New Drug/Vaccine Approval

Flyrcado™ (flurpiridaz F 18) Injection – New Drug Approval – September 27, 2024 – GE HealthCare (Nasdaq: GEHC) announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado™ delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. <Read More> Cobenfy™ (xanomeline and trospium chloride) Capsules – New Drug Approval – September 26, 2024 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Cobenfy™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults. Cobenfy™ represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors. <Read More> Aqneursa™ (levacetylleucine) Granules for Oral Suspension – New Drug Approval – September 24, 2024 - The U.S. Food and Drug Administration approved Aqneursa™ (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kilograms. <Read More> Miplyffa™ (arimoclomol) Capsules – New Drug Approval – September 20, 2024 - The U.S. Food and Drug Administration approved Miplyffa™ (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa™, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older. Miplyffa™ is the first drug approved by the FDA to treat NPC. <Read More> Ebglyss™  (lebrikizumab-lbkz) injection – New Drug Approval – September 13, 2024 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Ebglyss™ (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies. Eczema inflammation under the skin can lead to symptoms seen and felt on the outside. Ebglyss™ works by targeting eczema inflammation throughout the body that can lead to dry, itchy and irritated skin. <Read More> Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) Injection – New Drug Approval – September 13, 2024 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo™ is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options. <Read More> Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) Injection - New Drug Approval – September 12, 2024 - The Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza™, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq®, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications. <Read More>

New Indication/Dosage/Formulation Approval

Dupixent® (dupilumab) Injection – New Label Expansion – September 27, 2024 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent® is the first biologic medicine approved in the US to treat these patients. <Read More> Retevmo® (selpercatinib) Capsules and Tablets – New Label Expansion – September 27, 2024 - The Food and Drug Administration granted traditional approval to selpercatinib (Retevmo®, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. <Read More> Tagrisso® (osimertinib) Tablets – New Label Expansion – September 25, 2024 - AstraZeneca’s Tagrisso® (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). Tagrisso® is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. <Read More> Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – September 20, 2024 - UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). Bimekizumab-bkzx is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). These newly approved indications follow the first U.S. approval for Bimzelx® in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. <Read More> Sarclisa® (isatuximab-irfc) Injection – New Label Expansion – September 20, 2024 - The US Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). Sarclisa® is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant. <Read More> FluMist® (Influenza Virus Vaccine, Live, Intranasal) Nasal Spray – New Label Expansion – September 20, 2024 - FluMist® has been approved in the US as the only self-administered influenza vaccine. FluMist®, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age. The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FluMist® to eligible individuals 2-49 years of age. <Read More> Rybrevant® (amivantamab-vmjw) Injection – New Label Expansion – September 19, 2024 - Johnson & Johnson (NYSE: JNJ) announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.1 This FDA action converts the May 2021 accelerated approval of Rybrevant® to a full approval based on the confirmatory Phase 3 PAPILLON study. <Read More> Fasenra® (benralizumab) Injection – New Label Expansion – September 17, 2024 - AstraZeneca’s Fasenra® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval by the US Food and Drug Administration (FDA) was based on positive results from the MANDARA Phase III trial published in The New England Journal of Medicine, which compared the efficacy and safety of Fasenra® to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA. <Read More> Kisqali® (ribociclib) Tablets – New Label Expansion – September 17, 2024 - Novartis announced that the US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease. <Read More> Keytruda® (pembrolizumab) for Injection – New Label Expansion – September 17, 2024 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). <Read More> Dupixent® (dupilumab) Injection – New Label Expansion – September 12, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent® for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. <Read More> Tremfya® (guselkumab) Injection – New Label Expansion – September 11, 2024 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed. Tremfya® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. <Read More>  Filspari® (sparsentan) Tablets - New Label Expansion – September 5, 2024 - Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Filspari® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. Filspari® was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. <Read More>

New Drug Shortage

September 30, 2024

• Irinotecan Hydrochloride Injection (Discontinuation)

September 27, 2024

• Fluconazole Tablet (Discontinuation)

• Voxelotor Tablet (Discontinuation)

September 26, 2024

• Caspofungin Acetate Injection (Discontinuation)

September 25, 2024

• Testosterone Cypionate Injection (Discontinuation)

September 24, 2024

• Fentanyl Citrate Tablet (Discontinuation)

• Fentanyl Citrate Troche/Lozenge (Discontinuation)

• Indium In-111 Chloride Injection (Discontinuation)

Updated Drug Shortage

October 01, 2024

• Sodium Chloride 0.9% Irrigation (Currently In Shortage)

• Sterile Water Irrigant (Currently In Shortage)

September 27, 2024

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage)

• Dobutamine Hydrochloride Injection (Currently In Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently In Shortage)

• Heparin Sodium Injection (Currently In Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently In Shortage)

• Hydromorphone Hydrochloride Injection (Currently In Shortage)

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Morphine Sulfate Injection (Currently In Shortage)

• Penicillin G Benzathine Injection (Currently In Shortage)

• Sodium Bicarbonate Injection (Currently In Shortage)

• Sodium Chloride 0.9% Injection (Currently In Shortage)

• Sodium Chloride 23.4% Injection (Currently In Shortage)

September 25, 2024

• Lidocaine Hydrochloride Injection (Currently In Shortage)

• Lorazepam Injection (Currently In Shortage)

• Methotrexate Sodium Injection (Currently In Shortage)

• Methylprednisolone Acetate Injection (Currently In Shortage)

• Promethazine Hydrochloride Injection (Currently In Shortage)

September 24, 2024

• Penicillin G Benzathine Injection (Currently In Shortage)

September 20, 2024

• Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently In Shortage)

New Drug Recall and Safety Alerts

Veklury® (Remdesivir) for Injection 100 mg/vial by Gilead – New Voluntary Recall – September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation. <Read More> Atovaquone Oral Suspension by Bionpharma Inc. – New Voluntary Recall – September 17, 2024 - Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria. <Read More>

New Generic/Biosimilar Approval and Launch

Otulfi™ (ustekinumab-aauz) Injection – New Biosimilar Approval for Stelara® – September 27, 2024 - Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced that the European Commission (EC) granted marketing authorization for its ustekinumab biosimilar candidate, indicated for the treatment of several serious inflammatory diseases. <Read More> Pavblu™ (aflibercept-ayyh) Injection – New Biosimilar Approval for Eylea® – August 23, 2024 - We have approved your BLA for Pavblu™ (aflibercept-ayyh) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Pavblu™ under your existing Department of Health and Human Services U.S. License No. 1080. Pavblu™ is indicated for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). <Read More>

Clinical and Pharmacy News

Pfizer to Pull Sickle Cell Drug From Market, Shut Down Trials – September 26, 2024 – Pfizer is pulling the sickle cell disease drug Oxbryta® off the market and ending clinical trials of the medicine around the world due to safety concerns. Clinical data “now indicates that the overall benefit of Oxbryta® no longer outweighs the risk,” Pfizer said Wednesday. The company said data show an imbalance of deaths and vaso-occlusive crises, the excruciating episodes of pain that patients with sickle cell disease experience. The company said it notified regulatory authorities of the results. <Read More> Managing the High Cost of Specialty Medication – September 20, 2024 – Employers and health plans are concerned about managing high-ticket items such as cell and gene therapies, and interested in potential savings from biosimilars, according to a large managed care survey presented at Asembia’s AXS24 Summit, in Las Vegas. The survey, detailed in the Trends in Specialty Drug Benefits Report by the Pharmaceutical Strategies Group (PSG), sampled 185 benefits leaders representing employers, health plans and unions/Taft-Hartley plans covering an estimated 86.6 million lives. Employers made up 68% of respondents and health plans made up 28%. The majority of respondents (73%) used one of the three largest pharmacy benefit managers (PBMs): CVS, Express Scripts or OptumRx. <Read More> FTC Sues Major Pharmacy Benefit Managers Over Insulin Prices – September 20, 2024 – The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs. The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers. As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions. <Read More> The Role of Clinical Pharmacists in Transforming Therapeutic Drug Monitoring – September 19, 2024 – Personalised medicine, the tailoring of medical treatment to each patient's individual characteristics, is revolutionising healthcare. At the heart of this transformation lies therapeutic drug monitoring (TDM), which measures drug concentrations in patients' blood to optimise therapy and minimise adverse effects. The clinical pharmacist or pharmacologist plays a pivotal role in the TDM laboratory, architecting personalised medication strategies. They are uniquely equipped for their role in the TDM laboratory due to their specialised training and expertise. Their in-depth knowledge of drug mechanisms, interactions, and metabolism allows them to interpret TDM data precisely and nuance. <Read More>

340B in the News

HRSA Issues Final Warning to J&J to Cease Implementation of its 340B Proposed Rebate Program – September 27, 2024 – The Health Resources and Services Administration Sept. 27 sent a final warning letter to Johnson & Johnson urging the company to inform the agency by Monday, Sept. 30 that it would halt its proposed 340B rebate model scheduled to go into effect next month. “As outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act,” HRSA wrote. “If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement. In addition, if J&J moves forward with implementation of its rebate proposal, HRSA will initiate a referral to the HHS Office of Inspector General pursuant to 42 U.S.C. § 256b(d)(1)(B)(vi).” <Read More> Hopewell Health Centers Lays Off 35 Employees Because of Drug Manufacturers' Restrictions on a Little-Known Federal Program – September 24, 2024 – Being on Hopewell’s RN care management team was Erin Eddleblute’s dream job. “We were kind of — and this was how our boss referred to it and I loved it — the junk drawer of Hopewell,” Eddleblute said. She and the other RN care managers would work one-on-one with clients on all manner of issues...The team was small — just six people — but Eddleblute said their impact was large. Eddleblute estimates she saw around 250 people a year. And then, suddenly, it was all over…What Eddleblute didn’t understand was that the loss of her job was the direct result of a national sparring match between drug manufacturers and the beneficiaries of an obscure, but vital, initiative called the 340B Drug Pricing Program, which provides medication at a discount for vulnerable populations. The battle had played out far, far away from Eddleblute’s day-to-day life. Now, she was paying the cost. <Read More>

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform? – September 18, 2024 – As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s administrative dispute resolution (ADR) process represented a positive development in program reform, many questions remain as to how the Health Resources and Services Administration (HRSA) along with Congress may resolve stakeholder concerns with the drug pricing program’s future. <Read More>