After having its first offer rejected by ISTA Pharmaceuticals, and after ISTA indicated that an increased offer was still insufficient, Valeant Pharmaceuticals has withdrawn its offer of $7.50 per share a day before its announced deadline of January 31, 2012. ISTA has several bepotastine nasal sprays in development for the treatment of allergic rhinitis. Valeant … [Read more...] about Valeant withdraws offer for ISTA
News
Company to launch THC e-cigarette in US
A company called Rapid Fire Marketing says that its subsidiary Medical Cannabis Management is launching a tetrahydrocannabinol (THC) e-cigarette in the US immediately and will follow with a second-generation device in 30-60 days. The device, called the CannaCig, is designed to deliver THC "in an oil form," according to the company, and will be sold through physicians … [Read more...] about Company to launch THC e-cigarette in US
Almirall and Galapagos partner to find new respiratory drug candidates
Spanish pharmaceutical company Almirall and Belgian biotech Galapagos have entered into a three-year agreement "aimed at delivering drug development candidates directed to a key respiratory target of interest to Almirall." According to the companies, the deal could be worth €7.5 million to Galapagos subsidiary BioFocus, which will be doing the research. Almirall's … [Read more...] about Almirall and Galapagos partner to find new respiratory drug candidates
Aptar opens new nasal/pulmonary device manufacturing facility in India
Aptar Pharma has opened a new manufacturing facility in Rabale, Navi Mumbai, India, where it will produce the DF30 metering valve for pressurized metered dose inhalers (MDIs) and spray pump assemblies for nasal spray delivery. The site was officially declared open on January 21, 2012 with a ceremony attended by the president of the Indian Pharmaceutical Association … [Read more...] about Aptar opens new nasal/pulmonary device manufacturing facility in India
Meda files patent infringement suit against Apotex, Perrigo
Meda Pharmaceuticals has filed a patent infringement suit against Apotex and Perrigo in US District Court in regard to their generic versions of its Astepro azelastine nasal spray for the treatment of rhinitis. The suit alleges infringement of a patent granted to Meda in December 2011 when the two companies submitted abbreviated new drug applications for generic … [Read more...] about Meda files patent infringement suit against Apotex, Perrigo
FDA review of Adasuve application extended
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
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