Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.

The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).

This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc.

“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

The FDA evaluated manufacturing data to support the change to the 2023-2024 formula of the Novavax COVID-19 Vaccine, Adjuvanted. Additionally, the FDA evaluated non-clinical immune response data suggesting that the vaccine provides protection against the currently circulating COVID-19 variants. The agency also relied on its evaluation of safety and effectiveness data from clinical trials of Novavax COVID-19, Vaccine, Adjuvanted (Original monovalent) and investigational monovalent and bivalent Novavax COVID-19 adjuvanted vaccines, as well as postmarketing data. The data accrued with these Novavax COVID-19 vaccines are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process.

The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has met the statutory criteria for issuance of an EUA, and that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older.

As part of today’s action, the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.

The FDA granted the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) to Novavax Inc. of Gaithersburg, Maryland.

INDIANAPOLIS, IN - Eli Lilly and Company (NYSE: LLY) and POINT Biopharma Global, Inc. (NASDAQ: PNT) today announced a definitive agreement for Lilly to acquire POINT, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer. Radioligand therapy can enable the precise targeting of cancer by linking a radioisotope to a targeting molecule that delivers radiation directly to cancer cells, enabling significant anti-tumor efficacy while limiting the impact to healthy tissue.

POINT's lead programs are in late-phase development. PNT2002¹ is a prostate-specific membrane antigen (PSMA) targeted radioligand therapy in development for patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on hormonal treatment. Topline data from this study are expected in the fourth quarter of 2023. PNT2003¹ is a somatostatin receptor (SSTR) targeted radioligand therapy in development for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Beyond the late-stage clinical pipeline, POINT has several additional programs in earlier stages of clinical and preclinical development. Additionally, POINT operates a 180,000-square-foot radiopharmaceutical manufacturing campus in Indianapolis, as well as a radiopharmaceutical research and development center in Toronto. These facilities will be utilized alongside POINT's extensive network of supply chain partners for sourcing radioisotopes and their precursors.

"Over the past few years, we have seen how well-designed radiopharmaceuticals can demonstrate meaningful results for patients with cancer and rapidly integrate into standards of care, yet the field remains in the early days of the impact it may ultimately deliver," said Jacob Van Naarden, President of Loxo@Lilly, the oncology unit of Eli Lilly and Company. "We are excited by the potential of this emerging modality and see the acquisition of POINT as the beginning of our investment in developing multiple meaningful radioligand medicines for hard-to-treat cancers, as we have done in small molecule and biologic oncology drug discovery and development. We look forward to welcoming POINT colleagues to Lilly and working together to build upon their achievements as we develop a pipeline of meaningful new radioligand treatments for patients."

Joe McCann, Ph.D., CEO of POINT added: "The combination of POINT's team, infrastructure and capabilities with Lilly's global resources and experience could significantly accelerate the discovery, development and global access to radiopharmaceuticals. I look forward to a future where patients all over the world can benefit from the new cancer treatment options made possible by the joining of our two companies today."

Terms of the Agreement

Lilly will commence a tender offer to acquire all outstanding shares of POINT for a purchase price of $12.50 per share in cash (an aggregate of approximately $1.4 billion) payable at closing. The transaction has been approved by the boards of directors of both companies.

The transaction is not subject to any financing condition and is expected to close near the end of 2023, subject to customary closing conditions, including the tender of a majority of the outstanding shares of POINT's common stock, and license transfer approval from the U.S. Nuclear Regulatory Commission. Following the successful closing of the tender offer, Lilly will acquire any shares of POINT that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

The purchase price payable at closing represents a premium of approximately 87% to POINT's closing stock price on Oct. 2, 2023, the last trading day before the announcement of the transaction, and 68% to the 30-day volume-weighted average price. POINT's board of directors unanimously recommends that POINT's stockholders tender their shares in the tender offer.

Lilly will determine the accounting treatment of this transaction as a business combination or an asset acquisition, including any related acquired in-process research and development charges, according to Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly's financial results and financial guidance.

For Lilly, Goldman Sachs & Co. LLC is acting as exclusive financial advisor and Kirkland & Ellis LLP is acting as legal counsel. For POINT, Centerview Partners LLC is acting as exclusive financial advisor and Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal counsel.

SAN MATEO, Calif.SAN MATEO, Calif.SAN MATEO, CA - AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it is advancing Niyad™ (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an Investigational Device Exemption (IDE) submission to the United States Food and Drug Administration (FDA).  This clinical trial will evaluate the safety and efficacy of Niyad to support a premarket approval application (PMA) expected to be submitted in the second half of 2024. The single study will consist of 166 adult patients undergoing renal replacement therapy (RRT) who cannot tolerate heparin or are at risk for bleeding.  If approved, Niyad would be the first-ever FDA-approved regional anticoagulant for the extracorporeal circuit in the U.S.

"We are thankful that the FDA has reviewed and approved our IDE application so we can now proceed with our registrational study to evaluate our lead product candidate, Niyad, which we believe to be a paradigm-shifting product candidate for the medically supervised setting," said Vince Angotti, Chief Executive Officer of AcelRx.  "We are on track to start this study later this year, with top-line data expected by mid-2024 and submission of a PMA planned in the second half of 2024."

The registration study is designed as a prospective, double-blinded trial to be conducted at approximately 10 U.S. hospital intensive care units that will enroll and evaluate 166 patients that will be randomized into either active or placebo arm.  The primary endpoint of the study is mean post-filter activated clotting time (ACT) over the first 24 hours versus placebo.  Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.

Pamela P. PalmerPamela P. Palmer, M.D., Ph.D., Chief Medical Officer and Co-Founder of AcelRx, commented, "Importantly, we are encouraged by our interactions with the FDA - not only by being granted Breakthrough Device Designation status for Niyad, but also in terms of the Agency's acceptance of a straightforward registrational trial design to evaluate Niyad.  Based on the feedback from the  Emergency Use Authorization request, the FDA stated that AcelRx should proceed with the clinical study. We're looking forward to our upcoming Investigator's Meeting just prior to starting enrollment.  We remain steadfast in our commitment to advance Niyad for use as a regional anticoagulant during renal replacement therapy, as current options are limited and patients often receive care below the recommended international standards.  We also look forward to publishing our independent qualitative market research related to these findings later this year."

NASHVILLE, TN - The prevalence of mental health conditions continues to rise across the country. Yet, even with a decrease in the stigma surrounding mental health, many are still not receiving care. More than half of adults with a mental illness do not receive treatment, and 160 million live in a mental health professional shortage area. To better equip other frontline care workers to provide much-needed mental health support, Psych Hub, the leading provider of mental health education, connection, and engagement solutions, announces the launch of curated learning experiences for health and healthcare professionals.

Addressing mental health issues and their detrimental effects on physical health is placing a significant strain on clinical and wellness settings across the care continuum. Psych Hub's new learning experiences are created for critical roles well-positioned to provide mental health literacy and support: nurses and other healthcare clinicians, pharmacists, and behavioral health and health and wellness coaches. Available on-demand on Psych Hub's online education platform, each program includes CE-eligible coursework, shareable supporting resources, and engaging videos on a variety of mental health topics that provide a foundation for empowering these professions with training in evidence-based approaches.

These specific learning programs include the content most appropriate to upskill care and provide mental health support with evidence-based information in alignment with each role's scope of practice. While these professionals do not deliver mental health therapy, their regular interactions with individuals in health and healthcare environments are improved when mental health and wellness components are integrated into care. Psych Hub's evidence-based training empowers them to help create a holistic healthcare model inclusive of mental health support across common patient access points.

• Patients are turning to healthcare clinicians and nurses for help understanding and treating mental health symptoms. Psych Hub's evidence-based courses educate these medical professionals about mental health issues, diagnoses, and treatment pathways so they can offer their patients the most up-to-date and accurate recommendations.
   
• Pharmacists have become frontline workers when it comes to mental health care. When individuals choose not to or are unable to engage in therapy, they may benefit from less formal conversations with trusted pharmacists they interact with on a routine basis. Psych Hub helps pharmacists discover practical ways to engage with clients around mental health issues in the pharmacy setting.
   
• Behavioral health and health and wellness coaches can serve as an accessible source of support for individuals experiencing mental health struggles. Whether coaches work with their clients as an extension of therapy or independent of it, Psych Hub equips them with the knowledge and skills to discuss mental health issues and help clients learn effective coping skills.

"Access to mental health care continues to be one of our most pressing healthcare challenges, and the ongoing practitioner shortage makes it difficult to address the growing demand for care and support effectively," said Marjorie Morrison, co-founder and CEO of Psych Hub. "We know that healthcare providers and health professionals can step in to provide this much-needed support, helping patients understand mental health and their options for treating symptoms. But they need evidence-based training and tools to do so efficiently and with maximum impact. We are honored to support healthcare professionals in increasing their practical skills related to mental health by providing these targeted learning opportunities."

The new evidence-based CE learning programs for healthcare clinicians, nurses, pharmacists, and behavioral health and health and wellness coaches are now available through Psych Hub. Visit psychhub.com for more information.

GAITHERSBURG, MD -  (NYSE: EBS) today announced the appointment of Neal Fowler and Don DeGolyer to its Board of Directors effective October 1, 2023, with initial terms expiring at Emergent’s 2024 Annual Meeting of Stockholders. Both joined as independent directors and bring more than 70 years of combined biopharmaceutical industry and sales experience.

“Neal and Don bring unique and extensive expertise to Emergent as the company defines its future in this post-pandemic environment,” said Emergent Chairman Dr. Zsolt Harsanyi, Ph.D. “Maintaining our focus on our mission of protecting and enhancing life, these industry veterans add valuable insight and experience as Emergent continues to partner with governments to prepare for public health threats and save lives.”

Mr. Fowler will serve on the Audit and Finance Committee, and Mr. DeGolyer will serve on the Compensation Committee.

About Mr. Fowler:

Currently, Mr. Fowler is the Chief Executive Officer of Pathalys Pharma, Inc., a biomedicines company focused on chronic kidney disease. He previously served as CEO of Liquidia Corporation (Nasdaq: LQDA), transforming the company from an early-stage research platform into a publicly traded biomedicines company. While at Liquidia, Mr. Fowler also co-founded and served as CEO of Envisia Therapeutics (acquired), an ophthalmology company focused on therapeutics. Prior to Liquidia, Mr. Fowler worked for seven years with Johnson and Johnson, serving as President of Centocor, Inc., a global multi-billion dollar subsidiary focused on biomedicines, and President of Ortho-McNeil Neurologics, a company focused on neurological disorders. He started his career with Eli Lilly and Company, working for thirteen years in a variety of sales, marketing and business development roles in both the pharmaceutical and medical device divisions. Mr. Fowler is the current chair of NCBIO and a past chair of the UNC Eshelman School of Pharmacy Foundation.

Mr. Fowler earned his Bachelor of Science degree in Pharmacy and Master of Business Administration both from the University of North Carolina at Chapel Hill.

About Mr. DeGolyer:

With over 35 years of healthcare and corporate leadership experience, Mr. DeGolyer was most recently the Founder and Director of Vertice Pharma (a Warburg Pincus company), focused on specialty pharmaceuticals for U.S. institutional use, from 2015 until the company’s sale in 2022. Prior to Vertice, he was Chief Operating Officer of Endo International, a Nasdaq-listed specialty pharmaceutical company, from 2013-2015. Between 2009 and 2013, he served on the Executive Committee of Sandoz AG (a Novartis company), one of the largest global generic companies, as CEO, Sandoz Inc., a $3.5bn generic pharmaceuticals and biosimilars company where he was responsible for leading over 3,000 associates in North America.

Mr. DeGolyer started his career with Pfizer, Johnson & Johnson and Novartis in commercial roles of increasing responsibility. He previously served on the Board of HLS Therapeutics (commercial stage CV/CNS company) and TYME Technologies (development stage cancer company), both publicly traded companies, where he was also Chairman of the Compensation Committees. He also serves on several non-profit boards including Make-a-Wish-NJ and The Strong Women Foundation.

Mr. DeGolyer received his Bachelor of Arts from the University of Rochester and earned a Master of Business Administration from Fairleigh Dickinson University.

Pharmacolog is initiating a cost-saving program that will significantly reduce ongoing operating costs while streamlining the company organization to support existing customers and external distributors. The implementation of cost-reducing measures will start immediately and will be fully implemented by January 2024. At full effect, the measures will reduce operating costs by at least 35% compared to the operating costs of the full year 2022, this corresponds to a sum of at least SEK 10 million.

The background is that Pharmacolog’s direct sales efforts have not met the expectations of the company and its shareholders. As one of the first steps, Pharmacolog intends to considerably reduce the organization while retaining necessary competencies for driving and increasing sales through Pharmacolog’s distributor network and maintaining first-class support for the existing customer base. At the same time, further measures will be implemented in all areas on the group level, which will lead to overall lower costs.

Necessary steps immediately taken to perform the intended cost reductions may, inter alia, include negotiations with affected trade unions.

“With these measures now being implemented we will align our organization with our strategic direction and simultaneously protect our balance sheet. These are tough decisions to take but necessary in order to remain focused on the commercialization of our solutions for the benefit of our customers, partners, and shareholders.” says Lars Gusch, CEO of Pharmacolog.

This disclosure contains information that Pharmacolog is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 02-10-2023 09:35 CET.

Minnetonka, MN – The Alter Pharma Group, a group of generic and pharmacy sales companies, is rebranding all its brands and businesses into A.forall. This change, starting 27 September, represents an important milestone in A.forall’s pursuit of a world where patients can access high-quality, safe and innovative medicines at an affordable price. The move strengthens A.forall’s commitment to #MakingAffordableMedicinesAvailableToAll, offering new synergies and ways to leverage the skills and capacities of its 144 employees around the world.

Alter Pharma started pharmacy sales in 2006. In 2010, it became the Alter Pharma Group after the consolidation of several entities and last year, the group reached an important milestone with its first major acquisition. Its generics business currently markets more than 30 in-house developed added value products that are being sold in more than 60 countries around the globe including US, whereas A.forall’s Benelux Pharmacy House provides medicine shortage services through hospital and retail pharmacies. In 2022 alone, by helping pharmacists to source medicines in shortage, the group managed to bring relief to more than 100,000 hospitalized patients and to supply more than 650,000 months of missing treatments to patients that would otherwise be lacking their medication.

Throughout this journey, the Alter Pharma Group and its brands have always been focused on delivering secure access to high-quality, affordable medicines. The current rebranding will unify businesses and commercial brands of the group*, countless stories and talents, while continuing to make sure that no one is left behind in the pursuit of better health and wellbeing.

Sacramento, CA-The California Pharmacists Association (CPhA) is proud to represent the dynamic community of pharmacists and pharmacy technicians across all practice settings. As members of this frontline health provider community, we stand with our colleagues across the nation who are bravely protesting poor working conditions to preserve and protect patient safety. The Pharmacist’s Oath is not mere words on paper, rather, it calls upon pharmacists to advocate for their patients’ care and safety. When patient safety is compromised, pharmacists must speak up and act.

In California, CPhA continues to take action to improve patient safety and to preserve the professional status and clinical judgment of our pharmacists. In 2021, CPhA sponsored Senate Bill 362 which became law in 2022, banning the use by chain stores of any prescription, vaccination or sales quotas to measure a pharmacist’s performance. As a result, the California State Board of Pharmacy is actively taking enforcement action against stores when such quotas are reported. It is also notable that in response to California law, Walgreens announced in October of 2022 that they will cease to use these quotas nationally. There are pharmacies that do recognize that it is essential for pharmacists to have sufficient time and support to perform medication safety checks, to provide important patient counseling and to render clinical services to ensure the best outcomes for their patients. In stark contrast, CVS is mired in massive prescription backlogs of its own making, in large part due to aggressive patient-steering tactics driven by its Pharmacy Benefit Manager (PBM) company, CVS Caremark. Due to these practices, patients are increasingly being denied access to other community and independent pharmacies where their pharmacy needs could be met. This cherry-picking of patients away from other pharmacies, coupled with persistent understaffing at its own pharmacies, along with unreasonable workloads, has caused the untenable situation that its pharmacists and patients face today.

Currently, Assembly Bill 1286, sponsored by the California Board of Pharmacy and strongly supported by CPhA, is sitting on the desk of the Governor awaiting signature. AB1286 aims to address patient safety by instituting mandatory reporting of medication errors while empowering the Pharmacist in Charge (PIC) to make staffing decisions to ensure that the work environment does not contribute to increased errors. The reporting is done in aggregate, without punitive measures against individual pharmacists, thus fostering an atmosphere of transparency and continuous improvement. The goal is to create an environment in which pharmacists may openly report errors while working collaboratively to identify and correct them. Using the professional judgment of a pharmacist in staffing decisions will ultimately create a safer work environment and thus improve patient safety.

We firmly believe that pharmacists need proper resources and support to maintain healthy and safe working conditions. As the demands of our profession are substantial and ever-increasing, it is incumbent upon us to advocate for the well-being of our members. As an association, we are committed to addressing these challenges, ensuring that pharmacy professionals have access to the resources, support and the advocacy required to thrive in their roles as essential health care providers.

The California Pharmacists Association is here to stand with you, united with your colleagues across all practice settings as One Profession, One Voice. We will work tirelessly to protect the integrity of our profession, the well-being of our members, and the communities they serve.

Resources:

AB 1286 Call to Action
http://cpha.informz.net/z/cjUucD9taT0yODQ2MjY0JnA9MSZ1PTUyNTQxNzE4MyZsaT0zMDgwMDUwOA/index.html

Reporting Pharmacy Quotas Violations
https://www.pharmacy.ca.gov/consumers/complaint_phy_performance_quotas.pdf

Founded in 1869, the California Pharmacists Association (CPhA) represents pharmacy professionals across all pharmacy practice settings. Our mission is to advance the practice of pharmacy for the promotion of health. We are One Profession, One Voice.

Oregon & SW Washington – UFCW Local 555 has just notified Kaiser Permanente that our members working under the pharmacy contract will be conducting an Unfair Labor Practice (ULP) strike beginning on Sunday, October 1, 2023, through Saturday, October 21, 2023.

The ULP strike was authorized by the membership in ULP strike authorization votes last week, which were near unanimous at 99.6%.

Kaiser has committed numerous Unfair Labor Practices (ULPs), including failing to provide information regarding bargaining and grievances, attempting to directly deal with our members, and attempting to dictate to the Union who may serve as its representative.

The vote comes after months of negotiations between Kaiser Permanente and UFCW 555, as well as with the Coalition of Kaiser Unions. Local 555’s bargaining team has pushed for first-year wage adjustments, increased wage differentials such as for nights and weekends, and increased staffing.

“The number one issue at Kaiser is the lack of staffing. Workers are burning out, patients are having to wait months to receive care, and the problem is only getting worse. We were prepared to work on a deal that’s sustainable for the patients, our healthcare professionals, and the company, but Kaiser has been completely unwilling to accept the real impact of underpaying healthcare professionals and understaffing job sites.” – Dan Clay, President, UFCW Local 555.

Washington, DC – The Healthcare Supply Chain Association (HSCA), which represents the nation’s leading healthcare group purchasing organizations (GPOs), today announced that Children’s Hospital Association Vice President of Pharmacy Terri Lyle Wilson will serve on HSCA’s Board of Directors. The appointment comes after the departure of Children’s Hospital Association Vice President Jennifer Gedney, who served as Board Chair. TPC President and CEO Roger Nolan will replace Gedney as Immediate Chair. 

“Terri is an industry leader in supporting the collaborative efforts of hospitals and health systems to improve healthcare through pharmacy, group purchasing, and clinical quality initiatives,” said HSCA President and CEO Todd Ebert. “Terri’s experience in patient care, hospital sustainability, and comprehensive pharmacy strategy will help HSCA and its member GPOs as they continue to confront issues such as ongoing drug shortages and work to strengthen the healthcare supply chain. 

“HSCA and its members are grateful to Jennifer Gedney for her service as Board Chair. Her leadership, expertise, and guidance have been invaluable to HSCA, and we wish her the best,” added Ebert.