population. A decision from the U.S.
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The Year in AdComms – A Look Back at 2023
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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Adagrasib
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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Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)
The Pharma Data
OCTOBER 22, 2021
With 25 request share in soybean pesticides in Brazil, Bayer plans to upgrade this product in 2022 with the launch of Fox Supra, further expanding its commanding position in this largely important request, with a peak deals eventuality of further than€ 500 million. is underway.
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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)
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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Deuruxolitinib
New Drug Approvals
SEPTEMBER 10, 2024
Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,
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Breakthrough drug candidates and cancer treatment innovations
Drug Target Review
JUNE 5, 2023
As such, our team remains on track to complete our 5×5 strategy – laid out in October 2022 – by harnessing our technology and resources to continue efficiently growing Zymeworks’ pipeline of in-house and partnered candidates. Author Bio: Paul Moore, PhD Dr Moore joined Zymeworks in July 2022 as Chief Scientific Officer.
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Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government
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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A new viral surveillance system in West Africa is showing the world how to prevent the next pandemic
Broad Institute
APRIL 25, 2024
The Sentinel team put an early version of their system to the test in 2020 to respond to COVID-19 and again in 2022 for Mpox surveillance and response efforts. Sentinel is also developing a SHINE test to detect Lassa virus in rural clinics in Nigeria, where there are currently no FDA-approved diagnostics for the disease.
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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability
The Pharma Data
FEBRUARY 25, 2022
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
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Sanofi to acquire Kadmon to further strengthen growth of transplant.
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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Where's the Synthetic Blood?
Codon
JULY 14, 2024
In January 2022, the American Red Cross declared its first-ever national blood crisis owing to a severe blood shortage—the worst shortfall in more than a decade. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial.
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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious
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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An Evolving Regulatory Environment for Rare and Orphan Diseases
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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GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9bn
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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Ocular Therapeutix Announces Receipt of a Permanent Category I CPT Code from the American Medical Association for the Insertion of Intracanalicular Inserts
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.
Five Promising Treatment Areas in Early-Phase Drug Development in 2024
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.,
Resources, services, and tools
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.
The genetic modifier approach: identifying the right target for rare diseases
Drug Target Review
JUNE 21, 2023
Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2022 Aug;21(8):551. 2022 Jul 8;23(14):7570. 2022 Mar;603(7899):124-130. Epub 2022 Feb 23. DOI: 10.1101/2023.02.07.23285407. Ochoa D, Karim M, Ghoussaini M, Hulcoop DG, McDonagh EM, Dunham I. Nat Rev Drug Discov. PMID: 35804044.
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Sloane’s Journey with ASO Therapy
KIF1A
APRIL 25, 2024
September 2022 – We were contacted by n-Lorem to obtain blood from Sloane, my husband, and me. However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane.
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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
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]
Navigating the Challenges in Clinical Research for Hepatitis C Therapies
Vial
DECEMBER 11, 2023
The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. 2022) identified the limitations of current HCV diagnostic methods for early diagnosis and discussed the potential of nanotechnology in HCV diagnosis due to its simplicity, reliability, durability, and low cost. Zhao et al.
Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)
FDA Law Blog: Biosimilars
FEBRUARY 29, 2024
The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. FDA-2022-E-3124 ). 6,992,207 covering PEPAXTO (Docket No.
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FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
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.” The sponsor requested a hearing, which was held in October 2022.
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Eplontersen
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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