Aspen Pharmacare Australia Pty Ltd.

Healthcare business global roundup Eli Lilly's experimental cardiovascular drug ‘promising’; Aspen Pharmacare to manufacture mpox vaccines; Novo Nordisk says Ozempic shortage ‘worsening’ Eli Lilly's experimental cardiovascular drug ‘promising’ In a significant development for obesity treatment , Eli Lilly 's experimental GLP-1 drug, retatrutide, has demonstrated promising results beyond weight loss. At the European Society of Cardiology meeting, researchers reported that the drug significantly reduced blood lipid levels and cardiovascular risks in a mid-stage trial. After 48 weeks, patients experienced reductions in triglycerides by up to 40.6% and in apoC-III, a protein linked to glucose metabolism and inflammation, by 38%. These findings complement earlier data showing substantial weight loss and improvements in liver fat. Retatrutide's unique mechanism, mimicking three hormones instead of one or two, positions it as a potential advancement over current popular weight-loss medications. Question over tube tying as birth control method In contraceptive news, a study published in NEJM Evidence challenges the reliability of tubal ligation as a permanent birth control method. The research, involving 4,184 women who underwent tubal sterilisation between 2002 and 2015, found that 3% to 5% of participants reported unplanned pregnancies post-procedure. Dr. Eleanor Bimla Schwarz of UCSF and Zuckerberg San Francisco General Hospital emphasised that contraceptive arm implants or intrauterine devices may offer superior pregnancy prevention compared to tubal ligation. Aspen Pharmacare to manufacture mpox vaccines African pharmaceutical company Aspen Pharmacare is exploring partnerships to manufacture mpox vaccines at its facilities, according to CEO Stephen Saad. This initiative comes as the African continent faces pressure to address the mpox outbreak , with 13 countries reporting over 22,800 mpox cases and 622 deaths this year. Aspen's involvement is contingent upon volume commitments and financial support for technology transfer, reflecting lessons learned from its experience with COVID-19 vaccine production. Pneumococcal vaccine study sees Vaxcyte's shares soar Vaxcyte's shares rose by 48% to a record high after the company said its experimental pneumococcal vaccine showed promising results in an early-stage study. The drug has a safety profile similar to rival Pfizer's shot. Pneumococcal disease is a serious bacterial infection caused by bacteria called streptococcus pneumoniae. It spreads through direct contact with respiratory secretions such as saliva and mucus. Vaxcyte's stock rose to $119.27 – its highest level since its Nasdaq debut in 2020. It closed up 36.4%. As a result the vaccine developer added more than $4 billion to its market capitalisation. Novo Nordisk says Ozempic shortage ‘worsening’ Novo Nordisk has reported an worsening of the Ozempic shortage, and says intermittent supply issues are likely to run into the fourth quarter of 2024 across all strengths of the diabetes medication. The company attributes this to increased demand and manufacturing capacity constraints. Healthcare professionals are advised to limit treatment initiation for new patients on both Ozempic and Victoza until the supply situation improves, as per recommendations published by the European Medicines Agency.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Astellas Gene Therapies is shuttering its facility in San Francisco and shifting the work to another site in Sanford, NC, the company told Endpoints News in an email. The closure is expected to complete by March next 2025 and will affect around 100 employees. According to WARN notices, 17 workers have been terminated so far. The decision to wind down the site came on the back of the company evaluating its capacity for making adeno-associated viruses. The story was first reported by BioSpace . The US Drug Enforcement Administration is upping its production limit for Takeda’s ADHD drug Vyvanse and its generic versions by 24% to tackle ongoing drug shortages for the condition. The problem dates back to October 2022, when Teva Pharmaceuticals’ Adderall was hit with manufacturing delays, increasing demand for Takeda’s norepinephrine and dopamine reuptake inhibitor. Vyvanse is classified as a schedule II controlled substance. Eli Lilly is working with EVA Pharma to expand access to its JAK inhibitor Olumiant in certain low and middle-income African countries. The pharma company will license some of its manufacturing know-how to EVA, which will then make the drug locally and start selling it in 2026. Olumiant is used for rheumatoid arthritis and alopecia areata, among other conditions. China’s National Healthcare Security Administration has cut Dr. Reddy’s from its bulk-buy drug program after it identified “ serious defects ” in manufacturing operations during an inspection. These included problems with the management of raw materials, process validation and quality control. The Indian pharma is now banned from the program through Feb. 28, 2026. Thermo Fisher is opening a new global business services center in Manila, Philippines, to provide customer service support for its healthcare and biotech customers. The new office will create 100 jobs in the short term, and the company has plans to bring aboard more than 450 staffers there by the end of 2026. Aspen Pharmacare’s full-year revenues have jumped 10% due in part to strong manufacturing performance. The South African company’s manufacturing revenue grew 25% from the previous year to ZAR 307 million ($17.2 million), driven by sales from finished dose forms. Bend Bioscience is joining up with CoreRx and Societal CDMO to form a combined development and manufacturing services company. The new CDMO, which will keep the Bend Bioscience moniker, will have facilities in Bend, OR; Clearwater, FL; and Gainesville, GA. The announcement follows CoreRx’s $130 million buyout of Societal CDMO in February. Antibody manufacturer Leinco Technologies has acquired QED Biosciences in a deal with undisclosed financials. QED supplies recombinant proteins, antibodies and antigens for in vitro diagnostic and research purposes. Japan-based Otsuka Pharmaceutical was handed a Form 483 after an inspection between March 13 and March 22, according to a document published on the FDA website Friday. Inspectors found five issues, including equipment cleaning concerns and failure to investigate unexplained issues in drug batches. Indian API manufacturer Global Calcium also received a Form 483 from the FDA after an inspection at its site in Tamil Nadu, India between July 29 and Aug. 2. The seven-page letter detailed six observations from the FDA inspectors, including equipment contamination issues and failure to keep complete records. Cellares has appointed Justin McAnear as its new CFO , the company said Tuesday. McAnear was previously the CFO at 10x Genomics, having held prior executive positions at Tesla and Google. Cellares is also appointing Jonathan Butler, who most recently worked at Tesla and Lucid Motors, as its general counsel. The World Health Organization on Tuesday published its first ever guidance on how antibiotic manufacturing can cause pollution and spread antibiotic resistance. The guidance is for regulatory bodies, inspection regulators, manufacturers and waste management services. It outlines how to reduce waste from all stages of manufacturing, from API production to finished products and packaging. CDMO Rentschler Biopharma has expanded its services to add lentiviral vector manufacturing at its site in Stevenage, UK, according to a Tuesday release.

Novo Nordisk and U.S.-based Actylis made a pact to provide the antiseptic and disinfectant benzalkonium chloride to a number of countries in Europe. Novo Nordisk’s Pharmatech unit and U.S.-based Actylis, which manufactures and supplies raw materials for pharmaceuticals, inked a deal to provide the antiseptic and disinfectant benzalkonium chloride to a number of countries in Europe. Pharmaceutical grade benzalkonium chloride will be distributed by the two companies in Germany, Spain, Portugal, the U.K. and Ireland, according to a March 25 press release. The product is often used before surgeries or for wound care, according to the Cleveland Clinic. It can also be used as an antimicrobial preservative for pharma products. Financial terms of the deal weren’t disclosed. “This new agreement, built on our existing partnership in North America, represents a major opportunity for Actylis Europe to complete our pharmaceutical product portfolio while supporting the development of Novo Nordisk Pharmatech BKC for new applications,” Ian Jenning, an Actylis senior vice president, said in the release. The name Actylis is fairly new to the manufacturing game, having been cobbled together by chemical supplier Aceto and 10 other companies in 2022. Prior to the launch two years ago that was initiated by CEO Gilles Cottier, Aceto spent more than 70 years as a source and supplier in the industry. Last September, Novo Nordisk, which is known for its blockbuster drugs Ozempic and Wegovy, signed a production agreement with South Africa’s Aspen Pharmacare to expand insulin supplies with a goal of reaching more than 500,000 diabetes patients in sub-Saharan Africa. More recently, Novo Holdings, which operates under Novo Nordisk’s owner the Novo Nordisk Foundation, agreed to pay $16.5 billion to snap up contract manufacturing giant Catalent. The deal is one of the driving forces behind the seismic changes in the CDMO industry right now. As part of that deal, Novo Nordisk plans to buy three large Catalent facilities for $11 billion.