Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion
The FDA asked private biotech Genervon to release all available clinical trial data for its experimental ALS treatment.
The FDA approves generic Copaxone; AstraZeneca's experimental lung-cancer drug demonstrates that it can delay disease progression; PhRMA CEO John Castellani to step down
IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza
AstraZeneca diabetes drug may have increased mortality rate; Pfizer accused of knowing about birth defect risks from Zoloft; Eisai to cut 25% of its US workforce
Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times
The panel will focus on heart failure hospitalization rates associated with the diabetes medication.
The company has received seven warning letters since 2010.
FDA accepts previously rejected Novo Nordisk insulin application; Merck HCV doublet regimen receives Breakthrough designation for patients with kidney disease; researchers say that rising costs for cancer drugs aren't reasonable
A more general warning encourages consumers to engage in a personal discussion with their doctor about a drug, and it promotes engagement with longer-format printed or digitally-delivered information.
Merck funds protein-degrading technology; Shire expects approval for a new ADHD medication in 2017; state biosimilar notification laws focus on subtext
Opioids lacking abuse-foiling technology will remain available.
Regeneron's Eylea won its fourth indication; Sun Pharma wants to revive trust in its products; confidentiality agreements keep Amgen from telling patients their cancer risk
Eleven new drugs with blockbuster potential are expected to launch this year; a bill would require FDA to quickly review drugs approved in the EU; Biogen reinforces its focus on hard-to-treat diseases
A judge rules against Amgen in Neupogen case; FDA advisory panel recommends Breio Ellipta for adults with asthma; AstraZeneca partners with Daiichi Sankyo to sell Movantik
The SEC said some company drug prices can be made public, 23andMe launched an R&D division, and Public Citizen is asking the FDA to withdraw a proposal it says will undermine drug safety information.
The agency's Office of Prescription Drug Promotion said a website indicated safety and effectiveness of a diagnostic tool that has not been approved by the FDA.
The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.
FDA approves the first biosimilar, judge rules that FDA panel members had conflicts of interest, and a new venture will evaluate the effectiveness of digital health technologies.
The drugmaker released interim clinical trial information in an SEC filing that the FDA wanted kept quiet until the trial was completed.
Drugmakers face increasing pressure on pricing from insurers and PBMs.
A treatise on understanding the FDA's latest guidance of low-risk general wellness products.
Bayer exec may be Sanofi's new CEO, GSK gets a new North American Pharma lead, and Pfizer sends painkiller ALO-02 to the FDA.
The list of objections by the Office of Prescription Drug Promotion, which oversees medical advertising, is a familiar one, and includes concerns such as claims that go beyond the approved indication.
FDA's latest guidance says it is ok to reduce the amount of risk information in print ads, Google amplifies the health information it will serve up with searches and HBO's John Oliver takes on pharmaceutical marketing.
FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.
The original required 26 bits of information and seven attachments.
The label will now include Waldenstrom's macroglubulinemia.
Former FDA chief tells court J&J knew of Risperdal risk, pay-for-delay deals get new court criteria, lawmakers may declare pharmacists healthcare providers.
The FDA approved NPS Pharmaceuticals's rare-disease drug Friday. The company, which Shire shelled out $5.2 billion to buy, expects it to hit the market during the second-quarter.
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