The Pharma Data

NOVEMBER 23, 2020

His most recent position was at Amgen as Director Global Business Development – Transactions, a position he assumed in August 2019 following the acquisition of Nuevolution, a Danish small molecule development company, at which he led the commercial and business activities as Chief Business Officer.

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Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

JANUARY 13, 2021

Structure 3:1031-1039 (1995) 3 Waters J, Biocentury ; October 26, (2018) 4 NCT02273960; ClinicalTrials.gov ; “Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)”; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021 5 Ferrant JL et al., International Immunol. (11):1583

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The Pharma Data

DECEMBER 2, 2020

The Phase IIb induction study in patients with moderate-to-severe UC, enrolled the first patient in August 2019. The drug is a small-molecule inhibitor of the S. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

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New Drug Approvals

DECEMBER 16, 2023

April 2019). “Small-molecule factor B inhibitor for the treatment of complement-mediated diseases” Proceedings of the National Academy of Sciences of the United States of America. 2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. . 116 (16): 7926–7931.

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The Premier Consulting Blog

AUGUST 8, 2024

As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024). October 2019. [iv] July 28, 2023. iii] US Food and Drug Administration. Guidance for Industry. Website: [link].

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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

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series EUA Statement Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older.

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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

NOVEMBER 4, 2020

million as of December 31, 2019. million for the same period in 2019. million for the same period in 2019. per share, for the quarter ended September 30, 2019. 2019. 2019. License and research and development revenue.

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The Pharma Data

JANUARY 18, 2021

for the treatment of post-herpetic neuralgia. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

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Clinical Trials Small Molecule Trials Therapies 40

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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Vaccine Clinical Trials Licensing Licensing 52

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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Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 11, 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.:

Vaccine 52

Vaccine Clinical Trials Hospitals Licensing 52

The Pharma Data

FEBRUARY 4, 2021

a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets.

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The Pharma Data

OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.

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The Pharma Data

SEPTEMBER 12, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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Vaccine Trials Clinical Trials Small Molecule 52

The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth).

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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. other regulatory submissions, the anticipated timing of regulatory submissions (including the anticipated timing of filing of a Biologics License Application in the U.S.),

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

OCTOBER 26, 2020

2019. 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.

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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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Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

Agency IQ

JULY 26, 2024

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. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

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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Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. December 29, 2019. December 31, 2019. , Johnson & Johnson’s.

Science 52

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The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. A Phase 2 proof-of-concept study of Pfizer’s potential first-in-class pentavalent meningococcal vaccine candidate (Penta; MenABCWY).

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The Pharma Data

SEPTEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

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The Pharma Data

SEPTEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials RNA Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Forward-Looking Statement of Moderna, Inc.,

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 10, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 20, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

AUGUST 20, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

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 ® ? BRUKINSA was approved by the U.S.

Production 52

Production Therapies Treatment Drugs 52

The Pharma Data

NOVEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 40

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The Pharma Data

DECEMBER 1, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccine 40

Vaccine Clinical Trials Trials Production 40

The Pharma Data

APRIL 27, 2021

due to the earlier supply to the market as compared to the 2019/2020 flu season. SAR441566 , a first, next generation, oral small molecule TNF inhibitor that in contrast to anti-TNF biologics blocks specifically the TNFR1 pathway, started Phase I in inflammatory conditions. Influenza vaccines sales increased by 23.8% In the U.S.,

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Vaccine Production FDA Disease 52

The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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