Approval

Five things for pharma marketers to know: Wednesday, February 3, 2016

Five things for pharma marketers to know: Wednesday, February 3, 2016

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Seven potential blockbusters set to launch in 2016; Amarin case may lead to 'misleading' marketing; Valeant, Turing raised prices to meet preset targets

Speeding up FDA Approvals Calls for Pause

Speeding up FDA Approvals Calls for Pause

The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.

Five things for pharma marketers to know: Friday, January 15, 2016

Five things for pharma marketers to know: Friday, January 15, 2016

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The FDA declines to approve two drugs for Duchenne muscular dystrophy; government watchdog questions FDA's post-market drug tracking; WebMD denies acquisition talks

Five things for pharma marketers to know: Monday, January 4, 2016

Five things for pharma marketers to know: Monday, January 4, 2016

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The FDA approved 45 new drugs in 2015; Baxalta signs immuno-oncology deal; pharma M&A activity may slow this year

Five things for pharma marketers to know: Tuesday, December 29, 2015

Five things for pharma marketers to know: Tuesday, December 29, 2015

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Generic-drug approval backlog criticized; KaloBios board members step down; Sovaldi costs as little as $4 in India

Five things for pharma marketers to know: Thursday, December 17, 2015

Five things for pharma marketers to know: Thursday, December 17, 2015

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The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges

Five things for pharma marketers to know: Wednesday, November 25, 2015

Five things for pharma marketers to know: Wednesday, November 25, 2015

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FDA advisers vote against BioMarin's Duchenne drug; the FDA approves Lilly's lung-cancer drug; criticism mounts for Pfizer's proposed deal with Allergan

Five things for pharma marketers to know: Tuesday, November 24, 2015

Five things for pharma marketers to know: Tuesday, November 24, 2015

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Opdivo receives another indication; increasing generic prescriptions may boost patient adherence; hep.-C drugs should be prescribed during earlier stages of disease

Five things for pharma marketers to know: Monday, November 16, 2015

Five things for pharma marketers to know: Monday, November 16, 2015

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PBMs crack down on specialty pharmacies; Merck's cholesterol drug soldiers on; rare-disease drug nabs approval

Five things for pharma marketers to know: Wednesday, October 28, 2015

Five things for pharma marketers to know: Wednesday, October 28, 2015

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Walgreens buys Rite Aid in $9.4 billion deal; Arena fires a third of its workforce and discontinues Belviq clinical trials; FDA approves Amgen melanoma immunotherapy

Five things for pharma marketers to know: Tuesday, October 6

Five things for pharma marketers to know: Tuesday, October 6

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The FDA approves another generic version of Abilify; drug price increases driving profit growth; Spark plans to submit eye-drug to the FDA in 2016

Five things for pharma marketers to know: Thursday, October 1, 2015

Five things for pharma marketers to know: Thursday, October 1, 2015

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The FDA approves Opdivo/Yervoy combination to treat melanoma; BioMarin acquires global rights to Kuvan; Allergan's Juvederm receives marketing approval for lip augmentation

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.

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