The Pharma Data

AUGUST 30, 2021

Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. This is not related to any changes in either the efficacy or safety associated with Tecentriq.

Medicine 52

Medicine Antibody Hormones FDA Approval 52

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. “We

Medicine 40

Medicine In-Vitro Antibody Development 40

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

Research 112

Research Vaccination Vaccine Drugs 112

XTalks

DECEMBER 22, 2021

RNA, and its protein-generating form messenger RNA (mRNA) discovered in 1961 , has quickly transitioned from being an obscure, finicky molecule that is difficult to work with, to becoming a significant cornerstone of therapeutic innovation in pharma and biotech. The RNA Revolution: From mRNA Vaccines to RNA Editing.

Life Science 98

Life Science RNA Vaccination Vaccine 98

The Pharma Data

FEBRUARY 8, 2021

Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. About Metastatic Castration-Sensitive Prostate Cancer. About ERLEADA ® (apalutamide).

HR 52

HR Hormones Development Production 52

The Pharma Data

AUGUST 3, 2021

. “As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” LUMAKRAS received accelerated approval based on overall response rate and duration of response.

Sales 52

Sales Production Antibody Development 52

The Pharma Data

JANUARY 4, 2021

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions, with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This marks the 37th BTD for Genentech’s portfolio of medicines. About tiragolumab. receptors.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

APRIL 7, 2021

Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. months vs. 6.9

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Taking IMBRUVICA ® ?with

Medicine 40

Medicine Production FDA Approval Trials 40

The Pharma Data

JUNE 18, 2021

deputy head of hematology, University of Amsterdam Faculty of Medicine. The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Tell your healthcare provider about all the medicines you take, ?including

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. Barr , M.D.,

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. P-gp, BCRP or OATP1B1 Substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically.

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. About Opdivo. Immune-Mediated Pneumonitis.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. About Opdivo. Immune-Mediated Pneumonitis.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 10, 2021

Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. In the U.S., In the U.S., An estimated six million women in the U.S. WARNINGS AND PRECAUTIONS.

Hormones 52

Hormones FDA Approval Drugs Development 52

The Pharma Data

MAY 4, 2021

Internal Medicine. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). REVENUES. . . . . . ($ in millions). 1,611. . *. *.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

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Drugs Gene Hormones Clinical Trials 317