All articles tagged with #manufacturing issues
The FDA rejected ITM-11, ITM Isotope Technologies Munich’s radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors, due to manufacturing issues, halting a potential rival to Novartis’ therapy; early ITM data suggested ITM-11 could extend progression-free survival (23.9 months vs 14.1 months with everolimus).
Airbus has reduced its delivery targets for the A320 aircraft due to ongoing problems with the aircraft, impacting its production schedule and commitments.
The FDA has recalled over 67,000 cases of Power Stick deodorants due to manufacturing deviations, highlighting ongoing concerns about product safety and quality in personal care items.
Tens of thousands of cases of Power Stick deodorant made by A.P. Deauville in Northampton County are being recalled nationwide due to manufacturing practice deviations, affecting three types of antiperspirant sold in major stores like Walmart and Walgreens.
Boeing is set to present a plan to the FAA on how it will address ongoing safety and quality issues, following a fuselage panel blowout on a 737 Max 9. The FAA had mandated this plan after the incident, which has further damaged Boeing's reputation and led to multiple investigations. The company faces potential criminal prosecution and has been struggling with various manufacturing flaws, impacting its production and financial performance.
Texas Attorney General Ken Paxton has launched an investigation into Spirit AeroSystems, a Boeing supplier, to examine recurring issues with airplane parts provided to Boeing and to probe the company's Diversity, Equity, and Inclusion policy. The investigation follows concerns about manufacturing defects and an incident involving missing bolts on a Boeing 737-9 MAX. The Attorney General's request for documents also includes an examination of Spirit AeroSystems' diversity program and the termination of a whistleblower who raised concerns about declining quality standards at the company's Wichita plant.
Boeing is in talks to take over Spirit Aerosystems, a major global air parts supplier that was spun out of Boeing in 2005. The potential takeover comes as Boeing faces pressure over manufacturing issues, including a recent incident where a piece of one of its planes blew off in mid-air. The US government's review found that bolts meant to fasten the panel had been removed at Boeing's factory in Washington, apparently to fix damaged rivets, and had never been re-installed. Boeing believes that reintegration with Spirit would strengthen aviation safety and improve quality. Following reports of takeover talks, shares in Spirit jumped by more than 10%, while shares in Boeing slid more than 1%.
Boeing faces potential labor unrest as its largest union, the International Association of Machinists and Aerospace Workers, prepares to demand a 40% pay raise over three or four years, citing a decade-old grudge over pension sacrifices and minimal raises. With the current contract set to expire in September, the union's demands come amidst a resurgent US labor movement, a scarcity of qualified aerospace workers, and pressure on Boeing to stabilize work in its factories. The company, already grappling with manufacturing problems and increased regulatory scrutiny, faces the risk of a work stoppage that could further impact its financial outlook and production goals.
Tom Gentile has resigned as the president and CEO of Spirit AeroSystems, the largest employer in Wichita, following a year of problems for the aerospace manufacturer. The company's board of directors has appointed Patrick Shanahan as the interim president and CEO. Spirit AeroSystems has faced manufacturing issues on Boeing planes, causing delivery delays, and its stock prices have significantly declined since January.
The US FDA has declined to approve Outlook Therapeutics' experimental eye disease drug, citing manufacturing issues observed during pre-approval inspections. The drug, ONS-5010, is being developed as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases. Outlook Therapeutics will request a meeting with the FDA to address the issues, while the European Medicines Agency is set to begin its review process for the drug.
Apple's flagship iPhone 15 Pro Max is facing manufacturing issues, with both LG Display and BOE struggling to gain approval to produce screens for the model due to problems with the new slim bezels and the exclusive periscope camera. Production issues also extend to the new 48-megapixel cameras on the iPhone 15 and iPhone 15 Plus. Apple is focusing production on the iPhone 15 Pro to maintain a balance between Pro and non-Pro models. Despite the challenges, Apple is expected to announce all iPhone 15 models in September, but there are uncertainties about when they will go on sale.
Boeing has warned of a new defect on its 787 Dreamliner planes, which will delay deliveries of the wide-body aircraft. The issue relates to tiny spacing in the horizontal stabilizer, but Boeing said it isn’t related to flight safety and that planes in service can continue operating. Near-term deliveries will be delayed by about two weeks, but the latest issue currently doesn’t affect Boeing’s full-year outlook for Dreamliner deliveries. This is the latest in a spate of manufacturing issues on Boeing planes that have slowed if not paused deliveries of certain aircraft outright, just as airlines are clamoring for new planes to capitalize on the travel boom.
The FDA has declined to approve ImmunityBio's combination therapy for bladder cancer due to deficiencies in the company's application related to manufacturing issues. The company's shares slumped nearly 57% in premarket trading, and it reiterated doubts about its ability to remain in business. The FDA did not request any new preclinical or late-stage clinical trials to evaluate the safety or efficacy of the therapy, but requested the company to provide more data and a safety update in its resubmission. ImmunityBio plans to request a meeting with the FDA to address the matter and seek approval as fast as possible.
Catalent delays its Q3 financial results and investor call due to manufacturing issues at three plants, and expects to cut $400 million in net revenue guidance for the year. BioPharma Solutions is sold for $4.25 billion to Advent International and Warburg Pincus. EQRx abandons its mission of drug price reform and will cut more than half of its employees. Europe faces medicine supply shortages, and Viatris leans into its brand drug portfolio for future growth.