2019 and FDA Approval - Drug Discovery Digest

‘Ice Bucket Challenge’ funds FDA-approved ALS treatment

Drug Discovery World

OCTOBER 4, 2022

Frates passed away in 2019 and Quinn passed away in 2020. . Balas added: “The approval of AMX0035 is further proof of how the Ice Bucket Challenge dramatically accelerated the fight against ALS. The post ‘Ice Bucket Challenge’ funds FDA-approved ALS treatment appeared first on Drug Discovery World (DDW).

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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. 2019), although many of these are very minor.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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Medicare program spent $1.8 billion in 2019 on drugs without confirmed clinical benefits

The Pharma Data

MAY 27, 2022

billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019. federal government spent an estimated $1.8

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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

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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Hanmi Pharmaceutical expects U.S. FDA approval for 2 new drugs

The Pharma Data

JANUARY 17, 2021

FDA approval this year. LAPS GLP-2 Analog was also designated as an orphan drug by FDA and EMA in 2019 and was subsequently designated as a drug for rare pediatric diseases (RPDs) by FDA in 2020. . Hanmi Pharmaceutical Co., Hanmi Pharmaceutical Co., .

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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.

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FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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Can an antibody therapy prevent fentanyl overdoses?

Drug Discovery World

FEBRUARY 15, 2024

As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose. There are very few treatments available to treat opioid use disorder (OUD) and we do believe the ones that are FDA approved should be made widely available to patients. The post Can an antibody therapy prevent fentanyl overdoses?

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How to advance AAV-based gene therapies

Drug Discovery World

OCTOBER 18, 2023

Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. Food & Drug Administration (2019) FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality.

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FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

The Pharma Data

SEPTEMBER 28, 2020

Nucala was first approved in 2015 to treat severe eosinophilic asthma as an add-on maintenance therapy for the condition, and for the treatment of eosinophilic granulomatosis with polyangiitis. It also received approval in 2019 to treat severe eosinophilic asthma in children. .

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Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

The Pharma Data

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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FDA approves first over-the-counter naloxone nasal spray

The Pharma Data

MARCH 31, 2023

In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products.

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Janssen submits EMA filing for bladder cancer treatment

Drug Discovery World

SEPTEMBER 14, 2023

N Engl J Med 2019; 381(4):338-348. “Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. Fernandez E, et al. J Clin Med. 2022;11(15): 4483.

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FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS –(BUSINESS WIRE)– Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Source link.

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Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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International Women’s Day: Female life science leaders

Drug Discovery World

MARCH 7, 2023

She has previously been named an MIT Technology Review Top Innovator Under 35, a Forbes 50 Top Women In Tech, a Deloitte Fast 50 Women in Leadership, and has won several prizes, including CEO of Year 2019 at the Cambridge Independent Science and Technology Awards and Best Female-Led Startup at the StartUp Europe Awards in 2019.

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TaiGen Announces FDA Approval of IND for Its Flu Antiviral TG-1000

The Pharma Data

OCTOBER 31, 2020

With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. billion USD in 2019 and is estimated to reach 5.03 in the near future.” ” According to Global Data, the global market for influenza antivirals reached 2.34 billion USD by 2026 at a CAGR of 11.5%.

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Mylan secures first FDA approval for generic version of Biogen's Tecfidera following patent dispute

The Pharma Data

AUGUST 20, 2020

The approval follows just one month after Mylan triumphed in the US District Court for the Northern District of West Virginia to invalidated Biogen’s patent on Tecfidera, though the company is appealing the decision. billion for Biogen through 2019. The drug generated $3.79 Matt Fellows. Source link.

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Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children

The Pharma Data

DECEMBER 9, 2020

.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. Gifford, R.

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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] World Health Organization (2019).

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GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older

The Pharma Data

JUNE 6, 2022

1] [2] In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries. [3].

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Concussion drug therapies on the horizon

Drug Discovery World

APRIL 23, 2024

More than 413,000 service members were diagnosed with a TBI between 2000 and Q3 of 2019. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI. A number of studies of US service men and women give a good picture of links between concussion and subsequent diagnoses.

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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Motixafortide

New Drug Approvals

SEPTEMBER 20, 2023

Jump up to: a b “Aphexda approval letter” (PDF). World Health Organization (2019). Motixafortide 4F-benzoyl-TN-14003 BKT-140 BKT140 BL-8040 Protein Chemical FormulaC 97 H 144 FN 33 O 19 S 2 Protein Average Weight2159.6 8 September 2023. Archived from the original (PDF) on 14 September 2023. BioLineRx Ltd. 11 September 2023.

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Overcoming diverging regulatory expectations to bring CGTs to market

Drug Discovery World

AUGUST 14, 2023

A Mutual Recognition Agreement (MRA) 2 for inspections of manufacturing sites for certain human medicines, signed and implemented by the United States and EU in July 2019, served as an important milestone in harmonising certain regulatory aspects in developing a global drug.

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FDA More Selective About Convening Advisory Committee Panels During Pandemic | 2021-01-18

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. 9, 2020 ).

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Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment

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. in January 2019 and is similar to EYSUVIS except at a higher 1% concentration of LE for post-surgery, versus.25%

FDA

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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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. Before 1983, only 38 orphan drugs had received U.S.

Disease

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Researchers reprogram gene therapy viral vectors to bind specific protein targets

Broad Institute

JULY 19, 2023

Related news How one lab uses machine learning to solve a key gene therapy problem In 2019, Deverman’s group identified the protein that serves as a receptor for AAV-PHP.B, a capsid that is efficiently transported across the blood-brain barrier.

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Artificial Intelligence (AI), Machine Learning (ML) and the FDA

The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders.

FDA

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Etrasimod

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] June 2019). 1] It is taken by mouth. [1] 20 (4): 413–420. 2017.03.007.

FDA

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Otsuka beats back Novartis opposition with $15M purchase of smart pill developer Proteus

The Pharma Data

AUGUST 20, 2020

Through a collaboration first signed in 2012, the two companies in 2017 successfully won FDA clearance for the first digital pill, Abilify MyCite, an ingestible drug-device combination that can track whether a patient adheres to the Japanese drugmaker’s antipsychotic Abilify (aripiprazole). One potential reason for the struggle?

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Brain organoids: a fascinating and powerful tool for drug discovery

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. 22:669-679 (2019). Companies using organoids and focused on cross-therapeutic areas. References Giandomenico SL, et al. Nature Neuroscience.

Targeted Protein Degradation

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Sumitovant to Snap Up Development Partner Urovant Sciences

The Pharma Data

NOVEMBER 15, 2020

Federal Drug Administration (FDA) for vibegron in December 2019 after reporting positive data from its 12-week Phase III EMPOWUR study. Vibegron also showed favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. .

Science

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Improving Drug Safety Through Cardiotoxicity Assessment

PerkinElmer

JANUARY 7, 2022

Sci Rep 9, 18911 (2019). link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet]. References Hingorani, A.D., Improving the odds of drug development success through human genomics: modelling study. 2021 [cited 16 December 2021].

Drugs

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Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). The approval marks the first drug approved by the U.S. Organizational Actions/Announcements .

Vaccine

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Breaking C-F bonds in drugs

Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. 2019 Oct 14;58(42):14824-14848, [link] [4] See [link] [5] The Dark Side of Fluorine. 2019 Jun 20;10(7):1016-1019, [link] [6] Voriconazole-Associated Periostitis: New Insights into Pathophysiology and Management. Angew Chem Int Ed Engl.

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First And Only Randomized, Double-blind, Head-to-head Study Comparing Aimovig® (erenumab-aooe), An Anti-CGRP Pathway Therapy, To Topiramate Published In Cephalalgia

The Pharma Data

NOVEMBER 8, 2021

4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 About Aimovig® (erenumab-aooe) Aimovig is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.6

Therapies

Therapies FDA Approval Small Molecule Treatment

Collegium Reports Net Income of $11.3 Million in the Third Quarter of 2020

The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). million for the quarter ended September 30, 2019 (the “2019 Quarter”) and $33.6

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Metabolism of macrocyclic drugs

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]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Avicenna J Med 12:154–156.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

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]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Avicenna J Med 12:154–156.

Metabolic Stability

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‘Ice Bucket Challenge’ funds FDA-approved ALS treatment

Metabolism of 2022 FDA approved small molecule drugs PART 1

Trending Sources

FDA-Approved Labeling: Is Enough Enough?

Medicare program spent $1.8 billion in 2019 on drugs without confirmed clinical benefits

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Hanmi Pharmaceutical expects U.S. FDA approval for 2 new drugs

Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

Can an antibody therapy prevent fentanyl overdoses?

How to advance AAV-based gene therapies

FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

FDA approves first over-the-counter naloxone nasal spray

Janssen submits EMA filing for bladder cancer treatment

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

International Women’s Day: Female life science leaders

TaiGen Announces FDA Approval of IND for Its Flu Antiviral TG-1000

Mylan secures first FDA approval for generic version of Biogen's Tecfidera following patent dispute

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children

Olutasidenib

GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older

Concussion drug therapies on the horizon

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Motixafortide

Overcoming diverging regulatory expectations to bring CGTs to market

FDA More Selective About Convening Advisory Committee Panels During Pandemic | 2021-01-18

Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

An Evolving Regulatory Environment for Rare and Orphan Diseases

Researchers reprogram gene therapy viral vectors to bind specific protein targets

Artificial Intelligence (AI), Machine Learning (ML) and the FDA

Etrasimod

Otsuka beats back Novartis opposition with $15M purchase of smart pill developer Proteus

Brain organoids: a fascinating and powerful tool for drug discovery

Sumitovant to Snap Up Development Partner Urovant Sciences

Improving Drug Safety Through Cardiotoxicity Assessment

Biopharma Update on the Novel Coronavirus: October 27

Breaking C-F bonds in drugs

First And Only Randomized, Double-blind, Head-to-head Study Comparing Aimovig® (erenumab-aooe), An Anti-CGRP Pathway Therapy, To Topiramate Published In Cephalalgia

Collegium Reports Net Income of $11.3 Million in the Third Quarter of 2020

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

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