The FDA is set to announce its decision on the drug in April.
SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes
Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog
A House lawmaker called pricing strategies used by Turing and Valeant "repulsive."
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 plans to release new guidance on advertising in 2016; Trump supports Medicare price negotiations; Novartis CEO: golden days of drug pricing are over
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
Government pressure can influence drug-pricing decisions; Samsung's biosimilar version of Enbrel is approved in Europe; J&J to cut jobs in medical-devices business
While DTC advertising does significantly impact consumer demand, most evidence suggests the majority of this demand benefits the overall state of consumer health.
The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks
Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.
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.
Fitbit faces allegations of inaccurate heart monitoring; Viiv Healthcare to collaborate with Janssen; Guardant Health raises funding for its cancer blood tests
Generic Nexium will be blue; researcher says scientific papers should be anonymous; patients with health insurance still struggle to cover the costs of drugs
Shkreli resigns from Turing; Keytruda approved as first-line melanoma treatment; drugmakers seek to fend off California pricing ballot initiative
Sprout CEO departs; Senate committee sounds off on Valeant, Turing repricing, JAMA viewpoint raises safety concerns about Entresto
Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.
Not-for-profit ranks Gilead Sciences and Sanofi as the lowest-scoring drugmakers in terms of clinical trial transparency; Perrigo shareholders to vote on Mylan deal; new Valeant allegations
Dr. Reddy's is blocked from selling generic purple Nexium; the FDA approves Roche's melanoma drug; Novartis says Entresto keeps heart-failure patients from being readmitted to the hospital
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
Valeant made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.
One analyst said he expects that the change in label "will meaningfully commercially impair Viekira Pak sales."
Valeant receives subpoenas over drug pricing; BMS signs new immuno-oncology deal with Five Prime Therapeutics; Pfizer CEO says insurance coverage to blame in price debate
Critics question the FDA's decision to approve OxyContin for children; AstraZeneca temporarily stops to lung-cancer trials; Sanders will oppose Califf's nomination as FDA commissioner
Sanofi's Aubagio reduces brain volume loss; cancer specialists avoid pricey cancer meds; analysis says placebo effect is on the rise
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
Hillary Clinton proposes stricter regulation of opioid painkillers; the FTC argues drugmakers make slight changes to drugs to prevent generics; MannKind layoffs continue
Democrats request subpoena over Valeant price hikes; Clinton adds research incentive to drug-pricing proposal; Roche files approval for novel MS therapy