PharmaFocus Today – Page 150 – media

Q&A with Alvana Maliqi

Mike Hollan Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges. Alvana Maliqi, Associate director of value and access strategy Alvana Maliqi served as lead author on Cencora’s latest research initiatives focused on pre-approval information exchange (PIE). She spoke with Pharmaceutical Executive about the research and how the industry can utilize this information more efficiently. Pharma Executive: What does the passage of the PIE legislation allow biopharma companies to do? Alvana Maliqi: The Consolidated Appropriations Act, 20231 (or pre-approval information exchange [PIE] legislation”) was signed into law in 2022, providing a safe harbor for pharmaceutical companies to proactively engage in PIE with payers about new products and/or new indications. Previously, this pathway was initially supported by the 2018 FDA Final Guidance for pre-approval communications. Since 2018, biopharma manufacturers are permitted to share unbiased, factual, accurate, ...
- Source: drugdu
- 200
- May 27, 2024
AstraZeneca, Nona Biosciences Strike Global License and Option Deal to Develop Monoclonal Antibodies for Tumor Targeted Therapies

Don Tracy, Associate Editor Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones. Nona Biosciences announced a major global license and option agreement with AstraZeneca, focusing on the development of monoclonal antibodies into targeted therapies for cancer treatment. Under terms of the deal, Nona Biosciences will receive an initial payment of $19 million. Additionally, the company will have the opportunity to receive up to $585 million pending the completion of milestones along with royalty payments on net sales.1 “We are delighted to announce this agreement with AstraZeneca, global leaders in developing tumor targeted therapies, to maximize the potential of our novel antibodies,” said Jingsong Wang, MD, PhD, chairman, Nona Biosciences, in a press release. “This agreement further validates our leading antibody discovery platform, and we look forward to seeing our antibodies developed ...
- Source: drugdu
- 168
- May 27, 2024
Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024

SUZHOU, China, May 23, 2024 /PRNewswire/ — On May 10, 2024, Cure Genetics announced the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity. This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of ...
- Source: drugdu
- 151
- May 27, 2024
Positive Results Achieved in Phase III Study of Benmosubimab in Combination with Anlotinib for First-Line Treatment of Advanced Renal Cell Carcinoma

Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
- Source: drugdu
- 192
- May 27, 2024
Emcure and Gennova to resume mRNA collaboration with HDT

Emcure Pharmaceuticals and its biotech subsidiary, Gennova Biopharmaceuticals have amicably resolved all legal disputes with HDT Bio Corporation. The litigation between them, including before US courts and the arbitral tribunal in London, has been settled and dismissed. Gennova and HDT, who previously collaborated on the successful development of Gennova’s mRNA Covid-19 vaccines, will once again collaborate on the development and commercialisation of mRNA vaccines. The parties have entered into a long-term agreement to develop mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields. https://www.business-standard.com/companies/news/emcure-gennova-settle-legal-dispute-with-us-based-hdt-bio-sign-agreement-124052300762_1.html
- Source: drugdu
- 189
- May 27, 2024
Gerresheimer to acquire Blitz LuxCo Sarl, for EUR 800 million

Gerresheimer Glas GmbH, an indirect subsidiary of Gerresheimer AG, has signed a purchase agreement with funds advised by Triton for the acquisition of Blitz LuxCo Sarl, the holding company of the Bormioli Pharma Group (Bormioli Pharma). The purchase price is based on a determined enterprise value of around EUR 800 million, which corresponds to an adj. EBITDA multiple of around 10 Bormioli Pharma, has 9 production sites in Europe. The Group generates revenues of around EUR 370 million and an adj. EBITDA margin of around 21 per cent. Bormioli Pharma has a complementary portfolio of pharmaceutical primary packaging made of glass and plastic, as well as closure solutions, accessories, and dispensing systems. With this acquisition, Gerresheimer strengthens its European footprint with additional production sites, especially in Southern Europe, and underpins its market position as a leading full-service provider and global partner for the pharmaceutical and biotech industries. The acquisition is ...
- Source: drugdu
- 157
- May 27, 2024
Innovative Fundus Disease Drug Busilixumab Completes First Injections in Mainland Public Hospitals, Benefiting More Fundus Disease Patients

Recently, Guangdong Provincial People’s Hospital successfully completed the injection of the innovative drug Busiliximab, which is also the first batch of injection of this drug in public hospitals in mainland China. Relying on the “Hong Kong-Macau Pharmaceutical and Device Access” policy, Busiliximab has been approved for urgent clinical use in designated medical institutions in the Greater Bay Area. This new generation of anti-VEGF (vascular endothelial growth factor) drugs in public hospitals will enhance the accessibility of innovative therapies and benefit more patients with fundus diseases. China has more than 40 million patients with endophthalmic disease, and is in urgent need of new drugs to break through the treatment dilemma. The number of patients with fundus diseases in China is increasing, with the potential number of patients with fundus diseases reaching 40 million. The most common of them are diabetic retinopathy and age-related macular degeneration, in addition to many other types ...
- Source: drugdu
- 172
- May 25, 2024
Pharma companies urged to act on antimicrobials to combat drug resistance

A new report from the Access to Medicine Foundation calls for urgent changes in research and development (R&D) to ensure new antibiotics and antifungals reach patients facing drug-resistant infections. The report examines five late-stage antimicrobial projects targeting severe drug-resistant pathogens, revealing that structured advance planning for access and stewardship is not yet standard among companies. Four out of five companies—GSK, Pfizer, Innoviva, and Venatorx—are conducting clinical trials involving children, aiming to improve access for paediatric patients. Despite these efforts, only five low- and middle-income countries (LMICs)—China, India, Mexico, South Africa, and Thailand—have concrete commitments for drug registration. Many of the remaining 108 LMICs with high burdens of targeted diseases lack such commitments. The report underscores the need for partnerships and licensing agreements to enhance access in LMICs. SMEs have pursued wider access through collaborations, like those with the Global Antibiotic Research and Development Partnership (GARDP). However, the report finds that ...
- Source: drugdu
- 163
- May 25, 2024
Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL

Sucralfate is used to treat stomach ulcers,GERD, radiation proctitis, and stomach inflammation and to prevent stress ulcers. Strides Pharma Science (Strides) recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL of AbbVie. Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation and to prevent stress ulcers. Sucralfate Oral Suspension, 1gm/10 mL has a market size of ~US$ 124Mn as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India. https://www.expresspharma.in/strides-receives-usfda-approval-for-sucralfate-oral-suspension-1gm-10-ml
- Source: drugdu
- 189
- May 25, 2024
The Supplemental Applications of HANDAYUAN(adalimumab injection) for the New Indications Approved by the NMPA

Shanghai, China, May 22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases [1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases [2]. It has been proven that many autoimmune diseases such as ...
- Source: drugdu
- 167
- May 24, 2024

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