XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review. billion to $1.28

HR 98

HR FDA Approval Gene Trials 98

The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). About Metastatic Castration-Sensitive Prostate Cancer.

HR 52

HR Hormones Development Production 52

Pfizer

AUGUST 15, 2022

Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Contraception : Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Anticonvulsant: carbamazepine, primidone, phenytoin. Herbal Products: St. John’s Wort (hypericum perforatum).

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

The Pharma Data

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84];

HR 52

HR Trials Dermatology Hormones 52

XTalks

FEBRUARY 5, 2024

It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Price of Verzenio: The list price of Verzenio is $15,405.72 per month; however, the actual amount patients pay will largely depend on their insurance plan. For Kisqali, sales reached $1.5

FDA Approval 101

FDA Approval Drugs Sales Development 101

Pfizer

JANUARY 27, 2023

Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. No dosage adjustment is needed in patients with mild renal impairment.

Marketing 75

Marketing Production Drugs Licensing 75

XTalks

FEBRUARY 5, 2024

It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Price of Verzenio: The list price of Verzenio is $15,405.72 per month; however, the actual amount patients pay will largely depend on their insurance plan. For Kisqali, sales reached $1.5

FDA Approval 52

FDA Approval Drugs Sales Development 52

Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. It is important to note that these studies are required by U.S. and around the world.

Research 112

Research Vaccination Vaccine Drugs 112

Pfizer

DECEMBER 20, 2022

Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Anticancer drugs: apalutamide. Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin. Antimycobacterials: rifampin. Herbal Products: St.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 2022

Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin. Antimycobacterials: rifampin. Herbal Products: St. John’s Wort (hypericum perforatum) .

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

FEBRUARY 8, 2021

months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001).

HR 52

HR In-Vitro Development Clinical Trials 52

The Pharma Data

MARCH 3, 2021

The expanded approval of LORBRENA is based on the results from the pivotal Phase 3 CROWN trial, which showed a 72% reduction in risk of progression or death vs. XALKORI ® (crizotinib) in a previously untreated patient population (HR 0.28: 95% CI, 0.19 to 0.41; p<0.0001) as assessed by blinded independent central review (BICR).

FDA Approval 52

FDA Approval Hormones Trials Medicine 52

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

NOVEMBER 23, 2022

Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin . Antimycobacterials: rifampin. Herbal Products: St. John’s Wort (hypericum perforatum).

Licensing 40

Licensing Licensing Drugs Manufacturing 40

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. Isolated growth hormone deficiency. ?

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). Isolated growth hormone deficiency. ? 1 Additionally, at 6.5 European Heamtology Association 2021 Virtual Congress. November 2020.

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

announced that the EMA has validated for review the MAA for somatrogon, a long-acting recombinant human growth hormone intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency. Somatrogon — In February 2021, Pfizer and OPKO Health Inc.

Vaccination 40

Vaccination Vaccine Production Sales 40