The Pharma Data

MARCH 11, 2021

In the pharmaceutical sector, new technologies could help us not only to treat but probably cure or even prevent diseases,” Baumann said. Sustainability forms an integral part of Bayer’s business strategy, growth plans and incentive systems, Baumann stressed, citing as an example the company’s decision to become carbon-neutral by 2030.

Science 52

Science Pharmaceuticals Licensing Licensing 52

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 24] These submissions all related to a single disease. In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6]

FDA 69

FDA Laboratories Regulations Production 69

The Pharma Data

AUGUST 5, 2021

Food and Drug Administration for the treatment of adult patients with chronic kidney disease and type 2 diabetes. Earnings were also diminished by a negative product mix, currency effects of 111 million euros, and the later receipt of license revenues. The latter product was approved in July by the U.S. to 4.494 billion euros.

Production 52

Production Pharmaceuticals Science Therapies 52

The Pharma Data

NOVEMBER 5, 2020

This quarter we had robust top- and bottom-line growth driven by EYLEA in retinal diseases and Dupixent in atopic dermatitis and asthma. R&D: Up-front payments related to license and collaboration agreements. (85). Oncology Program. 50% PD-L1 expression. In millions). GAAP R&D. $. Non-GAAP R&D. $. GAAP SG&A. $.

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Production FDA Trials FDA Approval 40

The Pharma Data

APRIL 27, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the first quarter, Rare Disease sales increased 4.4% District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which expire in October 2030. Net sales (€ million). Change at CER. Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Disease 52

The Pharma Data

JULY 11, 2021

In the last decade there has been an increase in the incidence of invasive meningococcal disease due to serogroups W & Y in Europe , 1 demonstrating a need for routine MenACWY vaccination.” Children under five and adolescents are most at risk from IMD, a rare but potentially deadly disease which can have devastating consequences.

Immune Response 52

Immune Response Disease Vaccine Licensing 52

The Pharma Data

FEBRUARY 8, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

NOVEMBER 22, 2020

This patent completes the Ezeprogind related patents granted in the USA for composition of matter (US 9,562,018) and therapeutic uses in the treatment of Alzheimer’s and Parkinson’s diseases (US 10,537,569). Alzprotect is committed to the development of innovative therapeutic solutions in the field of neurodegenerative diseases.

Drugs 40

Drugs Disease Clinical Trials Licensing 40

Agency IQ

JUNE 16, 2023

See Asbestos Disease Awareness Organization v. Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

Regulations 40

Regulations Compliance Production Science 40