US FDA rejects Ultragenyx’s gene therapy
Bengaluru — The US Food and Drug Administration (FDA) has declined to approve Ultragenyx Pharmaceutical’s experimental gene therapy to treat a rare inherited disorder, citing manufacturing concerns, the company said on Friday.
The therapy, UX111, was developed to treat Sanfilippo syndrome type A — a rare, inherited disorder that begins in early childhood causing severe brain damage and early death.
The company said the FDA’s observations, related to facilities and processes, are addressable and not directly related to the therapy’s quality.
Ultragenyx plans to address the concerns and resubmit the application, expecting a six-month review period after the resubmission. Reuters
Italy’s Leonardo rules out drone factory in Ukraine
Milan — Italy’s Leonardo is open to supplying technology for drones but it does not plan to open a factory in Ukraine, the CEO of the state-controlled defence group told daily Corriere della Sera in an interview published on Saturday.
Rome hosted a conference on Thursday to mobilise international support for Ukraine and Italian Prime Minister Giorgia Meloni said the participants pledged more than €10bn to help the war-torn country.
Leonardo has clinched an agreement with Turkish defence company Baykar and will soon begin production of drones in Italy, the Italian group’s CEO, Roberto Cingolani, told Corriere, adding that Baykar was co-operating with Ukraine. Reuters
Trump Organisation targets Bucharest apartments
Bucharest — The Trump Organisation — US President Donald Trump’s family business — will team up with Romanian real estate developer SDC Imobiliare to build a tower block with luxury apartments in the capital Bucharest, the companies said.
“Trump Tower Bucharest will be developed in the heart of Romania’s capital, one of Europe’s most vibrant and dynamic emerging markets, bringing premium residences under the Trump brand to the region,” the companies said in a statement.
They did not specify the location or start date for work on the tower block, which is being branded as luxury residential apartments in Romania, the region’s second-biggest economy. Reuters
India eases emission rules for coal-fired power plants
New Delhi — India has reversed a decade-old mandate to install $30bn worth of clean-air equipment, easing sulphur emission rules for most coal-fired power plants, a government order said.
Reuters in December reported the government was reviewing 2015 norms that required nearly 540 coal-based power units to install flue-gas desulphurisation (FGD) systems that remove sulphur from the plants’ exhaust gases in phases starting in 2027.
The federal environment ministry late on Friday issued a gazette notification that exempted 79% of the coal-fired power plants, outside a 10km radius of populated and polluted cities, from the 2015 mandate. Reuters
Chery rebuffs government subsidy allegations
Shanghai — Chinese automaker Chery on Saturday denied assertions that it had improperly claimed government subsidies for environmentally friendly vehicles.
An audit by the ministry of industry and information technology disqualified declarations by Chery and BYD for a combined $53m in government subsidies for thousands of vehicles sold in the five years to 2020, accounting for nearly 60% of such improper claims.
Chery denied its declarations were improper. It said in a statement it had previously consulted the authorities about the challenges of missing receipts because the cars were sold more than five years ago and that the government had advised the company to declare the cars for the ministry to determine if they should be qualified. Reuters
Firefly Aerospace reports revenue rise in IPO filing
Bengaluru — AE Industrial Partners-backed space and defence technology company Firefly Aerospace on Friday disclosed a 10% rise in 2024 revenue in its filing for an initial public offering in the US.
Firefly revealed a revenue of $60.8m in 2024, compared with $55.2m the previous year.
The US IPO market is witnessing renewed interest and vigour, especially for space listings, as investors return after months of sluggish activity earlier this year triggered by policy shifts and tariff uncertainty under President Donald Trump. Reuters
Wireless carrier T-Mobile transactions get nod
Washington — The Federal Communications Commission has approved two transactions involving T-Mobile this week, a statement by the commission showed on Friday, after the wireless carrier said it was ending its diversity, equity and inclusion programmess. Reuters.
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