New & Noteworthy

Prastera: A Drug Listing Submission Case Study

Mark Gross offers a case study in using structured product labeling (SPL) to reduce time to market.

Stamping on MAPPs: Is Europe Trapped Again by Division?

Just as the medicine adaptive pathways to patients (MAPPs) gains currency, the EU has introduced STAMP, which is intended to assist the process but might well suffocate it. Reflector reports.

Are Global Markets Free-riding on the United States?

"Global free-riding" is the perception that the U.S. is subsidizing drugs for the rest of the world due to its high drug prices compared to other countries in the world. Ed Schoonveld reports.

The End of Pharma Marketing — or a New Beginning?

Two commercial marketing experts discuss how this mission critical function must change to stay relevant in bringing new therapies to the patients who need them.

A Blueprint for Launch

William Looney breaks down the four steps to a successful drug launch, using Keryx Biopharmaceuticals’ model for Auryxia, its new treatment for chronic kidney disease.

Europe

The NICE Threshold Debate Heats Up

The debate around NICE's threshold for cost effectiveness has always been heated; recent theories add more fuel to the fire, writes Leela Barham.

Stamping on MAPPs: Is Europe Trapped Again by Division?

Just as the medicine adaptive pathways to patients (MAPPs) gains currency, the EU has introduced STAMP, which is intended to assist the process but might well suffocate it. Reflector reports.

Slow Growth to 2020 for France's Pharma Market

The French pharmaceutical market is forecast to grow at a "tepid" CAGR of 0.7% from $46.2 billion in 2014 to $48.2 billion by 2020, according to GlobalData.

Global

Ebola Vaccines, Treatments Ramp Up for Clinical Trials

Several vaccine candidates are moving into larger clinical trials, supported by government and industry efforts to address manufacturing and research challenges. Jill Wechsler reports.

VC Optimism to China: Leading Biologics Company Raises $100m C Round

2014 was a banner year for investment in biotech, and there is little sign of decline. With an unprecedented $100m Series C round of financing, Innovent has demonstrated this optimism extends as far as China.

Got Ideas? Go North!

The Canadian R&D industry, which boasts a rich history of drug innovation, celebrates a series of anniversaries.

Strategy

Pharma 2015: Industry in Flux

What's hot and what's not this year? Is pharma still a 21st century growth industry? See our 2015 Strategic Outlook.

Supply Chain Analytics: Pharma’s Next Big Bet

Examining a new three-part formula to enable the supply chain function to manage market pressures while delivering on the bottom line.

Sanofi’s Big Bet on Integrated Patient Care

Pharm Exec profiles Sanofi EVP Pascale Witz, tagged with the assignment to move a lumbering biopharma giant closer to the embrace of the patient perspective in healthcare.

PEspeaks

Pharma's Love Affair with Buzzwords

How pharma can finally put true meaning behind its juiced-up jargon and turn the bluster into reality, by Lundbeck's Timothy White.

The NICE Threshold Debate Heats Up

The debate around NICE's threshold for cost effectiveness has always been heated; recent theories add more fuel to the fire, writes Leela Barham.

The Truth Doesn't Hurt: Why It Pays to Be Straight in Pharma

The Jim Carrey film Liar Liar showed us the comic consequences of always telling the truth. What if people in business did the same? Mike Straw considers what the impact on pharma would be.

Trending: Shire's Valley of the Dolls

Thanks to Shire's star drug Vyvanse, if you don't know much about binge-eating disorder, you soon will, writes Marylyn Donahue.

More Guidance, Fewer Warnings on Drug Advertising

FDA officials have been busy rolling out advisories for pharma marketers, and there’s no let-up in sight, writes Jill Wechsler.

Regulatory

Manufacturers Weigh Strategies to Prevent Drug Shortages

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers and biopharma manufacturers, writes Jill Wechsler.

We Need New Financial Models for Biomedical Innovation

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high U.S. revenues to fund biopharmaceutical R&D, writes Jill Wechsler.

Obama's Mixed Message for Biopharma R&D

President Obama has unveiled his $215m “Precision Medicine Initiative” to support the future biomedical research, while calling for a reduction in exclusivity on brand biologics from 12 to 7 years and a curb on "evergreen” patents on certain biologics. Jill Wechsler reports.

Does the Adaptive Pathways Debate Go Far Enough?

While such discussions have advanced in Europe, two key omissions from the dialogue may limit any real changes.

Sales & Marketing

What's Wrong with the Annual Sales Kickoff: And How to Fix it

New ways for pharma to make sure its sales reps stay sharp amid a flood of new information and a more complex selling climate. By Duncan Lennox.

Digital's Place in the Pharma Marketing Mix

The rush to digital will continue at a fast clip, but marketers need to reacquaint themselves with their brands' audiences.

OTC Drug Advertising: Alfred Hitchcock Style

The legendary director's on-screen attitude to his TV show's sponsor, Bristol-Myers, caused some consternation—until the drugmaker saw the results.

Social Media and the In-House Counsel

What is and what should be keeping you up at night.