The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

FDA 52

FDA Clinical Trials Trials Treatment 52

Agency IQ

MARCH 1, 2024

history was in 2018-2019, totaling 35 days. It’s worth noting here that according to one drug sponsor , their application submitted “the day before the shutdown started” in 2018 was not able to be reviewed during the “lapse” period, meaning there is some sort of pre-shutdown deadline. What are the impacts for regulated industry?

Government 40

Government FDA Biosimilars Regulations 40

Agency IQ

JUNE 29, 2023

The notice specifically made mention of a 2018 draft guidance document, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, and noted that “it is not fully understood how consumers will interpret specific quantitative claims.”

FDA 40

FDA Drugs Regulations Biosimilars 40

The Pharma Data

DECEMBER 27, 2020

Following changes to our leadership team in late 2018 and early 2019, we have sought to transform Lineage into the preeminent allogeneic cell transplant company. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

Therapies 52

Therapies Production Clinical Trials Treatment 52

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Biosimilars International 52

The Pharma Data

JULY 15, 2021

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.

Disease 52

Disease Biosimilars Government Treatment 52

The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. The primary efficacy endpoint was the annualized asthma exacerbation rate during the 52-week treatment period.

Trials 52

Trials Production Clinical Trials Government 52

FDA Law Blog: Biosimilars

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Production 53

Production FDA Treatment Disease 53

The Pharma Data

JULY 8, 2021

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.

Disease 52

Disease Government Clinical Trials Research 52

The Pharma Data

DECEMBER 21, 2020

“The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. Detailed results from the SOURCE trial will be presented at a future medical meeting.

Trials 40

Trials Production Clinical Trials Government 40

The Pharma Data

APRIL 7, 2023

BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. “For more than a decade, Pfizer Oncology has been at the forefront of bringing biomarker-driven treatment options to patients with cancer.

FDA 40

FDA FDA Approval Small Molecule Drugs 40

The Pharma Data

FEBRUARY 8, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Fourth-quarter Fabrazyme ® sales decreased 0.9%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Fourth-quarter Fabrazyme ® sales decreased 0.9%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. 2018) , Arnold Partnership v. Patent Nos. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed.

FDA Approval 59

FDA Approval FDA Production Therapies 59

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recent Events.

Production 52

Production International Clinical Trials Small Molecule 52

The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. reflecting lower treatment compliance during the COVID-19 pandemic. First-quarter Fabrazyme ® sales increased 4.7% In the U.S. sales decreased 2.9%

Vaccine 52

Vaccine Production FDA FDA Approval 52

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; 21 U.S.C. §

FDA 111

FDA Treatment FDA Approval Drugs 111

The Pharma Data

APRIL 11, 2021

under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. The CHRONOS-3 data signals a much-needed advancement in the iNHL treatment paradigm,” said Pier Luigi Zinzani, M.D., Copanlisib is already approved as a monotherapy in the U.S.

Treatment 52

Treatment Therapies Trials Disease 52

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The FDA action converts the 2018 accelerated approval to full approval. It does not include an allocation of corporate or other overhead costs.

Vaccine 40

Vaccine Production FDA Biosimilars 40

FDA Law Blog: Biosimilars

JUNE 23, 2024

For example, intrathecal infusion therapy, via an implanted infusion pump, or Targeted Drug Delivery (TDD”), is a last-line therapy for patients who have failed all other conventional pain therapies. However, two events conspired to undermine this prior guidance.

Nurses 98

Nurses Pharmacy Regulations Therapies 98