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Ludhiana: In violation of the Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act 1994, the state health department suspended the licences of three ultrasound centres and issued show-cause notices to two such centres. 

The action was taken following an inspection that revealed numerous irregularities and illegal activities in the hospitals/centres. Dr Jasbir Singh Aulakh, the civil surgeon of Ludhiana who carried out the inspections last week, discovered that the centres violated the PC-PNDT Act 1994. Consequently, stringent measures were implemented to uphold the enforcement of the PC-PNDT Act. 

These three health centres/hospitals located at Jagraon, Raikot and Maachiwara came under the scanner of the health department which inspected around 15 ultrasound centres in Samrala, Maachiwara, Jagraon and Raikot on March 18 and 19 under the leadership of Hatur Senior Medical Officer Dr Varun Saggar and Sahnewal SMO Dr Ramesh. 

Although ultrasound machines were seized and the licenses have been suspended at these three facilities, the health department also issued a show cause notice to two such centres in Jagraon and Machiwara asking them to submit a response in three days.   

Also read- Illegal Sex Determination Racket Busted In Gujarat, Doctor Arrested

On March 18, Dr Jasbir inspected a facility at Jagraon and found that it was running with a licence for echocardiography only, the scanner was used for pelvic scans. Moreover, the records of the patients who got tested at this facility were not found on OPD records. As a result, the authorities suspended the licence of the hospital and sealed the ultrasound sonography machine until further notice under Section 20(3) of the PC-PNDT Act. The centre received a show-cause notice and was given a three-day deadline to respond.

On March 19, a second hospital in Raikot was inspected where it was found that the facility failed to maintain a proper record of patients under the Act. The form F, which includes patient details, the indication of the test, the patient’s declaration of not wanting to know the sex of the fetus, and the doctor’s declaration of not determining/conveying the sex of the fetus, was not filled out. Additionally, the ultrasound machine in this facility was sealed under Section 20(3) of the Act.

In another hospital in Machhiwara, Dr Jasbir found that the facility was involved in shady practices as some forms were found cancelled at that time. Therefore, the authorities issued a show cause notice to this facility and asked them to submit a response within two days, HT reports.

It was discovered that the in-charge doctor was out of the country without informing the medical authority concerned. The keys to the centre were with the staff. The machines were sealed and the licence was cancelled under Section 17(4) of the Act.

Also read- Haryana Doctor, Repeat Offender Under PNDT Act Absconding After Another Raid

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This comprehensive study included a total of 178 subjects with increased levels of lipoprotein(a), or Lp(a), a genetic factor known to contribute to cardiovascular disease in up to 20% of the global population. This double-blind, placebo-controlled phase 2 trial administered zerlasiran at doses of 300 mg every 16 or 24 weeks and 450 mg every 24 weeks to participants, who had a median baseline Lp(a) of approximately 215 nmol/L. Also, the study reported a median reduction in Lp(a) levels of 90% or greater at the 36-week mark when compared to the placebo group, with no new safety concerns emerging.

The ongoing 60-week study will further assess secondary endpoints of changes in Lp(a) levels from baseline to 48 and 60 weeks, along with potential impacts on other lipid profiles. These findings bolster the potential of zerlasiran as a transformative treatment for patients with high Lp(a) by addressing a significant unmet need in cardiovascular disease management.

The Head of Research and Development at Silence, Dr. Steven Romano, expressed enthusiasm about the phase 2 results marking their consistency with phase 1 outcomes and the competitive profile of zerlasiran for treating high Lp(a) levels. The company anticipates the release of further data from the ALPACAR-360 study in the coming months with the hopes to advance zerlasiran towards regulatory approval and commercial availability.

Silence Therapeutics stands at the forefront of RNA interference (RNAi) technolog and is constantly developing a new class of precision medicines aimed to silence genes implicated in various diseases. Its proprietary mRNAi GOLD™ platform facilitates the creation of siRNAs targeting disease-associated genes in the liver that offer a broad therapeutic potential. Along with zerlasiran, the pipeline includes divesiran for hematological conditions and ongoing collaborations with industry leaders like AstraZeneca and Hansoh Pharma. While the future of zerlasiran looks promising, Silence Therapeutics cautions the investors and stakeholders about forward-looking statements by illuminating the inherent risks and uncertainties in drug development and approval processes.

Source:

(N.d.-a). Silence-therapeutics.com. Retrieved March 22, 2024, from https://silence-therapeutics.com/investors/press-releases/press-releases-details/2024/Silence-Therapeutics-Announces-Positive-Topline-36-Week-Data-from-Ongoing-Phase-2-Study-of-Zerlasiran-in-Patients-with-High-Lipoproteina/default.aspx