Adverse Events Reporting

Novartis apologizes for slow reporting

Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark underbelly

By

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.

Novartis says it buried studies

The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.

FDA seeks EMR data-mining partner

The regulator's proposed database could help identify adverse events.

Ariad hunkers down

Ariad hunkers down

By

The drugmaker's latest financial plans could power it through mid-2015.

Ariad workforce shrinks by 40%

The company announced the layoffs Friday.

Biogen reports sales jump, backs tolerability of new MS pill

By

Execs unveiled 10% sales growth and told investors the safety news does not implicate their just-approved MS pill.

Data show Gilead's sofosbuvir has 'clean' safety profile

By

Phase III findings on sofosbuvir, released in a medical journal, suggest no cause for concern from a safety perspective.

Business briefs: GlaxoSmithKline, Adverse Event reporting, Elan

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

Business briefs: Reps mum on adverse events; FCC's new mHealth director; med schools tighten speaking limits

A study finds sales reps find time to talk benefits, but not risks, even when touting black-box drugs; FCC has named its new mHealth director; pharma scaled back its food budgets last year; and AMSA says 18 med schools now ban faculty from speakers bureau participation

Janu-"Meh": pancreatitis study fails to cause uproar

By

A study linking higher levels of hospitalizing pancreatitis among Januvia and Byetta patients has not caused a patient backlash.

Social media an outcomes listening post for pharma

By

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

Pfizer, AZ let clinicians query medical affairs staff via mobile phone

Pfizer, AZ let clinicians query medical affairs staff via mobile phone

By

Drug companies are putting their in-house medical staffs on call for prescribers to ask product-related questions or report adverse events via smartphone.

Pfizer seeks ways to ease adverse events reporting digitally

Pfizer seeks ways to ease adverse events reporting digitally

By

Pfizer is experimenting with electronic medical records and mobile technology to detect safety issues sooner.

The Women's Health landscape is ripe with opportunity for pharma marketers. This seven-page eBook offers product managers a guide to capitalizing on the trends, growth areas and unmet needs. Includes alternative channels to engage OB/GYNs and oncologists, and plenty of tips. Click here to access it.

Email Newsletters