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All News - Page 59

FDA Approves Erbitux/Braftovi Combination for Advanced Colorectal Cancer
FDA Approves Erbitux/Braftovi Combination for Advanced Colorectal Cancer
FDA Approves Erbitux/Braftovi Combination for Advanced Colorectal Cancer
September 30, 2021
This is the seventh approval for Erbitux and the only anti-EGFR antibody approved for this indication.
Sanofi Selects Orsini as Limited Distribution Partner for Nexviazyme
Sanofi Selects Orsini as Limited Distribution Partner for Nexviazyme
Sanofi Selects Orsini as Limited Distribution Partner for Nexviazyme
September 30, 2021
The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.
FDA Accepts Application for Libtayo for Advanced Cervical Cancer
FDA Accepts Application for Libtayo for Advanced Cervical Cancer
FDA Accepts Application for Libtayo for Advanced Cervical Cancer
September 30, 2021
The PDUFA target action date for the FDA decision is Jan. 30, 2022.
AstraZeneca Presents Positive Results for COVID-19 Monoclonal Antibody, RSV Treatments
AstraZeneca Presents Positive Results for COVID-19 Monoclonal Antibody, RSV Treatments
AstraZeneca Presents Positive Results for COVID-19 Monoclonal Antibody, RSV Treatments
September 29, 2021
Data is being presented at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.
FDA Approves Novel Therapy to Prevent Migraine
FDA Approves Novel Therapy to Prevent Migraine
FDA Approves Novel Therapy to Prevent Migraine
September 29, 2021
AbbVie’s Qulipta is a once-daily oral to prevent migraines in adults.
Pfizer and BioNTech Submit Initial Data of COVID-19 Vaccine in Children
Pfizer and BioNTech Submit Initial Data of COVID-19 Vaccine in Children
Pfizer and BioNTech Submit Initial Data of COVID-19 Vaccine in Children
September 29, 2021
The companies plan to request an emergency use authorization in a few weeks.
Biogen/Eisai Submits Rolling Application for Second Alzheimer’s Therapy
Biogen/Eisai Submits Rolling Application for Second Alzheimer’s Therapy
Biogen/Eisai Submits Rolling Application for Second Alzheimer’s Therapy
September 28, 2021
The companies are seeking accelerated approval based on the surrogate end point of beta amyloid reduction.
Pfizer Begins Trial of mRNA-based Flu Vaccine
Pfizer Begins Trial of mRNA-based Flu Vaccine
Pfizer Begins Trial of mRNA-based Flu Vaccine
September 28, 2021
The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.
Lilly Lowers List Price of Insulin Lispro
Lilly Lowers List Price of Insulin Lispro
Lilly Lowers List Price of Insulin Lispro
September 28, 2021
Effective Jan. 1 2022, the move brings the price to 2008 levels.
Study: Substantial Variation of Branded Drug Prices Exists Among Payers
Study: Substantial Variation of Branded Drug Prices Exists Among Payers
Study: Substantial Variation of Branded Drug Prices Exists Among Payers
September 27, 2021
Prices paid by Veterans Affairs were the lowest and were 50% to 60% below list prices.
FDA Accepts Applications for Opdivo Combinations for Advanced Esophageal Squamous Cell Carcinoma
FDA Accepts Applications for Opdivo Combinations for Advanced Esophageal Squamous Cell Carcinoma
FDA Accepts Applications for Opdivo Combinations for Advanced Esophageal Squamous Cell Carcinoma
September 27, 2021
The FDA assigned a Prescription Drug User Fee Act goal date of May 28, 2022.
The FDA Approves Repatha for Children with Rare Genetic Disease
The FDA Approves Repatha for Children with Rare Genetic Disease
The FDA Approves Repatha for Children with Rare Genetic Disease
September 27, 2021
Repatha is now available for children 10 and older to lower low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia.
Lilly Recalls One Lot of Glucagon
Lilly Recalls One Lot of Glucagon
Lilly Recalls One Lot of Glucagon
September 26, 2021
The diabetes therapy is being recalled because of a lack of potency.
Drug Shortages Update — September 26, 2021
Drug Shortages Update — September 26, 2021
September 25, 2021
Report: Biosimilars Have Saved the Health Care System $9.8 Billion
Report: Biosimilars Have Saved the Health Care System $9.8 Billion
Report: Biosimilars Have Saved the Health Care System $9.8 Billion
September 24, 2021
Amgen’s Biosimilar Trend Report finds that biosimilars have been introduced at a price that is generally 15% to 37% lower than the reference product.
Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting
Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting
Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting
September 24, 2021
Shifting cancer patients to the physician setting for administration of cancer therapies could save insurers $1.28 billion.
Onco360 Chosen as a Specialty Pharmacy for Takeda’s Exkivity
Onco360 Chosen as a Specialty Pharmacy for Takeda’s Exkivity
Onco360 Chosen as a Specialty Pharmacy for Takeda’s Exkivity
September 24, 2021
Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations.
FDA Approves Jakafi for GVHD
FDA Approves Jakafi for GVHD
FDA Approves Jakafi for GVHD
September 23, 2021
This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.
Merck Shares Significant Keytruda Breast Cancer Results
Merck Shares Significant Keytruda Breast Cancer Results
Merck Shares Significant Keytruda Breast Cancer Results
September 23, 2021
Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.
FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine
FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine
FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine
September 23, 2021
People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.
Par Launches Generic of Smoking Cessation Drug Chantix
Par Launches Generic of Smoking Cessation Drug Chantix
Par Launches Generic of Smoking Cessation Drug Chantix
September 22, 2021
Dr. Reddy’s has also launched a generic of Librax. Recent generic approvals include clindamycin phosphate foam and sodium acetate.
FDA Approves Topical JAK inhibitor for Atopic Dermatitis
FDA Approves Topical JAK inhibitor for Atopic Dermatitis
FDA Approves Topical JAK inhibitor for Atopic Dermatitis
September 22, 2021
Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.
FDA Approves Tivdak for Advanced Cervical Cancer
FDA Approves Tivdak for Advanced Cervical Cancer
FDA Approves Tivdak for Advanced Cervical Cancer
September 22, 2021
Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.
FDA has Accepted Application for Rare Epilepsy
FDA has Accepted Application for Rare Epilepsy
FDA has Accepted Application for Rare Epilepsy
September 21, 2021
The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.
AbbVie Submits Skyrisi to FDA for Crohn’s Disease
AbbVie Submits Skyrisi to FDA for Crohn’s Disease
AbbVie Submits Skyrisi to FDA for Crohn’s Disease
September 21, 2021
In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy
FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma
FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma
FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma
September 21, 2021
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.
FDA Approves First Biosimilar to Treat Macular Degeneration
FDA Approves First Biosimilar to Treat Macular Degeneration
FDA Approves First Biosimilar to Treat Macular Degeneration
September 20, 2021
Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.
CMS Assigns J-Code for the Antibiotic Kimyrsa
CMS Assigns J-Code for the Antibiotic Kimyrsa
CMS Assigns J-Code for the Antibiotic Kimyrsa
September 20, 2021
Effective October 1, 2021, CMS will reimburse for the infusion product when dispensed in the outpatient setting.
FDA Approves Cabometryx for Thyroid Cancer
FDA Approves Cabometryx for Thyroid Cancer
FDA Approves Cabometryx for Thyroid Cancer
September 20, 2021
The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.
Formulary Watch Drug Shortage Tracker — September 19, 2021
Formulary Watch Drug Shortage Tracker — September 19, 2021
September 19, 2021
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