Legal/Regulatory

With support of FDA committee, Remicade biosimilar edges closer to market

With support of FDA committee, Remicade biosimilar edges closer to market

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The FDA is set to announce its decision on the drug in April.

Five things for pharma marketers to know: Wednesday, February 10, 2016

Five things for pharma marketers to know: Wednesday, February 10, 2016

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SEC is investigating Salix Pharmaceuticals; FDA adcomm recommends approval of Remicade biosimilar; Medicare considers payment changes

Five things for pharma marketers to know: Friday, February 5, 2016

Five things for pharma marketers to know: Friday, February 5, 2016

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Johnson & Johnson collaborates with biotech on diabetes stem-cell treatment; the FDA warms up to Remicade biosimilar; Woodcock warns about biosimilar backlog

House Oversight committee upbraids Turing, Valeant execs

House Oversight committee upbraids Turing, Valeant execs

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A House lawmaker called pricing strategies used by Turing and Valeant "repulsive."

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: Wednesday, January 27, 2016

Five things for pharma marketers to know: Wednesday, January 27, 2016

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The FDA plans to release new guidance on advertising in 2016; Trump supports Medicare price negotiations; Novartis CEO: golden days of drug pricing are over

Five things for pharma marketers to know: Tuesday, January 26, 2016

Five things for pharma marketers to know: Tuesday, January 26, 2016

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The FDA accepts bid for new label for Jardiance; Markey puts on a hold on Califf's FDA nomination; GSK is studying the Zika virus

Five things for pharma marketers to know: Tuesday, January 19, 2016

Five things for pharma marketers to know: Tuesday, January 19, 2016

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Government pressure can influence drug-pricing decisions; Samsung's biosimilar version of Enbrel is approved in Europe; J&J to cut jobs in medical-devices business

What the AMA's Proposed DTC Ban Overlooks

What the AMA's Proposed DTC Ban Overlooks

While DTC advertising does significantly impact consumer demand, most evidence suggests the majority of this demand benefits the overall state of consumer health.

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

Senate committee clears Califf as FDA head

Senate committee clears Califf as FDA head

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Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.

Five things for pharma marketers to know: Tuesday, January 12, 2016

Five things for pharma marketers to know: Tuesday, January 12, 2016

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HCPs sound off on CMS opioid proposal; Senate committee to decide if Califf gets FDA commissioner nod; Celgene names new CEO

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

Five things for pharma marketers to know: Thursday, January 7, 2016

Five things for pharma marketers to know: Thursday, January 7, 2016

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Fitbit faces allegations of inaccurate heart monitoring; Viiv Healthcare to collaborate with Janssen; Guardant Health raises funding for its cancer blood tests

Five things for pharma marketers to know: Thursday, December 31, 2015

Five things for pharma marketers to know: Thursday, December 31, 2015

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Generic Nexium will be blue; researcher says scientific papers should be anonymous; patients with health insurance still struggle to cover the costs of drugs

Five things for pharma marketers to know: Monday, December 21, 2015

Five things for pharma marketers to know: Monday, December 21, 2015

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Shkreli resigns from Turing; Keytruda approved as first-line melanoma treatment; drugmakers seek to fend off California pricing ballot initiative

Five things for pharma marketers to know: Thursday, December 10, 2015

Five things for pharma marketers to know: Thursday, December 10, 2015

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Sprout CEO departs; Senate committee sounds off on Valeant, Turing repricing, JAMA viewpoint raises safety concerns about Entresto

Five things for pharma marketers to know: Wednesday, November 18, 2015

Five things for pharma marketers to know: Wednesday, November 18, 2015

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Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday

Valeant woes continue, with lawsuit and new Philidor allegations

Valeant woes continue, with lawsuit and new Philidor allegations

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The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.

Five things for pharma marketers to know: Thursday, November 12, 2015

Five things for pharma marketers to know: Thursday, November 12, 2015

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Not-for-profit ranks Gilead Sciences and Sanofi as the lowest-scoring drugmakers in terms of clinical trial transparency; Perrigo shareholders to vote on Mylan deal; new Valeant allegations

Five things for pharma marketers to know: November 11, 2015

Five things for pharma marketers to know: November 11, 2015

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Dr. Reddy's is blocked from selling generic purple Nexium; the FDA approves Roche's melanoma drug; Novartis says Entresto keeps heart-failure patients from being readmitted to the hospital

Industry watches Pacira's off-label case against the FDA

Industry watches Pacira's off-label case against the FDA

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The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.

Valeant subsidiary discloses subpoena over doctor payments

Valeant subsidiary discloses subpoena over doctor payments

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Valeant made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.

FDA issues safety warning for AbbVie's HCV drugs

FDA issues safety warning for AbbVie's HCV drugs

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One analyst said he expects that the change in label "will meaningfully commercially impair Viekira Pak sales."

Five things for pharma marketers to know: Thursday, October 15, 2015

Five things for pharma marketers to know: Thursday, October 15, 2015

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Valeant receives subpoenas over drug pricing; BMS signs new immuno-oncology deal with Five Prime Therapeutics; Pfizer CEO says insurance coverage to blame in price debate

Five things for pharma marketers to know: Friday, October 10, 2015

Five things for pharma marketers to know: Friday, October 10, 2015

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Critics question the FDA's decision to approve OxyContin for children; AstraZeneca temporarily stops to lung-cancer trials; Sanders will oppose Califf's nomination as FDA commissioner

Six things for pharma marketers to know: Thursday, October 8, 2015

Six things for pharma marketers to know: Thursday, October 8, 2015

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Sanofi's Aubagio reduces brain volume loss; cancer specialists avoid pricey cancer meds; analysis says placebo effect is on the rise

Five things for pharma marketers to know: Wednesday, October 7, 2015

Five things for pharma marketers to know: Wednesday, October 7, 2015

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Califf reportedly removes name from research questioning FDA oversight of clinical trials; Express Scripts to cover both PCSK9 inhibitors; trial for experimental cancer drug halted after patient death

Five things for pharma marketers to know: Friday, October 2, 2015

Five things for pharma marketers to know: Friday, October 2, 2015

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Hillary Clinton proposes stricter regulation of opioid painkillers; the FTC argues drugmakers make slight changes to drugs to prevent generics; MannKind layoffs continue

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

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

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Democrats request subpoena over Valeant price hikes; Clinton adds research incentive to drug-pricing proposal; Roche files approval for novel MS therapy

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