Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort. In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for […]
Respiratory
Teva rises on mixed-bag Q4, sets 2022 guidance
Teva Pharmaceuticals (NYSE:TEVA) shares ticked up this morning on fourth-quarter results that topped the consensus EPS forecast. The Tel Aviv, Israel–based company posted losses of $159 million, or 14¢ per share, on sales of $4.1 billion for the three months ended Dec. 31, 2021, for a bottom-line slide into the red on a sales decline […]
FDA grants new drug approval to Glenmark’s rhinitis-treating nasal spray
Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais. Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA […]
Your favorite articles from Drug Delivery Business News in 2021
From continuous glucose monitors to insulin pens, plus needle-free injection devices and inhalers — here are the most popular articles on Drug Delivery Business News from 2021: Links to your favorite articles: Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’ Eli Lilly partners with four companies on insulin pen tech Scancell picks PharmaJet’s needle-free […]
Inhaled drug delivery tech company Aerami to go public through SPAC merger
Aerami Therapeutics announced today that it entered into a merger agreement with FoxWayne Enterprises Acquisition Corp. (NSDQ:FOXWU). Through the definitive business combination agreement with the special purpose acquisition company (SPAC), Aerami, a developer of inhaled therapies for treating respiratory and chronic diseases, will be listed on the Nasdaq market as “Aerami Therapeutics Holdings, Inc.” According […]
Teva announces two offerings worth $7.5 billion, dips on missed Q3 projections
Teva Pharmaceuticals (NYSE:TEVA) shares took a hit today on third-quarter results that fell short of the consensus forecast. TEVA shares were down -4.7% at $8.95 per share in mid-morning trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -0.8%. The Tel Aviv, Israel-based company posted […]
Philip Morris’ $1.2B offer for inhaled drug delivery tech developer becomes unconditional
Philip Morris (NYSE:PM) announced today that its offer to buy inhaled drug delivery technology developer Vectura has become unconditional. Having received valid acceptances for or acquired 74.77% of Vectura shares, in excess of the 50% required under the acceptance condition, along with confirming that all other conditions to the offer have been satisfied or waived, […]
Three companies to collaborate on potential inhaled COVID-19 treatment
Signal Rx Pharmaceuticals, Crystec and ADYA are working on a dry powder drug formulation for potentially treating COVID-19-related illness. The three companies’ collaboration for the dry powder formulation of SF2523 covers the treatment of pulmonary fibrosis, lung cancer and illnesses related to SARS-CoV-2, the virus causing COVID-19. SignalRx’s SF2523 is a novel, small-molecule, dual PI3K-BRD4 […]
Cigarette maker Philip Morris acquires another inhaled therapeutic company
Philip Morris (NYSE:PM) announced today that it acquired OtiTopic and its late-stage inhalable acetylsalicylic acid (ASA) treatment. Los Angeles-based OtiTopic develops the Asprihale patented dry powder inhalation ASA treatment to treat acute myocardial infarction as a self-administered aerosol. According to a news release, early clinical trials have shown that the product catalyzed peak plasma concentration […]
American Lung Association slams cigarette maker for inhaled medical therapy acquisition
The American Lung Association condemned the recently announced acquisition of Vectura by cigarette maker Philip Morris (NYSE:PM). Earlier this month, Philip Morris announced that it agreed to acquire inhaled drug delivery technology developer Vectura for $1.2 billion. In response to the acquisition, American Lung Association president & CEO Harold Wimmer and American Thoracic Society president Dr. Lynn […]
