2021, FDA Approval and Trials - Drug Discovery Digest

Current insights and molecular docking studies of HIV?1 reverse transcriptase inhibitors

Chemical Biology and Drug Design

OCTOBER 10, 2023

million people worldwide were living with HIV in 2021. Nucleoside reverse transcriptase inhibitors (NRTIs) were the first class of approved antiretroviral drugs. Later, a new type of non-nucleoside reverse transcriptase inhibitors (NNRTIs) were approved as anti-HIV drugs.

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Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). In 2023, the FDA approved a 2.7

FDA Approval

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Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

The Pharma Data

JANUARY 18, 2021

Biederman, Director of Cardiovascular Imaging and Cardiac MRI at Allegheny General Hospital/Allegheny Health System in Pittsburgh and an author on the groundbreaking 2017 MagnaSafe trial published in NEJM. Typically, MRI is preferred by imaging specialists because it’s the safest alternative for most patients.

FDA Approval

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Pirtobrutinib

New Drug Approvals

MAY 8, 2025

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 4] The trial was conducted at 49 sites in 10 countries in the United States, Europe, Australia, and Asia. [6] 6] The same trial was used to assess safety and efficacy. [6]

FDA Approval

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

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

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FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. in the first quarter of 2021. BOSTON, Nov.

FDA Approval

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FDA Approves First Monthly Injectable Regimen for HIV

The Pharma Data

JANUARY 22, 2021

22, 2021 — The U.S. Food and Drug Administration approved the first monthly injectable, complete regimen for HIV-infected adults, the agency announced Thursday. Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults.

FDA Approval

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials

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Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

The Pharma Data

JANUARY 11, 2021

12, 2021 /PRNewswire/ — MicroVention, Inc., 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. .

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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. during the first quarter of 2021. BUFFALO, N.Y.,

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Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)

The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial.

Research

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Inavolisib

New Drug Approvals

APRIL 25, 2025

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] 3 November 2006.

FDA

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FDA Approves First Once-a-Month HIV Therapy, Cabenuva

The Pharma Data

JANUARY 22, 2021

22, 2021 — The first monthly shots to treat adults with HIV were approved by the U.S. The FDA’s approval of Cabenuva is based on two randomized, open-label, controlled clinical trials that included nearly 1,200 HIV-infected adults who had HIV suppression before they began treatment with Cabenuva.

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4 Unique Challenges of Oncology Trials

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

Trials

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FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease

The Pharma Data

AUGUST 7, 2021

Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance. In the pivotal Phase 3 trial (COMET), Nexviazyme showed improvements in respiratory function and walking distance measures in people with LOPD and established its safety profile. meters farther (SE=9.9)

FDA Approval

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Neuroscience Portfolio at the 2021 American Academy of Neurology (AAN) Annual Meeting

The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Clinical Trials Plenary Session.

Clinical Trials

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CNS Pharmaceuticals Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate Berubicin

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland.

FDA Approval

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AbbVie Reports Second-Quarter 2021 Financial Results

The Pharma Data

AUGUST 1, 2021

to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.” ” Second-Quarter Results. Worldwide net revenues were $13.959 billion, an increase of 33.9

FDA

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Next Generation Sequencing (NGS) in Clinical Trials: Challenges and Opportunities

Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Fountzilas et al. Zeng et al. A study by Park et al.

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2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD).

Clinical Trials

Clinical Trials Trials Disease Therapies

Crinecerfont

New Drug Approvals

APRIL 18, 2025

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] 1 December 2024.

FDA

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

JANUARY 7, 2025

Explain the FDA Approval Process Many patients are unaware of the rigorous approval process generic drugs must undergo. Educate them about the FDA’s role in ensuring the safety and efficacy of generic medications. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research Sources cited: U.S.

Drugs

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UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

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. . HELLERUP, Denmark , Jan.

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Aurinia Pharmaceuticals to Present at Two Upcoming Virtual Healthcare Conferences

The Pharma Data

JANUARY 7, 2021

8, 2021 11:05 UTC. NASDAQ: AUPH / TSX: AUP) (the “Company”) today announced that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner: H.C. Wainwright Virtual BioConnect 2021 Conference.

Pharmaceuticals

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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

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. Pfizer Disclosure Notice.

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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Taletrectinib

New Drug Approvals

JUNE 29, 2025

1] [2] Adverse effects The FDA prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. [1] Food and Drug Administration (FDA).

International

International FDA Clinical Trials Treatment

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. Retevmo is an U.S.

Research

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FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Food and Drug Administration in 2017.

FDA Approval

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lazertinib

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. 1 It was approved by the FDA on August 19, 2024. 20 August 2024. 20 August 2024.

FDA Approval

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Vorasidenib

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]

FDA Approval

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Oncorus Pivots to Scale Up Manufacturing with New GMP Facility

The Pharma Data

JANUARY 6, 2021

Process development and quality control will begin in 2021, and full manufacturing capabilities at the 88,000-square-foot facility will be available in 2023. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021.

Virus

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Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. Nature Cancer. 2022;3(4):418-36. Frontiers in Physiology.

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GW Pharma Hopes to Bring Its Second Cannabis-Based Drug to Market in the U.S.

The Pharma Data

NOVEMBER 2, 2020

This morning, California-based GW said it will launch the first Phase III trial studying nabiximols, which is known as Sativex outside the United States, as a potential treatment for multiple sclerosis-associated spasticity. Sativex is approved for use in parts of Europe for this indication. It also forced the U.S.

FDA Approval

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Sanofi to acquire Kadmon to further strengthen growth of transplant.

The Pharma Data

SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.

FDA Approval

FDA Approval Therapies Small Molecule FDA

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. WAKEFIELD, Mass., Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

Clinical Trials

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Radius Health, Inc. Announces Acquisition of Orphan Disease Program

The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. BOSTON, Jan.

Disease

Disease FDA Approval Clinical Trials Trials

Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir comp

The Pharma Data

MAY 4, 2021

Posted 04 May 2021 | By Michael Mezher . Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. © 2021 Regulatory Affairs Professionals Society.

Vaccine

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Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

The Pharma Data

JANUARY 13, 2021

13, 2021 (GLOBE NEWSWIRE) — Harpoon Therapeutics, Inc. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. About the Phase 1/2 Trial for HPN217. Dose escalation for HPN217 in the Phase 1/2 clinical trial is progressing rapidly.

Treatment

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New Hope Against Diseases Marked by Progressive Scarring of Lung Tissue

The Pharma Data

JANUARY 15, 2021

15, 2021 — An inhaled medication might make every day physical activity a bit easier for patients with serious scarring of the lungs, a new clinical trial finds. Right now, no medication is approved specifically for pulmonary hypertension caused by ILD, said Dr. Steven Nathan, senior researcher on the new trial.

Disease

Disease Doctors Trials FDA Approval

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. This study was completed in December 2021; results align with the findings of the RISE study.

FDA Approval

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Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

DECEMBER 13, 2020

The company believes the clinical comparability requirement will be met if the time to neutrophil engraftment in patients from the company’s ongoing expanded access program (EAP) using omidubicel produced at Gamida Cell’s planned commercial manufacturing sites is consistent with the results achieved in the Phase 3 clinical trial.

Licensing

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Current insights and molecular docking studies of HIV?1 reverse transcriptase inhibitors

Limited Evidence for Nalfmefene

Trending Sources

Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

Pirtobrutinib

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

FDA Approves First Monthly Injectable Regimen for HIV

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

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

Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)

Inavolisib

FDA Approves First Once-a-Month HIV Therapy, Cabenuva

4 Unique Challenges of Oncology Trials

FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease

Neuroscience Portfolio at the 2021 American Academy of Neurology (AAN) Annual Meeting

CNS Pharmaceuticals Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate Berubicin

AbbVie Reports Second-Quarter 2021 Financial Results

Next Generation Sequencing (NGS) in Clinical Trials: Challenges and Opportunities

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

Crinecerfont

Educating Patients about Generic Drugs: Strategies for Success

UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

Aurinia Pharmaceuticals to Present at Two Upcoming Virtual Healthcare Conferences

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

Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

Taletrectinib

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

lazertinib

Vorasidenib

Oncorus Pivots to Scale Up Manufacturing with New GMP Facility

Advanced 3D cell-based technologies

GW Pharma Hopes to Bring Its Second Cannabis-Based Drug to Market in the U.S.

Sanofi to acquire Kadmon to further strengthen growth of transplant.

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Radius Health, Inc. Announces Acquisition of Orphan Disease Program

Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir comp

Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

New Hope Against Diseases Marked by Progressive Scarring of Lung Tissue

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

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