The legislation is part an effort to protect American health data and pharmaceutical supply chains from potential foreign threats. Credit: 010110010101101 / Shutterstock

The US House of Representatives has passed a bill aiming to restrict business with certain Chinese biotech companies, citing national security concerns, Reuters has reported.

Known as the Biosecure Act, the bill seeks to limit federal contracts with specific Chinese biotech firms and those engaging in business with them.

In a transcript published on Congress.gov, a website providing US federal legislative information, the “biotechnology companies of concern” were named as BGI, MGI, Complete Genomics, WuXi AppTec and WuXi Biologics.

The legislation is part of a broader effort to protect American health data and pharmaceutical supply chains from potential foreign threats.

The bill was passed with a significant majority: 306 votes in favour and 81 against. This surpasses the two-thirds majority required.

It now awaits approval by the US Senate and US President Joe Biden’s signature to become law. 

RegenxBio has announced that the pivotal dose level from its multiphase study of RGX-121 has demonstrated positive long-term data for the treatment of patients with mucopolysaccharidosis type II (MPS II) or Hunter syndrome.

As per the 3 September press release, patients who received a pivotal dose of RGX-121, described as dose level 3, had a median reduction of cerebrospinal fluid (CSF) heparan sulfate D2S6 levels of 85%. These levels were found to be approaching normal measures and were reportedly sustained for up to two years. RGX-121 is a gene therapy designed to deliver a functional copy of the IDS gene to the central nervous system via the NAV AAV9 vector.

The biotech is on track to submit a rolling biologics license application (BLA) through the accelerated approval pathway in Q3 2024. RegenxBio intends to use CSF D2S6 as a surrogate endpoint to predict clinical benefit. 

The Phase I/II/III CAMPSIITE study (NCT03566043) is an open label study comprised of two parts. Part 1 marked the Phase I/II single arm dose escalation study evaluating RGX-121 in 16 pediatric participants with neuronopathic MPS II over a period of 24 weeks. Assessing safety was the primary objective during the study period, after which participants continued to be evaluated for safety and efficacy for up to 104 weeks.

The US Food and Drug Administration (FDA) has approved Roche’s Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

The treatment offers a quicker and more comfortable administration option compared to the standard intravenous infusion.

Tecentriq Hybreza is administered in seven minutes, as against the 30 to 60-minute duration required for the intravenous version of Tecentriq.

This new formulation is set to be available for all of Tecentriq’s intravenous indications approved for adults in the US, including specific types of liver, lung, skin and soft tissue cancer.

The FDA’s decision was informed by data from the Phase IB/III IMscin001 clinical trial, which demonstrated that Tecentriq Hybreza achieved comparable blood levels to the intravenous formulation and maintained a consistent safety and efficacy profile.

Findings from the Phase II IMscin002 study indicated a strong patient preference for Tecentriq Hybreza over intravenous atezolizumab, with 71% of patients favouring the subcutaneous option. 

Pharmaceutical manufacturers have been called out by a US Senator who has announced a new bill to ensure vulnerable and low-income communities are provided more affordable drug access.

Peter Welch, the senator for Vermont, criticised manufacturers for placing restrictions on the 340B drug pricing programme which provides financial help to US hospitals to allow communities to access prescription drugs amid rising costs.

During the Covid-19 pandemic, several companies placed restrictions on the programme, putting a threshold on the number of pharmacies that 340B providers can use to dispense medications to patients. Welch called out the companies saying that the changes would disproportionately impact rural states facing a decline in pharmacies.

“Right now, the 340B programme is under attack from big pharma, endangering care for patients who rely on small rural healthcare providers for their healthcare needs,” said Welch in an 11 September press release.

GSK’s asthma drug Nucala (mepolizumab) has met the primary endpoint in a Phase III trial treating patients with chronic obstructive pulmonary disease (COPD).

Data from the MATINEE study showed that when added to inhaled maintenance therapy, patients had a reduced annualised rate of moderate or severe exacerbations when compared to placebo.

GSK did not disclose further data, saying only there was a “statistically significant and clinically meaningful reduction” between the two treatment groups up to two years. The drugmaker added that further analysis of the data is ongoing, with preliminary safety results consistent with Nucala’s known safety profile.

The late-stage trial (NCT04133909) involved 806 patients aged 40 years and older with COPD – the name given to a group of lung conditions that cause breathing difficulties. The disease affects more than 300 million people globally, with middle-aged and older adults who smoke representing the main patient group.