The Pharma Data

NOVEMBER 2, 2020

Food and Drug Administration, Gover said he believes there is a “clear path” to the submission of a New Drug Application as soon as 2021. If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. Now is the ideal time to develop nabiximols in the U.S.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. 2018 Feb;37(2S):S48-S51.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S

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The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test.

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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. We will have to look to 2024 to assess whether there is any meaningful change in FDA policy in regard to voting.

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Drug Target Review

JULY 5, 2024

1 Considerations for creating complex organoids Despite the numerous advantages of using brain organoids in drug discovery, some limitations should be considered. 1 Considerations for creating complex organoids Despite the numerous advantages of using brain organoids in drug discovery, some limitations should be considered.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials.

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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 Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Jump up to: a b “Novel Drug Approvals for 2024” U.S. IV -Blocker max. AOP Health.

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The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics. Jason Scott. Source link.

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA). 19 August 2024. Retrieved 21 August 2024.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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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. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm.

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New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] Food and Drug Administration (FDA) (Press release).

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Practical Cheminformatics

AUGUST 3, 2023

Most papers describing new methods for machine learning (ML) in drug discovery report some sort of benchmark comparing their algorithm and/or molecular representation with the current state of the art. I wrote more about the problems with this dataset in a Practical Cheminformatics post in 2018. We want to design drugs that are safe.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

In the veterinary world, where rolling applications are common, the testing phase is usually particularly important because the review phase, which starts only when the last component of the rolling New Animal Drug Application (NADA)—called the Administrative NADA—is submitted, is short, typically around 60 days.

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Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

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The Pharma Data

MARCH 30, 2021

Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. UBRELVY® Indication.

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Eye on FDA

JANUARY 16, 2023

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. Third, AdComms aren’t as approving as they used to be. But there are others.

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Practical Cheminformatics

FEBRUARY 1, 2023

The 2018 paper by Gómez-Bombarelli, which launched the field, has already been cited more than 2,100 times. Most early papers focused on optimizing simple objectives such as a calculated LogP and/or some computed measure of drug-likeness. As of 2021, there are over 70 FDA-approved drugs that are kinase inhibitors.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 In 2018, Janssen Biotech, Inc.

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New Drug Approvals

AUGUST 26, 2023

Zuranolone CAS 1632051-40-1 Zurzuvae FDA APPROVED 8/4/2023, To treat postpartum depression Press Release WeightAverage: 409.574 Monoisotopic: 409.272927379Chemical FormulaC 25 H 35 N 3 O 2 SAGE 217 SAGE-217 SAGE217 Zuranolone , sold under the brand name Zurzuvae , is a medication used for the treatment of postpartum depression. [1]

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The Pharma Data

JANUARY 31, 2021

Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018 , following U.S. S-Trimer is intended to be adjuvanted.

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Agency IQ

APRIL 26, 2024

In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. However, the 2018 guidance it did not offer advice for interchangeable product labeling. Today, FDA published a revised version of the Q&A guidance on promotional labeling. Read AgencyIQ’s analysis of this guidance here.]

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The Pharma Data

DECEMBER 3, 2020

Trimer-Tag © is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. S-Trimer is intended to be adjuvanted.

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Agency IQ

JUNE 7, 2024

Over the years, the retroactive structure of DSHEA has encouraged the influx of bad actors who have identified the dietary supplement sector as a venue for the introduction of unapproved drugs into the U.S. Some examples of products available as both drugs and dietary supplements quietly exist in the marketplace without much fanfare.

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The Pharma Data

JUNE 28, 2021

” Aimovig (erenumab-aooe) was approved as a preventive treatment for migraine in adults in the United States on May 17, 2018. As of May 2021, it has been approved in 71 countries or territories, including the European Union, the United Kingdom, Canada, and Australia, and is approved by many regulatory authorities worldwide.

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Europe and Japan.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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The Pharma Data

AUGUST 1, 2021

The approval decision from the European Commission (EC) is anticipated in the third quarter of 2021 and if approved, this will be the fourth indication for Rinvoq in the European Union. This is the second collaboration extension and builds on the partnership established in 2014 and extended in 2018.

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The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

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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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Drug Target Review

JUNE 21, 2023

1 With novel emerging drug modalities further expanding the druggable genome, connecting the right target genes to a disease will only become more relevant. As most inherited diseases are caused by gene mutations that lead to a defect or loss of function, the benefit of using genetics to find new drug targets is compelling.

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Eye on FDA

AUGUST 4, 2021

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. Fewer meetings – more approvals.

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Metabolite Tales Blog

MAY 12, 2023

Breaking C-F bonds in drugs – metabolism mediated release of fluorine By Samuel Coe and Julia Shanu-Wilson Lenacapavir, recently approved for multi-drug resistant HIV-1 infection, contains 10 fluorine atoms. Increasingly used in drug design, some drug structures are now bristling with fluorine atoms.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

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