The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.

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Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Concert Pharmaceuticals, Inc. License and research and development revenue. Concert Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. About Q BioMed Inc.

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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. COMIRNATY® will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. AUTHORIZED USE IN THE EU: COMIRNATY® ?

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The Pharma Data

NOVEMBER 5, 2020

Merger completed with Rexahn Pharmaceuticals creating a Nasdaq-listed Biopharmaceutical Company Focused on Advancing Ocuphire’s Late-Stage Clinical Pipeline of Ophthalmic Drug Candidates. Trading under “OCUP” on the Nasdaq Capital Market to begin November 6, 2020. Concurrent $21.15

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The Pharma Data

MAY 6, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

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Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 4, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) and Ovid Therapeutics Inc. Ovid may benefit significantly, but without the obligation to commit the substantial capital needed over the coming years as soticlestat completes pivotal trials and, if successful, enters the global market.

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Treatment Clinical Trials Pharmaceutical Companies Trials 52

The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by 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. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

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The Pharma Data

SEPTEMBER 12, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more information, please visit www.BioNTech.de.

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Agency IQ

NOVEMBER 3, 2023

Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research. Most of the strains that are found on the market were developed in a lab and are marketed as proprietary ingredients.

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The Pharma Data

SEPTEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. About the BNT162 Vaccine Candidate Program. For more information, please visit www.BioNTech.de.

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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. Canada and Europe.

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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. For more information, please visit [link]. Learn more at Learn more at www.jnj.com.

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Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. Bahrain, and Canada. About the Phase 2/3 Study. For more information, please visit www.BioNTech.de.

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The Pharma Data

NOVEMBER 20, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more information, please visit www.BioNTech.de.

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Vaccine FDA Clinical Trials 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. About the Janssen Pharmaceutical Companies of. Bayer Animal Health.

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Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 1, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. The first doses are expected to arrive in the U.K. Manufacturing and Delivery Capabilities.

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The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

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The Pharma Data

NOVEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more information, please visit www.BioNTech.de.

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The Pharma Data

AUGUST 20, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more information, please visit www.BioNTech.de.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. 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. CAMBRIDGE, England & BOSTON –(BUSINESS WIRE)–Dec.

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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 vaccine is also currently available for individuals 12 through 15 years of age in the European Union under a Conditional Marketing Authorization. . Pfizer Inc. Source link: [link].

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ What kind of biologic products entered the market?

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FDA Biosimilars Science Production 52

Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products. Any CMC changes (e.g.,

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The Pharma Data

DECEMBER 2, 2020

The drug is a small-molecule inhibitor of the S. ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. in Mainland China.

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The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. HLE BiTE ® molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 percentage points to 13.5%.

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Biosimilars Production Treatment FDA 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. About Eloxx Pharmaceuticals. Eloxx Pharmaceuticals, Inc. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. SOURCE: Eloxx Pharmaceuticals, Inc.

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Pharmaceuticals RNA Small Molecule Protein Production 52

The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. In November , the European Medicines Agency agreed to review the Marketing Authorization Application for avacopan for the treatment of patients with ANCA-associated vasculitis.

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Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

JANUARY 10, 2021

Development of TransCon CNP is progressing as planned with the recent initiation by VISEN Pharmaceuticals of a second phase 2 trial in patients with achondroplasia, the ACcomplisH China Trial, which provides for dose expansion at an effective dose determined from the ACcomplisH Trial. . . ?.

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The Pharma Data

SEPTEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more information, please visit www.BioNTech.de.

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The Pharma Data

DECEMBER 20, 2020

Auxora is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation. Regeneron Pharmaceuticals reported that it is pausing enrollment in two of its clinical trials for odronextamab for lymphoma. Graphite Bio licensed the product from Stanford University.

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The Pharma Data

SEPTEMBER 15, 2020

Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. BNT162 mRNA-based Vaccine Program. and -50.4% mg/dL reduction for placebo.

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The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. Pharmaceuticals business operating income. to €2,638 million.

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The Pharma Data

MARCH 11, 2021

The vaccine has now been granted a conditional marketing authorization, emergency use authorization or temporary authorization in a total of more than 60 countries. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

JUNE 24, 2021

As part of the plan, the United States will allocate the vaccine doses to 92 low- and lower middle-income countries and economies as defined by Gavi’s COVAX Advance Market Commitment (AMC) and the 55 member states of the African Union. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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Government Vaccine Clinical Trials Licensing 52

The Pharma Data

FEBRUARY 24, 2022

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. Source link: [link].

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