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 accepts bid for new label for Jardiance; Markey puts on a hold on Califf's FDA nomination; GSK is studying the Zika virus
The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks
HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO
It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.
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
The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.
Valeant agrees to cut prices in deal with Walgreens; FDA committee votes against Merck's Vytorin claims; Pacira settles off-label marketing case with the FDA
An FDA advisory committee voted 11-3, recommending approval of reslizumab in adults with severe asthma.
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
Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
FDA panel recommends AZ gout drug for approval; Valeant to form committee to examine specialty pharmacy ties; patients treated with Keytruda had longer survival than those who took chemo
23andMe relaunches its DTC genetic test; Valeant's woes increase as shares plummet; the FDA questions the safety of AstraZeneca's gout drug
Califf reportedly removes name from research questioning FDA oversight of clinical trials; Express Scripts to cover both PCSK9 inhibitors; trial for experimental cancer drug halted after patient death
An analysis conducted by J&J executives found that 58% of FDA warning letters and untitled letters over the last two years omitted risk information.
The agency announced a new committee to help integrate patient perspectives into the regulation of medical devices.
Proteus and Otsuka seek approval of "digital" drug; J&J moves its US media-buying business back to UM; FDA committee votes no on Purdue's new opioid
Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life
Longer-term use of AstraZeneca's Brilinta approved; Google streamlines health-related searches; Zarxio's price is higher than expected
Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors
Amgen's Repatha receives FDA nod; Mylan shareholders vote in favor of Perrigo deal; doctors push for below-average price of experimental cancer drug
The FDA is expected to announce this week whether it has approved the epilepsy drug as a monotherapy for partial-onset seizures.
The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
Contrary to popular belief, Addyi is not the female Viagra. That's the message drug-maker Sprout must get across to doctors and patients in the coming weeks.
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations
- Five things for pharma marketers to know: Friday, February 5, 2016
- Why Gathering Health Economic Data for Cancer Drugs is Now Essential
- Ascension Health ups Ragone to chief marcomms officer
- House Oversight committee upbraids Turing, Valeant execs
- Burcin departs Havas network for Klick Health in senior-staffing push