The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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The Pharma Data

APRIL 1, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. Tecartus is an autologous, anti-CD19 CAR T cell therapy.

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The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% There was a 1.08 combined dose groups; 6.5% placebo; p=0.024). REGN-COV2 was well tolerated in the trial.

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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. WARNINGS AND PRECAUTIONS.

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The Pharma Data

OCTOBER 25, 2020

The UK government’s COVID-19 Vaccine Taskforce and a contract research company called Open Orphan announced a $13 million (£10 million) plan to test investigational COVID-19 vaccines in volunteers who are then intentionally exposed to SARS-CoV-2, the virus that causes COVID-19. No serious adverse events were observed.

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The Pharma Data

OCTOBER 26, 2020

Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. SAN JOSE, Calif. , AR-711 (COVID-19).

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The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” IMPORTANT SAFETY INFORMATION: Events of anaphylaxis have been reported. A slightly lower frequency of reactogenicity events was associated with greater age.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. who require oxygen therapy due to COVID-19, OR. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Adverse Events.

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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. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. In the U.S.,

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The Pharma Data

OCTOBER 29, 2020

In the Phase 2 portion, the most common adverse event was upper respiratory tract infection which occurred in 17.9%, 11.1% No serious adverse events, deaths, thrombotic events or new safety concerns were reported. Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

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The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. , who require oxygen therapy due to COVID-19, OR.

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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. who require oxygen therapy due to COVID-19, OR.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. It is important to remember that while the virology results from this analysis of hospitalized patients were robust, the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. No serious adverse events were reported in this study and the vaccine candidate was well-tolerated. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

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The Pharma Data

JANUARY 18, 2021

The fireside chat will be available for 90+ days following the event at: [link] 5 69. Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. . A live webcast of this presentation will be available for registered participants at: [link].

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The Pharma Data

SEPTEMBER 12, 2020

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Pfizer: Breakthroughs That Change Patients’ Lives.

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The Pharma Data

MARCH 22, 2021

New infections continue to rise globally with over three million reported cases last week, so this investigational antibody cocktail may offer hope as a potential new therapy to high-risk patients – particularly in light of recent evidence showing that casirivimab and imdevimab together retain activity against key emerging variants.

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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. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders. LONDON and BOSTON, Jan.

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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. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

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Codon

JANUARY 21, 2024

2 AP: A news story in Nature about your organization, 1Day Sooner, discussed some recent challenge trials involving the hepatitis C virus. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines.

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The Pharma Data

JUNE 24, 2021

This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. BioNTech COVID-19 Vaccine. The Pfizer?BioNTech

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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

DECEMBER 19, 2020

Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. Under Operation Warp Speed, the U.S. Department of Defense contract no.

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The Pharma Data

NOVEMBER 29, 2020

Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance. Three cases of human leukocyte antigen (HLA)-sensitization have been reported, two as serious adverse events. An archived replay will be accessible for 30 days following the event.

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The Pharma Data

DECEMBER 14, 2020

With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts.

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The Pharma Data

AUGUST 20, 2020

We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U. Systemic events after administration of BNT162b2 were milder than those with BNT162b1. No severe systemic events were reported by older BNT162b2 recipients.

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The Pharma Data

SEPTEMBER 9, 2020

BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About the Phase 2/3 Study. billion doses by the end of 2021.

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The Pharma Data

NOVEMBER 20, 2020

Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Many Progeria patients have received continuous Zokinvy therapy for more than 10 years. PALO ALTO, Calif., 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc.

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The Pharma Data

JUNE 30, 2021

With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. This press release features multimedia.

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The Pharma Data

DECEMBER 10, 2020

The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days. Rates of serious adverse events were similar between vaccine and placebo groups (0.6% kg/m2); and 21% had at least one underlying comorbidity.

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The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, Tonix Pharmaceuticals Holding Corp.

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The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 74% of responders (n=14) remain on treatment. About Regeneron Pharmaceuticals, Inc.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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The Pharma Data

SEPTEMBER 8, 2020

About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

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Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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