The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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New Drug Approvals

SEPTEMBER 8, 2024

1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] FDA” (Press release). July 2024). “Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis” Hepatology. 14 August 2024.

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The Pharma Data

MARCH 25, 2021

Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on tanezumab. We will continue to work with the FDA as the agency continues its review of our application.”. Pfizer Inc. NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced the outcome of the U.S.

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

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The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. FDA this year. SEOUL, South Korea , Jan.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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ASPET

OCTOBER 12, 2023

The Countering Emerging Threats - Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Repurposing is one such method.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

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Drug Discovery Today

DECEMBER 17, 2019

s (Bridge) opioid addiction development therapeutic product, BT-219, and executed an Exclusive Licensing Agreement to use Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology. FDA for BT-219 under the “505(b)(2)” regulatory submission pathway as well as a possible future single entity buprenorphine product.

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The Pharma Data

MAY 15, 2023

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.”

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

All DEA-registered practitioners may continue to prescribe via audio-visual telemedicine encounters schedule II-V controlled substances, and schedule III-narcotic controlled substances that are FDA-approved for opioid use disorder management and treatment.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). president and chief executive officer of Passage Bio.

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The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?1%,

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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.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. chief executive officer of Gamida Cell.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. We look forward to working with the FDA to bring ABP 798 to market.”. Although much of the U.S.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Premier Consulting Blog

OCTOBER 21, 2024

The FDA defines a serious condition as “a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning.” To address these delays, the FDA has required certain confirmatory trials to be underway before granting accelerated approval.

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 1] [5] Medical uses Palopegteriparatide is indicated for the treatment of adults with hypoparathyroidism. [1] Food and Drug Administration (FDA) (Press release).

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Vibegron could be a potentially important and differentiated new oral treatment, if approved by the FDA, for patients suffering with OAB.”.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We will see if FDA is willing to accept those changes later this month.

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The Pharma Data

APRIL 26, 2022

This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s experimental gene therapy program, PR001, for the treatment of neuronopathic Gaucher disease (nGD). In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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Agency IQ

JULY 12, 2024

FDA gives companies leeway to go after misinformation, but not free reign In a new revised draft guidance document, the FDA says it will allow life sciences companies to address misinformation about their products that is posted online. Promotional labeling information must be submitted to the FDA “at the time of initial dissemination.”

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The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). The FDA’s Fast Track designation is a process designed to expedite or facilitate the review of product candidates to treat serious conditions and fill an unmet medical need.

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The Pharma Data

APRIL 4, 2022

FDA approval is expected in the second half of this year. The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., today announced that the U.S.

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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] Comenzo, M.D.,

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). 4 The FDA is expected to make a decision on approval by 23 October 2021.

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

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The Pharma Data

NOVEMBER 22, 2020

Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. The FDA approved it under the brand name Gavreto on September 4. Liquidia Technologies has a target action date of November 24 for its NDA for LIQ861 for treatment of pulmonary arterial hypertension (PAH).

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The Pharma Data

MARCH 22, 2022

NYSE: PFE) announced today an agreement with UNICEF to supply up to 4 million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), to 95 low- and middle-income countries, pending authorization or approval. Pfizer Inc. Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron).

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The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. Stages of process validation Process validation involves three distinct stages as described in the 2011 FDA guidance, “Process Validation: General, Principles and Practices.”

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.

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