Regulatory

India establishes inspection guidelines

The new rules are expected to do away with the haphazard nature of facility inspections.

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.

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

HealthKit won't tangle with the FDA

Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.

NICE says no to Xofigo, Zaltrap

NICE says no to Xofigo, Zaltrap

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The UK's National Institute for Health and Care Excellence says it bounced Bayer's drug for failing to compare itself to current treatments, and Sanofi's over cost.

Regulators, unite! Hamburg urges global cooperation

Plans for a "new regulatory supergroup" are reported to have been in the works for some time.

Italy fines Novartis and Roche

Italy's regulator says the companies conspired to suppress Avastin sales so Lucentis could gain market share.

NICE wants more Soliris information

The UK watchdog wants to know what's behind the rare-disease drug's high price.

FTC poised to referee telemedicine

The regulator—which oversees an array of matters that include deceptive advertising and robocalls—is being nudged into this part of the medical field because of the technology involved.

FDA slammed over generics

Critics say the FDA is not doing enough to ensure generics quality and that communications between industry and the regulator need to improve.

Industry wants EMA to open its books

Industry associations want to see how money for review applications is spent.

FDA's Hamburg says India is a significant pharma partner

FDA's Hamburg says India is a significant pharma partner

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The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.

NICE gives Aubagio the nod

The price watchdog said Sanofi's oral MS drug Aubagio is a go. The decision follows a September directive to prove the drug's cost-effectiveness.

Discontinued OTC asthma med may make comeback

An FDA committee is poised to review a new Primatene Mist in February.

EMA publishes noncompliance letters

The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.

Janssen gets diabetes CRL

The FDA wants more data for the proposed canagliflozin-metformin medication mix.

FDA limits antibiotic use

The regulator tells farmers to limit antibiotic use.

FDA's 2013 so far: 26 approvals

FDA's 2013 so far: 26 approvals

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The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.

Novo compounds Tresiba troubles

Danish police are investigating the drugmaker over its decision to wait two days before announcing the FDA's February rejection.

OIG subpoenas United Therapeutics paperwork

The government division is scrutinizing marketing information for three drugs.

Deal could put FDA reps in China

Reports of a Dec. 5 deal between the US and China could deepen inspectors' reach.

Europe says Ariad's Iclusig can stay

The leukemia drug is staying on the market, but for a more restricted patient population.

FDA official talks up new review approach

Critics worry the talked-about approval plan could mean adverse events surface far too late.

OPDP letter dings Kadmon for previous violation

OPDP letter dings Kadmon for previous violation

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The agency's bad-ad warning letter calls the new violations "particularly troubling."

Roche lands EU Kadcyla approval, ducks EMA criticism

The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.

Researcher finds black-box drugs have high Warning Letter risk

EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.

FDA delays Sarepta MD drug

The regulator says the drugmaker needs to do more testing.

Ariad hunkers down

Ariad hunkers down

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

Ariad workforce shrinks by 40%

The company announced the layoffs Friday.

FDA proposal puts generics, brands on equal footing

The proposed change would allow generics makers to update labels even if branded drugmakers do not, possibly opening up generics to new liability issues.

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