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All News - Page 47

FDA Issues CRL for Natpara for Hypoparathyroidism
FDA Issues CRL for Natpara for Hypoparathyroidism
FDA Issues CRL for Natpara for Hypoparathyroidism
March 22, 2022
The CRL delays the commercial return in the United States, Takeda didn’t release any information about the reason for the CRL.
Pfizer Recalls Blood Pressure Drug Accuretic
Pfizer Recalls Blood Pressure Drug Accuretic
Pfizer Recalls Blood Pressure Drug Accuretic
March 22, 2022
The recall of Accuretic and generics distributed by Greenstone is a result of the presence of a cancer-causing agent.
FDA Approves Keytruda for Advanced Endometrial Cancer
FDA Approves Keytruda for Advanced Endometrial Cancer
FDA Approves Keytruda for Advanced Endometrial Cancer
March 22, 2022
The FDA also approved a companion diagnostic to select patients with mismatch repair deficiency who would be eligible for treatment with Keytruda.
Study: Eliquis Can Lower Hospitalizations after VTE
Study: Eliquis Can Lower Hospitalizations after VTE
Study: Eliquis Can Lower Hospitalizations after VTE
March 21, 2022
But there is no significant difference in rate of hospitalization for major bleeding when Eliquis is compared with Xarelto or warfarin.
BMS’s Opdualag Snags Approval for Melanoma
BMS’s Opdualag Snags Approval for Melanoma
BMS’s Opdualag Snags Approval for Melanoma
March 21, 2022
Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.
Provention Bio Resubmits Application for Teplizumab
Provention Bio Resubmits Application for Teplizumab
Provention Bio Resubmits Application for Teplizumab
March 21, 2022
Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.
FDA Approves First Therapy for Rare, Genetic Seizure Disorder
FDA Approves First Therapy for Rare, Genetic Seizure Disorder
FDA Approves First Therapy for Rare, Genetic Seizure Disorder
March 19, 2022
Ztalmy was approved for seizures associated with CDKL5 deficiency disorder in patients two years of age and older. It is expected to be available in July 2022.
Prodigy Rx Tackles Transparency in Workers’ Comp Pharmacy
Prodigy Rx Tackles Transparency in Workers’ Comp Pharmacy
Prodigy Rx Tackles Transparency in Workers’ Comp Pharmacy
March 18, 2022
Del Doherty, co-founder of Prodigy Rx, discusses how the PBM aims to give payers control so they can lower costs and can improve clinical and return-to-work outcomes.
Amneal to Manufacture Generic Version of Paxlovid to Treat COVID-19
Amneal to Manufacture Generic Version of Paxlovid to Treat COVID-19
Amneal to Manufacture Generic Version of Paxlovid to Treat COVID-19
March 18, 2022
Amneal is of 35 global companies selected to manufacture and commercialize generic version of COVID-19 treatment Paxlovid.
Biogen Releases Positive Data on Aduhelm, Takes Over Decision Making
Biogen Releases Positive Data on Aduhelm, Takes Over Decision Making
Biogen Releases Positive Data on Aduhelm, Takes Over Decision Making
March 17, 2022
New data show longer-term benefits from Aduhelm, which was approved last year to treat Alzheimer’s disease.
ICER Evaluates Novel Agents to Prevent Infection with Chemotherapy
ICER Evaluates Novel Agents to Prevent Infection with Chemotherapy
ICER Evaluates Novel Agents to Prevent Infection with Chemotherapy
March 17, 2022
ICER analyzed two therapies — Cosela and plinabulin — to prevent chemotherapy-induced neutropenia and other myelosuppressive effects. Both moderately increased quality-adjusted life-years.
FDA Approves Rinvoq for Ulcerative Colitis
FDA Approves Rinvoq for Ulcerative Colitis
FDA Approves Rinvoq for Ulcerative Colitis
March 17, 2022
This approval is the first indication for Rinvoq in gastroenterology.
Civica’s Allan Coukell Talks about Its Insulin Program
Civica’s Allan Coukell Talks about Its Insulin Program
Civica’s Allan Coukell Talks about Its Insulin Program
March 16, 2022
Allan Coukell, Civica’s senior vice president of public policy, discusses how the generic manufacturer is disrupting the market for insulins.
Evio Pharmacy Solutions Plans to Offer Biosimilars
Evio Pharmacy Solutions Plans to Offer Biosimilars
Evio Pharmacy Solutions Plans to Offer Biosimilars
March 16, 2022
Evio Pharmacy Solutions plans to provide biosimilar alternatives for autoimmune and cancer therapeutics.
FDA Approves First Generic of Symbicort for Asthma and COPD
FDA Approves First Generic of Symbicort for Asthma and COPD
FDA Approves First Generic of Symbicort for Asthma and COPD
March 16, 2022
Called Breyna, this drug-device combination generic product is a metered-dose inhaler, which contains both budesonide and formoterol.
Merck Discontinues Keytruda Combo Trial for Prostate Cancer
Merck Discontinues Keytruda Combo Trial for Prostate Cancer
Merck Discontinues Keytruda Combo Trial for Prostate Cancer
March 15, 2022
In an interim analysis, Keytruda/Lynparza did not improve overall survival in patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy.
Cabometyx Combo Doesn’t Meet Survival Endpoint in Advanced Liver Cancer Trial
Cabometyx Combo Doesn’t Meet Survival Endpoint in Advanced Liver Cancer Trial
Cabometyx Combo Doesn’t Meet Survival Endpoint in Advanced Liver Cancer Trial
March 15, 2022
After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.
The FDA Issues Complete Response Letter for Fasenra
The FDA Issues Complete Response Letter for Fasenra
The FDA Issues Complete Response Letter for Fasenra
March 15, 2022
The FDA has asked for clinical data for Fasenra, which is being reviewed as a treatment for chronic rhinosinusitis with nasal polyps.
FDA Approves New Delivery Method for Alzheimer’s Disease
FDA Approves New Delivery Method for Alzheimer’s Disease
FDA Approves New Delivery Method for Alzheimer’s Disease
March 14, 2022
Adlarity delivers donepezil to patients using a skin patch, lowering the risk of gastrointestinal adverse events. It will be available in early fall 2022.
FDA Extends Review of Opzelura for Skin Condition
FDA Extends Review of Opzelura for Skin Condition
FDA Extends Review of Opzelura for Skin Condition
March 14, 2022
Opzelura is being reviewed as a treatment for vitiligo, a disease that causes the loss of skin color. The new PDUFA date is July 18, 2022.
FDA Approves Lynparza for Early Breast Cancer
FDA Approves Lynparza for Early Breast Cancer
FDA Approves Lynparza for Early Breast Cancer
March 14, 2022
Lynparza reduced the risk of death by 32% versus placebo. It is the first targeted treatment for patients with early breast cancer to be used after surgery or prior treatment.
Fresenius Kabi Recalls Seven Lots of Sodium Acetate
Fresenius Kabi Recalls Seven Lots of Sodium Acetate
Fresenius Kabi Recalls Seven Lots of Sodium Acetate
March 12, 2022
The lots could contain trace amounts of sodium, silicon, chromium, aluminum, and cellulose, which could result in irritation or infection and has the potential to block blood vessels in the heart, lungs, or brain.
Recent Generic Approvals
Recent Generic Approvals
Recent Generic Approvals
March 11, 2022
The FDA has granted first approval for cartridges for use with Apokyn for Parkinson’s. Other approvals include: a generic of anticancer therapy Vidaza, the antibacterial Erythrocin, and the anti-epilepsy therapy Lamictal.
B. Braun Recalls Sodium Chloride Injection
B. Braun Recalls Sodium Chloride Injection
B. Braun Recalls Sodium Chloride Injection
March 11, 2022
B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
March 11, 2022
This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.
FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene
FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene
FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene
March 10, 2022
The company will distribute nalmefene for no profit, which is part of the company’s bankruptcy filing and settlement with states.
Recent Regulatory Submissions
Recent Regulatory Submissions
Recent Regulatory Submissions
March 10, 2022
Supplemental applications have been submitted for the cancer therapies Nubeqa and Tibsovo, the gout treatment Krystexxa, and Oxlumo, which treats a rare disease.
NCCN Includes Besremi on Cancer Treatment Guideline
NCCN Includes Besremi on Cancer Treatment Guideline
NCCN Includes Besremi on Cancer Treatment Guideline
March 10, 2022
Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.
FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis
FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis
FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis
March 9, 2022
With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
March 9, 2022
Aadi Bioscience recently launched Fyarro, the first FDA-approved therapy to treat an ultra-rare sarcoma.
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