Archive for month: April, 2024

Seoul: Medical professors in South Korea are preparing to challenge the government’s decision to increase medical school admissions, citing concerns over their constitutional rights. The move comes amid ongoing disruptions to the country’s medical services, triggered by a plan to add 2,000 new medical students next year to alleviate a shortage of doctors.

The Medical Professors Association of Korea is scheduled to file the petition with the Constitutional Court before the April 10 general elections against the government’s plan to raise the number of medical students by 2,000 starting next year from the current 3,058 seats to address a shortage of doctors, Yonhap news agency reported.

The plan has caused a massive walkout by junior doctors since February 20, as well as major disruptions to the country’s medical service.

“Following the dismissal, we cannot expect any redemption of our rights by lower courts so we are entitled to bring the case to the Constitutional Court. We will file the petition before the elections next week,” he added.

In addition to the constitutional appeal, the association plans to seek a court injunction this month, preempting the government’s release of detailed entrance requirements for next year’s college admissions.

Meanwhile, the government is determined to accomplish medical reform, Second Vice Health Minister Park Min-soo said on Friday.

He made the remarks at a government response meeting, a day after President Yoon Suk Yeol met a leader of a group of trainee doctors, Yonhap reported.

“The government is determined to accomplish medical reform in a flexible, inclusive, but unwavering manner that upholds principles,” Park said.

Park also called for trainee doctors to end their walkout and continue talks with the government over medical reform.

Hyderabad: In a significant development for dental healthcare in Hyderabad, Ocean International Dental Hospital unveiled its newest branch in Madhapur, Hyderabad, on Friday. The inauguration ceremony was graced by the esteemed presence of Chhattisgarh Governor Biswabhushan Hari Chandan.

he state-of-the-art facility promises to provide a wide array of ultra-modern dental services, ranging from invisalign and braces to smile design, root canal treatments, laser whitening veneers, implants, dentures, and a host of other specialized procedures. The hospital boasts advanced diagnostic tools such as CBCT and OPG, along with expertise in orthognathic surgeries, crowns, and bridges.

According to an UNI report, Speaking on the occasion, the governor said, “For any dental problems, proper diagnosis and accurate treatment will be done through AI (artificial intelligence) at Ocean International Dental Hospital. The new facility will enable us to know in advance how the result will be after the treatment.”.

Our key objective is to make medical services available to people from all walks of life, he said.

“We provide holistic and all-encompassing dental care at affordable prices using the most recent technology and cutting-edge procedures, he added.

Pre-checkup counseling, dental health awareness, and discussions are all part of our dental practice. We assist patients with the diagnosis, care, and prevention of dental problems while maintaining a stress-free atmosphere,” he added.

The company already has dental clinics in Visakhapatnam, Vijayawada, and Hyderabad.

Medical Dialogues team recently reported that Jamia Millia Islamia has created 2 new departments including the Department of Medical Sciences, and the Department of Dental Sciences.

BDS (Bachelor of Dental Surgery) is a 5-years undergraduate program and the only approved professional dental course in India. Students become doctors after the BDS course. It is a compulsory course for students aspiring to work as dentists at government or private hospitals. BDS mainly focuses on training and introducing students to the dental sciences and surgeries. The 5-year program involves 4 years of classroom education and 1 year of compulsory rotating internship.

FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of CARVYKTI reduced the risk of disease progression or death by 59 percent compared to standard therapies—pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)—in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The study, which was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, also included and reported key secondary results such as overall response (OR) and overall survival (OS).

“CARVYKTI demonstrated remarkable efficacy as a personalized, one-time infusion in the earlier treatment of relapsed/refractory multiple myeloma as shown through the CARTITUDE-4 study results,” said Binod Dhakal, M.D., Associate Professor, Medical College of Wisconsin, Division of Hematology and Oncology.^* “With this approval, I’m excited for patients who may have the opportunity for a treatment-free period for their multiple myeloma as early as first relapse, with the hope of eliminating the burden of having to be on continuous treatment while living with this challenging disease.”

More than 35,000 estimated new cases of multiple myeloma, an incurable blood cancer, will be diagnosed in 2024 in the United States. Real-world studies show that only an estimated 15% of patients initially diagnosed with multiple myeloma are able to start a 5th line of therapy. With this new indication, more patients will be able to access this innovative treatment.

“This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “We are proud to bring an important, highly effective immunotherapy that has demonstrated a favorable benefit/risk profile to physicians and patients for the earlier treatment of relapsed/refractory multiple myeloma, and we look forward to building on this latest milestone as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma.”

CARVYKTI is a cell therapy that works by harnessing a patient’s immune system, or T cells, to fight the disease. Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients. Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI production.

“We understand the urgency for patients in need of CARVYKTI, and we have been making considerable progress in increasing supply and availability in anticipation of this milestone approval,” said Tyrone Brewer, President, U.S. Hematology, Johnson & Johnson Innovative Medicine. “We more than doubled manufacturing of CARVYKTI in 2023, we are striving to double again in 2024, and we will continue to invest in our capacity so we can provide this critical therapy to as many patients as possible.”

The safety profile for CARVYKTI includes a boxed warning for Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barre syndrome and their associated complications, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), Prolonged and Recurrent Cytopenias and Secondary Malignancies including myelodysplastic syndrome, acute myeloid leukemia, and T-cell malignancies. Warnings and Precautions include Increased Early Mortality, Hypogammaglobulinemia, Infections, Hypersensitivity Reactions and Effects on Ability to Drive and Use Machines.

CARVYKTI (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. CARVYKTI is now approved in the U.S. for the second-line treatment of adult patients with relapsed or refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide.

In addition to a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication, in March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of a Type II variation for CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI for the treatment of adults with relapsed or refractory multiple myeloma in patients that have no history of CAR-positive T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy.

CARVYKTI is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI.

Read also: USFDA grants Fast Track designation to JnJ nipocalimab to reduce fetal neonatal alloimmune thrombocytopenia risk in alloimmunized pregnant adults

New Delhi: With the condition to be sold by retail under the prescription of a Gynaecologist only, pharmaceutical major Sun Pharma Industries has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSCO to manufacture and market Elagolix tablets 150mg and 200mg.

However, this nod is subjected to a condition that the firm should conduct the Phase IV clinical trial (CT) on Elagolix 200 mg tablet for which Phase IV clinical trial protocol is required to be submitted to CDSCO within 3 months.

In addition to the above, the expert panel mentioned that the said drug should be sold by retail under the prescription of a Gynaecologist only.

This came after Sun Pharma Industries presented the Phase III CT report of Elagolix 150mg tablet and therapeutic justification and rationale for Elagolix 200 mg tablets.

Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the body. Elagolix works by decreasing the body’s production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). These lower levels may help decrease some symptoms of endometriosis.

Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding).

At the recent SEC meeting for Reproductive held on 20th March 2024, the expert panel reviewed the Phase III CT report of Elagolix 150mg tablet and the therapeutic justification and rationale for Elagolix 200 mg tablets.

After detailed deliberation, the committee recommended the grant of manufacturing and marketing of Elagolix 150mg and 200mg for the proposed indication subject to the condition that

(a) The firm should conduct Phase IV CT on Elagolix 200 mg tablet for which Phase IV CT protocol is to be submitted to CDSCO within 3 months of approval for further evaluation by the committee.

(b) To be sold by retail under the prescription of a Gynaecologist only.

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