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 FDA

Business Briefs: Merck and Forest Labs

May 23, 2013

Merck's proposed insomnia drug scores a thumbs-up from an FDA advisory panel, and long-time Forest Labs CEO Howard Solomon announces his coming retirement.
 

Business briefs: Pfizer, Novartis, Boehringer Ingelheim, Elsevier

May 22, 2013

Pfizer seeks full Zoetis split, Novartis gets another NICE Lucentis indication, BI tussles with the FDA and Elsevier names a Cleveland Clinic doc EIC
 

Business briefs: Actavis, Bayer, Oramed, Elan

May 20, 2013

Actavis buys Warner Chilcott, FDA clears oral insulin for testing, Elan swallows AOP Orphan for $340M
 

Business briefs: Bayer, FDA, Ranbaxy

May 15, 2013

Bayer's prostate cancer drug clears FDA three months early; a House committee is pressing the regulator for employment transparancy; and Ranbaxy takes a multi-million dollar hit over violations
 

FDA gut-checks DTC clarity

May 14, 2013

The new survey will study whether patients understand how efficacy is calculated and experiment with ways to make communications clearer.
 

J&J's Janssen looks to the margins with hep C agent

May 14, 2013

J&J scored an unexpected "priority review status" for its HCV agent simeprivir, whose initial approval is expected to be with interferon.
 

FDA move gives Purdue edge in painkiller market

May 13, 2013

Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status.
 

GSK adds competitor to COPD market

May 10, 2013

The FDA approved the Breo/Ellipta combo, but analysts are wary about its potential to go beyond the COPD indication in the US.
 

Business Briefs Merck, GSK, Novo, Walgreen, Epocrates, Doximity

May 09, 2013

HPV vaccine price cut; Merck files new allergy med with FDA; GSK pursues online transparency; Walgreens ready for greater nurse autonomy; Epocrates ranks high among docs with tablets.
 

Business briefs: Arena, Takeda, Teva, Cubist

May 08, 2013

Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status.
 

FDA streamlines patient access information

May 06, 2013

A new FDA site gives patients a one-stop shop for commenting on pending regulations, finding clinical trials and navigating treatment options.
 

Business briefs: Sanofi, Allergan, Otsuka, Genmab, NIH, Novartis, DOJ

May 02, 2013

Lantus cushions Sanofi's quarterly sales; Allergan holds back on Eylea competitor; FDA limits use of Otsuka drug; Genmab lands Breakthrough label; NIH finds a link among cancers; and Novartis offers lunch with a side of medical information; DOJ appeals Plan-B Ruling.
 

Docs haven't mellowed on DTC, snap poll suggests

May 01, 2013

The FDA wants to know how physician attitudes towards direct-to-consumer advertising have evolved since the agency last asked them, in 2002. If a snap poll by CMI/Compas is any indication, drug companies probably won't like the answers.
 

Duchesnay returns morning sickness drug to US market

May 01, 2013

The first drug for morning sickness in thirty years enters the market this month.
 

BMS scores "breakthrough" label for hep. C candidate

April 25, 2013

The regulatory coup means BMS gets to work with FDA to develop its home-grown hep. C cocktail, which is on a competitive track to another hep. C alliance with Merck.
 

Novartis: lawsuits, layoffs and, by the way, earnings

April 24, 2013

It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year.
 

After Q1 sales slip, GSK seeks to reassure investors

April 24, 2013

CEO Andrew Witty said the quarter's results were what the company expected.
 

Amgen sales up for the quarter, but biosimilars grab buzz

April 24, 2013

Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars.
 

FDA widens scope of DTC impact survey

April 23, 2013

The agency is revisiting the impact DTC advertising can have on healthcare. What's new: NPs and PAs are being asked for input.
 

Business Briefs: GSK, Astellas, Vertex and Orexigen

April 22, 2013

GSK and Astellas kick off the race for a new anemia treatment; Orexigen's CEO joins PhRMA; BMS and Merck team up in a hep.-C clinical trial; Novartis lands glaucoma approval; Ireland starts naming preferred drugs; Novo has new New Jersey digs; Vertex releases promising data for new cystic fibrosis treatment.
 

GSK's Advair successor gets adcomm thumbs-up

April 18, 2013

An FDA advisory committee recommended approving Breo for COPD. Assuming it goes through, GSK will have to woo payers to upgrade from the older drug.
 

Lilly digs deeper into Alzheimer's

April 17, 2013

The company has licensed two tracers that will be used in its anti-amyloid and anti-tau research, and its still-breathing solanezumab binds to beta-amyloid proteins
 

Analysts on Qsymia: show me the payers

April 17, 2013

Analysts write expanded Qsymia distribution will do little to boost sales if payers are not on board.
 

Business briefs: GlaxoSmithKline, Adverse Event reporting, Elan

April 15, 2013

GSK's Avandia woes continue, study finds a new way to identify adverse events, and Royalty ups its bid for Elan.
 

Rare disease awareness fails to ease physician, patient burden

April 15, 2013

A study shows FDA approvals and awareness efforts are having little impact on physician awareness or patient frustration.
 

Pfizer pipeline breast cancer drug gets fast tracked

April 11, 2013

FDA is accelerating review of Pfizer's experimental breast cancer drug palbociclib, which analysts say already has a fan base among KOLs.
 

Business briefs: PwC, Novartis, iDoc24, FDA

April 10, 2013

PricewaterhouseCoopers says consumers are talking healthcare, but not about the good stuff; Novartis shuffles 120 Texas jobs; 73% of STD app queries came from men last month; FDA is keeping very busy; and OgilvyCommonhealth hires a consumer head
 

Business briefs: Roche, Vital Art and Science, Gilead, Sanofi

April 09, 2013

Roche and Isis pair up for Huntingtons, Vital's prescription vision app gets approved, FDA approval revives maligned morning sickness drug, Gilead sends hep C therapy to regulators and Sanofi's emerging market exposure grabs attention.
 

Business briefs: AstraZeneca, Everyday Health, J&J

April 02, 2013

AstraZeneca loses in patent court and Pulmicort goes generic, Barbara Ryan joins FTI, Everyday Health and Mayo Clinic expand their advertising alliance, analyst says Ivokana side effect could limit sales
 

Business briefs: Chandler Chicco, Pfizer, FDA, Dainippon, CDC

April 01, 2013

Gwee exchanges Edelman offices for Chandler Chicco's, Pfizer can't shake Celebrex lawsuits, FDA issues draft guidance for biosimilars meetings, Dainippon Sumitomo acquires Edison Pharmaceuticals, CDC reports on growing ADHD diagnoses.
 
  

Web Exclusive

Angelina Jolie's fearless but flawed message

Paul Oestreicher, Ph.D. May 17, 2013

Angelina Jolie's story raises important questions about education, outreach and access—but her nod to holistic treatments is less helpful
 

Podcasts

How to engage even the busiest physicians

March 04, 2013

Sponsored by TRUE Health + Wellness. The increasingly demanding schedules of healthcare professionals continue to narrow the window of opportunity for pharma sales teams, and, as a result, marketers are focusing more on non-personal promotion. However, there's a lot more to it than simply bombarding physicians with brand messages, as Anne Stroup, Managing Director at TRUE Health + Wellness, explains to MM&M's James Chase in this special podcast presentation.
 

2013 Hall of Fame Inductees

An entertaining look at the extraordinary lives and careers of the Medical Advertising Hall of Fame's 2013 inductees: Peter Frishauf, Dorothy Philips and David Labson. Clips produced by JUICE Pharma. 

Slideshows

MAHF 2013: Honors Class

A gallery of images from the 2013 Medical Advertising Hall of Fame induction dinner