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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.
Prime Therapeutics Removes Three Products from Medicare Formularies
Prime Therapeutics Removes Three Products from Medicare Formularies
Prime Therapeutics Removes Three Products from Medicare Formularies
March 9, 2022
Generics are now available for the three therapies: Cystadane, Selzentry, and AmBisome.
Teva Launches First Generic to Blockbuster Cancer Med
Teva Launches First Generic to Blockbuster Cancer Med
Teva Launches First Generic to Blockbuster Cancer Med
March 8, 2022
This is the first generic available for Revlimid in the United States.
FDA Issues Complete Response Letter for Long-Acting HIV Therapy
FDA Issues Complete Response Letter for Long-Acting HIV Therapy
FDA Issues Complete Response Letter for Long-Acting HIV Therapy
March 8, 2022
The FDA cited issues related to the compatibility of lenacapavir and the vial used. The agency has not requested new clinical studies.
Three Companies Recall Immune Globulin Products
Three Companies Recall Immune Globulin Products
Three Companies Recall Immune Globulin Products
March 8, 2022
A total of 28 lots have been recalled because of a high rate of allergic reactions.
Novartis Updates Safety Label of Egaten
Novartis Updates Safety Label of Egaten
Novartis Updates Safety Label of Egaten
March 7, 2022
Over time, Egaten, an antiparasitic, can increase the QTc interval, resulting in a heart rhythm condition that can cause chaotic heartbeats.
FDA Okays a Third Biosimilar to Neupogen
FDA Okays a Third Biosimilar to Neupogen
FDA Okays a Third Biosimilar to Neupogen
March 7, 2022
Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.
Civica Plans to Sell Lower-Cost Insulins
Civica Plans to Sell Lower-Cost Insulins
Civica Plans to Sell Lower-Cost Insulins
March 7, 2022
Once approved, the insulins will be available to patients for no more than $30 per vial.
FDA OKs Vonjo for Certain Myelofibrosis Patients
FDA OKs Vonjo for Certain Myelofibrosis Patients
FDA OKs Vonjo for Certain Myelofibrosis Patients
March 5, 2022
Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
March 3, 2022
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
FDA Clears New CAR-T Therapy for Multiple Myeloma
FDA Clears New CAR-T Therapy for Multiple Myeloma
FDA Clears New CAR-T Therapy for Multiple Myeloma
March 2, 2022
FDA approved Legend Biotech’s chimeric antigen receptor T-cell (CAR-T) treatment, Carvykti (ciltacabtagene autoleucel; cilta- cel), to treat relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy.
Employers Face Barriers With Adopting Biosimilars
Employers Face Barriers With Adopting Biosimilars
Employers Face Barriers With Adopting Biosimilars
March 1, 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
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