BETHLEHEM, PA — B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.

The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.

Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. 0.9% Sodium Chloride for Injection USP in E3 is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. Sodium Chloride Injection USP is also indicated as a pharmaceutic aid and diluent for the infusion of compatible drug additives. Product was distributed Nationwide within the United States to domestic distributors.

B. Braun has notified its distributors and customers by an official recall notice sent via certified registered mail and has arranged for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.

Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to B. Braun’s Postmarket Surveillance Department by calling 1-833-425-1464.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

BOSTON, MA — Vertex Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) submission for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain. 

The FDA granted suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025January 30, 2025. Suzetrigine has already been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.

“Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients suffering from moderate-to-severe acute pain each year in the U.S.,” said Nia Tatsis, Ph.D., Executive Vice President, Chief Regulatory and Quality Officer at Vertex. “The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” said Scott Weiner, M.D., M.P.H., Vertex Acute Pain Steering Committee Chair, Associate Professor of Emergency Medicine at Harvard Medical School and Attending Emergency Physician in the Department of Emergency Medicine at Brigham and Women’s Hospital. “Prescribers and patients deserve new options."

Suzetrigine (formerly VX-548) is an investigational oral, selective NaV1.8 pain signal inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain. Suzetrigine also demonstrated positive results and a well-tolerated profile in a Phase 2 study in patients with pain associated with diabetic peripheral neuropathy, a type of chronic peripheral neuropathic pain. Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.

CHICAGO, IL — Today at ADLM 2024 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo), researchers will present data on a novel test that predicts whether Alzheimer's patients are genetically predisposed to side effects from anti-amyloid drugs, a promising new class of Alzheimer's therapeutics. The test could improve outcomes for patients with Alzheimer's by helping to prevent instances of brain swelling or bleeding caused by these drugs.

Just last year, the anti-amyloid drug lecanemab became the first medication ever to receive Food and Drug Administration (FDA) approval for slowing the progression of Alzheimer's. More anti-amyloid drugs have received FDA approval since then, offering much-needed hope to individuals with this condition. At the same time, however, concerns have been raised about the safety of these drugs, with the FDA warning that they can cause brain swelling and/or bleeding. This side effect is known as amyloid-related imaging abnormalities (ARIA), and while it's usually mild, in rare cases, it can lead to death. The risk of ARIA is elevated in those who have particular variants of the gene APOE, which is implicated in many forms of Alzheimer's. The FDA therefore also recommends that patients undergo genetic testing before taking anti-amyloid drugs.

A team of researchers from the medical diagnostics company Revvity's Euroimmun has developed a new PCR-based test that determines if a patient has a high-risk combination of APOE variants (also known as a genotype). This method tests for all six possible APOE genotypes simultaneously, which allows for quicker processing by laboratories and ensures that patients receive results faster. To evaluate the test's performance, the researchers used it to analyze 100 blood samples from Alzheimer's patients and 10 samples from healthy blood donors. The researchers also analyzed the same samples using a CE-IVD-marked APOE test and a method known as bidirectional Sanger sequencing, then compared the results from all three methods. All the results agreed in 110 out of 110 cases, showing that the Revvity's Euroimmun test detects a patient's APOE genotype with 100% accuracy.

"There's been a lot of progress with new [anti-amyloid] drugs approved by the FDA, and as a consequence, diagnostic assays need to be updated to be able to test for the consequences of these drugs," said Dr. Maite Sabalza, senior scientific affairs manager at Revvity's Euroimmun. "There is a need to screen patients before receiving treatment, and if they are [positive for a high-risk APOE genotype], doctors can discuss the possibility of stopping or monitoring the treatment or trying something different."

The team at Revvity's Euroimmun is hopeful that their test will become part of the care Alzheimer's patients receive before taking these drugs.

"We want to help these patients," Dr. Sabalza said.

LONDON and CAMBRIDGE, MA — GSK and Flagship Pioneering, today announced they have entered a collaboration with the goal of discovering and developing a portfolio of future transformational medicines and vaccines, starting in respiratory and immunology.

This alliance brings together GSK's disease area expertise and development capability with Flagship's ecosystem of bioplatform companies, inclusive of its novel modalities and technologies, to make major advances in healthcare.

GSK and Flagship will initially fund up to $150 million upfront to support an exploration phase to identify the most promising concepts for further research and development with Flagship's bioplatform companies. From these explorations, the collaboration aims to identify a portfolio of up to 10 novel medicines and vaccines which will each be subject to an exclusive option by GSK for further clinical development. Under the terms of the agreement, Flagship and its bioplatform companies will be eligible to receive up to $720 million in upfront, development and commercial milestones from GSK, as well as preclinical funding and tiered royalties, for each acquired program.

Tony Wood, Chief Scientific Officer, GSK, said: "Together with Flagship, we will use science and technology to deliver best-in-class innovation at pace. We look forward to partnering with the talented team at Flagship, and their ecosystem of bioplatform companies, to further accelerate our pipeline and discover practice-changing medicines and vaccines for patients."

"Flagship and GSK have a shared focus on delivering breakthrough medicines for patients. This collaboration is the latest example of Flagship's Innovation Supply Chain Partnership model, which is designed to generate transformational medicines together with our pharma partners by leveraging our ecosystem of first-in-category bioplatforms to create a sustainable source of treatments for patients with the greatest unmet needs" said Paul Biondi, General Partner, Flagship Pioneering and President, Pioneering Medicines.

MUMBAI, India and PRINCETON, NJ — Sun Pharmaceutical Industries Limited 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.

Alopecia areata affects around 700,000 people in the United States, and 300,000 have severe alopecia areata. Alopecia often leads patients to self-treat before seeking professional help, driven by dissatisfaction with the slow progress of existing treatments.

"LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians," said Abhay Gandhi, CEO, North America Business, Sun Pharma. "Our fast-growing dermatology business is excited to add this novel treatment to its portfolio."

Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body. LEQSELVI is a new, twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata.

"We welcome the approval of LEQSELVI as a significant step for the alopecia areata community," said Nicole Friedland, President and CEO, National Alopecia Areata Foundation (NAAF). "Alopecia areata is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss. Today's announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata."

The approval is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

"For many people with severe alopecia areata, early intervention with effective treatment is critical," said Natasha Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology, University of California, Irvine, and investigator in the LEQSELVI clinical development program. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."

Across the Phase 2 dose-ranging study and Phase 3 randomized, placebo-controlled trials, few patients (3.1%) receiving LEQSELVI 8 mg twice daily were discontinued from the trials due to adverse reactions.¹ In clinical trials, more than 100 people continued taking deuruxolitinib for more than three years.

“We are pleased with the timely approval of LEQSELVI by the U.S. FDA,” said Marek Honczarenko, MD, PhD, Senior Vice President, Head of Development, Sun Pharma. “This validates our team’s capability to effectively bring treatments from research and development to approval in a way that is meaningful for physicians and patients. I want to thank all the investigators and patients for their participation in the clinical trials.”

Princeton, NJ and Deerfield, IL — Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

The sNDA submission is based on data from three randomized clinical trials evaluating the safety and efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD.

The primary endpoint for all three trials was the change from randomization (Week 1) to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

The trials were randomized, double blind, active-controlled, and Trial 061 (Phase II) and 071 (Phase III) were flexible dose trials, while Trial 072 (Phase III) was a fixed dose trial.¹ In Trial 061 and 071, brexpiprazole in combination with sertraline was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the CAPS-5 total score from randomization (Week 1) to Week 10 (primary endpoint). In Trial 072, while the primary endpoint was not met, reductions in PTSD symptoms with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071. Improvements were consistently observed across the Clinical Global Impression Severity (CGI-S) scale and the four CAPS-5 clusters of re-experiencing, avoidance, negative cognition/mood and arousal/reactivity symptoms in Trials 061 and 071.

Across the three randomized trials, the combination of brexpiprazole and sertraline in adult patients with PTSD was generally well-tolerated, and no new safety observations were identified. The safety and tolerability results were consistent with the known profile of brexpiprazole in its approved indications and what has been observed in other clinical trials. The overall incidence of treatment-emergent adverse events (TEAEs) across the three trials was 55.5 percent with brexpiprazole plus sertraline, and 56.2 percent with sertraline plus placebo.²

“Post-traumatic stress disorder is one of the most common mental health disorders in the United States. Approximately 13 million adults in the U.S. have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “This is a significant development, and we look forward to continuing our efforts to provide a treatment option that may benefit the millions of patients and caregivers who are impacted by the debilitating effects of PTSD.”

“Brexpiprazole in combination with sertraline could represent an important advancement over current standard of care, and we look forward to working with the FDA in the process of seeking approval of this combination,” said Johan Luthman, Ph.D., executive vice president, Lundbeck Research & Development. “We are grateful to the patients and caregivers who participated in these important trials.”

Arlington, VA — Surescripts® released a new data report that highlights the biggest issues facing care providers, pharmacist prescribing trends and opportunities for patient care teams to continue evolving to meet the needs of patients.

“Barriers that limit health intelligence sharing between clinicians prevent the benefits of an evolving care team, like greater efficiency and more accessible care for patients, from being fully realized,” said Frank Harvey, Chief Executive Officer of Surescripts. “Policies are evolving at the state level to allow pharmacists to provide care at the top of their education and training. While this is a step in the right direction, a truly comprehensive policy shift is still needed to bring reimbursement and access to patient intelligence sharing in line with how care is being delivered today so that we can continue helping healthcare heal itself.”

Key Highlights:

• 85% of pharmacists and 76% of other clinicians (including physicians, physician assistants and nurse practitioners) ranked prescription medication costs as the top issue and 85% of pharmacists and 72% of other clinicians ranked burnout as the second biggest issue.
• Since 2023, a growing number of pharmacists (75%, up from 65% in 2023) and other clinicians (29%, up from 26% in 2023) agree with the statement: "we should allow pharmacists to take on more primary care duties like performing point-of-care testing and diagnostics, managing medications used to treat chronic conditions, and prescribing medications for certain conditions."
• About one-third of pharmacists feel their current position allows them to offer patients all the care they need (36%).
• Unlike other clinicians, more than 8 in 10 pharmacists regard connecting pharmacists and other clinicians with centralized clinical information about their patients as a high priority. (85% of pharmacists and 57% of other clinicians).
• Pharmacists and other clinicians agree that it is somewhat or very difficult to share patient information securely and confidently with other care providers (46% of pharmacists and 31% of other clinicians).
• The top 100 most active pharmacist e-prescribers were responsible for 561,054 new prescriptions nationwide in 2023. Pharmacists in California, New Mexico, and New York accounted for 52.9% of the total nationwide pharmacist-issued e-prescriptions.

Between 2022 and 2023, Surescripts’ analysis shows that e-prescriptions issued by a pharmacist have increased 13% and the number of pharmacists e-prescribing also increased 28.8% in the same timeframe.

“This new data shows that patients are driving demand for pharmacists to provide a broader range of clinical care services closer to home, but they need to be reimbursed for these services and gain access to key patient insights to ensure they can provide better quality, safe and less costly care,” said Shannon Reidt, PharmD, MPH, MS, BCPS, Director Medication Research and Analytics for Surescripts. “Given the primary care provider shortages we are seeing, it’s becoming more critical to advance policies that allow pharmacists to care for patients at the full scope of their education and training – which includes medication management for patients with chronic conditions and provide test-to-treat services for patients for routine illnesses.”

CHAPEL HILL, NC — RxLink™, a leading provider of medication affordability and price transparency solutions for healthcare systems, is excited to announce its strategic partnership with ConnectiveRx, a premier provider of patient support, affordability, awareness, and adherence solutions for branded and specialty prescription medications. This collaboration takes a patient-first approach, enabling healthcare providers to help patients reduce their out-of-pocket prescription costs by providing access to available savings options from pharmaceutical manufacturers and sending those directly to the patient via text. This allows patients to compare all available options—from pharmacy switches to insurance coverage and therapeutic alternatives—in real-time, often before leaving the provider's office, facilitating more informed, patient-driven discussions with their healthcare provider.

RxLink's innovative platform, MedMap™, delivers savings options directly to the patient in a user-friendly web interface at the point of care. Coupled with ConnectiveRx's robust portfolio of patient support programs, MedMap will help extend the care team's ability to easily identify the most appropriate and affordable options for patients and enable pharma brand teams to effectively drive awareness of affordability programs through hyper-targeted and personalized notifications based on diagnosis, payer strategy, demographics, etc. This is especially helpful for cost-sensitive patients who typically don't make it to the pharmacy counter despite having already been prescribed a particular therapy.

"By partnering with ConnectiveRx, RxLink reaffirms its commitment to improving patient outcomes and expanding access to affordable medications for all patients," said Joe Jackson, VP, Pharma Partnerships at RxLink. "ConnectiveRx's industry-leading portfolio of pharmaceutical manufacturer sponsored savings programs will further empower healthcare providers to support their patients without adding work to their plate. Our partnership objective is to ensure every patient can simply follow their doctor's orders by offering education and savings at a critical point in the care journey – while the patient is on the way to the pharmacy."

ConnectiveRx programs can equip both physicians and patients with real-time information on cost-saving opportunities for their prescribed medications. 

"By integrating our platform with RxLink's extensive and fast-growing health system network, currently supporting over 20M patients, this partnership will enable physicians to play a proactive role in educating the patient, reducing medication costs, and improving overall patient satisfaction—all without adding any additional effort to the provider workflow," said Danielle Daly, Chief Marketing and Communications Officer, ConnectiveRx.

Together, RxLink and ConnectiveRx are committed to driving positive change in the healthcare industry by providing physicians with the resources and support they need to deliver high-quality, cost-effective care to their patients.

ROSEMONT, IL — Long Grove Pharmaceuticals, LLC, a supplier of differentiated pharmaceuticals, received Food and Drug Administration (FDA) approval for a generic Eribulin Mesylate Injection. Long Grove’s Eribulin Mesylate is an AP-rated chemotherapy medication bioequivalent to HALAVEN^®.

“Our goal is to create more affordable pathways to pharmaceuticals. The introduction of a generic in a market where choices are limited is an important step to ensure patient access,” said Peter Karas, Chief Commercial Officer of Long Grove Pharmaceuticals. “We’re grateful for the opportunity to ensure that more patients benefit from this cancer treatment.” 

Eribulin Mesylate Injection is a cancer medication that disrupts the growth of cancer cells. It was originally approved by the FDA in November 2010 to treat adult patients with locally advanced or metastatic breast cancer whose treatment has not progressed well through other cancer medicines. The FDA expanded its approval in January 2016 to adult patients who have already received anthracycline-containing therapy for advanced or metastatic liposarcoma.

Long Grove Pharmaceuticals received FDA approval for the drug through an Abbreviated New Drug Application (ANDA). The company’s Eribulin Mesylate Injection comes in a single dose vial with a rubber stopper not made with latex. The drug is manufactured in the European Union and is Trade Agreement Act (TAA) compliant.

FLORHAM PARK, N.J — Phathom Pharmaceuticals, Inc. 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.

“Today marks a significant milestone for millions of GERD patients as we proudly announce the approval of VOQUEZNA for the treatment of Non-Erosive GERD,” said Terrie Curran, President, and Chief Executive Officer at Phathom. “For decades GERD sufferers had no new class of treatment to turn to in the U.S. This approval provides patients and healthcare providers with immediate access to the first and only FDA-approved treatment of its kind, from a new class of acid suppression therapy, and the power to help provide complete 24-hour heartburn-free days and nights. We are very excited to introduce VOQUEZNA to the broader GERD community and look forward to its potential to help change the way this disease is treated.”

Non-Erosive GERD is the largest category of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. An estimated 45 million U.S. adults living with Non-Erosive GERD, and approximately 15 million are treated with a prescription medicine annually. Despite longstanding treatment options, many patients remain dissatisfied with such therapies and continue to suffer from heartburn symptoms which may impact overall quality of life with episodic heartburn, occurring during the day and at night.

“Millions of patients with Non-Erosive GERD continue to suffer from heartburn despite current treatment options,” said Colin W. Howden, M.D., Professor Emeritus, University of Tennessee College of Medicine. “The pivotal study that led to this approval showed that VOQUEZNA significantly reduced heartburn episodes in patients with Non-Erosive GERD along with an established safety profile. Today’s approval of VOQUEZNA provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients.”

This approval is supported by the positive results from the PHALCON-NERD-301 study (NCT05195528), a Phase 3 randomized, placebo-controlled, double-blind, multi-site U.S. study evaluating the efficacy and safety of VOQUEZNA for the daily treatment of adults with Non-Erosive GERD. The trial enrolled 772 adult patients with Non-Erosive GERD who experienced four or more days of heartburn per week, with the majority having six to seven days of heartburn per week, and compared patients treated with VOQUEZNA 10 mg to placebo in the relief of heartburn over four weeks. The trial also included a 20-week extension period where all patients received VOQUEZNA to evaluate long-term treatment.

In the trial, VOQUEZNA quickly and significantly reduced heartburn with daily treatment through week 4. VOQUEZNA demonstrated the power of more complete all-day and all-night heartburn-free days with significantly more 24-hour heartburn-free days through week 4 versus placebo, the primary endpoint. The mean percentage of heartburn-free days for patients taking VOQUEZNA was 45% versus 28% for placebo (p<0.001), and the median percentage of 24-hour heartburn-free days was 48% versus 17%, respectively. Improvements for those taking VOQUEZNA were also seen in the percentage of each of heartburn-free days and nights, in addition to the percentage of days without rescue antacid use. Results from the pivotal study were previously presented at Digestive Disease Week^® (DDW) 2024 and also published in Clinical Gastroenterology and Hepatology.

The most common adverse reactions (≥2%) reported in patients treated with VOQUEZNA during the four-week placebo-controlled trial include abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. Upper respiratory tract infection and sinusitis were also reported in patients who received VOQUEZNA in the 20-week extension phase of the trial.