Texas oral drug delivery specialist Neos Therapeutics pulled in $15.5 million in a Series C round of financing to help propel its line of ADHD controlled-release treatments to the market.
European regulatory authorities gave Teva a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease. With the recommendation from the Committee for Medicinal Products for Human Use, Teva hopes to have final approval within a few months.
With the FDA's all-clear under its belt, AMRI's once-troubled Burlington, MA, "money pit" is poised to push the Albany, NY, company into new markets, the company's new CEO reportedly told investors at the J.P. Morgan Healthcare Conference last week. The former Teva executive said he's eyeing generics and high-tech drug delivery among potential expansion areas.
The company is investing substantially in plant expansions and manufacturing improvements over the next few years so it can produce more drugs more efficiently.
With sequestration currently in place to rein in government spending across the board, much of the $1 billion that user fees bring in over 2013 will be frozen, with the FDA unable to tap the funding. But now, those funds are the target of the FDA Safety Over Sequestration Act--or FDA SOS Act--a bipartisan bill that would exempt user fees from the mandatory budget cuts.
A new rule in the United Arab Emirates will allow its 14 drug manufacturers to start up production on generic drugs sooner so they will be available as soon as the branded products go off patent.
U.S. preclinical CRO Absorption Systems has signed a deal with Indian consulting firm Synerzys Lifecare, looking to pitch its testing services to the nation's growing generics market.
Pfizer has launched a joint venture with China's Zhejiang Hisun Pharmaceuticals, a contract API manufacturer, planning to develop, manufacture and commercialize off-patent pharmaceutical products in China.
Less than four months after it recalled 155,000 bottles of tainted eye solution from its plant in Gujarat, India, Sun Pharmaceutical Industries says it is taking steps to streamline and standardize its manufacturing.
Once finalized, Pernix hopes the acquisition will improve its profit margins on generics, while laying the foundation for developing future over-the-counter and prescription products, according to the pharma company