Approval

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

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

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Valeant acquires Sprout for $1 billion; AbbVie buys Priority Review voucher from United Therapeutics; FDA approval rate stands at 89% so far for 2015.

Five things for pharma marketers to know: Wednesday, August 19

Five things for pharma marketers to know: Wednesday, August 19

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Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations

Eyeing big returns, drugmakers ready new hepatitis-C drug launches

Eyeing big returns, drugmakers ready new hepatitis-C drug launches

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More patients are seeking treatments with even fewer side effects and shorter durations.

Graphic: the new hepatitis-C drug market

Graphic: the new hepatitis-C drug market

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View on a quarter-by-quarter basis the competitive market for four new hepatitis-C treatments and track how Gilead Sciences' Harvoni became the market leader within months of receiving approval from the FDA.

Five things for pharma marketers to know: Friday, July 24

Five things for pharma marketers to know: Friday, July 24

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UnitedHealth looks for refunds when drugs don't work; the European Medicines Agency recommends Sanofi's and Regeneron's PCSK9 inhibitor, Praluent, for approval; Biogen's multiple-sclerosis drug, Tecfidera, reports lower-than-expected sales growth

Orchestrating Key Stakeholder Engagement for Launch Success

Orchestrating Key Stakeholder Engagement for Launch Success

The modern healthcare landscape is complicated, and the terrain is even more gnarled for life sciences companies trying to bring new products to market.

Patients expect pharma will boost engagement

Patients expect pharma will boost engagement

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The pharma business needs to take engagement far more seriously than it has in the past. At the same time, there are signs that the industry is finally acting with more urgency and even transparency.

House expected to vote on 21st Century Cures

House expected to vote on 21st Century Cures

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The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.

Five things for pharma marketers to know: Thursday, July 9

Five things for pharma marketers to know: Thursday, July 9

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Pregnant women taking Prozac or Paxil have higher risks of birth defects; study finds J&J's experimental psoriasis drug works better than Humira; AstraZeneca divests global rights to Entocort

Novartis bets on demand for new heart-failure drug Entresto

Novartis bets on demand for new heart-failure drug Entresto

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The FDA approval this week of a new heart-failure drug is expected to spur interest among cardiologists seeking new ways to keep patients with heart failure out of the hospital.

Five things for pharma marketers to know: Wednesday, July 8

Five things for pharma marketers to know: Wednesday, July 8

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CDC report finds prescription painkiller abuse contributed to an increase in heroin use; Novartis heart-failure drug gets FDA approval; Isis Pharmaceuticals obtains orphan-drug designation for volanesorsen

Five things for pharma marketers to know: Tuesday, July 7

Five things for pharma marketers to know: Tuesday, July 7

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Groups urge disclosure of payments to nurse practitioners and physician assistants; Horizon seeks $3-billion acquisition of Depomed; Sanofi closes $245-million agreement to buy priority-review voucher

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.


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