Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
Pharmaceuticals
Ensuring safe and effective distribution of COVID-19 vaccines
By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
BD to put $1.2B into drug-delivery plant expansions
Becton Dickinson (NYSE:BDX) announced today that it plans to invest $1.2 billion to expand and upgrade multiple drug-delivery facilities. Franklin Lakes, N.J.-based BD plans to invest the $1.2 billion over a four-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes (PFS) and advanced drug-delivery systems (ADDS) across its six global manufacturing locations, […]
Teva Pharmaceuticals’ stock sinks 6.5% on Q3 results
Teva (NYSE: TEVA) reported third-quarter results today that matched analysts’ consensus forecast. The company will maintain its guidance for the rest of the year. Teva, which has dual headquarters in Israel and Parsippany, N.J., reported a loss of -$4.3 billion or -$3.97 per share on revenue of $3.9 billion for the quarter ended September 30, […]
FDA produces list of ‘essential’ devices, drugs for health, military emergencies
The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]
West Pharmaceuticals dips despite strong Q3, raised guidance
West Pharmaceutical Services (NYSE:WST) shares dipped slightly despite third-quarter results that topped the consensus forecast. The Exton, Pa.-based company posted profits of $82.3 million, or $1.09 per share, on sales of $548 million for the three months ended Sept. 30, 2020, for a 46.2% bottom-line gain on sales growth of 0.3%. Adjusted to exclude one-time items, […]
Dexcom, Lilly partner on diabetes management for healthcare providers
Eli Lilly (NYSE:LLY) and Dexcom (NSDQ:DXCM) today announced a joint program for U.S. healthcare providers that includes Lilly’s new, rapid-acting Lyumjev mealtime insulin pen and Dexcom G6 continuous glucose monitoring (CGM) systems. The program is designed to help clinicians use data to inform diabetes management, including promoting the benefits of a new mealtime insulin dose, the companies […]
Ampio gains investigational drug nod for COVID-19 inhaler
Ampio recently announced that it received FDA investigational new drug designation to proceed with clinical trials of its Ampion inhaler for patients with COVID-19 respiratory distress. The company is expanding on its recent successful Phase I trial that administered the drug intravenously to COVID-19 patients. The new Phase I trial of inhaled Ampion will total […]
Teva launches 2 digital inhalers in U.S.
Teva Respiratory (NYSE:TEVA) announced that it launched its AirDuo Digihaler and ArmonAir Digihaler digital inhalers in the U.S. The U.S. affiliate of Teva Pharmaceutical Industries launched both digital inhalers as treatments for asthma. The AirDuo Digihaler is a prescription inhalation powder for controlling symptoms of asthma and preventing symptoms such as wheezing in people 12 years […]
Report: China begins testing COVID-19 nasal spray vaccine
China has reportedly begun human testing for a COVID-19 vaccine which utilizes nasal spray instead of an injection. A report in Bloomberg cites a registration in the Chinese Clinical Trial Registry confirming that the nasal spray vaccine candidate developed by Xiamen University, Hong Kong University and Beijing Wantai Biological Pharmacy Enterprise is undergoing Phase I human testing. Get the […]
