New Drug/Vaccine Approval

Tecelra™ (afamitresgene autoleucel) Suspension for Intravenous Infusion – New Drug Approval – August 1, 2024 - The Food and Drug Administration granted accelerated approval to afamitresgene autoleucel (Tecelra™, Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. <Read More> Erzofri® (paliperidone palmitate) Extended-Release Injectable Suspension – New Drug Approval – July 26, 2024 - Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Erzofri® (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. <Read More> Zunveyl® (benzgalantamine) Delayed-Release Tablets - formerly ALPHA-1062 – New Drug Approval – July 26, 2024 – Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has granted approval for Zunveyl® (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease. <Read More> Leqselvi™ (deuruxolitinib phosphate) Tablets – New Drug Approval – July 25, 2024 – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) announced that the U.S. Food and Drug Administration (FDA) approved Leqselvi™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. <Read More> Femlyv™ (ethinyl estradiol and norethindrone acetate) Orally Disintegrating Tablets – New Drug Approval – July 22, 2024 – The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  The FDA approved Femlyv™ (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv™, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968. <Read More>

New Indication/Dosage/Formulation Approval

Jemperli® (dostarlimab-gxly) Injection – New Label Expansion – August 1, 2024 – The Food and Drug Administration approved dostarlimab-gxly (Jemperli®, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC). Dostarlimab-gxly previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent EC that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). <Read More> Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – July 30, 2024 – Johnson & Johnson (NYSE:JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). Patients will have the opportunity to receive this Darzalex Faspro®-based quadruplet therapy at initial diagnosis, providing them with a new treatment that may significantly improve outcomes. <Read More> Palforzia® (Peanut (Arachis hypogaea) Allergen Powder-dnfp) Capsules and Sachets – New Label Expansion – July 26, 2024 – The U.S. Food and Drug Administration approved Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia® may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia® must continue to avoid peanuts in their diets. <Read More> Livmarli® (maralixibat) Oral Solution – New Label Expansion – July 25, 2024 – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Livmarli® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as the higher concentration formulation of Livmarli® evaluated in the MARCH Phase 3 study. <Read More>  Brineura® (cerliponase alfa) Injection – New Label Expansion – July 24, 2024 – BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Brineura® (cerliponase alfa) to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Previously, Brineura® was indicated in symptomatic children 3 years of age and older with late infantile CLN2 disease. This expanded indication now includes children of all ages with CLN2 disease, regardless of whether they are symptomatic or presymptomatic. <Read More> Xembify® (immune globulin subcutaneous, human - klhw) Injection – New Label Expansion – July 18, 2024 – Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, announced that the United States Food and Drug Administration (FDA) has approved an expanded label for Xembify®, the company’s 20% subcutaneous immunoglobulin (SCIg), to include treatment-naïve patients with primary humoral immunodeficiencies (PI). Xembify® becomes the first 20% SCIg with this extended label, allowing patients to begin SCIg therapy without first having intravenous administration. <Read More> Voquezna® (vonoprazan) Tablets – New Label Expansion – July 17, 2024 – Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced the U.S. Food and Drug Administration (FDA) has approved Voquezna® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals suffering from frequent heartburn. This is the third FDA approval for Voquezna®, which is also approved to treat all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) infection. <Read More>

New Drug Shortage

August 05, 2024

• Glipizide Tablet, Extended Release (Discontinuation)

July 26, 2024

• Bisoprolol Fumarate; Hydrochlorothiazide Tablet (Discontinuation)

July 22, 2024

• Dacarbazine Injection (Currently in Shortage)

• Posaconazole Tablet, Delayed Release (Discontinuation)

Updated Drug Shortage

August 02, 2024

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

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Dacarbazine Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dulaglutide Injection (Currently in Shortage)

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

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

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

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Naltrexone Hydrochloride Tablet (Currently in Shortage)

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride 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)

• Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Resolved)

• Somatropin Injection (Currently in Shortage)

• Tirzepatide Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Currently in Shortage)

July 31, 2024

• Somatropin Injection (Currently in Shortage)

July 30, 2024

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

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

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

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

• Etomidate Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketamine Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Leucovorin Calcium 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)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

• Potassium Acetate Injection (Currently in Shortage)

• Quinapril Hydrochloride Tablet (Currently in Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Sodium Acetate Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sodium Chloride 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

July 25, 2024

• Cefotaxime Sodium Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

July 24, 2024

• Gentamicin Sulfate Injection (Resolved)

• Penicillin G Benzathine Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets by Aurobindo Pharma USA, Inc. – New Voluntary Recall – July 24, 2024 – Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within the US market due to the product missing the manufacturer label. <Read More> Acetaminophen Injection, 1000mg/100mL, (10mg/mL) Bags by Hikma Pharmaceuticals USA Inc. – New Voluntary Recall – July 22, 2024 - Hikma Pharmaceuticals PLC (Hikma, Group), announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). <Read More>

New Generic/Biosimilar Approval and Launch

Epysqli® (eculizumab-aagh) Injection – New Biosimilar Approval – July 19, 2024 – Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli® (eculizumab-aagh) as a biosimilar to Soliris® (eculizumab). Epysqli® has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Epysqli® is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). <Read More>

Clinical and Pharmacy News

Many Online Pharmacies Selling Weight Loss Products Illegally: Study – August 3, 2024 – Many online pharmacies that are selling semaglutide, the main ingredient in weight loss drugs such as Ozempic® and Wegovy®, are doing so illegally, according to new research. The study, released Friday in the journal JAMA Network Open, found that when researchers used search engines to try and find “websites advertising semaglutide without a prescription” in the summer of last year, 42.27 percent of the online pharmacies that came up “belonged to illegal pharmacy operations.” <Read More> Preoperative, Pharmacist-Led Medication Reconciliation Improves Safety – July 30, 2024 – Pharmacist-led medication reconciliation, implemented prior to a patient’s admittance to the hospital for surgery, improved safety and outcomes. Studies have shown that medical errors involving prescriptions in the hospital setting often stem from medical history obtained at admission. Causes include missing information and discrepancies in the patient’s medication history. Many of these studies examined post-admission-led medication reconciliation (MR) by pharmacists; however, little, if any, information is available on the impact of pre-admission pharmacist intervention in MR. <Read More> BRCA1/2: Why Men Should be Screened for the “Breast Cancer Gene” – July 25, 2024 –New research shows that men can carry mutations in the BRCA1 and BRCA2 genes that increase their risk of several cancers, but new national guidelines are helping to educate patients… These risks for men traditionally have been under-recognized, but newly developed national screening guidelines offer hope for identifying the cancer risk of BRCA mutations in men through genetic testing and tailored cancer screening, according to an article published from Fred Hutch Cancer Center and University of Washington scientists in the journal JAMA Oncology. <Read More> Industrial Policy to Reduce Prescription Generic Drug Shortages – July 23, 2024 – Shortages of prescription generic drugs, which account for nearly 90 percent of prescriptions, are frequent and can last for several months or even years. A recent study shows that from 2017 to 2021, the U.S. Food and Drug Administration (FDA) received 731 manufacturer “supply chain issue reports,” which are meant to identify shortages that could affect the national supply of an important prescription drug. Of those, 113 drugs had a “meaningful” shortage, defined as a reduction of 33 percent or more in the quantity supplied within six months of the issuer report compared with the preceding three months. A substantial majority of these shortages were for drugs where generics are available, a majority lasted for more than a year, and the median age of the drug was 17 years. <Read More> Early Aggressive Treatment May Work Best in Newly Diagnosed Multiple Sclerosis – July 23, 2024 – For many years, physicians have been treating multiple sclerosis (MS) with an "escalation" approach. This has typically meant starting patients on a mild-moderately effective disease-modifying therapy (DMT) until symptoms and/or imaging reveal disease breakthrough activity. At that point, treatment is often escalated to a higher-efficacy DMT. Over time, however, this traditional treatment paradigm seems to be less entrenched as international treatment guidelines continue to vary on their recommendations for using specific DMTs. Data from a wide variety of clinical studies have shown that newer, higher-efficacy DMTs can have a positive long-term impact when started earlier in the disease course. <Read More> Comer: Pharmacy Benefit Managers Must be Held Accountable for Role in Rising Drug Prices –July 23, 2024 – House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) delivered opening remarks at a full committee hearing titled “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability.” In his opening statement, Chairman Comer detailed how the House Oversight Committee has obtained over 140,000 pages of documents and communications exposing Pharmacy Benefit Managers’ (PBMs) anticompetitive policies and their role in rising drug prices. The information, outlined in an Oversight Committee report, shows how the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—have prioritized deliberate pricing tactics to line their own pockets, which have increased prescription drug costs, hurt independent pharmacies, and harmed patient care. He concluded that the House Oversight Committee will continue to seek bipartisan solutions to hold PBMs accountable for undermining the health of all Americans. <Read More>

340B in the News

SET Enterprises Launches 340B Covered Entity Suspicious Purchase Identification Service for Pharmaceutical and Biological Manufacturers – August 2, 2024 – SET Enterprises ( set-enterprises.com ), a leading independent management consulting firm serving the government pricing compliance needs of life sciences manufacturers, announced the launch of SPI340B℠. This new service offering identifies specific 340B covered entities that exhibit suspicious purchasing patterns that suggest the entire volume of products purchased from pharmaceutical and biotechnology manufacturers may not be dispensed solely to eligible patients of the covered entity. 340B entities are required to dispense covered outpatient drugs only to a person who is a patient of the entity and are specifically prohibited from reselling the drug to another entity. Reselling discounted 340B drugs or dispensing to a non-patient is known as diversion. <Read More>