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.
23andMe is back in the DTC game; Sanofi has named its new CEO; drug companies are contemplating a pay-for-performance sales model.
FDA approves Eisai's thryoid cancer drug two months early, Gilead and Germany agree to a Sovaldi price cut, and Valeant looks set to make a bid for Salix.
Google teams up with PwC for DOD EHR project bid; FDA approves first weight-loss device since 2007; research says opioid abuse may be on the decline.
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.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
Promacta was previously indicated for chronic immune thrombocytopenia.
Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.
The FDA has approved Arnuity Ellipta for asthma.
Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.
The FDA greenlighted the drug for three cancers.
The FDA approved the inhaled insulin last week.
Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.
The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.
The fast-tracked drug netted another indication today, this one for a form of leukemia. Lower dosage of the drug for that indication shrinks the price compared to lymphoma.
Two JAMA articles and an editorial give a rundown of what the FDA leaves unsaid in its approvals process and how general housekeeping items can get drugs rejected.
Reports are that the UK wants an expedited process that will mirror the FDA's.
The GlaxoSmithKline-Pfizer-Shionogi joint venture scored an FDA approval in August.
The FDA approved Orenitram (treprostinil), after rejecting it twice before.
The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
Janssen's hepatitis C drug Olysio (simeprevir) offers modest benefit over standard of care, but resistance in a subgroup of patients could hinder broader uptake.
The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.
Known as Breo Ellipta in the US, GlaxoSmithKline's Relvar Ellipta was approved by the EMA for asthma and COPD. The overall market is expected to continue to grow, but an NIH study indicates more patient conversations need to happen.
The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.
Investment in healthcare IT stands at an all-time high. The government has spent billions to promote EHR adoption. Yet the physician wish list is a mile long, while hospitals and patients are not where they need to be. To peel back the layers of what we've all been waiting for in the Great Data Capture of the 21st Century, and to review the changes enabling the healthcare data ecosystem to coexist, MM&M presents this e-Book. Click here.
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