FDA

Five things for pharma marketers to know: Wednesday, July 1

Five things for pharma marketers to know: Wednesday, July 1

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Purdue withdraws plans to participate in FDA meeting on painkillers; Allscripts takes 10% stake in NantHealth in advance of IPO; union advocates to end pharma support for CME

Clinton tells pharma to explain drug prices

Clinton tells pharma to explain drug prices

Speakers at Klick Health's event criticized, lauded the role of technology in healthcare.

Amicus briefs pile up in Amarin lawsuit

The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.

Five things for pharma marketers to know: Monday, June 15

Five things for pharma marketers to know: Monday, June 15

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CVS Health to buy Target's pharmacy business; experimental gene therapy improves condition of teen with sickle-cell disease; PatientsLikeMe partners with the FDA to improve postmarket surveillance

Amarin lawsuit about more than fish oil

Amarin lawsuit about more than fish oil

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An FDA letter says there was no need to go to court but experts tell MM&M this lawsuit highlights an issue that is bigger than a single pill.

Five things for pharma marketers to know: Thursday, June 11

Five things for pharma marketers to know: Thursday, June 11

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Amgen's PCSK9 inhibitor is the second in its class to get an FDA panel endorsement; a new drug could threaten Shire's hold on a rare-disease category; a study shows pharma invests less in Hispanic audiences than in other groups

Five things for pharma marketers to know: Tuesday, June 9

Five things for pharma marketers to know: Tuesday, June 9

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Study shows Merck's Januvia does not increase heart risks; a former Genentech exec launches a behavioral health business; lawmakers want black-box warnings on more opioids

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, Thursday, June 4

Five things for pharma marketers to know, Thursday, June 4

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Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting

Five things for pharma marketers to know: Tuesday, June 2

Five things for pharma marketers to know: Tuesday, June 2

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A House committee is looking into the FDA's warning letter publication process; Amgen and Roche collaborate on cancer combination drug; study shows online health information fails teenagers

New bill seeks to spur FDA to form clearer social media rules

New bill seeks to spur FDA to form clearer social media rules

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Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.

Five things for pharma marketers to know: Friday, May 22

Five things for pharma marketers to know: Friday, May 22

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Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

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The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.

OPDP finds fault with Rapaflo website

The FDA's advertising division said images and copy for the BPH drug Rapaflo are misleading.

Five things for pharma marketers to know: Wednesday, May 20

Five things for pharma marketers to know: Wednesday, May 20

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FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs

Five things for pharma marketers to know: Friday, May 15

Five things for pharma marketers to know: Friday, May 15

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Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease

Five things for pharma marketers to know: Friday, May 8

Five things for pharma marketers to know: Friday, May 8

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Amarin sues FDA over off-label discussions; spike in HCV infections in US blamed on Endo opioid; Pfizer settles gambling, eating and sex addiction lawsuit

Five things for pharma marketers to know: Monday, May 4

Five things for pharma marketers to know: Monday, May 4

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Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways

Five things for pharma marketers to know: Thursday, April 30

Five things for pharma marketers to know: Thursday, April 30

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FDA advisory panel recommends Amgen's T-Vec; Teva again makes the case for a merger with Mylan; the FDA approves injection to treat double chins

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

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The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.

FDA takes aim at Abilify marketing material

The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.

Five things for pharma marketers to know: Tuesday, April 21

Five things for pharma marketers to know: Tuesday, April 21

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Teva proposes acquisition of Mylan; start-up offers BRCA testing for $249; Botox receives another label expansion

FDA takes unusual stance on ALS drug

FDA takes unusual stance on ALS drug

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The FDA asked private biotech Genervon to release all available clinical trial data for its experimental ALS treatment.

Five things for pharma marketers to know: Friday, April 17

Five things for pharma marketers to know: Friday, April 17

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The FDA approves generic Copaxone; AstraZeneca's experimental lung-cancer drug demonstrates that it can delay disease progression; PhRMA CEO John Castellani to step down

Five things for pharma marketers to know: Tuesday, April 14

Five things for pharma marketers to know: Tuesday, April 14

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IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza

Five things for pharma marketers to know: Friday, April 10

Five things for pharma marketers to know: Friday, April 10

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AstraZeneca diabetes drug may have increased mortality rate; Pfizer accused of knowing about birth defect risks from Zoloft; Eisai to cut 25% of its US workforce

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

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

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Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times

FDA Onglyza panel review set for Tuesday

FDA Onglyza panel review set for Tuesday

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The panel will focus on heart failure hospitalization rates associated with the diabetes medication.

Hospira gets fifth FDA warning in two years

The company has received seven warning letters since 2010.

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

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

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FDA accepts previously rejected Novo Nordisk insulin application; Merck HCV doublet regimen receives Breakthrough designation for patients with kidney disease; researchers say that rising costs for cancer drugs aren't reasonable

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What does going "beyond the pill" actually mean? At MM&M's recent inaugural spring conference, audience members heard from real-world companies that are managing the organizational, technological, and promotional challenges inherent in this transition, such as partnering with health neophytes, harnessing technologies that allow deeper engagement with patients, and adopting a new commercial mindset to serve, not sell. Download here.


A wave of more effective anti-cancer drugs has set the oncology world on fire with enthusiasm. While many hail this as a new era, an equally vocal faction questions the money spent for the value gained. This medical and commercial trend report for marketers of anti-cancer modalities touches on many of the latest shifts that have expedited product launches and otherwise impacted promotion and reimbursement of these drugs. Click here.