New Drug/Vaccine Approval

Orlynvah™ (sulopenem etzadroxil and probenecid) Tablets – New Drug Approval – October 25, 2024 – The U.S. Food and Drug Administration has approved Orlynvah™ (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options. Orlynvah™ is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI). Orlynvah™ is taken as one oral tablet twice daily for 5 days. <Read More> Vyloy™ (zolbetuximab-clzb) Injection – New Drug Approval – October 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. Vyloy™ is the first and only CLDN18.2-targeted therapy approved in the U.S. <Read More> Vyalev™ (foscarbidopa and foslevodopa) Injection – New Drug Approval –October 16, 2024 – AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD)…The approval was supported by the pivotal Phase 3, 12-week study evaluating the efficacy of continuous subcutaneous infusion of Vyalev™  in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR), along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev™. <Read More> Hympavzi™ (marstacimab-hncq) Injection – New Drug Approval – October 11, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Hympavzi™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors. <Read More> Itovebi™ (inavolisib) Tablets – New Drug Approval – October 10, 2024 – The Food and Drug Administration approved inavolisib (Itovebi™, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. FDA also approved the FoundationOne® Liquid CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with inavolisib with palbociclib and fulvestrant. <Read More>

New Indication/Dosage/Formulation Approval

Abrysvo® (respiratory syncytial virus vaccine) Injection – New Label Expansion – October 22, 2024 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Abrysvo® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Abrysvo® now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age. <Read More> Botox® Cosmetic (onabotulinumtoxinA) for Injection – New Label Expansion – October 18, 2024 – Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of Botox® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults. Botox® Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face. <Read More> Lumryz™ (sodium oxybate) Granules for Extended-Release Oral Suspension – New Label Expansion – October 16, 2024 – Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Lumryz™ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. <Read More> Bimzelx® (bimekizumab-bkzx) Injection – New Label Expansion – October 11, 2024 – UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx). These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration. “Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. <Read More> Opdivo® (nivolumab) Injection – New Label Expansion – October 3, 2024 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo® as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.  The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC. Opdivo® is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen. <Read More>

New Drug Shortage

October 28, 2024

• Exenatide Synthetic Injectable Suspension, Extended Release (Discontinuation)

October 25, 2024

• Exenatide Synthetic Injection (Discontinuation)

October 24, 2024

• Amoxapine Tablet (Currently in Shortage)

October 22, 2024

• Atomoxetine Hydrochloride Capsule (Discontinuation)

• Telmisartan Tablet (Discontinuation)

October 21, 2024

• Technetium Tc-99m Sodium Pertechnetate Generator (Currently in Shortage)

Updated Drug Shortage

October 24, 2024

• Cisplatin Injection (Resolved)

• Epinephrine Injection, Syringes (Resolved)

October 22, 2024

• Peritoneal Dialysis Solution (Currently in Shortage)

October 18, 2024

• Amino Acid Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

October 16, 2024

• Azacitidine Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lactated Ringers Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

October 15, 2024

• Amoxapine Tablet (Currently in Shortage)

• Amoxicillin Powder, For Suspension (Currently in Shortage)

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

• Azacitidine Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Clonazepam Tablet (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Isoniazid Tablet (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Mefloquine Hydrochloride Tablet (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methylphenidate Hydrochloride Tablet, Extended Release (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Resolved)

New Drug Recall and Safety Alerts

Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL by Staska Pharmaceuticals, Inc. – New Voluntary Recall – October 16, 2024 – Staska Pharmaceuticals, Inc. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch. <Read More>

New Generic/Biosimilar Approval and Launch

Imuldosa™ (ustekinumab-srlf) Injection – New Biosimilar Approval for Stelara® – October 10, 2024 – Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved Imuldosa™ (ustekinumab-srlf), a biosimilar to Stelara® (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The FDA approved Imuldosa™ for all indications of its reference medicine, Stelara®. <Read More>

Clinical and Pharmacy News

Centene Sues CMS Over Medicare Advantage Star Ratings – October 24, 2024 – Centene has joined the list of insurers that are suing the Centers for Medicare and Medicaid Services over the 2025 Medicare Advantage Star Ratings. Centene of Missouri and 10 affiliated plans such as Meridian Health Plan of Michigan and several Wellcare plans filed the lawsuit Tuesday in federal court in Missouri. Centene is suing over one of the measures used by CMS to calculate star ratings, the success rate of calls that CMS interviewers, called secret shoppers, make to the plan through text-to-voice teletypewriter (TTY) services. Secret Shoppers use internet protocol enabled text-to-voice-teletypewriter services (IPTTY) to make these calls. A score is based on the number of successful calls that connect to the plan's call center compared to the number of calls made, the complaint said. CMS held a single call against Centene, the lawsuit said. This call never reached the call center. <Read More> Independent Pharmacies Face Potential Closure Without Stricter PBM Regulation – October 24, 2024 – Several local independent pharmacies warn they may go out of business unless there’s more regulation on pharmacy benefit managers, or PBMs, who play a pivotal role in drug pricing. Lawmakers recently introduced House Bill 9096, also known as the “Pharmacists Fight Back Act,” in the House. The proposed legislation aims to make the prescription drug system more equitable for pharmacies and patients. “Prescription drug prices have gone up, and they have passed those prices along to the patients at the pharmacy counter,” said Trent McLemore, director of pharmacy at Star Discount Pharmacy. He points to PBMs as the main issue. PBMs act as intermediaries between insurance companies and pharmacies, often steering patients toward their own mail-order services for more profitable prescriptions. <Read More> PBM Math: Big Chains are Paid $23.55 to Fill a Blood Pressure Rx. Small Drugstores? $1.51 – October 24, 2024 – While customers at Adams Family Pharmacy picked up their prescriptions on a hot summer day, some stopped in for coffee, ice cream, homemade cake, or cookies. It wasn’t a bake sale, but the sweets bring extra revenue as pharmacist and co-owner Nikki Bryant works to achieve profitability at her business on the town square. Bryant said she is doing all she can to bolster it against a powerful force that threatens her and other independent pharmacists: the middlemen who manage virtually all prescriptions written in the U.S., called pharmacy benefit managers, or PBMs. Serving as brokers among drugmakers, pharmacies, and health insurers, these health care entities have drawn scrutiny from Congress, the Federal Trade Commission, and state legislatures for their role in the increase in drug prices. Bryant and other independent pharmacists say PBMs not only create higher costs but also make it harder for patients to access medications. <Read More> Novo Nordisk Asks US to Stop Compounding Pharmacies From Making Weight-Loss Drug Copies – October 23, 2024 – Novo Nordisk (NOVOb.CO), asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely. U.S. regulations allow compounders to copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand. Novo's Wegovy® and diabetes drug Ozempic®, both known chemically as semaglutide, have been in shortage in the U.S. for much of this year. In its submission, the Danish drugmaker asked the FDA to consider placing semaglutide on a list of drugs that, even though they are in shortage, are too complex to be copied. Novo said compounded versions of Wegovy® are being sold in incorrect dosage strengths, have been found to contain unknown impurities, and have been linked to nearly 400 serious adverse events since 2018. <Read More> Pharmacy Comes Full Circle as Site of Care – October 23, 2024 – Historically, pharmacists were community-based healthcare providers who made and prescribed medicines. With rapid shifts in healthcare occurring in the 20th and 21st centuries, pharmacies once again should be considered as low-cost medical homes for patients, panelists said in a presentation at Asembia’s AXS24 Summit, in Las Vegas. Three of them spoke with Specialty Pharmacy Continuum after the meeting…However, payment for pharmacist services is still a significant barrier faced by the industry, panelists said. “We have to reach the inflection point where we have enough payors willing to pay pharmacists for these services, in spite of the fact that [the Centers for Medicare & Medicaid Services] has not yet recognized us as providers,” said Alexandra Broadus, PharmD, the senior director of clinical pharmacy strategy at Walgreens. <Read More> Oscar Health Expands ACA Presence and Chronic Condition Plans – October 23, 2024 – Healthcare insurtech Oscar Health will be expanding its presence on the Affordable Care Act marketplace in 2025 and is introducing new plans for people with multiple chronic conditions. The company will expand into 405 markets across 18 states next year, it said. Oscar is launching a multi-condition plan for members with diabetes, pulmonary and cardiovascular disease – three common conditions impacting ACA members, it said. Internal research showed managing those conditions can lower costs by up to 25%. Benefits of the plan include no out-of-pocket costs for cardiologists, pulmonologists, endocrinologists, screenings and labs, primary and behavioral care, and medications. Members can enroll in Oscar's single-condition plans, Diabetes Care and Breathe Easy, in select states. <Read More> FDA Updates Biosimilars Action Plan – October 21, 2024 – With the April approval of trastuzumab-strf (Hercessi™, Accord BioPharma), a HER2/neu receptor antagonist that is a biosimilar for Herceptin® (Genentech)—the FDA marked its approval of 50 biosimilar agents. At the same time, the agency also updated its Biosimilars Action Plan (BAP), first released in 2018, to reinforce its strategy to further expand biosimilar product availability and use. “The [updated] BAP describes the agency’s high-level vision to encourage innovation and competition for biologics and to facilitate the development of safe and effective biosimilar and interchangeable biosimilar products at potentially lower costs for patients,” said Sarah Yim, MD, the director of the FDA’s Office of Therapeutic Biologics and Biosimilars. <Read More> Reproductive Care, Including Abortion, Facing Challenges – October 17, 2024 – Reproductive care is becoming more difficult for women to access, and that's especially true in the case of abortion care, finds a new Wisp survey. Over the last decade, about 20% of women tried to access abortion services, but a third of them faced barriers ranging from cost to lack of insurance, and legal restrictions in some states. The survey is a snapshot of reproductive care in the aftermath of the 2022 Supreme Court decision to overturn Roe v. Wade, the legal precedent that for decades had enshrined the right to abortion. In a 5-4 vote the Justices ruled that the Constitution does not confer a right to abortion, and that regulating abortion should be reverted back to the states. <Read More> Quantifying the Cost of Specialty Pharmacist Interventions for 'Outside' Prescriptions – October 15, 2024 – Interventions performed by health-system specialty pharmacists (HSSPs) for patients who don’t fill their specialty prescriptions with the system—due to either payor or manufacturer restrictions, or because the patient chooses an outside pharmacy—cost thousands of dollars per month, according to a new study from Vanderbilt University Medical Center (VUMC). “Payor and manufacturer lockouts limit HSSPs’ ability to dispense specialty medications to health-system patients, often limiting patient visibility and increasing workload,” said Autumn Zuckerman, PharmD, VUMC’s director of specialty pharmacy. “We wanted to document the cost of interventions that our pharmacists perform for patients we can’t bill for.” The study focused on patients filling their prescriptions at non-Vanderbilt pharmacies from neurology, hepatology and adult GI/IBD (inflammatory bowel disease) clinics between Jan. 1 and May 31, 2023. <Read More>

340B in the News

No new update.