The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

DECEMBER 2, 2020

This License Agreement represents an important corporate milestone. The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. Overall, these unique vaccines address several current obstacles in COVID-19 vaccine development.”

Licensing 52

Licensing Licensing Vaccine Virus 52

The Pharma Data

JANUARY 12, 2021

. “Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. Yancopoulos , M.D.,

Government 52

Government Hospitals Virus Clinical Trials 52

Codon

FEBRUARY 27, 2024

Patient YY’s neighbors quickly started to become infected, passing on the virus in turn. While the consensus that emerged among experts was that the virus spread primarily via airborne transmission , it also made use of another route: fomite transmission. Puzzled, epidemiologists sought to understand the source of the outbreak.

Virus 73

Virus Hospitals Production Regulations 73

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. Hepatotoxicity: Hepatic adverse events were reported.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Nature Neuroscience. Read You love to see it! Ricciardi M.J.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

NOVEMBER 20, 2020

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. based Mogrify Limited expanded its research collaboration with MRC Laboratory of Molecular Biology.

Licensing 52

Licensing Licensing Clinical Trials Vaccine 52

The Pharma Data

MARCH 11, 2021

This clearly demonstrates the power of the COVID-19 vaccine to fight this virus and encourages us to continue even more intensively with our vaccination campaign. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

Vaccine Clinical Trials Hospitals Licensing 52

Broad Institute

MAY 14, 2024

William Studier for development of widely used protein- and RNA-production platform The $400,000 award recognizes the far-reaching medical impacts of Studier’s development, in the 1980s, of an efficient and scalable technology to produce mass amounts of RNA and proteins in laboratories that is widely used today all over the world.

RNA 84

RNA Production Molecular Biology Laboratories 84

The Pharma Data

NOVEMBER 21, 2020

.” “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. Yancopoulos , M.D.,

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 29, 2020

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. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

SEPTEMBER 1, 2021

Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. MOVe-AHEAD Study.

Laboratories 52

Laboratories Clinical Trials Virus Trials 52

The Pharma Data

NOVEMBER 20, 2020

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. LABORATORY ABNORMALITIES. Some patients treated with ZOKINVY developed laboratory abnormalities. Lonafarnib caused retinal toxicity in monkeys at 3.7 times the human dose. Outside the U.S.,

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production 40

Production Trials FDA FDA Approval 40

The Pharma Data

OCTOBER 12, 2021

Participants had a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (e.g. Participants were adults 18 years-old and over who were non-hospitalised with mild-to-moderate COVID-19 and symptomatic for seven days or less.

Trials 52

Trials Treatment Virus Disease 52

The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus.

Trials 52

Trials Virus Long-Term Care Facilities Government 52

The Pharma Data

MARCH 16, 2021

Pascal Soriot, Chief Executive Officer, said: “The long-acting antibody combination has the potential to offer almost immediate protection to those who are not able to be vaccinated, to both prevent infection or treat the disease in patients already infected with the virus. Financial considerations. Source link:[link].

Treatment 52

Treatment Virus Trials Government 52

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA 40

FDA Science Regulations Production 40

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). A YouTuber, The Thought Emporium , is growing rat neurons in the laboratory. ” The tool was crafted with a virus, called GIL16.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). A YouTuber, The Thought Emporium , is growing rat neurons in the laboratory. ” The tool was crafted with a virus, called GIL16.

Therapies 52

Therapies RNA DNA Engineering 52

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. on October 22, including those at high risk of severe complications of COVID-19 disease.

Vaccine 52

Vaccine FDA Clinical Trials Disease 52

The Pharma Data

DECEMBER 27, 2020

Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. The most common Grade 3 or higher infection was pneumonia. Cytopenias.

Production 52

Production Therapies Treatment Drugs 52

The Pharma Data

JANUARY 13, 2021

said, “Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function 1. ; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc. Tonix Pharmaceuticals Holding Corp.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

OCTOBER 26, 2020

billion related to certain license and collaboration agreements, and certain other items. Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. Non-GAAP EPS of $1.74

Vaccine 40

Vaccine Trials Treatment Therapies 40

Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

FDA 40

FDA Science Regulations Production 40

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.

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly’s chief scientific officer and president of Lilly Research Laboratories. In the U.S.,

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

The Pharma Data

MARCH 22, 2021

Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work.

Clinical Trials 52

Clinical Trials Virus Trials FDA 52

The Pharma Data

NOVEMBER 9, 2020

. “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, M.D.,

Treatment 52

Treatment FDA Hospitals Long-Term Care Facilities 52

The Pharma Data

MAY 4, 2021

Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

Treatment 52

Treatment Virus Therapies Hospitals 52

Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

FEBRUARY 12, 2022

Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron – currently the predominant variant in the U.S.

Treatment 40

Treatment Hospitals FDA Clinical Trials 40

The Pharma Data

OCTOBER 29, 2020

Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

Treatment 52

Treatment Drugs Clinical Trials Therapies 52