Pulmatrix (NSDQ:PULM) said today that it landed an agreement with several institutional investors to purchase $5.0 million of shares of common stock in a registered direct offering. The Lexington, Mass.-based company agreed to sell 2 million shares of common stock at $2.50 apiece. The offering is expected to close on Feb. 2. Pulmatrix said it […]
Respiratory
Teva wins FDA nod for inhaled asthma medications
Teva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved 2 inhaled asthma medications to be delivered using the company’s RespiClick breath-activated, multi-dose dry powder inhaler. The products, AirDuo RespiClick and ArmonAir RespiClick, are indicated for use in asthma patients as young as 12 years old. The Jerusalem-based company’s AirDuo RespiClick is a fixed dose combination of […]
Johnson & Johnson to pay $30B for Actelion
After weeks of exclusive negotiations, Johnson & Johnson (NYSE:JNJ) said on Thursday that it plans to buy Swiss biotech firm Actelion (VTX:ATLN) for $30 billion in an all-cash deal. The companies have reportedly been in talks for months – Sanofi (NYSE:SNY) was also involved in discussions for Actelion, but was sidelined after J&J entered into exclusive negotiations with Actelion last […]
Vectura wins IND for drug-device combo for pediatric asthma
Vectura said yesterday that the FDA approved an Investigational New Device application for its drug-device combination to treat asthma in children 12 months to 8 years old. The UK-based company’s device, VR647, uses the Akita Jet nebulizer for the delivery of nebulized budesonide. Vectura’s drug-device combination product provides faster delivery time and better lung deposition of budesonide, […]
J&J, Actelion still in talks despite Opsumit failure
Although Actelion (VTX:ATLN)’s Opsumit drug candidate missed its primary endpoint in a phase III trial for patients suffering from a deadly heart-lung condition, analysts reportedly concluded that the result is unlikely to have an impact on merger talks with Johnson & Johnson (NYSE:JNJ). The Swiss drugmaker’s trial involved 226 patients with Eisenmenger Syndrome, which causes untreated congenital heart […]
Kaleo announces US availability, pricing of allergy auto-injector
Kaléo Inc. said yesterday that its Auvi-Q epinephrine auto-injector will be available by prescription in the U.S. beginning Feb. 14th. The Richmond, Virginia-based company’s emergency allergy treatment was pulled from the market in 2015 due to manufacturing issues. The Epipen competitor device will be sold at a list price of $4,500, but Kaléo said that as a […]
Pulmatrix shares soar after winning FDA designation
Pulmatrix (NSDQ:PULM) shares were up 159% to $1.79 apiece in mid-afternoon trading today after the company announced that its drug candidate for treating fungal infections in the lungs of cystic fibrosis patients was designated as a ‘qualified infectious disease product’ by the FDA. With the designation, the Lexington, Mass.-based company will receive 5 years of […]
CVS to sell cheaper, generic version of Impax’s allergy injection
CVS Health Corp. (NYSE:CVS) said today that it will start selling a generic version of Impax Laboratories‘ (NSDQ:IPXL) emergency allergy injection, Adrenaclick. The device is similar to Mylan‘s (NSDQ:MYL) EpiPen, although regulators do not consider the 2 devices to be exactly the same. The Adrenaclick has a list price of more than $400, but the generic […]
Mast Therapeutics, Savara ink merger deal
Mast Therapeutics (NYSE:MSTX) and privately-held Savara Inc. said today that the 2 companies have landed a definitive merger agreement, combining their operations. The newly-formed Austin, Texas-based company is expected to be named Savara Inc., and trade on the NYSE market under a new ticker symbol. The combined company will focus on advancing a pipeline of […]
Primatene Mist Inhaler rejected by FDA
Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]