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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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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BioPharma Drive: Drug Pricing

AUGUST 2, 2023

The company is discussing various payment models for its sickle cell treatment with government and commercial insurers ahead of an FDA approval decision later this year.

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Drug Discovery World

JUNE 1, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2. DDW’s Megan Thomas explores three trends in the market.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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The Pharma Data

AUGUST 11, 2020

government and health care authorities around the globe to address the treatment needs of patients with COVID-19. Due to the US government buying up all of the supply of remdesivir, the company have signed deals with Pfizer and Hikma to make the drug available around the world.

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The Pharma Data

JANUARY 12, 2021

Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. million doses. . We are pleased to work with the U.S.

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The Pharma Data

DECEMBER 12, 2020

” The logistics of a national COVID vaccination campaign are daunting: Every state, along with six major cities, has submitted to the federal government a list of locations — mainly hospitals — where the Pfizer vaccine is to ship initially. . “More than 100,000 in long-term care have died from this virus in the U.S.

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The Pharma Data

NOVEMBER 23, 2020

The FDA allowed its use in adults and children aged 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions. Many European countries are tightening restrictions, the Associated Press reported.

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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] Haematologica.

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FDA Law Blog: Biosimilars

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.”

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Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Most FDA user fee amounts are published at a regular cadence.

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The Pharma Data

JULY 29, 2021

government and health authorities to support the use of our vaccine, including among those who wish to be fully vaccinated with one shot. A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic. Source link: [link].

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The Pharma Data

MAY 6, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. For more than 170 years, we have worked to make a difference for all who rely on us.

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The Pharma Data

NOVEMBER 18, 2020

France began a nationwide lockdown last week, and Germany and Austria have started partial lockdowns as government officials across the continent scramble to slow a sharp rise in infections that threatens to overwhelm their health care systems. Many European countries are tightening restrictions, the Associated Press reported.

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Drug Target Review

FEBRUARY 15, 2024

To survive this era, governments, multi-lateral organisations, foundations, and industry will need to work collectively on researching and developing new drugs that can prevent or treat a broad range of epidemic-prone pathogens, some of which have not yet been identified.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

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The Pharma Data

MAY 13, 2021

Government, Regulatory & Legal. . Thermo Fisher, Quest step up K-12 COVID-19 testing as school districts look to safely reopen ( MedtechDive ). Medtronic issues 3rd Class I recall of the year related to HeartWare blood pump ( Fierce ). Purdue’s Ch.

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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

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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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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Drug Discovery World

MARCH 7, 2023

Other roles include Head of Biology at TopoTarget A/S, where she was responsible for the pre-clinical development of belinostat which went on to gain FDA approval to treat peripheral T-cell lymphoma.

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The Pharma Data

MAY 7, 2021

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 Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We For more than 170 years, we have worked to make a difference for all who rely on us.

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ASPET

OCTOBER 12, 2023

The CET RAIDR program currently focuses on strengthening collaborations with industry, academia, and other government partners to survey and test and evaluate (T&E) U.S. CBRN MCMs).

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

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Policy Prescription

OCTOBER 3, 2023

Second, governments in high-income foreign countries engage in some form of bargaining with drug companies on drug prices. Of course, India is the largest supplier of FDA-approved generic drugs sold in U.S. The theory covers four “stylized facts” of the international market in prescription drugs. First, drug prices in the U.S.

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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. For more than 170 years, we have worked to make a difference for all who rely on us.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here ). Usually at this point in a post we would identify the date of approval of the relevant NDA.

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The Pharma Data

MAY 27, 2022

federal government spent an estimated $1.8 The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. . “Patients and the government are paying a lot for drugs that may not work.”

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Drug Discovery World

APRIL 27, 2023

Dr Vaessen says that local government and business development partners work closely within the industry to attract companies like FUJIFILM Irvine Scientific to the region. As a well- known life science hub, we will benefit from the pool of talent concentrated in RTP.

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The Pharma Data

MAY 4, 2021

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. FDA approves expanded use for Chiesi’s sickle cell drug Ferriprox ( PMLive ).

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic. A decision on U.S. Actemra/RoActemra is not U.S.

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The Pharma Data

NOVEMBER 30, 2020

While the test could make it much easier for people to learn if they have Alzheimer disease, independent experts noted that information about the test’s accuracy have not been published and the test has not been approved by the U.S. government funded some of the research leading to the test, according to Eliezer Masliah, M.D.,

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Broad Institute

APRIL 25, 2024

Sabeti and her lab had also responded quickly to Ebola in 2014, working with hospitals and government officials in Sierra Leone to sequence viral genomes from patients and make the data available to local communities. This year they began testing for 19 bloodborne pathogens such as Ebola, yellow fever, Lassa, and HIV.

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Pharmaceutical Development Group

AUGUST 9, 2021

Since 1982, when the Federal Drug Administration (FDA) approved the first recombinant biotechnology drug, insulin, for human use, biotechnology, particularly biologic entities and biological processes, has provided key inputs for the development of pharmaceutical goods.

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