According to Alexza Pharmaceuticals, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the Adasuve Staccato loxapine NDA from February 4, 2012 to May 4, 2012. On January 10, 2012, Alexza submitted an updated proposed Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA is considering a major amendment, allowing the agency to … [Read more...] about FDA review of Adasuve application extended
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FDA lifts clinical hold on Arikace for NTM
According to Insmed, the US FDA has lifted the clinical hold on Arikace liposomal amikacin for inhalation for the treatment of patients with non-tuberculous mycobacteria (NTM) lung disease. In October 2011, the FDA had asked for additional data for that indication. The hold on Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients remains in … [Read more...] about FDA lifts clinical hold on Arikace for NTM
Prosonix appoints Rob Crocker as Head of Regulatory Affairs
As UK-based Prosonix transitions from a particle engineering specialist into a pharmaceutical company with three inhaled respiratory drugs in its pipeline, it has announced the appointment of Rob Crocker as its first Head of Regulatory Affairs. Crocker, who has overseen marketing applications for a number of inhaled and nasal drug products as Managing Director of the … [Read more...] about Prosonix appoints Rob Crocker as Head of Regulatory Affairs
Takeda to lay off 2,800 as it integrates Nycomed
Takeda Pharmaceutical has announced that it will lay off approximately 2,800 employees -- 2,100 in Europe and 700 in the US -- as it realigns to accommodate its 2011 acquisition of Nycomed. Nycomed's products include Alvesco ciclesonide MDI, Omnaris ciclesonide nasal spray, Zymelin/Xymelin xylometazoline nasal spray, and Instanyl intranasal fentanyl; in addition, an … [Read more...] about Takeda to lay off 2,800 as it integrates Nycomed
MHRA announces recall of contaminated saline nasal spray
Manufacturer Church & Dwight UK has informed the Medicines and Healthcare products Regulatory Agency (MHRA) of possible bacterial contamination of its Sterimar Isotonic 100ml saline nasal spray, which is available over the counter in the UK. The company has recalled two batches, numbers FE1248b and FE1249, identifying Pseudomonas stutzeri and Sphingomonas paucimobilis … [Read more...] about MHRA announces recall of contaminated saline nasal spray
Valeant increases offer for ISTA
After the rejection of its last offer in December, Valeant Pharmaceuticals says that it has increased its offer for ISTA to $7.50 per share from $6.50 and adds that it has informed ISTA that the price could rise to $8.50 per share "assuming that ISTA provides it selected confirmatory due diligence related to the company that is consistent with what Valeant expects to … [Read more...] about Valeant increases offer for ISTA
MAP adds James O’Shea to board of directors
MAP Pharmaceuticals has appointed W. James O'Shea, a former President and COO of Sepracor, to its board of directors. During eight years at Sepracor, O'Shea held a number of positions in operations and commercialization and had previously worked for Zeneca Pharmaceuticals, including as Senior VP of Sales and Marketing and Medical Affairs. MAP is preparing for the … [Read more...] about MAP adds James O’Shea to board of directors
Respiratory drug delivery market projected to reach $44 billion by 2016
A new report available from BCC Research projects a compound annual growth rate (CAGR) of 14.3% for the respiratory drug delivery technologies market, meaning that the global market would approximately double to $44 billion by 2016. According to the report, the market, including MDIs, DPIs, and other devices, was $19.6 billion in 2010 would be about $22.5 billion for … [Read more...] about Respiratory drug delivery market projected to reach $44 billion by 2016
Vectura anticipates continued cuts in R&D expenditures
According to an interim management statement released by Vectura, the company anticipates a cut R&D expenditures by £1m for the fiscal year ending March 31 2012 and expects additional cuts for FY2013. The company said, "We continue to pay close attention to R&D expenditure to ensure appropriate investment is placed behind key assets, including device and product … [Read more...] about Vectura anticipates continued cuts in R&D expenditures
Fleming sells Ocean saline nasal spray to Valeant
Fleming Pharmaceuticals says that it sold the rights to its Ocean brand saline nasal products, along with three other products, to Valeant, which will distribute the product through Valeant Pharmaceuticals North America LLC. Ocean nasal sprays, irrigator, gel, and mist are available over the counter in the US. The company, which provides contract manufacturing of … [Read more...] about Fleming sells Ocean saline nasal spray to Valeant