FDA

Five things for pharma marketers to know: Monday, August 31

Five things for pharma marketers to know: Monday, August 31

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Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors

Five things for pharma marketers to know: Friday, August 28

Five things for pharma marketers to know: Friday, August 28

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Amgen's Repatha receives FDA nod; Mylan shareholders vote in favor of Perrigo deal; doctors push for below-average price of experimental cancer drug

Sunovion prepares for FDA decision on Aptiom

Sunovion prepares for FDA decision on Aptiom

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The FDA is expected to announce this week whether it has approved the epilepsy drug as a monotherapy for partial-onset seizures.

Five things for pharma marketers to know: Thursday, August 27

Five things for pharma marketers to know: Thursday, August 27

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The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision

Experts: Sprout needs to show Addyi is not Viagra for women

Experts: Sprout needs to show Addyi is not Viagra for women

Contrary to popular belief, Addyi is not the female Viagra. That's the message drug-maker Sprout must get across to doctors and patients in the coming weeks.

Five things for pharma marketers to know: Friday, August 21

Five things for pharma marketers to know: Friday, August 21

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The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra

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

Judge grants relief to Amarin in off-label case

Judge grants relief to Amarin in off-label case

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The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.

Five things for pharma marketers to know: Thursday, August 6

Five things for pharma marketers to know: Thursday, August 6

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AstraZeneca signs two immuno-oncology collaboration deals; UK cost watchdog goes after Pfizer over epilepsy medication price tag; Boston Globe reports drugmakers are funneling more money through CME programs

Five things for pharma marketers to know: Wednesday, August 5

Five things for pharma marketers to know: Wednesday, August 5

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The FDA updates Gilenya's label over definite case of PML; generic drug companies are consolidating for negotiating power; the FDA revises guidance on DTC risk information

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

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

Copaxone sales rise despite generic competition; Valeant to defend tax strategy; Bristol-Myers Squibb to test Opdivo with mogamulizumab in the US

The FDA seeks comments on DTC ad perception

The agency plans to research extrinsic factors that influence the way a patient perceives a drug.

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

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

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The FDA approves AstraZeneca's Iressa as a first-line lung-cancer therapy; Mylan and Dr. Reddy's launch generic versions of dementia treatment Namenda; health insurer consolidation may lead to pressure on drug prices

More than 400 drugs in development for neurological disorders

PhRMA and the Epilepsy Foundation said 50-million Americans are affected by disorders such as Alzheimer's disease and multiple sclerosis.

21st Century Cures, Amarin Court Case Advance

21st Century Cures, Amarin Court Case Advance

Pharma's efforts to evolve restrictions about off-label marketing move forward.

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.

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: 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


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