The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020. BOSTON–( BUSINESS WIRE )– Gamida Cell Ltd.

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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] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 48,000) consisting of 34 amino acid residues.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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The Pharma Data

JUNE 7, 2023

The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 September 2023. Dostarlimab also was recently granted Breakthrough Therapy designation for this potential new indication. 3][4] An estimated 20-29% of all endometrial cancers are dMMR/MSI-H. [5]

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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. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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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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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

DECEMBER 21, 2020

The FDA granted cilta-cel Breakthrough Therapy and Orphan Drug designations in 2019, and the therapy received a PRIME Priority Medicines designation from the European Commission (EC) that same year and an Orphan Drug designation from the EC in February 2020.

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New Drug Approvals

SEPTEMBER 10, 2024

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] Food and Drug Administration (FDA). mol), and potassium carbonate (0.43 Hz, 1H), 5.70-5.13

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New Drug Approvals

SEPTEMBER 6, 2024

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. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA). 5 Lazertinib is used alone or in combination with other chemotherapeutic agents.

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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. Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) are starting to pick up. The study enrolled 5,050 patients who received either vericiguat or placebo in combination with available heart failure therapies. The FDA granted the NDA Priority Review, which expedited the review from the typical 10 months to six months. Sarah Silbiger/Getty Images.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 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. FDA has been holding bi-monthly “Town Hall” meetings to prepare.

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The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Without sufficient resources, the FDA is unable to do so. modernization efforts.

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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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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 Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

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The Pharma Data

DECEMBER 29, 2020

a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. LyGenesis’s lead allogeneic cell therapy program is focused on liver regeneration for patients with end stage liver disease.

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The Pharma Data

MAY 31, 2022

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. The target action date for the FDA decision is September 30, 2022. The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

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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. The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA. NEW YORK, Nov.

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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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The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) in terms of PDUFA dates. Here’s a look at some of the upcoming target action dates on the FDA’s calendar. . The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We

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The Pharma Data

NOVEMBER 24, 2020

25, 2020 /PRNewswire/ — RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to the company’s drug candidate, RV001. More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers.

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. An example is the collaboration between Novartis and the University of Oxford to develop a gene therapy for spinal muscular atrophy, a rare genetic disease.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) 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

APRIL 4, 2022

The target action date for the FDA decision on this investigational use is August 3, 2022. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. If approved, Dupixent would be the first medicine available in the U.S. In September 2020, the U.S.

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The Pharma Data

JANUARY 13, 2021

Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA. . NEW YORK , Jan. MindMed Co-CEO J.R. About MindMed.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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The Pharma Data

NOVEMBER 29, 2020

Food and Drug Administration (FDA). Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The FDA approved the drug on November 24. Here’s a look.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. 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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