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.

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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 REGN-COV2 was well tolerated in the trial. high dose, 1.6% low dose; 2.3%

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The Pharma Data

SEPTEMBER 1, 2021

MOVe-AHEAD (MK-4482-013) ( NCT04939428 ) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. About Molnupiravir.

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The Pharma Data

MARCH 8, 2021

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

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The Pharma Data

OCTOBER 26, 2020

Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET.

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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. Among the patients who died after receiving Tecartus, one had a fatal CRS event. Serious events associated with CRS included hypotension, fever, hypoxia, acute kidney injury, and tachycardia.

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The Pharma Data

NOVEMBER 17, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. COVID-19 Vaccine AstraZeneca is known as Vaxzevria in Europe. About AstraZeneca. United Nations.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. This was despite the 6-month data also demonstrating clinical benefits in reduction of bleeding events and declines in the use of FIX replacement therapy.

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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

DECEMBER 28, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

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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. Adverse Events.

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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 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

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

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The Pharma Data

JANUARY 18, 2021

Utilizing drug delivery platform technologies, BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV).

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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. and Mexico, and Phase 1/2 studies in Australia and the U.S.

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The Pharma Data

MARCH 2, 2021

Bayer is a main sponsor of the event, which invites scientists and industry leaders to discuss the latest achievements and developments in horticulture. It is licensed for commercial use by Ecología y Protección Agricola (EPA) in Valencia and provides 400 days of pest control. Bayer is the main sponsor of the SHE2021 congress.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. The event began within 1 hour of completion of the infusion, and required treatment including epinephrine. The event resolved. All events resolved. Serious AEs occurred in 2 placebo patients, 1 low-dose patient and 0 high-dose patients.

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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

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is approved in the U.S.

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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

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

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.,

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate. Download this exclusive report here.

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The Pharma Data

MARCH 22, 2021

Number of patients with events. Serious adverse events (SAEs) were largely related to COVID-19 and occurred in 1.1% The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. Patients with ? Risk reduction. p<0.0001). p<0.0001).

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The Pharma Data

DECEMBER 20, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

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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

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. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. LONDON and BOSTON, Jan.

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The Pharma Data

DECEMBER 29, 2020

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. Similar clinical and virologic efficacy was observed for the high and low doses of the antibody cocktail.

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The Pharma Data

SEPTEMBER 21, 2020

Licensed premises such as pubs and bars will need to shut by 23:00 every night. ‘People just come out earlier’ Customers at the The Pen and Wig pub in Newport on Monday were not convinced a pub curfew would help to control the virus. He said “all-Wales” measures may be needed to tackle the virus.

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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

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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The Pharma Data

NOVEMBER 5, 2020

Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

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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

SEPTEMBER 12, 2020

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

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The Pharma Data

DECEMBER 14, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumors to treat specific types of cancer.

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