The Pharma Data

JANUARY 6, 2021

2018)2: Menter MA, Armstrong AW, Gordon KB, Wu JJ. 2018 Feb;37(2S):S48-S51. UNION is headquartered in Hellerup ( Denmark ) and is managed by an experienced international team. For more information please visit: www.uniontherapeutics.com. Sources 1: Li et al. Common and Not-So-Common Comorbidities of Psoriasis. Semin Cutan Med Surg.

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Drug Discovery World

OCTOBER 4, 2022

“Global dementia prevalence is expected to increase to 152 million in 2050, a 204% increase compared to 2018. billion in 2013 to less than $3 billion in 2018) due to loss of patent protection for the five FDA approved pharmacologic treatments available for AD, none of which slow or stop the damage from the disease. .

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The Pharma Data

NOVEMBER 2, 2020

If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. In 2018, the FDA approved Epidiolex as a treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. It also forced the U.S.

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The Pharma Data

OCTOBER 26, 2020

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. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. .

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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. There are two things of note from this year.

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The Pharma Data

JANUARY 18, 2021

Given the pandemic, 2020 can’t be viewed as a typical year, but Prevision noted that the number of applications for new drugs or indications sent to the committees had already decreased steadily pre-pandemic, with only 23 in 2019 and 30 in 2018.

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The Pharma Data

JUNE 17, 2022

This potential approval of Hyrimoz HCF builds on the already approved and well-established Sandoz biosimilar portfolio in immunology, including Erelzi ® (biosimilar etanercept), Zessly ® (biosimilar infliximab) and Rixathon ® (biosimilar rituximab, including rheumatoid arthritis indication).

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Drug Target Review

JULY 5, 2024

Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 15(9):700-706 (2018) [link] Deshmukh V, et al. 12(3) (2023). link] Madhavan M, et al. Nat Methods. 502:327-332 (2013).

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The Pharma Data

DECEMBER 9, 2020

The FDA approved the first ADC just this year – Immunomedics’ Trodelvy, for treating adult and pediatric glioblastoma. . The German company bought ViraTherapeutics in 2018 and cancer vaccine creator AMAL Therapeutics the next year. While they’ve been around for decades, not many ADCs have made it to the market yet.

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Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. Chemical Research in Toxicology 2018 31 (7), 570-584, [link] [8] Interindividual Variability in Cytochrome P450 3A and 1A Activity Influences Sunitinib Metabolism and Bioactivation. Bourgeois, James A. Perkins, Arsany A. Abouda, Kahari J.

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Eye on FDA

JANUARY 16, 2023

Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. Looking at the second chart below, one can see that the number of AdComms since 2018 peaked in the same year FDA approved a record number of new molecular entities (NMEs).

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Drug Discovery World

APRIL 14, 2023

Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. M Celeste Simon, PhD, FAACR – GHA Clowes Award for Outstanding Basic Cancer Research Simon, a Fellow of the AACR Academy, is the Arthur H Rubenstein, MBBCh, Professor in Cell and Developmental Biology in the Perelman School of Medicine at the University of Pennsylvania.

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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]. link] [10] FDA prescribing information for gepirone. Health Sci Rep. 6(10):e1610.

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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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Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

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The Pharma Data

SEPTEMBER 28, 2021

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

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. This DNA Science post from 2018 traces the history of the efforts.

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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. link] [2] Zhang and Tang, 2018. 2018 Sep;8(5):721-732. Br J Pharmacol.

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The Pharma Data

DECEMBER 30, 2020

Andexxa, was approved by the U.S. Food and Drug Administration in 2018 and is currently the only approved Factor Xa inhibitor reversal agent. billion in cash to gain control of FDA-approved Palforzia , a first-of-its-kind treatment for patients with peanut allergies.

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The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Department of Health and Human Services FDA Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.

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The Pharma Data

JANUARY 31, 2021

The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018 , following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

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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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Drug Discovery World

AUGUST 10, 2023

The number of people using e-cigarettes continues to climb, as the World Health Organization reported that 41 million adults used e-cigarettes globally in 2018. JB: Nicotine dependency continues to be a prominent health issue worldwide.

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Agency IQ

NOVEMBER 3, 2023

In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP. As with dietary supplements, cosmetic products do not need to have FDA approval before they go on the market; they are regulated after the fact.

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The Pharma Data

MARCH 30, 2021

The results were announced in a June 2018 press release and were also presented at the 2019 American Headache Society Annual Meeting.

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The Pharma Data

DECEMBER 3, 2020

The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. However, BeiGene announced that it is seeking approval in the U.S. for the years 2020 to 2022.

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. Like branaplam, risdiplam enhanced exon 7 inclusion and raised the levels of the SMN protein in cells.

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The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG is the first and only FDA-approved subcutaneous, self-administered medicine for NMOSD and the first medicine for NMOSD that is designed to target the interleukin-6 receptor, which is believed to play a key role in the inflammation associated with this disorder.”. ENSPRYNG has been designated as an orphan drug in the U.S.,

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Nat Rev Dis Primers 4, 1(2018). 14 In August 2019 , RINVOQ received U.S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16.

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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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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018.

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The Pharma Data

AUGUST 31, 2021

FDA approval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2To date, more than 40,000 patients worldwide have been treated with ERLEADA ®. 2] ERLEADA ® received U.S. For more information, visit www.ERLEADA.com.

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The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. ASCO Answers: Prostate Cancer (2018). ERLEADA ® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC.

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