Breakthrough status for Janssen’s RSV vaccine

PharmaTimes | September 05, 2019

Janssen has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults 60 or older. The designation was based on clinical data with Janssen’s prophylactic RSV senior vaccine that “may demonstrate substantial improvement compared to available standard of care on a clinically significant endpoint,” announced the company. The investigational prophylactic vaccine is currently in a Phase IIb proof of concept study to investigate the safety and efficacy of the vaccine against RSV in adults aged 65 years and older. “With no preventive vaccines or effective antiviral treatments currently available, RSV remains a significant cause of illness in at-risk populations, particularly older adults,” said Johan Van Hoof, global therapeutic area head, vaccines, and managing director, Janssen Vaccines & Prevention.

Spotlight

Fresh from the recent 41st Annual J.P. Morgan Healthcare Conference in San Francisco, Frost & Sullivan Research Director Unmesh Lal presented his insights on the Key Growth Opportunities in Contract Research.

Spotlight

Fresh from the recent 41st Annual J.P. Morgan Healthcare Conference in San Francisco, Frost & Sullivan Research Director Unmesh Lal presented his insights on the Key Growth Opportunities in Contract Research.

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BUSINESS INSIGHTS, PHARMA TECH

Avita Acquires Q Care Plus, Renames It Avita Care Solutions

Avita Care Solutions | January 10, 2023

PMQ Investors, LLC, the parent company of Avita, has acquired Q Care Plus, Inc. This community-focused care management solution offers stigma-free access to care via telehealth, focusing on telePrEP services. Meanwhile, the terms and conditions of the deal are yet to be revealed. "Bringing Avita and Q Care Plus together comes at a time when reducing health inequities among underserved populations is more critical than ever," said Avita Chief Executive Officer Michael Yount. He further added, "A multiyear pandemic, partisanship-based politics that limit health care rights, and long-standing stigma, fear, and discrimination against marginalized populations like the LGBTQ+ community have exacerbated existing obstacles to health care and created a host of new ones." (Source: PR Newswire) Avita can now broaden its commitment to a community care management strategy that eliminates obstacles for patients and covered entities throughout the care continuum due to its acquisition of Q Care Plus. The company promotes patients' and covered entity partners' capacity to acquire culturally competent LGBTQ+, HIV, PrEP, and sexual wellness care by providing comprehensive access to pharmacy services, 340B program administration, clinical care delivery, and digital health choices. Avita is transitioning to Avita Care Solutions in light of its recent growth. This brand will encompass Avita Pharmaceutical, the company's pharmacy services section, and AvitaCare Atlanta, its new Atlanta medical and primary care center and pharmacy previously owned by AbsoluteCare. There are no plans to rebrand Q Care Plus' digital health platforms. In 2023, Avita will start selling Q Care Plus under the Avita family of brands. About Avita Care Solutions Avita Care Solutions is committed to improving health equity by giving underserved communities comprehensive, caring, and all-inclusive health care and pharmacy services. Its strategy for managing care in the community makes it possible for patients and covered entities to eliminate barriers across the care continuum. Over 145,000 patients and 320+ covered organizations at 65+ locations benefit from Avita's community care management strategy, which includes pharmacy services, program administration, digital health, and clinical care delivery.

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PHARMA TECH

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp. | November 28, 2022

Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence. Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes. Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039. “We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.” Dr. Howard Verrico, CEO About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.

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EU Approves Zynlonta for Relapsed or Refractory Diffuse Large B-cell Lymphoma

ADC Therapeutics | January 03, 2023

Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September. Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer. The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL. Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs. ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein. According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics. About ADC Therapeutics ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.

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