The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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The Pharma Data

JANUARY 18, 2021

RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. for the treatment of post-herpetic neuralgia. for the treatment of post-herpetic neuralgia.

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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The Pharma Data

OCTOBER 26, 2020

The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus. AR-711 (COVID-19). AR-201 (RSV infection).

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The Pharma Data

APRIL 27, 2021

the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. AUTHORIZED USE IN THE EU: COMIRNATY® ?

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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. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:

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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. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. About the Phase 2/3 Study.

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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. AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S. myocarditis and pericarditis. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

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The Pharma Data

OCTOBER 26, 2020

I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”. 2019. 2019. Financial Summary. .

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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. This trial involves 93 sites in the U.S. and Europe.

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.

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The Pharma Data

NOVEMBER 5, 2020

Prior to joining Imperative Care in 2019, Davis served as chief commercial officer and president of North America at Penumbra, Inc., Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007.

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The Pharma Data

NOVEMBER 20, 2020

18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S.,

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The Pharma Data

AUGUST 20, 2020

Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. and Germany.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

NOVEMBER 9, 2020

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. Pfizer Inc.

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The Pharma Data

DECEMBER 1, 2020

This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, M.D., The Emergency Use Authorization in the U.K.

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New Drug Approvals

DECEMBER 16, 2023

PMID 35561315. ^ “Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients” Novartis (Press release). . April 2019). 5 December 2023. . 6 (15): 4450–4460. 2022006960. PMC 9636331.

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The Pharma Data

MAY 6, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age.

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Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products.

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The Pharma Data

NOVEMBER 8, 2020

YTD September 2019. In addition, to the strategic opportunity that the strengthening of the French market brings, Ilumetri ® is showing excellent momentum continuing its growth trend with sales increasing by +125% YoY is versus Q3 2019. Financial highlights (€ million). .

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The Pharma Data

FEBRUARY 4, 2021

billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates. Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Recorded a $4.7 Central time.

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The Pharma Data

OCTOBER 14, 2020

This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. President and Chief Executive Officer of Tonix Pharmaceuticals.

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The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

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Drug Discovery World

OCTOBER 7, 2022

By working together, industry partners will be able to take advantage of a portfolio of IP licensing opportunities, as well as access, at the ground level, a growing list of new and innovative start- ups being formed and seed-funded through and by the organisation. . Our commercial setup is rare.

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The Pharma Data

SEPTEMBER 9, 2020

The study is an event-driven trial. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. The companies are also working together with investigator sites and advocacy partners to raise awareness about the importance of participation in this trial.

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The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. due to the earlier supply to the market as compared to the 2019/2020 flu season. A re-start of dosing and recruitment in the pediatric trial is expected later this year. In the U.S.,

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The Pharma Data

MARCH 11, 2021

We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase 3 clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to COVID-19,” said Luis Jodar, Ph.D., AUTHORIZED USE IN THE U.S.:

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The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

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The Pharma Data

DECEMBER 27, 2020

XGEVA for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity (Amgen obtained approval of XGEVA in China in May 2019). QARZIBA ® ? Tislelizumab is not approved for use outside of China.

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The Pharma Data

FEBRUARY 24, 2022

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.

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