The city of Chicago made big news when it sued 5 drugmakers, alleging that their painkiller marketing broke the law. But much of the juicy detail in that lawsuit was hidden from view, redacted under a confidentiality agreement with the companies.
Now, it's open for viewing. As Bloomberg reports, a federal judge ruled that the information filed under seal could be made public, despite objections f...
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How to prep for a ‘megablockbuster’ launch? Novartis lines up cost-savings data
Here's the shape of pharma marketing to come. Months before Novartis ($NVS) can ask the FDA to approve its "megablockbuster" heart failure drug, the company is trumpeting new data--not on efficacy or safety, but on cost.
Basically, the experimental med cut ER visits by 30% and reduced hospitalizations by 16%, compared with an older standard treatment, elanapril. The LCZ696 patients who did find t...
Smartphone apps to assess mental health based on everyday behavior proliferating
Diagnostic smartphone apps are proliferating. No, these apps don't somehow turn the phone into a needle for drawing blood; instead they monitor stuff we take for granted, like talking or the movement of our eyes.
Dror Ben-Zeev
"The intensity and creativity of these things that are infusing the mHealth (mobile health) field, both the research and private sector, are directly l...
Beware sketchy biotechs with big plans for Ebola, SEC says
The SEC has suspended the trading of a few microcap companies touting unverifiedEbola treatments and tests, warning investors of penny stock peddlers looking to cash in on the West African outbreak that has killed thousands.
The agency's Microcap Fraud Task Force has suspended the OTC listings of four companies, including California's Immunotech Laboratories, which announced last month that it ha...
Novartis’ Enbrel beater bounds toward psoriasis approval ahead of the crowd
Novartis ($NVS) is well on its way to leading a new class of anti-inflammatory treatments, convincing European regulators to recommend approving its injected therapy for psoriasis and putting the company in line for transatlantic launches next year.
The European Medicines Agency is putting its weight behind secukinumab, an injected antibody that blocks the an inflammation-related protein called i...
AbbVie gets an EU green light for its next-gen hep C treatment
AbbVie ($ABBV) is one step closer to challenging Gilead Sciences' ($GILD) dominance in the hepatitis C market, securing a likely European approval for its rival combo treatment as it awaits a U.S. nod.
The European Medicines Agency has recommended approval for AbbVie's three-agent combination, which, like Gilead's competing Harvoni, uses a cocktail of antivirals to halt viral replication and cure...
FDA finds another Indian drugmaker selling contaminated drugs!
Cadila Pharma's Formulations manufacturing plant at Dholka, near Ahmedabad--Courtesy of Cadila Pharmaceuticals
Yet another Indian drugmaker has run afoul of the FDA, this one for not doing enough to track down the source of impurities in some products and failing to investigate when customers complained about odors emanating from its APIs. The action comes as the FDA has stepped...
Another Pfizer run at AZ? Unlikely, Reuters’ sources say. But keep an eye on Actavis
With Pfizer's ($PFE) eligibility to bid again for AstraZeneca ($AZN) nearing, the drug giant seems unlikely to make another run at its one-time target, industry-watchers say. But that doesn't mean it isn't prepping a run at someone else.
As Nov. 26--the day it can pick up where it left off in its pursuit of AZ, as per U.K. takeover rules--approaches, Pfizer has been going through its takeover opt...
Reuters: Apollo interested in GSK’s entire $3B package of mature drugs
GlaxoSmithKline ($GSK) has long explored a sale of some $3 billion worth of its older drugs, planning to shed products by geographic region to meet buyers' interests. Now, the company could have a more enticing offer on its hands as private equity firm Apollo Global Management is planning to bid on GSK's entire portfolio of drugs, people familiar with the process toldReuters.
Last month, sources ...
Roche’s Avastin wins FDA green light in ovarian cancer
Roche's ($RHHBY) Avastin is now two-for-two on converting recent FDA priority review designations into label expansions. Just three months after the cancer giant nabbed the agency's blessing for use in cervical cancer, regulators have approved the drug in combination with chemotherapy as a treatment for platinum-resistant, recurrent ovarian cancer.
Sandra Horning, Roche's chief medi...