USFDA approves Bristol Myers Squibb Cobenfy for Schizophrenia treatment in adults

Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults. COBENFY represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors. 

“The landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” said Chris Boerner, PhD , board chair and chief executive officer at Bristol Myers Squibb. “As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval in schizophrenia.”

Schizophrenia is a persistent and often disabling mental illness affecting how a person thinks, feels and behaves.  It is estimated to impact approximately 2.8 million people in the United States. Symptoms typically first appear in early adulthood and present differently in each person, making symptoms difficult to diagnose and manage.  While the current standard of care can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy. 

“For people living with schizophrenia, it’s often difficult to find a treatment that works for them. Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition,” said Gordon Lavigne, chief executive officer of the Schizophrenia & Psychosis Action Alliance. “People living with schizophrenia want and deserve more. The approval provides a new option as people with schizophrenia move forward with proper support to rebuild their lives.”

The FDA approval of COBENFY is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of COBENFY for up to one year. In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, COBENFY met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five. COBENFY demonstrated a 9.6-point reduction (-21.2 COBENFY vs. -11.6 placebo, p<0.0001) and an 8.4-point reduction (-20.6 COBENFY vs. -12.2 placebo; p<0.0001) in PANSS total score compared to placebo at week five in EMERGENT-2 and EMERGENT-3, respectively. In EMERGENT-2, COBENFY demonstrated a statistically significant improvement in illness from baseline to week five, as measured by the Clinical Global Impression-Severity (CGI-S) score, a secondary endpoint in the trial. 

The safety and tolerability profile of COBENFY has been established across acute and long-term trials.

“Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies,” said Rishi Kakar, MD, chief scientific officer and medical director at Segal Trials and investigator in the EMERGENT program. “The approval of COBENFY is a transformative moment in the treatment of schizophrenia because, historically, medicines approved to treat schizophrenia have relied on the same primary pathways in the brain. By leveraging a novel pathway, COBENFY offers a new option to manage this challenging condition.”

The Company has also announced the launch of COBENFY Cares, a program designed to support patients who have been prescribed COBENFY. Patients will be able to enroll in the COBENFY Cares program in late October corresponding with product availability.

Read also: Bristol Myers Squibb India Gets CDSCO Panel Nod to Study anticancer drug Mezigdomide

Powered by WPeMatico

10 years of service, Rs 50 lakh penalty for Inservice candidates: Andhra notifies bond policy for NEET PG admissions this year

Vijayawada: Doctors getting admitted to PG medical courses (degree and diploma) in the Competent Authority Quota seats at Andhra Pradesh-based Dr. NTR University of Health Sciences will have to compulsorily serve the State Government or pay a penalty of Rs 40 lakh and Rs 50 lakh 

In the case of service candidates, they will have to serve the State Government for a minimum period of 10 years after completion of in-service PG Degree/Super Specialty course in any Government institution/health facility of the State. For them, the amount of bond penalty is Rs 50 lakh, in addition to the pay and allowances received during the years of study.

On the other hand, the non-service candidates will have to undergo Government Service for one year or pay Rs 40 lakh as a bond penalty. The candidates, based on their category (in-service or non-service), will have to execute a bond on non-judicial stamp paper worth Rs 100 at the time of their admission.

The bond conditions specified by the State Government for the service and non-service candidates under the Competent Authority Quota are as follows:

Bond Conditions for Service Candidates: 

√ The candidates shall execute a bond (Non-Judicial Stamp Paper worth Rs.100/-) to the effect that their services are liable to be absorbed into/utilized in Directorate of Secondary Health or Directorate of Medical Education or wherever necessary depending upon the need of the Government.

√ The candidate should serve for a minimum period of 10 years after completion of in-service PG Degree/Super Specialty course in any Government institution/health facilities of the state as per the requirement of administration. The PG candidate (under bond-service) who obtained PG degree as in-service candidate, shall be permitted to prosecute super specialty course on his/her own cost, subject to condition that he/she shall serve the balance period of compulsory minimum (10) years as prescribed, immediately after completion of such Super Specialty Course.

√ In case of failure to comply with the bond conditions, he/she shall pay a penalty/compensation of ₹.50,00,000/- (Rupees Fifty Lakhs only) in addition to the pay and allowances received for the duration of studies of in-service PG/Super Specialty courses with applicable rate of interest. The bond shall be executed in the prescribed format appended to this order and shall be signed by two sureties who are income tax assesses out of whom one of them should be a Government employee to recover the bond amount from the sureties, in the event of he/her failure to comply the bond conditions.

√ The P.G. Degree/Super Specialty Certificates secured under in-service quota shall be kept in the custody of the sponsoring authority (DME/DSH/DPH&FW) till the completion of mandatory period of 10 years service.

√ The University shall take action to cancel the PG Degree of the candidate who secured under in-service quota for non-rendering of services as per the bond conditions.

√ In the event of he/she leaves the course before its completion or the competent authority concludes that the in-service candidate has not shown sufficient progress in the studies or failed to complete the course in proper time or fails to resume duty even after expiry of the period of the deputation or discontinue of service at any time within a period of (10) years after completion of the higher studies, it shall be lawful to the HoD concerned to make recovery of the amount (including Pay and allowances, Stipend, DA, Tuition fee etc) along with penalty and applicable interest spent on higher studies.

Bond for Non-Service Candidates: 

 Each non-service candidate admitted to a PG course shall execute a bond as per proforma to serve the Government for a period of one year.

If they violate the bond condition either by not joining or by not completing the stipulated service period of one year within a maximum period of 18 months after obtaining the PG Degree, a penalty of Rs.40,00,000/- shall be levied as per G.O.Ms.No.251, dt.02-10-2022 of HM & FW (C1) Dept., Govt. of AP, mentioned the prospectus.

The prospectus for admission to PG Medical Degree/Diploma Courses under the Competent Authority quota also includes a prescribed format for the service and non-service candidates to execute the bond.

In the case of non-service candidates, the bond document states, “If I fail to abide by the bond either by not joining (or) by not completing the stipulated one year Rural/Government service period of one year within a maximum period of 18 months after obtaining the PG (Medical) Degree, a penalty of Rs.40,00,000/- (Rupees forty lakhs only) shall be levied against me.”

On the other hand, the bond document, to be executed by the in-service candidates states, “Whereas the party of the FIRST PART has agreed to serve the Government of Andhra Pradesh at any of the Government Institutions as ordered by the competent authority for a period of Ten (10) years after successful completion of the PG Degree/Super Specialty Course.”

“The Party of the FIRST PART is agreed to pay a sum of Rs. 50,00,000 (Rupees Fifty Lakhs Only) in addition to pay & allowances received during the study period with interest as applicable as on the date to the Government. The same shall be recovered from the Party of the FIRST PART by initiating the provisions under RR Act, in the event of failure of bond conditions,” it further mentions.

To view the prospectus, click on the link below:

https://medicaldialogues.in/pdf_upload/prospectus-competent-authority-quota-254636.pdf

Also Read: AFMS specifies seat-leaving penalty for MD, MS, DNB, MDS candidates, details

Powered by WPeMatico

Gynaecologist caught conducting sex determination tests for Rs 35,000

A gynaecologist in Ahmedabad has been caught conducting illegal sex determination tests for Rs 35,000. The Ahmedabad district health officer confirmed that action has been taken against the doctor, and the medical equipment used for the tests has been sealed.

The gynaecologist was conducting pregnancy tests at a hospital in Naroda, an act prohibited under the Pre -conception and Pre-Natal Diagnostic Techniques Act. Following a complaint, the district health officer and a team of doctors visited the hospital, gathered evidence, and sealed the pregnancy testing machine.

Powered by WPeMatico

Modified CBME 2024 guidelines specifies remedial measures for MBBS students ineligible to appear in University Exams

The newly released modified Competency-Based Medical Education (CBME) 2024 guidelines have specified the remedial measures for MBBS students found to be ineligible to appear in the University Examinations.

Even though in the CBME 2023 guidelines NMC had stated that the Universities should guide the colleges to formulate policies for remedial measures for students, there was nothing specific mentioned in this regard.

For more details, click the link below

MBBS Curriculum: CBME 2024 Guidelines Specify Remedial Measures for Students Ineligible to Appear in University Exams

Powered by WPeMatico

Jodhpur doctor duped of Rs 6 lakh by scammers impersonating police officers

In a recent cyber fraud case, a doctor in Jodhpur was duped out of ₹6 lakh by scammers impersonating police officers. The fraudsters kept the doctor digitally “arrested” for nearly 24 hours and manipulated her into transferring the amount from her account.

The incident occurred days after a doctor from Navi Mumbai fell victim to a cyber fraud, losing Rs. 26.52 lakh. The victim has been identified as a 31-year-old doctor working at Vyas Dental College. He reported the incident to the police after realizing she had been tricked.

For more details, click the link below

Digital Arrest: How Doctors are becoming soft targets

Powered by WPeMatico

Error in application form unintentional! PwD MBBS aspirant gets HC relief

Granting relief to a disabled MBBS aspirant, who had inadvertently selected the ‘no’ option in the Persons with Disabilities (PwD) column of the online application form, the Bombay High Court has directed a Government Medical College in Maharashtra to admit him.

Due to the error in the application form, the candidate, who suffers from a locomotor disability to the extent of 40%, was not examined for his disability status.
For more details, click the link below

Powered by WPeMatico

NBE submits response before SC regarding allegations of discrepancies, last minute changes in NEET PG 3024

After the Supreme Court’s direction last week, the National Board of Examinations in Medical Sciences (NBEMS) submitted its response before the Apex Court regarding the allegations of discrepancies and last-minute changes in the National Eligibility-and-Entrance Test Postgraduate (NEET-PG) Examination 2024.

However, the Apex Court bench took note of the fact that there was no appearance on behalf of the Central Government. Therefore, the bench comprising the Chief Justice of India (CJI) DY Chandrachud, Justices JB Pardiwala and Manoj Misra has asked any of the ASGs to assist the Court.

For more details, click the link below

Powered by WPeMatico

Pure & Cure Healthcare gets CDSCO Panel nod to study Ferric Maltol Capsules 30 mg

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to Pure and Cure Healthcare to conduct the bio-equivalence study of Ferric Maltol Capsules 30 mg as per the protocol presented.

This came after the firm presented the proposal for grant of permission to manufacture and market of Ferric Maltol Capsules 30 mg along with bioequivalence study protocol (No. VRL-23-004, Ver-1.0, dated: 01.09.2023 and Phase III clinical trial waiver justification before the committee.
Ferric maltol is a complex iron supplement used to treat iron deficiency in adults. Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it is associated with transferrin and ferritin.
At the recent SEC meeting for Hematology held on September 10, 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and market Ferric Maltol Capsules 30 mg along with the bioequivalence study protocol (No. VRL-23-004, Ver-1.0, dated: 01.09.2023, and Phase III clinical trial waiver justification before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct a bio-equivalence study as per the protocol presented.
Furthermore, the expert panel suggested that the result of the bio-equivalence study should be presented before the committee for further consideration.

Powered by WPeMatico

PGIMER forms committees to probe grievances filed against two Urology Professors

The Postgraduate Medical Institute of Medical Education and Research (PGIMER) has set up high-level committees to probe grievances filed against two different faculty members of the Urology Department of the institute.

The Director of PGIMER, Dr Vivek Lal received these two complaints in just three months. One of these two complaints was filed by a woman patient hailing from Punjab and the other one was filed by the senior residents of the Department.

For more details, click the link below

Powered by WPeMatico

On-duty doctor allegedly assaulted by patient’s attendants at Jaipur hospital

In a case of alleged violence against a medical professional, an on-duty resident doctor at Sawai Man Singh (SMS) Hospital in Jaipur was allegedly assaulted by family members who were unhappy with the treatment given to their patient admitted to the trauma centre.

The chaos erupted on Wednesday morning when the family members of a patient at the trauma centre confronted the doctor stating that they were dissatisfied with how the resident doctor had treated their patient. During this violent altercation, the doctor was injured.

For more details, click the link below

Powered by WPeMatico