New Drug/Vaccine Approval

Lazcluze™ (lazertinib) Tablets – New Drug Approval – August 19, 2024 – The Food and Drug Administration approved lazertinib (Lazcluze™, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant®, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. <Read More>

New Indication/Dosage/Formulation Approval

ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) – New Label Expansion – August 29, 2024 – Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000® vaccine was shown to be effective in protecting against mpox virus exposure. <Read More>  Spikevax® (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection - New Label Expansion – August 22, 2024 – Moderna, Inc. (NASDAQ:MRNA) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. Emergency Use Authorization (EUA) for the Moderna's COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA's decision, Moderna's updated vaccine is expected to be available in the coming days. <Read More> Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 22, 2024 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (Comirnaty® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. <Read More> Imfinzi® (durvalumab) Injection – New Label Expansion – August 15, 2024 – The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. <Read More>

New Drug Shortage

August 28, 2024

• Clobetasol Propionate Spray (Discontinuation)

August 23, 2024

• Indocyanine Green Injection (Currently in Shortage)

August 21, 2024

• Hydrocortisone Probutate Cream (Discontinuation)

August 20, 2024 

• Cyclosporine Solution (Discontinuation)

August 14, 2024 

• Sildenafil Powder, for Suspension (Discontinuation)

Updated Drug Shortage

September 03, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

August 30, 2024

• Remifentanil Hydrochloride Injection (Currently in Shortage)

August 29, 2024

• Oxybutynin Chloride Syrup (Resolved)

August 28, 2024

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Promethazine Hydrochloride Injection (Currently in Shortage)

August 27, 2024

• Cyclopentolate Hydrochloride Ophthalmic Solution (Currently in Shortage)

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

It’s Not Just Big Pharma: Meet the Middlemen Blocking Access to Medication– August 31, 2024 – In 2012, Loretta Boesing received a mail-order shipment of her then-toddler aged son’s immunosuppressant medication, which he takes every 12 hours to prevent his body from rejecting his liver transplant. The medication, which arrived on a 102-degree day, had been shipped in a plastic envelope. Soon after taking the medicine, her son’s body began to reject his liver, leading to a terrifying two-week hospital stay. Boesing transferred his prescription to the hospital pharmacy to avoid similar issues in the future…Boesing discovered that a key player in the health care landscape was to blame for her forced switch to mail-order drugs: pharmacy benefit managers, or PBMs. PBMs operate as middlemen in the health care space, managing the pharmacy benefits that an insurer offers its patients. <Read More> IRA Biosimilar Measure Intended to Boost Uptake so far has 'Limited' Impact: Report – August 29, 2024 – It’s been two years since the Inflation Reduction Act (IRA) was passed, and, while the law's Medicare-negotiated price cuts haven’t yet gone into effect, a change surrounding biosimilar reimbursement rates was instated in 2022. The new provision was meant to dismantle financial disincentives to biosimilar adoption and save the U.S. healthcare system billions of dollars, but has the legislation worked to plan so far? Drug development consultancy Certara sought to find out. In its “Boost or Bust?” report, the company surveyed oncology account staff at 79 healthcare facilities—including a mix of hospitals and community infusion sites—on their use of 17 biosimilar products targeting five reference medicines… <Read More> Management of Pulmonary Arterial Hypertension – August 29, 2024 – Pulmonary arterial hypertension (PAH), a rare disease that falls under the larger umbrella of pulmonary hypertension (PH), is defined as increased pulmonary arterial pressure of at least 20 mm Hg at rest. The arteries in the lung become narrow or blocked, impeding blood flow. This, in turn, increases pulmonary vascular resistance, causing the right side of the heart to work harder to pump blood to the lungs. Over time, the heart muscle weakens, eventually leading to right ventricular failure. <Read More> Pharmacy Standing Order for Narcan Distribution Linked to Reduction in Overdose Deaths –August 29, 2024 – Expanding access to naloxone is a key component of the national strategy to end the opioid crisis in America, and community pharmacies play a central role in distributing this overdose-reversing medication. Prior to naloxone receiving federal approval for over-the-counter availability as Narcan nasal spray in 2023, almost all US states allowed individuals to obtain the life-saving drug at community pharmacies without a prescription through a state authorization known as a standing order. But there remains a limited understanding on whether pharmacy naloxone distribution had any effect on reducing opioid overdose deaths in communities. <Read More> FDA Approves/Authorizes Updated COVID-19 Vaccines; Target KP.2 Omicron Variant of SARS-CoV-2 – August 23, 2024 – The FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula), which include a monovalent component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines by Moderna and Pfizer-BioNTech have updated the formula to more closely target circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death, the FDA said in a statement. <Read More>

340B in the News

The Future of the 340B Drug Pricing Program in Modern Health Care– August 30, 2024 – An examination of the 340B Drug Pricing Program's original intent, current challenges, and potential resolutions in today's complex health care landscape. The 340B Drug Pricing Program, established by Congress in 1992, has become a critical component of the US health care system. This federal program requires pharmaceutical manufacturers to provide outpatient drugs at significantly discounted prices to eligible health care organizations, known as covered entities.² As the program enters its fourth decade, it faces numerous challenges that threaten its original mission and impact pharmacy practice. <Read More> HRSA Tells Johnson & Johnson to Nix its Plan for 340B Drug Rebates – August 23, 2024 – The Health Resources & Services Administration has told Johnson & Johnson it cannot use a rebate model to replace upfront discounts in its 340B drug pricing program, according to the American Hospital Association. On Aug. 23, Johnson & Johnson announced that it will change the way it makes 340B pricing available for two of its most popular products, Stelara® and Xarelto®. Starting Oct. 15, J&J said it will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug's 340B status, the DSH hospitals will receive a rebate for the discounted 340B price. <Read More>