Cardinal and CVS Caremark said they will create a 50/50 partnership to source generic drugs, which they claim will make them the largest generic drug dealers in the U.S. The two already do business but intend to kick off their new arrangement July 1.
The FDA and other federal authorities have brought down an Arlington, VA-based company that bought unapproved, foreign versions of Botox and cancer drugs on the black market, often receiving the sterile drugs in a condition that left their quality and sterility in question.
Private equity investors JLL Partners put a sharp focus on the potential in the CMO industry last month when it orchestrated a $2.6 billion deal merging two contract manufacturing companies into a global operation. It also illustrated the pressure smaller players are under to beef up if they are to compete. Pharma Tech Industries (PTI) has been doing just that.
Generic drugmakers have been expanding production in low-cost countries to drive down costs in a highly competive market. Hospira has been slow to do that. Its focus in recent years has been plant remediation in the U.S. because key facilities were not meeting FDA standards. But CEO F. Michael Ball says that will change.
Biogen Idec has encountered its share of manufacturing headaches because of the multiple sclerosis drug Tysabri that it acquired from Elan. It will now have to add to that list some limited FDA concerns over its API manufacturing.
Biosimilars are expected to become a significant piece of the generics business worldwide, and Alvogen is spending $250 million to build a facility in Iceland to develop and manufacture biosimilars.
India's Jubilant Life Sciences has received a second warning letter this year for its operations in North America. This time, the company landed in hot water for problems at its Jubilant HollisterStier sterile manufacturing plant in Spokane, WA.
The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.
CMO Patheon is investing in a U.K. site to increase capacity and add capabilities, including automated capsule filling. The expansion comes as Patheon prepares to merge with DSM's pharma business under the ownership of JLL Partners.
In September, a federal judge set back drugmakers' efforts to avoid picking up the tab for drug-disposal schemes when he ruled in favor of Alameda County. Having failed in California, the lobbying juggernaut is trying to stop biopharma-funded disposal schemes spreading up the coast to Seattle.
When Boehringer Ingelheim began closing its Ben Venue site, it justified the decision by describing a grim future for the plant, with operating losses of $700 million forecast over the next 5 years. Now it hopes someone can look past the losses and troubled quality control record to see a business worth buying.
The past few weeks have seen a spate of pharma manufacturing cuts, with Actavis, Merck and Pfizer all whacking jobs. And Pfizer has continued its busy end to 2013 by revealing it is to close a packaging plant in Ireland, laying off 150 workers in the process.
When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
For any company entering the immunotherapy field, manufacturing and logistics are huge challenges. At newly formed Juno Therapeutics, they have a plan to overcome these obstacles--find a CEO who has done it before and back him with $120 million.
The hedge fund is now nearing the point at which it would own enough of Celesio to block the deal. "It's a big game of chicken. Elliott holds the keys," an investor told Reuters.
Every time the FDA has discussed compounding pharmacies and the need to keep fake drugs out of the supply chain in recent years, one message has shone through--we need more power. Now, the FDA is being given some, but not all, of the powers it wants, and has begun to discuss how it plans to use its new authority.
The boom years of the Indian pharmaceutical industry saw overseas businesses snap up Ranbaxy, Piramal Healthcare and a host of other firms, but consternation about the trend led some to try to curb such deals. Now though, with the Indian economy slowing, the government has thrown out the proposals.
When Gland Pharma became the first Indian company to win FDA approval for a liquid injectable in 2003, the drug shortage problem was in its infancy. Over the past decade, a FDA crackdown on sterile injectables has escalated the issue, creating opportunities for high-quality producers of these complex products.
When Wockhardt reported financial results in October, regulatory slapdowns in the U.S. and Europe made for a bleak quarter. Now, things are about to get much worse. The FDA has filed an import alert against the plant that generates 25% of Wockhardt's sales.
The list of Merck manufacturing plants affected by its restructuring is growing longer. With Puerto Rico, New Jersey and Pennsylvania already braced for job cuts, Merck confirmed this week it will add to Irish woes by shuttering its women's healthcare production plant in Swords by the end of 2017.