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.
FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.
The FDA is looking into whether abbreviated risk information is a good idea for DTC.
The FDA told Pfizer that it isn't bothering with a committee review for the experimental breast cancer drug Ibrance (palbociclib). The part two news exciting investors: Pfizer and the FDA are already talking labels.
A look at the content that grabbed most reader interest over the past year.
The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.
The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.
As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.
Ackman walks away with $2.5 billion, despite no Allergan deal; Ranbaxy sues FDA over generic Nexium rights; Indian government's Health Ministry recommends breaking BMS cancer drug patent.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
The new language is in response to a 2011 citizen's petition.
Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.
Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.
- US pharma market value projected to be $550 billion in five years
- Biosimilar uptake will require companies to tell a trustworthy backstory
- Lawmakers propose allowing pharma companies to share some off-label information
- Apple's ResearchKit: Five Guidelines for Pharma
- Everyday Health buys rare-disease agency Cambridge BioMarketing