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Osaka: Takeda has announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the U.S. Food and Drug Administration (FDA) for adults with mCRC who have been previously treated with oxaliplatin- and irinotecan-based regimens on November 8, 2023.
“People living with metastatic colorectal cancer face numerous difficulties, stemming both from their illness and the adverse effects of therapies. Given the complex nature of the disease, introducing innovative treatments such as fruquintinib – an oral, chemotherapy-free targeted agent – is essential. I am looking forward to having a new choice for appropriate patients,” said Josep Tabernero, MD, PhD, director of Vall d´Hebron Institute of Oncology (VHIO).
The approval is based on results from the Phase 3 multi-regional FRESCO-2 trial. The trial investigated FRUZAQLA plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC. FRESCO-2 met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with FRUZAQLA, regardless of the prior types of therapies they received. FRUZAQLA demonstrated a manageable safety profile in FRESCO-2. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with FRUZAQLA plus BSC versus 21% of those treated with placebo plus BSC. Data from FRESCO-2 were published in The Lancet in June 2023.
“The approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumors harbor actionable mutations,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “We look forward to offering patients a novel treatment option that has a manageable safety profile and can be effective regardless of the prior types of therapies they have received.”
FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. FRUZAQLA was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for potential use as part of combination therapy.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA was approved by the U.S. Food and Drug Administration (FDA) in November 2023. A submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE.
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New Delhi- The National Testing Agency (NTA) has invited online applications for the DHR-ICMR Non-Medical Fellowship – Biomedical Research Eligibility Test (BRET) for PhD 2024.
The interested candidates are required to apply “Online” only for the DHR-ICMR 2024 – Biomedical Research Eligibility Test (BRET) by accessing the NTA official website. The application other than online mode would not be accepted in any case.
DHR-ICMR Non-Medical Fellowship for PhD – 2024 – BRET will be conducted by NTA. This examination is being conducted to determine the eligibility of Indian National candidates for the award of Junior Research Fellowship (JRF) through DHR-ICMR. This exam will be conducted in Computer Based Test (CBT) mode in English medium only.
The schedule of the DHR-ICMR Non-Medical Fellowship for PhD 2024 – Biomedical Research Eligibility Test (BRET), are as follows-
|
S.NO |
ACTIVITY |
DATES |
|
1 |
Commencement of Online Registration of Application. |
19-06-2024. |
|
2 |
Closure of Registration of Application. |
09-07-2024. |
|
3 |
Last Date Of Online Fee Payment. |
09-07-2024. |
|
4 |
Correction Period. |
10-07-2024 to 11-07-2024. |
|
5 |
Hall Ticket/ Admit Card can be downloaded. |
27-07-2024. |
|
6 |
Date of Computer-Based Test. |
31-07-2024. |
EXAMINATION FEE
|
S.NO |
CATEGORY/SUB CATEGORY |
NONE |
PWBD |
TRANSGENDER |
|
1 |
General(UR). |
1800/- |
1200/- |
1200/- |
|
2 |
EWS/OBC/SC/ST. |
1500/- |
1200/- |
1200/- |
INSTRUCTIONS TO FILLING ONLINE APPLICATION FORM
STEP 1- Register for Online Form submission using a unique Email ID and Mobile No.
STEP 2- Fill in the Online Application Form and note down the system-generated Application No. Upload legible scanned images of-
i a recent photograph (in a jpg file, size 10Kb – 200Kb) either in colour or black & white with 80% face (without mask) visible including ears against a white background.
ii candidate’s signature (in jpg file size: 4kb – 30kb).
iii Duly verified Result Appearing/Awaited Form (in PDF format file size: 50KB to 500KB).
iv Category Certificate, if applicable (SC/ ST/ OBC/ EWS etc.) (in PDF format file size: 50KB to 300KB).
v PwD Certificate, if applicable (in PDF format file size: 50KB to 300KB).
STEP 3- Pay the prescribed fee through Net Banking / Debit Card / Credit Card and UPI, keep proof of fee paid for future reference.
Lastly, download save and print copies of the Confirmation Page after successful remittance of fee and keep copies safely for future reference.
Meanwhile, the age limit for admission to the eligibility test is 30 years as on the last date of the application form i.e. 09.07.2024. (Upper age limit relaxation up to five years in case of candidates belonging to SC/ST, PwBD and female candidates, three years in the case of OBC category).
As per the Information Bulletin, below are the education qualifications, scheme of examination, examination centre, admit card, etc. regarding the BRET.
EDUCATIONAL QUALIFICATIONS
1 M.Sc. or equivalent post-graduate (PG) degree (M. Tech/M. Pharma), in life sciences, zoology, botany, biomedical sciences, microbiology, biochemistry, genetics, biotechnology, biophysics, bioinformatics, forensic sciences, environmental sciences, food and nutrition, molecular biology, biological sciences, ecology, immunology, neurosciences, veterinary sciences, nursing, biostatistics, pharmacology, pharmaceutical sciences, public health, social work, with minimum 55% marks in PG test for General/EWS/OBC candidates and 50% for the SC/ST and PwBD candidates.
2 A candidate who is appearing/has appeared in the final year (IV/VI Semester whichever is applicable, and final year where semester system is not there) of M.Sc. or equivalent postgraduate test during the session (2023-24) can also apply for the test as RA (Result Awaited).
3 Such candidates will have to submit the attestation format (given in annexure-I duly certified by the Head of the Department/Institute over his/her signature and official seal/stamp (with address and name) where he/she is appearing in the final year PG test.
4 However, such candidates shall be admitted to the Test provisionally and shall be considered eligible for JRF only after they submit the proof of having passed the Master’s Degree test with the requisite percentage.
SCHEME OF EXAMINATION
The Test will consist of three parts. All the parts will consist of objective-type, multiple-choice questions. There will be no break between papers. The subject-wise scheme of examination is as per the details below-
1 The test will consist of one paper of two hours duration.
2 The question paper will be divided into three sections A, B and C as per the syllabus.
3 All questions in each section are compulsory carrying one mark each.
4 Negative markings @0.25 will be made for each of the wrong answers.
5 Questions not attempted will be marked zero.
EXAMINATION CENTRE
1 It is mandatory for candidates to select four cities of their choice while filling out the Online Application Form.
2 An effort will be made to allot a Centre of Examination to a candidate in a City of his/her Choice. However, due to logistic & administrative reasons, an exam centre may be allotted to him/her in a different city or nearby area.
3 The City for Examination Centre once chosen and allotted cannot be changed (after the closing of the correction window) and any request in this regard will not be entertained.
ADMIT CARD
1 The Admit Card will be issued provisionally to the candidates, subject to their satisfying the eligibility conditions.
2 The candidate has to download the Admit Card from the NTA website and appear for the Examination at the given Centre on the Date, timing and Examination as indicated in their Admit Card.
3 No candidate will be allowed to appear at the Examination Centre, on a Date and time other than that allotted to them in their Admit Card.
4 The candidates are advised to read the instructions on the Admit Card carefully and follow them during the conduct of the Examination.
5 In case of any discrepancy in the particulars of the candidate or his/her photograph and signatures shown in the Admit Card and Confirmation Page, the candidate may immediately approach the Helpline between 09:30 am and 5:30 pm. In such cases, candidates would appear in the Examination with the already downloaded Admit Card. However, NTA will take the necessary action to correct the record later.
To view the information Bulletin, click the link below
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Nagpur- Through a notice, the All India Institute of Medical Sciences (AIIMS), Nagpur has issued certain instructions regarding the reporting of Postgraduate (MD/MS/MDS) Round 1 candidates for the July 2024 session.
As per the notice, all students who have exercised option 1 (i.e. retaining their seat at AIIMS Nagpur) should get a DD of Rs. 3027/- in the name of “Director AIIMS Nagpur” payable at Nagpur at the time of reporting.
Along with this, candidates are also required to submit the following original documents along with a self-attested photocopy of the same at the time of reporting-
i Offer letter.
ii Allocation Slip.
iii Registration slip.
iv Admit card issued by AIIMS Delhi.
v Mark sheets of MBBS 1st, 2nd and 3rd Professional Examinations.
vi MBBS/BDS Degree certificate.
vii VIII. Permanent/Provisional Registration Certificate issued by MCI or DCl/State Medical or Dental Council.
viii High School/Higher Secondary Certificate/Birth Certificate for proof of date of birth.
ix The Candidate should also bring the following certificate, if applicable-
a SC/ ST Certificate issued by the competent authority and should be in English or Hindi in language. The community should be clearly mentioned in the certificate.
b OBC/EWS Original Certificate issued by the competent authority for central Govt. jobs/for admission in Central Govt. College/Institute. The sub-casts should tally with the Central List of OBC/EWS. OBC/EWS Candidates should not belong to Creamy Layer. OBC/EWS certificate must be in the Central Govt. Format as prescribed in the prospectus. The validity of (JBC/ EWS Certified shall be as follows: –
1 The OBC (NCL) certificates should have been issued between 20.05.2023 to 19.05.2024 (date of exam) both dates inclusive.
2 The EWS certificate must be valid for the financial year 2024-2025 and issued between 01.04.2024 to 19.05.2024 (on or before the date of the exam), both dates inclusive based on the income of the year 2023-2024.
c Physical. Disability Certificate issued from a duly constituted and authorised Medical Board as mentioned in the prospectus.
The dates and time for 1st round of reporting at AIIMS Nagpur are as follows:
|
S.NO |
DATES |
DAYS |
TIME |
|
1 |
24.06.2024 |
Monday |
11.00 AM to 05.00 PM |
|
2 |
25.06.2024 |
Tuesday |
11.00 AM to 05.00 PM |
|
3 |
26.06.2024 |
Wednesday |
11.00 AM to 05.00 PM |
|
4 |
27.06.2024 |
Thursday |
11.00 AM to 05.00 PM |
To view the notice, click the link below
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Karnataka- In a relief to medical students, the Karnataka government has decided not to increase the fees for MBBS course for the academic year 2024-25. With this, the MBBS course fee will continue to be ₹50,000 per year in government medical colleges and ₹1,28,746 per year for government quota seats in private medical colleges for the academic year 2024-25.
As per the Hindu report, the Karnataka government had not increased the fees for medical courses from 2021-22. However, in 2018-19 the government had allowed private medical and dental college managements to increase fees by 26% and further allowed a 15% increase each year in 2019-20 and 2020-21.
Apart from this, there was also a one-time fee hike of 199% for government quota seats in government medical colleges in 2018-19. On this, according to sources, there have also been discussions at the government level about increasing the seat fees of government quota in government medical colleges, but no decision has been taken yet.
The fee hike issue started after negotiations between private medical and dental college managements and the government failed over a fee hike for medical courses. Private medical and dental college managements were demanding a 10 to 15% fee hike. On this, the government had agreed to increase the fees by 10 per cent, but private medical colleges still insisted the Government to increase the fees by 15 to 20 per cent. However, private medical and dental college managements belonging to minority communities agreed to a fee hike of 10% and the remaining colleges did not increase the fees.
Meanwhile, private medical and dental college managements have again requested the government to increase fees by 10 to 20 per cent this year. In this regard, Medical Education Minister Sharan Prakash Patil recently held a meeting with the representatives of private medical and dental college management regarding fixing the fees for medical and dental courses.
On this, M.R. Jayaram, honorary secretary of the Karnataka Private Medical and Dental Colleges Association, told the Hindu, “Private medical and dental colleges are suffering from a financial crunch. The fee for medical courses has not been increased for the last three years. Although there is an opportunity to increase the fee by 10% every year, it has not been done. So, we have requested the government to increase the fee. The Minister of Medical Education has promised that an appropriate decision will be taken in the Cabinet meeting regarding the fee hike”.
Along with this, speaking to the TH, B.L. Sujatha Rathod, Director of the Directorate of Medical Education also informed Hindu, “Private medical and dental college managements were demanding to increase the fee based on inflation index and the cost of expenditure. But, the government did not agree. So, the last year’s fee will be continued this academic year. The consensual agreement is expected to be signed soon between the State government and private medical and dental college management”.
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Mumbai- The College of Physicians and Surgeons (CPS) is going to hold the Convocation ceremony on July 12, 2024. Regarding this, CPS has informed about the submission of the convocation form and fees.
The convocation ceremony will be held on July 12, 2024, at CPS House, Dr E. Borges Road, Parel, Mumbai.
As per the notice, the online convocation form and fees should be submitted till 29th June 2024 till 04:00 PM. All eligible students should submit their online convocation form through their respective CPS login. Meanwhile, all FCPS students will be required to attend the convocation in person.
CONVOCATION FEES
1 Diploma (In Person) – Rs. 2,500.00.
2 Diploma (In Absentia) – Rs. 3,000.00.
3 FCPS (In Person) – Rs. 3,500.00.
It is to be noted that the convocation fee is non-refundable and non-transferable, hence after making the payment, candidates are required to save the convocation fee receipt for future reference.
In case the candidates are unable to pay convocation form fees online, they may send a Demand Draft (DD) of fees to the CPS office, Mumbai before 29-Jun-2024 by 04:00 p.m. DD of requisite fees should be drawn in favour of the “College of Physicians and Surgeons of Mumbai” payable at Mumbai. Receipt of fees by DD shall be subject to clearance of DD.
CPS is not responsible if under any circumstances the DD does not reach to CPS office in Mumbai within a stipulated period of time. Convocation forms submitted without payment of fees shall not be considered for further process.
GUIDELINES FOR ONLINE PAYMENT OF FEES
1 CPS website links to a secure payment gateway website for the collection of the candidates’ fee payments. Upon completion of the payment transaction, the candidates will be redirected to the CPS website with a fee receipt. Please save and print this receipt for reference.
2 In case the candidate’s transaction is successful and amt. is deducted from their bank account but they will not redirected to the CPS website with the fee receipt, they need to wait for 1 hour. In this case please do NOT reinitiate payment or refresh the page to avoid duplicate payment.
INSTRUCTIONS FOR THE DIPLOMA STUDENTS
All Diploma students who have applied for Convocation In Person shall have to compulsorily sign the declaration required by the By-laws of CPS, on 10th July 2024 OR 11th July 2024 from 11:00 am to 04:00 pm. Convocation shall not be allowed if the declaration is not signed in advance before the ceremony day.
Declaration forms for Diploma In Absentia students shall be available after the Convocation Ceremony.
INSTRUCTIONS FOR THE FCPS STUDENTS
All FCPS students have to attend the convocation ceremony In Person compulsorily. They need to submit the notarized FCPS declaration form and 2 copies of their Aadhar Card and sign the declaration required by the By-laws of CPS on 10th July 2024 OR 11th July 2024 from 11:00 am to 04:00 pm. Convocation shall not be allowed if the declaration is not signed in advance before the ceremony day. Students are required to take print of the convocation form and Fee receipt.
Along with this, CPS has pointed out the instructions for the students who have applied for the convocation ceremony in person.
STRICT CODE OF CONDUCT
1. Entry into Convocation Hall and occupy a designated seat at 12 noon.
2. No entry into the convocation hall without an academic gown.
3. Dress Code: Strictly formal dress, no Jeans/T-shirts, No sleeper, No sports shoes.
4. No Mobile in the hall (it will be confiscated if found disturbing during Ceremony)
5. Candidates will not be allowed to leave the hall until the end of the Ceremony.
6. Rise and remain standing during the procession of the council.
ARRANGEMENTS FOR THE SUPPLY OF ACADEMIC GOWNS WILL BE MADE IN CPS ON A HIRE BASIS
1 Hiring charges Rs. 300/- for academic gown and refundable security deposit of Rs. 2,000/-.
2 Total Rs. 2,300/- to be paid directly to the contractor authorized by CPS.
3 Gown can be hired between 11 am to 4 pm on 10th July 2024 and 11th July 2024.
4 Please take note that Gown cannot be hired on 12th July 2024.
To view the instructions, click the link below
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Princeton: Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.
“Subcutaneous nivolumab has the potential to change the way patients living with cancer receive Opdivo treatment and to significantly reduce administration time by utilizing a single injection in three-to-five minutes. By providing patients the same quality of care as IV Opdivo in a fraction of the time, patients can focus on what is important to them rather than spending a longer wait time at the infusion center,” said Susan Parker, vice president, global program lead, product design & development, Bristol Myers Squibb. “We are committed to advancing medicines that improve the patient experience and are evaluating innovative formulations across our broad portfolio. We look forward to working with the EMA to advance this application with the goal of introducing the subcutaneous option of Opdivo.”
In the Phase 3 CheckMate -67T trial, subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state), the study’s primary endpoints, vs. intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received no more than two prior lines of systemic therapy. Additionally, subcutaneous nivolumab showed noninferiority of the key secondary endpoint of objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo. The safety profile of subcutaneous nivolumab was consistent with the IV formulation. The pharmacokinetics, efficacy and safety results from CheckMate -67T were presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. Additional safety analyses and patient reported outcomes were recently presented at the 2024 ASCO Annual Meeting.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
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