Legal/Regulatory

Sanofi R&D lead takes aim at global drug regulations

The Paris-based drugmaker's global president of R&D said that jumping through different and inconsistent regulatory hoops puts an "enormous" cost on drugmakers.

Five things for pharma marketers to know: Monday, March 16

Five things for pharma marketers to know: Monday, March 16

By

New data suggest Amgen's PCSK9 may reduce risks of heart attacks, Salix bidding is war too rich for Endo's blood, Actavis bipolar drug use is expanded to 10- to 17-year-olds.

Top insurance lobby backs New York AG in Actavis antitrust case

America's Health Insurance Plans offered its opinion of the Actavis Namenda IR antitrust case, giving its support to New York Attorney General Eric Schneiderman.

Five things for pharma marketers to know: Wednesday, March 11

Five things for pharma marketers to know: Wednesday, March 11

By

Zogenix spins off painkiller business; Biogen Idec investigates the use of wearables in MS patients; J&J sues Celltrion and Hospira to delay Remicade biosimilar.

FDA releases new e-informed consent guidance in bid for more efficient trials

FDA releases new e-informed consent guidance in bid for more efficient trials

By

The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer

A treatise on understanding the FDA's latest guidance of low-risk general wellness products.

Five things for pharma marketers to know: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

By

Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.

Five things for pharma marketers to know: Thursday, February 5

Five things for pharma marketers to know: Thursday, February 5

By

FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.

Five things for pharma marketers to know: Tuesday, February 3

Five things for pharma marketers to know: Tuesday, February 3

By

President Barack Obama states in budget proposal that government should negotiate drug pricing; J&J's rare cancer drug's review is expedited; inhalable insulin hits pharmacy shelves.

Five things for pharma marketers to know: Thursday, January 22

Five things for pharma marketers to know: Thursday, January 22

By

Takeda COO Weber refuses Sanofi CEO post; J&J seeks $7.2 billion from Boston Scientific over 10-year old-Guidant acquisition; UCB submits epilepsy drug for US and EU approval.

Five things for pharma marketers to know: Wednesday, January 21

Five things for pharma marketers to know: Wednesday, January 21

By By

President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.

Five things for pharma marketers to know: Friday, January 16

Five things for pharma marketers to know: Friday, January 16

By By

CMS head Marilyn Tavenner has resigned; Depomed acquires Nucynta pain pill from J&J; Merck's innovation lead leaves for insurer.

Five things for pharma marketers to know: Wednesday, January 14

Five things for pharma marketers to know: Wednesday, January 14

By By

Pharma ad budgets are growing, says IPG; Medical device tax debate rages on; Pfizer has PCSK9 pill in the works.

OPDP slams print ad in Untitled Letter

OPDP slams print ad in Untitled Letter

By

The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.

Email Newsletters