The Pharma Data

NOVEMBER 23, 2020

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com. . . View original content to download multimedia: [link].

Compliance 52

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. The global esophageal cancer drugs market is estimated to grow by USD $1.5 PharmaDrug Inc.

Drugs 52

Drugs Containment Development Sales 52

The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

Antibody 52

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XTalks

APRIL 24, 2023

This is an increase from the EMA’s approval of two novel ATMPs with orphan designation in 2021 (although the marketing authorization for one of these ATMPs was withdrawn in the European Union in November 2021) and three novel ATMPs with orphan designation in 2020. How Can Study Protocols Be More Effective?

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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Clinical Trials Clinical Trials Production Medicine 52

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. The information contained in this release is as of April 19, 2021. AUTHORIZED USE IN THE EU: COMIRNATY® ? Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Manufacturing Licensing 52

The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. . ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

Clinical Trials 52

Clinical Trials Clinical Trials Gene Editing Genome 52

The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Attention: Capital Markets, 499 Park Ave.,

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Clinical Trials Clinical Trials Clinical Development Antibody 40

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

Life Science 52

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical 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.

Manufacturing 52

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The Pharma Data

JANUARY 13, 2021

Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials. Our 5,000+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. Forward-Looking Statements.

Production 52

Production Trials Antibody Clinical Trials 52

The Pharma Data

JANUARY 25, 2021

million for the achievement of certain regulatory milestones including market approvals in Mainland China and Taiwan. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019.

Production 40

Production Clinical Development Licensing Licensing 40

Pfizer

SEPTEMBER 16, 2022

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5

Marketing 75

Marketing Vaccination Vaccine Clinical Trials 75

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. The information contained in this release is as of December 11, 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

FEBRUARY 12, 2024

When pharmacologist, Dr Bob Coleman, began his career with the pharmaceutical giant, Glaxo, his arrival coincided with the discovery of some well-known drugs such as the bronchodilator salbutamol (marketed as Ventolin) and beclomethasone (Becotide). Drug discovery and development tomorrow – Changing the mindset. 2009;37(SUPPL.

Medicine 59

Medicine Genome Genomics Drugs 59

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile. For more info, please visit abingworth.com.

Development 52

Development Life Science Protein Clinical Development 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

NOVEMBER 22, 2020

The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Conference Call and Webcast Information.

Development 52

Development Clinical Trials Clinical Trials Trials 52

The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.

Drug Delivery 52

Drug Delivery Clinical Trials Clinical Trials Medicine 52

The Pharma Data

SEPTEMBER 9, 2020

The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 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 information contained in this release is as of December 2, 2020.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

The Pharma Data

NOVEMBER 20, 2020

The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 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. The information contained in this release is as of December 10, 2020. Bahrain, and Canada.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. “We believe Prof.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

The Pharma Data

AUGUST 20, 2020

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. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees. About Krabbe Disease. F orward -Looking Statements.

Gene Therapy 40

Gene Therapy Drugs Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 5, 2020

By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021. Other expenses for the Company’s operations.

Marketing 40

Marketing Production Regulation Containment 40

The Pharma Data

NOVEMBER 9, 2020

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of November 9, 2020. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

Development 75

Development Regulation Medicine Containment 75

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. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain. LONDON and BOSTON, Jan.

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