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Key Trends from the 2024 J.P. Morgan Healthcare Conference

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry. By SUJAY JADHAV Beneath the Californian sunshine (and a few showers) at JP Morgan, a revolution simmers. Not a political one, but a healthcare revolution propelled by necessity and fueled by innovation. Imagine a future where groundbreaking therapies reach patients years sooner, personalized treatments offer hope for chronic diseases, and healthcare costs become more manageable for everyone. This isn’t science fiction; it’s the promise of the cutting-edge trends made at the annual J.P. Morgan Healthcare Conference earlier this month. For those that attended JPM in early 2023, you may recall it was quite gloomy coming off of a soft 2022 and an interest rate burdened 2023. JPM 2024 had an air of optimism. Emerging biopharma space: Challenges and innovations One ...
- Source: drugdu
- 100
- January 27, 2024
With record year, Samsung Biologics bucks CDMO industry’s troublesome 2023

Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional” performance. In the fourth quarter, Samsung reeled in 1.07 trillion Korean won (about $802 million), growing sales 11% over the same period in 2022. For the full year, Samsung grew sales 23.1% to 3.69 trillion Korean won ($2.8 billion), the company said in an earnings release Wednesday. Also last year, Samsung Biologics became Korea’s first domestic biopharma firm to generate 1 trillion won in annual profit, Business Korea reports. The 2023 result marks another revenue record for the CDMO giant, which has enjoyed fast growth over the last 8 years, according to Companies Market Cap. Samsung Biologics credited the “exceptional” performance to the ramp-up of operations at its massive Plant 4 in Songdo, South Korea, plus a “robust” sales backlog. ...
- Source: drugdu
- 95
- January 27, 2024
Apotex, Heritage and Breckenridge settle with purchasers in generics price-fixing case

Over the years, myriad generic drugmakers have had to ante up fines and settlement fees for allegedly colluding on the prices of copycat drugs. Now, Apotex and two of its generics peers have agreed to settle with direct purchasers of their drugs in a price-fixing case that stretches all the way back to 2017. Apotex plans to settle with the group of direct purchaser plaintiffs for $30 million, while Heritage Pharmaceuticals and Breckenridge Pharmaceutical will hand over $10 million and $5 million, respectively, according to a trio of motions filed Tuesday in the multidistrict litigation in Pennsylvania federal court. Each of the settlement amounts has the potential to increase or decrease, depending on the outcome of the legal proceedings. Apotex, for instance, could have its settlement fund reduced by up to $3.6 million if certain parties opt out of the deal. The case stretches back to 2017, when direct purchasers ...
- Source: drugdu
- 108
- January 27, 2024
Announcement of Gan & Lee Pharmaceuticals Receiving Bolivian Drug Registration Approval for Menthol Insulin Injection

Recently, Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as “Gan & Lee”) received the registration approval for Menthol Insulin Injection (Cassette Vial) (Lot No. II-87550/2023) from the National Agency for Medicines and Technology for Health (Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED) of Bolivia. Insulin Injection (Cassette Vial) (Lot No.: II-87550/2023). The relevant information is announced as follows: I. Basic information of the drug 1、Drug name: ASPARPEN 2、Generic Name of Drug: Mentholatum Insulin Injection 3、Indications: Diabetes mellitus 4、Dosage form: injection 5、Specifications: 3ml: 100U/ml (cassette bottle) 6、Batch No.: Ⅱ-87550/2023 7、Applicant: Gan & Lee Pharmaceutical Co. II. Other relevant information of the drug Mentholated insulin injection is a kind of rapid-acting insulin analog, which takes effect within 10~20 minutes after subcutaneous injection, the maximum action time is 1~3 hours after injection, and the duration of action is 3~5 hours, which can effectively control postprandial blood glucose. Mentholated insulin ...
- Source: drugdu
- 117
- January 27, 2024
Announcement of AOSAIKANG Pharmaceuticals on the Completion of Registered Clinical Phase III Study of its Subsidiary’s Bio-Innovative Drug ASKB589 in the First Patient in China

(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
- Source: drugdu
- 111
- January 27, 2024
IASO Bio’s IND application for new autoimmune indication of Equecabtagene Autoleucel Injection approved

January 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA – IASO Bio, a biopharmaceutical company dedicated to the development, production and sales of innovative cell-based drugs, announced the National Medical Products Administration (NMPA) Review Center (CDE) has officially approved its fully human BCMA-targeted chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel Injection, R&D code: CT103A) for the new expanded indication of refractory generalized myasthenia gravis (Myasthenia gravis, MG). ) clinical trial application (IND) (acceptance number: CXSL2300759). Equecabtagene Autoleucel Injection (trade name: Equecabtagene Autoleucel®) has been approved for marketing by the State Food and Drug Administration on June 30, 2023, for the treatment of relapsed and refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands This is the second autoimmune indication approved for IND after Neuromyelitis Optica Spectrum Disease (NMOSD). IASO Bio is the first company in China to use CAR-T products for autoimmune ...
- Source: drugdu
- 115
- January 27, 2024
NICE recommends two AI-powered software tools for stroke diagnosis in NHS

The National Institute for Health and Care Excellence (NICE) has recommended two artificial intelligence (AI)-powered software tools for use in the NHS for stroke diagnosis. The two softwares – e-Stroke and RapidAI – were selected after the health technology assessment agency found some evidence of faster and better access to treatment after using the software. Currently the leading cause of disability, responsible for more than 100,000 cases in the UK every year, a stroke is a life-threatening medical condition that occurs when the blood supply to parts of the brain is cut off. NICE advised that the software tools can be used within the NHS “while further evidence is generated to help better determine their cost-effectiveness”. The institute also noted that some form of AI was deployed in 99 out of 107 stroke units in England. e-Stroke, developed by Brainomix, was implemented in hundreds of hospitals in the UK, as ...
- Source: drugdu
- 94
- January 27, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 113
- January 26, 2024
Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy. By FRANK VINLUAN Gene therapy made its first breakthroughs slowing vision loss from inherited eye disorders. Eli Lilly is making the ear this therapeutic modality’s next proving ground, and the pharmaceutical giant now has some encouraging early clinical trial results showing it can work. An 11-year-old boy with profound hearing loss experienced restored hearing within 30 days of receiving the gene therapy, AK-OTOF, Lilly announced Tuesday. These are results for just one patient—the first in a clinical trial that could enroll up to 150 participants. But this early result is a promising sign for the therapy, which Lilly gained in 2022 through the $487 million acquisition of its developer, Akouos. ...
- Source: drugdu
- 99
- January 26, 2024
Announcement on the Acceptance of Application for Clinical Trial of 20-valent Pneumococcal Polysaccharide Conjugate Vaccine

Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
- Source: drugdu
- 100
- January 26, 2024

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