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] Janssen Biotech, Inc.

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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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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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Sosei Group Forward-looking statements.

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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. It is approved in the U.S.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. India, for example, has strict drug laws, and cannabis is illegal for any purpose 6.

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Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

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Delveinsight

JANUARY 5, 2021

The US FDA has accepted the initial Biologics License Application submission for the therapy with the target action date for an FDA decision is October 2021. FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device. SCONE Medical Solutions Inc.

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Advarra

JULY 19, 2022

If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. A: In IITs, an investigator is usually a physician or an academic institution, and the interest is usually in studying a drug in an area of research in which they practice. There is no problem doing this.

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The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. Source link: [link].

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XTalks

APRIL 24, 2023

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

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The Pharma Data

JANUARY 24, 2021

Research and development efforts will be led by Dr. Paul Van Slyke. Paul’s previous research interests, complementary to those of Sairiyo, span a number of indications including acute respiratory distress syndrome, acute kidney injury, vascular inflammatory disease, sepsis and oncology. PharmaDrug Inc.

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The Pharma Data

DECEMBER 8, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Source: Moderna, Inc. .

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. Pfizer Disclosure Notice.

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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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Pharmaceutical Technology

FEBRUARY 26, 2023

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

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The Pharma Data

AUGUST 17, 2021

Lyumjev U-200 contains 2 times as much insulin in 1 milliliter as Lyumjev U-100. Humalog U-100 contains 100 units of insulin per milliliter. All Lyumjev and Humalog products contain insulin lispro. drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog. Learn more.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S.

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The Pharma Data

JANUARY 21, 2021

Global Head, Janssen Research & Development, Johnson & Johnson. ” The once-monthly rilpivirine and cabotegravir injectable treatment was approved by Health Canada on March 20, 2020, and the European Commission approved a once-monthly and once every two-month version of the injectable treatment on December 21, 2020. .

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The Pharma Data

OCTOBER 30, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.

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The Pharma Data

NOVEMBER 20, 2020

Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., Source link.

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FDA Law Blog

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. Federal Research. A positive finding in this regard is critical to any potential that cannabis would be approved for medical use under federal law. 21 U.S.C. §

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The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As The information contained in this release is as of December 10, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Jansen, Ph.D.,

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The Pharma Data

NOVEMBER 9, 2020

The information contained in this release is as of November 9, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Pfizer Disclosure Notice. Source link.

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The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

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The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

JANUARY 12, 2021

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C. Details of the New Agreement.

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

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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). Research and development. . Xtampza ER net product revenues were $32.1

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FDA Law Blog

JANUARY 18, 2024

FDA’s Center for Drug Evaluation and Research Controlled Substances Staff conducts the scheduling analysis and makes recommendations. HHS forwards FDA’s analysis and recommendation to DEA. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3. 21 U.S.C. §

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Pfizer

JULY 26, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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