Containment, HR and Packaging - Clinical Research Informer

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

HR

HR Hormones FDA Approval Antibody

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 13, 2022. For more information, please visit www.PAXLOVID.com. . Disclosure Notice.

Drugs

Drugs Licensing Licensing Production

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. FDA Emergency Use Authorization Statement. No dosage adjustment is needed in patients with mild renal impairment.

Drugs

Drugs Vaccination Vaccine In-Vitro

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of December 20, 2022. For more information, please visit www.PAXLOVID.com. Disclosure Notice.

Drugs

Drugs Licensing Licensing Containment

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice The information contained in this statement is as of January 27, 2023.

Marketing

Marketing Production Drugs Licensing

Brochure: Dynabeads manual and automated SARS-CoV-2 enrichment

The Pharma Data

MARCH 20, 2021

Cell culture for virus isolation also remains a useful method for growing and studying viruses in research settings especially in the characterization of novel pathogenic viruses like SARS-CoV-2 although this requires more advanced containment facilities such as biosafety level 3 (BSL-3).

Protein

Protein Antibody Development RNA

New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

The Pharma Data

JUNE 18, 2021

months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]); with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; Concomitant use of preparations containing St. 7 VENCLEXTA (venetoclax) [Package Insert]. After a median follow-up of more than four years (52.4 0.45]); results are descriptive.

Medicine

Medicine HR Trials Production

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). The results passed the futility analysis (p<0.3 At day 5, the relative reduction compared to placebo was -1.1 log 10 copies/mL (nominal p=0.002 for combined doses).

Antibody

Antibody Trials Production Clinical Trials

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The information contained in this statement is as of November 23, 2022. Our Commitment to Access. Disclosure Notice.

Licensing

Licensing Licensing Drugs Manufacturing

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001). Chicago, IL.:

Medicine

Medicine Production FDA Approval Trials

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 The private sector price of Prevnar 20 is around $253.96 billion in 2022.

Sales

Sales Manufacturing FDA Approval Life Science

Top 10 Cancer Drugs to Watch in 2024 Based on Recent Sales Data

XTalks

NOVEMBER 26, 2024

Darzalex Faspro: Subcutaneous solution containing 1,800 mg and 30,000 units per 15 mL, priced from $10,563.33 for a 120-count package of 140 mg capsules. Price of Darzalex and Darzalex Faspro: Darzalex: Intravenous solution at a concentration of 20 mg/mL, priced starting at $783.81 for a 5 mL vial. for a 15 mL vial.

Sales

Sales FDA Approval Drugs Marketing

Clinical Research Informer

Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Trending Sources

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Brochure: Dynabeads manual and automated SARS-CoV-2 enrichment

New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Top 10 Cancer Drugs to Watch in 2024 Based on Recent Sales Data

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