In Focus

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

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FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark underbelly

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Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

Industry resists FDA's social-media stance

Industry resists FDA's social-media stance

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Months before FDA's expected main venture this summer into regulating medical marketers' activities in social media, the industry reacted sharply to a draft guidance the agency issued in January

How serious is India's pharma problem?

How serious is India's pharma problem?

Are the Ranbaxy Laboratories and Sun Pharmaceutical recalls of prescription generics isolated incidents, or signs of a pharma culture in which corners are too often cut in the interest of profits and process?

Playing the name game with biosimilars

Playing the name game with biosimilars

Allowing copies of branded biologic medicines to share the original drug's non-proprietary name will have little or no consequence for patient safety, most stakeholders and experts said during a February workshop convened by FTC

NuvaRing: another ethical crisis at Merck

NuvaRing: another ethical crisis at Merck

The ethical spotlight is once again pointed at Merck & Co., Inc. In December, Vanity Fair put a human face on the controversy swirling around the company's Nuva­Ring contraception product.

Agencies step up recruiting to capitalize on unrest

Agencies step up recruiting to capitalize on unrest

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Last year's merger of two big ad networks prompted indie shops to step up recruiting, and get creative. Blanketed media buys, organ-themed T-shirts and ice cream giveaways are among tactics.

New law aims to remedy drug supply chain

New law aims to remedy drug supply chain

Big pharma marketers who've been complaining to Washington for decades about the unregulated nibbling at their market shares won historic relief when the Drug Quality and Security Act was signed into law on Nov. 27.

Putting the big picture ahead of LDL levels

Putting the big picture ahead of LDL levels

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Aggressive new recommendations for treating patients at high risk of cardiovascular disease could significantly alter the treatment landscape.

It's time for J&J to challenge the Credo...again

It's time for J&J to challenge the Credo...again

Will J&J ever regain its once stellar reputation for ethics and social responsibility?

A growing wave of recalls rocks pharma

A growing wave of recalls rocks pharma

According to a Stericycle ExpertRecall report, drug and pharmaceutical recalls reported by FDA in the second quarter of this year surged 127% over the previous quarter

The challenges of opening up the data door

The challenges of opening up the data door

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Data-sharing advocates have been calling on manufacturers to release the raw data from clinical trials so that researchers can look at all the parameters related to specific drugs

Playing the numbers game with adherence

Playing the numbers game with adherence

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A study found that removing financial barriers to medication adherence improves the quality of patient care, but does not result in major savings

Pharmas accept reality of external R&D

Pharmas accept reality of external R&D

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There's been a paradigm shift among buy-side companies, which have finally accepted the fact that external R&D is going to be a big part of the future.

White House budget would cost pharmas

White House budget would cost pharmas

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The White House has released its proposed budget for the 2014 fiscal year, and while it gives a modest boost to Health and Human Services, it also seeks to extract more cost savings from pharmas.

Sequester cuts could slow FDA for years

Sequester cuts could slow FDA for years

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With sequester cuts taking effect at FDA and no sign of a deal to end them in sight, it's certain the approvals process will slow as the agency absorbs the loss.

Sunshine rule warms some, burns others

Sunshine rule warms some, burns others

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With the dust beginning to settle on CMS's final rule for the Sunshine provisions of Obamacare, winner and losers are starting to emerge from the fine print

Trial employing crowd input gets FDA nod

Trial employing crowd input gets FDA nod

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What's been called the first clinical study protocol developed using crowdsourcing methods received the FDA's imprimatur.

FDA touts approval speed as 2012 ends

FDA touts approval speed as 2012 ends

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Pushing back against complaints that the drug approvals process moves too slowly in the US, FDA issued a report saying it kept pace with its 2011 showing

Access could hold down prices globally

Access could hold down prices globally

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Due to the trend toward increased healthcare access, healthcare could go from being an additional benefit to "being regarded everywhere as a basic human right." That would mean more drugs prescribed.

Patients, pharmas fail to connect online

Patients, pharmas fail to connect online

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Hearing patient activists and pharma and agency execs talk about connecting through social and other online channels brings to mind a room full of awkward wallflowers at a high school dance.

Analysis sounds alarm on pipeline output

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A Bernstein Research report shows that, essentially, "Pipeline success rates across all phases of development have been slowly worsening or at best staying flat, depending on the phase (preclinical through registration)."

Social solutions top tech in Sanofi contest

Social solutions top tech in Sanofi contest

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The winner of Sanofi's second Data Design Diabetes Innovation Challenge was a community-focused proposition that focuses on face-to-face interactions

All-oral hep. C combos threaten interferon

All-oral hep. C combos threaten interferon

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Scientists are getting closer to finding the killer app in treating hepatitis C, but it may be too soon to pick a winner.

Social media's strengths as source of info

Social media's strengths as source of info

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FDA issues may deter drugmakers from engaging in social media, but that's no excuse to ignore what audiences are saying on these platforms

A shot over pharma's bow on co-pay cards

A shot over pharma's bow on co-pay cards

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Community Catalyst has declared war on prescription co-pay cards and coupons, calling the sales tools nothing more than kickbacks and bribes.

Komen Foundation nurses damaged brand

Komen Foundation nurses damaged brand

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Why the Susan G. Komen for the Cure Foundation's previously unassailable brand in healthcare fundraising may have sustained some permanent damage.

The factors behind WebMD's sale attempt

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News of WebMD's planned sale—since aborted—surprised many observers.

Since Vioxx, hard times for pharma R&D

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Everyone in biopharma knows that manufacturers are spending more to develop drugs that earn less than they did ten years ago, but a new study has put some eye-popping numbers on the industry's dwindling returns.

Despite ad push, HPV vax awareness flags

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A little over half of US girls ages 13 to 17 have not gotten even one dose of the HPV vaccine

Companies react to Facebook's open walls

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After Facebook's decision on August 15 to enforce open walls on the site's pharma pages, companies had two options: close down their pages altogether, or let the public openly comment on their products.

Why KOLs are up on Eliquis bloodthinner

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Oral anticoagulant Eliquis (apixaban) has demonstrated superior efficacy and bleeding profile to standard warfarin therapy. Barring any bombshells, that should be enough for this agent, being developed by Pfizer and Bristol-Myers Squibb, to get US approval and form a compelling sales narrative in the warfarin-alternative market, analysts say.

FDA says device process should remain

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The FDA is moving cautiously on a call by the Institute of Medicine (IOM) to scrap the approvals process for many medical devices.

App guidance puts pharma out of focus

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FDA issued draft guidance on mobile medical apps, focusing narrowly on those programs that augment regulated medical devices or turn mobile devices into medical devices.

Seeking to revive pharma's R&D mission

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Pharmaceutical R&D productivity hasn't always been an oxymoron. What has gone wrong, and how to improve it, was the subject of a Bernstein Research investor conference in May that pulled together eight industry experts from a variety of backgrounds.

Will healthcare reform gains outweigh pain?

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The Patient Protection and Affordable Care Act turned one in March, and it was, for the drug industry, an ambivalent occasion.

Paying moms for app reviews: ethical or not?

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An Abbott iPhone app is drawing attention to the practice of compensating bloggers for app reviews, as some call into question the ethics of pay-for-play PR.

An ex-Merck exec's grand bargain for DTC

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A former Merck exec says it's time to wind down a product advertising arms race that he says hurts pharma firms more than it helps them.

As GOP takes aim at FDA, Sharfstein bows out

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The FDA's point-man on prescription drugs, principal deputy commissioner Joshua Sharfstein, left the agency to head up public health in his home state of Maryland.

Cautious year for FDA yields few blockbusters

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The FDA stretched out the timing of approvals last year as the safety concerns made it increasingly hard to take a yes-no stand on pipeline drugs. Of those drugs that were approved, sales projections have been largely disappointing.

Coumadin gives lesson for new blood thinners

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A love-hate relationship for Coumadin is playing out online, say authors of a new report that may offer lessons for marketers of new blood-thinning products.

King gives Pfizer sales edge in the pain game

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Pfizer's $3.6 billion acquisition of King Pharmaceuticals will expand Pfizer's portfolio in the pain category, adding Embeda, Avinza and the Flector Patch to Pfizer's Lyrica and Celebrex products.

Social media provided unheard early warning on Avandia

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A new report whose findings could have profound implications for adverse events reporting says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk.

Frazzled pharma reporters chase scoops

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It was lunchtime on day two of ExL's pharma public relations conference at Pfizer headquarters, and the host, Pfizer PR chief Ray Kerins, took the podium to vent some steam with his fellow flacks.

Japanese pharmas buying American

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Even as US and European pharmas downsize their stateside sales forces, Japanese pharmas have become a significant driver of M&A activity in America, seeking to expand their business in a market that's still far and away the world's largest. But are they showing up to the party just as the punchbowl has been exhausted?

No easy way back from cliff for pharma

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With many high-margin blockbusters going off patent and a lack of replacements, a Sanford C. Bernstein Research conference explored three potential solutions to the patent cliff: business diversification, mergers and acquisition, and managing costs like sales and marketing.

Biosimilars mean competition for biologics

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When patents expire on brands like Merck's cholesterol pill Zocor, million-dollar ad budgets usually fizzle as cheap generic competition takes over the market.

Bringing heritage, education up to date

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Back in 1999, the Medical Advertising Hall of Fame (MAHF) published a breakthrough coffee table tome, Medicine Avenue, which charted the history of medical advertising through 116 expansive pages of friendly copy and plenty of large, inviting images of the best creative from the 1940s to the 1990s.

Pricing ire leaves pharmas vulnerable

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It was activism that drew the world's attention to the HIV epidemic and to the need for ethical standards in AIDS-drug testing. And activism is once again playing a role, this time in challenging a drug company, Merck, over the price of HIV/AIDS medicine Isentress.

Oncology journals: rough trade in 2009

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Thinking of launching an oncology journal? You may have missed a profitable window.

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MM&M EBOOK: PATIENT ACCESS

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