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]. link] [19] FDA prescribing information for zilucoplan.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

FDA Law Blog: Drug Discovery

MARCH 26, 2024

We authors eagerly await the publication of FDA’s Summary Basis for Approval for the Duvyzat NDA so that we can better understand the basis for the Agency’s finding of substantial evidence of effectiveness, particularly in light of recent FDA guidance on the topic of single study approvals with confirmatory evidence, available here.

FDA Approval 59

FDA Approval Therapies FDA Trials 59

FDA Law Blog: Biosimilars

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list.

Science 81

Science FDA Approval FDA Drug Development 81

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.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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.

FDA 52

FDA FDA Approval Biosimilars Science 52

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.

FDA Approval 52

FDA Approval FDA Clinical Trials Drug Development 52

BMG Labtech

JANUARY 18, 2023

And if you need to take an FDA-approved drug, there’s around a one in three chance that it’s a drug that targets a GPCR. In the first part of this blog article, we look at what GPCRs are, some of their responsibilities in the cell, and the overall approaches used to study these signaling molecules.

FDA Approval 52

FDA Approval FDA Research Drugs 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. 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.

FDA Approval 59

FDA Approval FDA Production Therapies 59

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] It is taken by mouth. [1] Hz, 1 H), 4.62−4.75

FDA Approval 52

FDA Approval FDA Treatment Pharmaceuticals 52

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. FDA Law Blog is a conference media partner for this event.

Compliance 52

Compliance FDA FDA Approval Drugs 52

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.

FDA 116

FDA FDA Approval Production Drugs 116

DS in Pharmatics

OCTOBER 14, 2022

An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]

FDA Approval 52

FDA Approval FDA Marketing 52

National Institute on Drug Abuse: Nora's Blog

APRIL 10, 2023

mfleming Mon, 04/10/2023 - 14:43 Nora's Blog April 13, 2023 Image Getty Images/ AleksandarGeorgiev This article originally appeared in the Milken Institute’s Power of Ideas series. Is It Too Soon To Start Talking about a Cure for Addiction? Our country remains in the grips of an opioid crisis claiming more than 100,000 lives every year.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The ChEMBL-og

FEBRUARY 22, 2021

Boxed warnings (also know as black box warnings) are provided on medicinal product labels for FDA approved drugs if the medicinal product can cause severe or life-threatening side effects. See our blog on Withdrawn Drugs. They are free text descriptions, enclosed within a black box, hence the name!

Drugs 52

Drugs FDA Approval Production FDA 52

Common Sense for Drug Policy Blog

MAY 1, 2024

However, prescription drugs must be approved by the Food and Drug Administration (FDA). Although FDA has approved some drugs derived from or related to cannabis, marijuana itself is not an FDA-approved drug.

FDA Approval 52

FDA Approval FDA Compliance Production 52

FDA Law Blog: Biosimilars

APRIL 21, 2024

Karst — If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. Usually at this point in a post we would identify the date of approval of the relevant NDA.

FDA 59

FDA FDA Approval Production Marketing 59

The Premier Consulting Blog

DECEMBER 28, 2023

Clinical studies are often conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions may require clinical data. In this blog post, we discuss key considerations for assessing the need for an IDE and complying with the reporting requirements under the IDE program.

FDA 52

FDA FDA Approval Regulations Compliance 52

New Drug Approvals

SEPTEMBER 20, 2023

1] Motixafortide was approved for medical use in the United States in September 2023. [2] 4 Similar in mechanism to the previously approved plerixafor , motixafortide is an inhibitor of C-X-C Motif Chemokine Receptor 4 (CXCR4), a protein that helps to anchor stem cells to bone marrow matrix. 1] It is given by subcutaneous injection. [1]

FDA Approval 52

FDA Approval FDA International Clinical Trials 52

Alta Sciences

FEBRUARY 8, 2024

Image Blog-Thumbnail_Driving-sim-webinar.jpg Synopsis Learn more about how Altasciences can test cognition, and the impact of driving under the influence of medication, using our state-of-the-art driving simulators. View the Driving Simulation Fact Sheet for more information.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

The Premier Consulting Blog

APRIL 15, 2024

In this blog, we will go into more detail about the unwritten nonclinical requirements for the PIND meeting.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

FDA Approval 52

FDA Approval DNA Small Molecule FDA 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. Koblitz & Karla L.

FDA 59

FDA FDA Approval International Production 59

KIF1A

APRIL 25, 2024

We are quickly approaching Sloane’s ASO dosing and I thought it might be helpful to “blog” about our experience so you all can follow along to see what the process is like. However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. Hello KIF1A Community!

Therapies 52

Therapies FDA Approval FDA Treatment 52

DS in Pharmatics

NOVEMBER 16, 2023

Proactive vendor evaluations, comprehensive domain expertise, and FDA-approved audits – DSI is your trusted partner for seamless 2024 GCP GMP audits.

FDA Approval 40

FDA Approval FDA 40

DS in Pharmatics

NOVEMBER 16, 2023

Proactive vendor evaluations, comprehensive domain expertise, and FDA-approved audits – DSI is your trusted partner for seamless 2024 GCP GMP audits.

FDA Approval 40

FDA Approval FDA 40

New Drug Approvals

DECEMBER 24, 2023

3] In November 2023, capivasertib was approved in the United States for people with hormone receptor-positive, human epidermal growth factor receptor 2 -negative breast cancer when used in combination with fulvestrant. [3] Jump up to: a b c d e f “FDA approves capivasertib with fulvestrant for breast cancer” U.S.

FDA Approval 62

FDA Approval FDA Production Therapies 62

PerkinElmer

JANUARY 7, 2022

link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet]. Available from: [link] The post Improving Drug Safety Through Cardiotoxicity Assessment first appeared on PerkinElmer Blog. Improving the odds of drug development success through human genomics: modelling study. Sci Rep 9, 18911 (2019).

Drugs 52

Drugs FDA Approval Pharmacokinetics Drug Development 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

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?

Small Molecule 102

Small Molecule Government FDA Approval Regulations 102

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.)

Government 59

Government FDA Pharmaceuticals FDA Approval 59

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Retrieved 21 December 2023. ^ “Wainua (eplontersen) granted regulatory approval in the U.S. 88 (12): 5389–5398.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings. 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.,

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

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.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

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?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

His unique background underscores his remarkable expertise as a cochlear implant researcher, a former FDA regulator, and his current role as a device attorney. The comprehensive agenda for the symposium can be accessed in its entirety here.

Science 52

Science FDA Approval FDA Regulations 52

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The FTC expressed concern that patent listings that do not meet the statutory criteria undermine the competitive process, may disincentivize investment in developing generic and follow-on products, and reduce patient access to more affordable drugs thereby increasing costs to the healthcare system.

FDA 105

FDA Drugs FDA Approval Biosimilars 105

New Drug Approvals

DECEMBER 16, 2023

Retrieved 10 December 2023. ^ “Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH” Novartis (Press release). 1 H NMR (400 MHz, methanol-d4) δ 10.73 (s, 1H), 8.23 (d, J = 8.2 Hz, 2H), 7.36−7.31

FDA 62

FDA Small Molecule FDA Approval Treatment 62

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. link] Take a look at our other blogs The post Metabolism of macrocyclic drugs appeared first on Hypha Discovery. Clin Cancer Res 27 (12): 3298–3306.

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52