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.

Marketing 245

Marketing FDA Approval Licensing Licensing 245

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.

FDA Approval 52

FDA Approval Treatment FDA Hospitals 52

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.

FDA Approval 52

FDA Approval FDA Government Virus 52

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.

Government 52

Government Hospitals Virus Production 52

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.

FDA Approval 52

FDA Approval Vaccine FDA Nurses 52

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.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

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.”

Government 72

Government FDA FDA Approval Doctors 72

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.

FDA 40

FDA Government Drugs Production 40

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.

FDA Approval 52

FDA Approval FDA Vaccine Virus 52

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.

Government 102

Government Small Molecule FDA Approval Regulations 102

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.

FDA Approval 52

FDA Approval FDA Vaccine Pharmacy 52

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.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

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.

Compliance 52

Compliance FDA FDA Approval Regulations 52

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.

International 246

International Science Pharmaceuticals DNA 246

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.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

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).

Therapies 40

Therapies Licensing Licensing FDA Approval 40

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.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

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.

FDA 59

FDA FDA Approval Production Marketing 59

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.”

FDA 52

FDA Clinical Trials Government Drugs 52

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.

Small Molecule 130

Small Molecule Science Drugs FDA Approval 130

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.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

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.,

Disease 52

Disease FDA Approval Doctors Government 52

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.

Virus 132

Virus Hospitals Disease Government 132

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.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies FDA Approval Production 52

The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S. On August 13, 2021, the U.S. adults and children against the TBEV when traveling or moving to TBE endemic areas.

Vaccine 52

Vaccine FDA Approval Laboratories Virus 52

FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

FDA 59

FDA FDA Approval Production Marketing 59

The Pharma Data

JANUARY 6, 2021

The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. COVID-19 Vaccine AstraZeneca, formerly AZD1222 AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

Vaccine 52

Vaccine Virus Clinical Trials Government 52

The Pharma Data

NOVEMBER 16, 2020

DJSI World is a leading global index comprised of organizations that are corporate leaders in environmental, social and governance (ESG) practices, representing the top 10 percent of most sustainable companies in each industry. President and Chief Executive Officer of Regeneron.

FDA Approval 52

FDA Approval Science Disease Laboratories 52

The Pharma Data

NOVEMBER 16, 2020

The partnership brings NIH together with other HHS agencies and government partners and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Source: NIH.

Clinical Trials 52

Clinical Trials Vaccine Trials FDA Approval 52

The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca . Posted: January 2021. Source link.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: January 2021. Source link.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

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.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. million to 7.5

Vaccine 40

Vaccine RNA Government Clinical Trials 40

FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

FDA 52

FDA Regulations Clinical Trials Production 52

The Pharma Data

AUGUST 25, 2020

In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. About IDHIFA.

Trials 52

Trials FDA Approval Therapies Treatment 52

Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

FDA 40

FDA Science Production FDA Approval 40

The Pharma Data

APRIL 8, 2022

LORBRENA is approved in the U.S. by the Food and Drug Administration (FDA) for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. For more than 170 years, we have worked to make a difference for all who rely on us.

Trials 52

Trials FDA Approval Treatment FDA 52