Regs

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.

Roche has no rights to Sovaldi, panel rules

Despite a collaboration with original Sovaldi owner Pharmasset in 2004, a panel ruled Roche has no rights to HCV treatment Sovaldi.

Eisai sues FDA for more patent life

The Japanese drugmaker is looking to add as much as a year onto the patent life of some of its drugs after the DEA dragged out their scheduling decisions.

FDA wants more info on Acura pain drug

FDA wants more info on Acura pain drug

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FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.

 Five things for pharma marketers to know: Friday, August 15

Five things for pharma marketers to know: Friday, August 15

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UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.

Kyprolis fails to wow in survival trial

Kyprolis fails to wow in survival trial

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Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.

FDA tackles women's sexual health

The regulator and patients will chat for two days in October.

AbbVie makes inroads in orphan drugs

AbbVie makes inroads in orphan drugs

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Not long after acquiring Shire to add to its orphan-drug portfolio, the drugmaker scored an orphan designation from both FDA and EMA last week.

Colorectal cancer test is FDA moment of sorts

Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.

FDA clocks record number of recalls

The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.

India establishes inspection guidelines

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

EU mulls new Prevnar 13 indication

A greenlight could garner Pfizer $1B in sales.

Investors want end to biosim trash talk

A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.

Britain's NICE sidelines Kadcyla

Britain's NICE sidelines Kadcyla

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Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.

Pfizer settles off-label Rapamune case for $35M

Pfizer settles off-label Rapamune case for $35M

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The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.

FDA grants Fast Track to Baxter JAK inhibitor

The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.

Lawmakers want FDA to boot phthalates

Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.

Zohydro to get marketing overhaul

Zohydro to get marketing overhaul

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The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.

Open Payments website 'temporarily' taken offline

The pharma payment verification site has been temporarily shut down by CMS due to incorrect information, ProPublica reported today.

Healthcare.gov price rises

The cost of fixing healthcare.gov is hovering at around $1 billion, up from the $677-million figure quoted in December

Lawmakers eye pricing

The Senate Judiciary Committee's antitrust panel is looking into how three major pharmaceutical manufacturers decided to set minimum prices for their contact lenses.

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to display Sunshine payment data

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Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like meals, travel, gifts, consulting and research

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.

Payment database confounds doctors

ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Court invalidates some healthcare subsidies

The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

FDA gets treatment guidance from patient advocates

FDA gets treatment guidance from patient advocates

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Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

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