Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets
The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.
The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks
The FDA approved 45 new drugs in 2015; Baxalta signs immuno-oncology deal; pharma M&A activity may slow this year
Generic-drug approval backlog criticized; KaloBios board members step down; Sovaldi costs as little as $4 in India
The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges
FDA advisers vote against BioMarin's Duchenne drug; the FDA approves Lilly's lung-cancer drug; criticism mounts for Pfizer's proposed deal with Allergan
Opdivo receives another indication; increasing generic prescriptions may boost patient adherence; hep.-C drugs should be prescribed during earlier stages of disease
PBMs crack down on specialty pharmacies; Merck's cholesterol drug soldiers on; rare-disease drug nabs approval
Walgreens buys Rite Aid in $9.4 billion deal; Arena fires a third of its workforce and discontinues Belviq clinical trials; FDA approves Amgen melanoma immunotherapy
The FDA approves another generic version of Abilify; drug price increases driving profit growth; Spark plans to submit eye-drug to the FDA in 2016
The FDA approves Opdivo/Yervoy combination to treat melanoma; BioMarin acquires global rights to Kuvan; Allergan's Juvederm receives marketing approval for lip augmentation
Valeant acquires Sprout for $1 billion; AbbVie buys Priority Review voucher from United Therapeutics; FDA approval rate stands at 89% so far for 2015.
Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations
More patients are seeking treatments with even fewer side effects and shorter durations.
View on a quarter-by-quarter basis the competitive market for four new hepatitis-C treatments and track how Gilead Sciences' Harvoni became the market leader within months of receiving approval from the FDA.
UnitedHealth looks for refunds when drugs don't work; the European Medicines Agency recommends Sanofi's and Regeneron's PCSK9 inhibitor, Praluent, for approval; Biogen's multiple-sclerosis drug, Tecfidera, reports lower-than-expected sales growth
The modern healthcare landscape is complicated, and the terrain is even more gnarled for life sciences companies trying to bring new products to market.
The pharma business needs to take engagement far more seriously than it has in the past. At the same time, there are signs that the industry is finally acting with more urgency and even transparency.
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
Pregnant women taking Prozac or Paxil have higher risks of birth defects; study finds J&J's experimental psoriasis drug works better than Humira; AstraZeneca divests global rights to Entocort
The FDA approval this week of a new heart-failure drug is expected to spur interest among cardiologists seeking new ways to keep patients with heart failure out of the hospital.
CDC report finds prescription painkiller abuse contributed to an increase in heroin use; Novartis heart-failure drug gets FDA approval; Isis Pharmaceuticals obtains orphan-drug designation for volanesorsen
Groups urge disclosure of payments to nurse practitioners and physician assistants; Horizon seeks $3-billion acquisition of Depomed; Sanofi closes $245-million agreement to buy priority-review voucher
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs
Zogenix spins off painkiller business; Biogen Idec investigates the use of wearables in MS patients; J&J sues Celltrion and Hospira to delay Remicade biosimilar.
HCV drugs and other specialty medications drove a 13% increase in last year's prescription spending, the CBO overestimated just how much healthcare reform would cost, and an FDA panel voted 17-0 in favor of Kythera's drug that can reduce double chins.
The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.
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.