FDA Approves Vaccine for Hepatitis B
PreHevBrio is a three-antigen hepatitis B vaccine for adults in the United States. It is expected to be available in the first quarter of 2022.
Merck Submits Application for Vaxneuvance for Children, Adolescents
The FDA has set a PDUFA action date of April 1, 2022.
FDA Accepts BMS Application for Psoriasis Therapy
The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022, for deucravacitinib. If approved, it would be the first TYK2 inhibitor approved for the treatment of any disease.
Advisory Committee Recommends Authorization of the COVID-19 Anti-viral Molnupiravir
If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.
FDA Approves Imaging Agent to Detect Ovarian Cancer
Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.
Merck Releases Updated Data on its COVID-19 Antiviral
Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.
FDA Approves Treatment for Post-Transplant Infection
Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.
Recent Generic Launches
Several new generics have launched in the United States, including for the migraine therapy Zomig, the anticancer therapy Doxil, and an anti-inflammatory used to treat respiratory conditions associated with COVID-19.
FDA Accepts for Priority Review Gene Therapy for Rare Blood Disorder
If approved, Bluebird Bio’s beti-cel would be the first one-therapy for β-thalassemia. The PDUFA date is May 20, 2022.
Long-term Study Shows Pfizer COVID-19 Vaccine is 100% Effective in Adolescents
Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.
Sagent Recalls Four Lots of Levetiracetam
The antiseizure medication affected by the recall could have sterility issues.
Formulary Watch Drug Shortage Update — November 21, 2021
Gilead Submits BLA for Chronic Hepatitis Therapy
Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
FDA Approves First Drug for a Form of Dwarfism
BioMarin’s Voxzogo is expected to be available in the United States by mid- to late-December.
FDA Expands EUA for Moderna and Pfizer COVID-19 Boosters
The boosters are now authorized for all people 18 years of age and older.
Onco360 Chosen as a Specialty Pharmacy Provider for Besremi
Besremi was approved recently to treat a rare blood disease.
FDA Grants Approval to Keytruda for Early Stage RCC
Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.
Pfizer Seeks EUA for COVID-19 Oral Antiviral
If authorized, Paxlovid would be the first oral 3CL protease inhibitor specifically designed to combat the virus that causes COVID-19.
Biocon Launches Biosimilar Semglee
Branded and unbranded versions of the interchangeable biosimilar to treat patients with diabetes are now available.
SterRx Recalls 240 Lots of 12 Products
Equipment and process issues could lead to a lack of sterility.
Ocular Therapeutix Ophthalmic Inserts Gain Ocular Itching Indication
Inserts replace steroid eyedrops.
FDA is Recalling One Lot of Firvanq
The lot contains kits with the incorrect solution for diluting vancomycin, which could lead to doses above or below recommended levels.
Teligent Recalls One Lot of Lidocaine
The product is considered “super potent” with a higher dose that could result in serious cardiac toxicities.
Genentech Withdraws Tecentriq Approval for Metastatic Breast Cancer
Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.
FDA Approves Tibsovo for Rare, Aggressive Cancer
Tibsovo is the first targeted therapy for IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside the liver.
FDA Approves Long-Acting Growth Hormone
Developed by Ascendis Pharma, this is the first therapy that delivers growth hormone over one week.
New Dosing Options are Available for Tirosint-SOL
The liquid therapy to treat hypothyroidism now comes in 15 different dosage strengths in single-use packaging.
FDA Safety Alert: Pepaxto is Associated with Increased Risk of Death
The agency has stopped enrollment in all ongoing trials.
NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines
The June 30 approval meets an unmet need in this cancer.
Plaque Psoriasis Treatment is Launched
Wynzora is a cream-based, fixed dose combination of calcipotriene and betamethasone for topical treatment of psoriasis.
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