Sun Pharma Laboratories Gets CDSCO Panel Nod To study Antidiabetic FDC Drug

New Delhi: The drug major Sun Pharma Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Glimepiride plus Extended Release Metformin Hydrochloride Tablets (10 mg + 1 mg + 1000 mg) and (10 mg + 2 mg + 1000 mg) Tablets.

This came after Sun Pharma Laboratories presented the Phase IV clinical trial protocol before the committee in light of the condition mentioned in permission in Form CT-23 dated 10.10.2023.

Dapagliflozin plus Glimepiride plus Metformin is a combination of three antidiabetic medications.

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron.SGLT2 facilitates 90% of glucose reabsorption in the kidneys, and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.

Glimepiride is a sulfonylurea drug used to treat type 2 diabetes mellitus. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.

Metformin is a biguanide antihyperglycemic agent and a first-line pharmacotherapy used in the management of type II diabetes.

Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an “insulin sensitizer,” leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.

Dapagliflozin plus glimepiride plus metformin is used in the treatment of type 2 diabetes mellitus.

At the recent SEC meeting for endocrinology and metabolism held on June 11, 2024, the expert panel reviewed the Phase IV clinical trial protocol of the antidiabetic FDC drug Dapagliflozin Propanediol Monohydrate plus Glimepiride plus Metformin Hydrochloride Tablets.

After detailed deliberation, the committee recommended a grant of permission to conduct the Phase IV clinical trial.

In view of the above, the expert panel suggested that the firm submit the Phase IV clinical trial report to CDSCO.

Also Read:Zydus Life Science Gets CDSCO Panel Nod To Manufacture and Market Anti-cancer Drug Nelarabine

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Health Ministry releases guidelines for ethical use of ‘leftover, de-identified and anonymous samples’ for commercial use

In a bid to promote innovation in diagnostics, the Union Health Ministry has issued guidelines governing the ethical use of ”leftover, de-identified and anonymous” samples generated from a diagnostic or surgical procedure on patients for commercial use.
These specimens include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for eHBsAG/HCV/HIV/Syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc.
For more information click on the link below:

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Alembic Pharma secures USFDA okay for Doxycycline Capsules for inflammatory lesions of rosacea

Alembic Pharmaceuticals Limited today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Oracea Capsules, 40 mg, of Galderma Laboratories, L.P. (Galderma).
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Doxycycline Capsules, 40 mg have an estimated market size of US$ 123 million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 205 ANDA approvals (179 final approvals and 26 tentative approvals) from USFDA.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company.
Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. .

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Health Bulletin 28/ June/ 2024

Here are the top health stories for the day:

No negligence found: NCDRC grants Rs 75 lakh relief to doctor for performing excisional biopsy to confirm cancer
Reiterating the Supreme Court’s observation that every death occurring in a hospital does not necessarily amount to medical negligence, the National Consumer Disputes Redressal Commission (NCDRC) recently exonerated a doctor, accused of operating on a cancer patient without obtaining a Biopsy report. The bench noted that the doctor had performed only an Excisional Biopsy to confirm cancer, which is a prescribed method to diagnose Cancer, and it does not come within the purview of surgery.
While considering the matter, the Apex Consumer Court relied on the Supreme Court order in the case of Devarakonda Suryasesha Mani v Care Hospital, Institute of Medical Sciences, where the Apex Court had held that “Every death in an institutionalized environment of a hospital does not necessarily amount to medical negligence on a hypothetical assumption of lack of due medical care.”
For more information, click on the link below:

Health ministry issues guidelines for ethical use of leftover human organs and blood for commercial purposes
In a bid to promote innovation in diagnostics, the Union Health Ministry has issued guidelines governing the ethical use of ”leftover, de-identified and anonymous” samples generated from a diagnostic or surgical procedure on patients for commercial use.
These specimens include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for eHBsAG/HCV/HIV/Syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc.
For more information, click on the link below:

First arrests made by CBI in NEET paper leak scandal, two men detained in Patna
For the first time after the Bihar police transferred the NEET UG paper leak case to the Central Bureau of Investigation, the agency arrested two individuals from Patna today who have now been taken into custody.
According to the CBI officials, the accused, Manish Kumar and Ashutosh Kumar, allegedly provided safe premises to the aspirants before the NEET examination, where they were given leaked papers and answer keys, reports PTI.
For more information , click on the link below:

NEET paper leak to be investigated, offenders will be punished: President Murmu
In her address to a joint sitting of Parliament, President Droupadi Murmu spoke on the raging row over NEET 2024 across the country.
The government is fully committed to investigating the recent incidents of paper leaks and ensure that the guilty are punished, President Droupadi Murmu said, as quoted by PTI.
For more information click on the link below:

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New research links air pollution exposure during childhood directly to adult bronchitis symptoms

A new study brings fresh revelations about the connection between early-life exposure to air pollution and lung health later in life. A research team led by the Keck School of Medicine of USC has shown that exposure to air pollution during childhood is directly associated with bronchitis symptoms as an adult.

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Kids given ‘digital pacifiers’ to calm tantrums fail to learn how to regulate emotions, study finds

Tantrums are part of growing up. How these outbursts of anger or frustration are managed, however, can impact children’s emotional development.

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Adults conceived by donors left behind by fertility industry

Children conceived by using egg or sperm donors have the same well-being outcomes as non-donor-conceived people. However, they are more likely to have identity difficulties and issues with trust, says a new study.

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Survey finds junior rank, male sex, younger age strongly linked to ‘harmful gambling’ among UK military

Several indicative factors, including junior rank, male sex, and younger age, are strongly linked to ‘harmful gambling’ among serving UK military personnel, finds an analysis of survey responses, published online in the journal BMJ Military Health.

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Poorer teen mental ability linked to as much as tripling in stroke risk before age of 50

A lower level of mental ability during the teenage years may be linked to as much as a tripling in the risk of having a stroke before the age of 50, finds research published online in the Journal of Epidemiology and Community Health.

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Lupin bags USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution(OTC)

Mumbai: Global pharma major Lupin Limited has announced that it has received a tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC), to market a generic equivalent of Pataday Once Daily Relief, 0.7% (OTC), of Alcon Laboratories Inc.

This product will be manufactured at Lupin’s Pithampur facility in India.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Olopatadine Hydrochloride Ophthalmic Solution USP (RLD Pataday) had an estimated annual sale of USD22 million in the U.S. (IQVIA MAT April 2024).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specialises in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.8% of its revenue in research and development in FY24.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally.

Read also: Lupin ropes in Abdelaziz Toumi as CEO of its API CDMO Subsidiary

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