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

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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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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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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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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Advarra

JULY 26, 2022

The 2018 Farm Bill. The 2018 Farm Bill removed hemp from the Controlled Substance Act. Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

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The Pharma Data

MAY 31, 2022

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Food and Drug Administration in 2017.

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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

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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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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The Pharma Data

APRIL 4, 2023

Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019.To ERLEADA ® received U.S. To date, more than 100,000 patients worldwide have been treated with ERLEADA ®.

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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

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

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The Pharma Data

AUGUST 10, 2020

65% of Americans said that they would be happy to get a COVID-19 vaccine that was both free and FDA approved. Several countries lost their measles elimination status in 2018. In 2015, immunisation rates were measured at 84% but in 2018 it had fallen dramatically to 31%. Photo by Senior Airman Areca Wilson. Conor Kavanagh.

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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. 2018) , Arnold Partnership v. Another case of same-day (and same-time) FDA approvals!

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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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Drug Target Review

FEBRUARY 15, 2024

12 That drug (tecovirimat) is now FDA-approved and stockpiled by the US and other governments for smallpox treatment, 13 while also being used in clinical practice globally for treatment of mpox and other viruses within the orthopox family. National Academies Press; 2018. 2018 Jul 5;379(1):44–53. The New York Times.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. Does HHS consider Epidiolex approved for cannabis rescheduling purposes?

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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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Drug Discovery World

JANUARY 17, 2024

Moreover, NGS testing is being used in three main clinical circumstances, including: (i) the determination of patient eligibility for clinical trials, (ii) for guiding advanced refractory disease treatment when first line treatments have failed, and (iii) for off-label use of FDA-approved drugs. 15 , 81–94 (2018). Narayan, P.

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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

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children. It has also been approved for newborns of mothers who have tested positive for Ebola. In 2019, the FDA approved an Ebola vaccine, Merck’s Ervebo. “We Today it announced that the U.S.

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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 Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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Eye on FDA

AUGUST 4, 2021

The blue represents the number of AdComms, Orange the number of new molecular entities and the gray the number of BT designations (Note that 2021 figures are through June 30): What we can see here is that there is a significant body growing of BT designated compounds and a growing number, generally speaking, of new molecular entities being approved.

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Agency IQ

MAY 17, 2024

Following FDA approval, these products are granted seven years of marketing exclusivity, preventing FDA from approving the “same drug for the same disease or condition” if the applicant does not have the right to reference the product (i.e., DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.), TAMMY BALDWIN (D-Wisc.).

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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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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. The FDA published recommendations for interchangeable products separately in a completely new guidance , issued two years later.

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Venclexta, an oral B-cell lymphoma-2 (BCL-2) inhibitor, was previously granted provisional approval in Nov.

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The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. 2018) 4;8:163. 2018) 9(507). 2018) 18(1).

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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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The Pharma Data

FEBRUARY 25, 2021

The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment with proven efficacy in adults, children and infants 2 months and older. Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older.

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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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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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