The Pharma Data

JULY 8, 2021

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. For more information about Eisai Co.,

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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pharmaphorum

AUGUST 31, 2022

It is actually the control formulation used in clinical development of its original product MED2005, which contained glyceryl trinitrate as an active ingredient. However, “the USA remains the largest market opportunity globally for ED treatments,” said Futura’s chief executive, James Barder.

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pharmaphorum

OCTOBER 2, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. INTERCHANGEABILITY.

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Pfizer

AUGUST 3, 2022

We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. Learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

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The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. In April 2020, Harpoon announced dosing of the first patient with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM).

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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. Food and Drug Administration (“FDA”) approval.

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology.

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The Pharma Data

JULY 21, 2021

–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat). KENILWORTH, N.J.–(BUSINESS In the EU, VERQUVO (2.5

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The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

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The Pharma Data

DECEMBER 15, 2020

is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix, Inc.

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The Pharma Data

DECEMBER 10, 2020

agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada. IDHIFA is also approved in Australia and Canada.

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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.

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The Pharma Data

DECEMBER 10, 2020

BNT162b2 has been authorized or approved for emergency use in several countries around the world including the U.K., 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. Bahrain, and Canada. Posted: December 2020.

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XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

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Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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The Pharma Data

OCTOBER 27, 2020

The FDA grants Orphan Drug designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies.

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The Pharma Data

NOVEMBER 30, 2020

It showcases our ability to advance strategically important candidates against specific disease targets through early development to become attractive partnering opportunities in parallel with the multi-target deals we have established. ” Abbreviations used: CGRP – calcitonin gene-related peptide. About Sosei Heptares.

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The Pharma Data

DECEMBER 11, 2020

The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. BioNTech will hold the regulatory approvals in the U.S.,

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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. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Pfizer Disclosure Notice.

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The Pharma Data

JANUARY 18, 2021

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. Enquiries: OKYO Pharma Limited.

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Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). GlobalData’s report assesses how Pembrolizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

SEPTEMBER 1, 2020

Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. FDA-APPROVED INDICATION FOR ZEPOSIA.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33

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The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . INDIANAPOLIS , Oct. The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA).

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Pfizer

JULY 26, 2022

The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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.

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Pfizer

JULY 19, 2022

Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. INTERCHANGEABILITY. Pfizer Disclosure Notice.

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Pfizer

JULY 8, 2022

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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. INTERCHANGEABILITY. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell. Forward-Looking Statements.

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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