Approval

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.

Five things for pharma marketers to know: Friday, June 5

Five things for pharma marketers to know: Friday, June 5

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FDA panel recommends approval of female Viagra; FDA says that Sanofi's and Regeneron's PCSK9 inhibitor lowers LDL; GSK cuts 350 jobs

Five things for pharma marketers to know: Wednesday, March 11

Five things for pharma marketers to know: Wednesday, March 11

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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.

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

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

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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.

FDA hands Amgen a biosimilar competitor

FDA hands Amgen a biosimilar competitor

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The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.

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.

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

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

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23andMe is back in the DTC game; Sanofi has named its new CEO; drug companies are contemplating a pay-for-performance sales model.

Five things for pharma marketers to know: Friday, February 13

Five things for pharma marketers to know: Friday, February 13

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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.

Five things for pharma marketers to know: Thursday, January 15

Five things for pharma marketers to know: Thursday, January 15

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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.

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.

Five things for pharma marketers to know: Friday, September 19

Five things for pharma marketers to know: Friday, September 19

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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.

Merck scores first US PD-1 approval

Merck scores first US PD-1 approval

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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).

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

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Promacta was previously indicated for chronic immune thrombocytopenia.

Five things for pharma marketers to know: Monday, August 25

Five things for pharma marketers to know: Monday, August 25

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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.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

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The FDA has approved Arnuity Ellipta for asthma.

Biogen twice-monthly MS drug approved

Biogen twice-monthly MS drug approved

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Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

MannKind's Afrezza approved

MannKind's Afrezza approved

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The FDA approved the inhaled insulin last week.

FDA OKs Merck clot drug

Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.

Latest Breakthrough nod goes to Novartis

The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.

J&J cancer med adds indication, lower dose

J&J cancer med adds indication, lower dose

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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.

JAMA studies look at FDA rejections and approvals

JAMA studies look at FDA rejections and approvals

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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.

UK seeks own Breakthrough Therapy program

Reports are that the UK wants an expedited process that will mirror the FDA's.

EMA approves ViiV's Tivicay

The GlaxoSmithKline-Pfizer-Shionogi joint venture scored an FDA approval in August.

Oral form of Remodulin approved

The FDA approved Orenitram (treprostinil), after rejecting it twice before.

FDA's 2013 so far: 26 approvals

FDA's 2013 so far: 26 approvals

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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.

J&J HCV drug OK'd; educational push planned

J&J HCV drug OK'd; educational push planned

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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.

Roche lands EU Kadcyla approval, ducks EMA criticism

The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.

GSK's Breo approved in Europe, COPD market may be underestimated

GSK's Breo approved in Europe, COPD market may be underestimated

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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.

FDA approves Imbruvica (ibrutinib) for MCL

FDA approves Imbruvica (ibrutinib) for MCL

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The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.

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