FDA

Five things for pharma marketers to know: Thursday, March 26

Five things for pharma marketers to know: Thursday, March 26

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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

Five things for pharma marketers to know: Monday, March 23

Five things for pharma marketers to know: Monday, March 23

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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

Five things for pharma marketers to know: Friday, March 20

Five things for pharma marketers to know: Friday, March 20

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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

Five things for pharma marketers to know: Thursday, March 12

Five things for pharma marketers to know: Thursday, March 12

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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.

FDA letter focuses on UCLA claims about an unapproved diagnostic

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.

FDA releases new e-informed consent guidance in bid for more efficient trials

FDA releases new e-informed consent guidance in bid for more efficient trials

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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.

Five things for pharma marketers to know: Friday, March 6

Five things for pharma marketers to know: Friday, March 6

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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.

Orexigen pleases shareholders, irks FDA

The drugmaker released interim clinical trial information in an SEC filing that the FDA wanted kept quiet until the trial was completed.

Oncologist's petition is latest salvo, as drug-pricing issue rises to new prominence

Oncologist's petition is latest salvo, as drug-pricing issue rises to new prominence

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Drugmakers face increasing pressure on pricing from insurers and PBMs.

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer

A treatise on understanding the FDA's latest guidance of low-risk general wellness products.

Five things for pharma marketers to know: Tuesday, February 17

Five things for pharma marketers to know: Tuesday, February 17

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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.

OPDP finds many flaws with Luitpold video

OPDP finds many flaws with Luitpold video

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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.

Five things for pharma marketers to know: Tuesday, February 10

Five things for pharma marketers to know: Tuesday, February 10

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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.

Five things for pharma marketers to know: Thursday, February 5

Five things for pharma marketers to know: Thursday, February 5

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FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.

FDA simplifies compassionate use application

The original required 26 bits of information and seven attachments.

J&J's Imbruvica snares fourth indication

J&J's Imbruvica snares fourth indication

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The label will now include Waldenstrom's macroglubulinemia.

Five things for pharma marketers to know: Thursday, January 29

Five things for pharma marketers to know: Thursday, January 29

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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.

NPS drug approval bolsters Shire acquisition decision

NPS drug approval bolsters Shire acquisition decision

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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 appoints Office of Generic Drugs director

FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.

FDA to study impact of shorter DTC risk list

FDA to study impact of shorter DTC risk list

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The FDA is looking into whether abbreviated risk information is a good idea for DTC.

Pfizer cancer drug skips FDA advisory panel

Pfizer cancer drug skips FDA advisory panel

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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.

MM&M's top reads of 2014

MM&M's top reads of 2014

A look at the content that grabbed most reader interest over the past year.

FDA 2014 approvals outpace those of 2013

FDA 2014 approvals outpace those of 2013

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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.

FDA tempers opioid approval impact

FDA tempers opioid approval impact

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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.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

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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.

FDA delays rule on generic drug labeling amid controversy

As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.

Five things for pharma marketers to know: Tuesday, November 18

Five things for pharma marketers to know: Tuesday, November 18

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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.

FDA clears new tool for Ebola arsenal

A US Senate bill would also make treatments for the disease eligible for priority review vouchers.

FDA adds language to GERD drugs

The new language is in response to a 2011 citizen's petition.

Five things for pharma marketers to know: Friday,  October 17

Five things for pharma marketers to know: Friday, October 17

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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.

 

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