FDA

Five things for pharma marketers to know: Friday,  October 17

Five things for pharma marketers to know: Friday, October 17

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Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.

Panel seems to like Novartis drug

Pre-review documents indicate a favorable opinion of the IL-17 inhibitor secukinumab.

New FDA division launches Jan. 1

Resignations stymied the Office of Pharmaceutical Quality's beginning.

Shire delays ADD medication submission

The company is working with the FDA on new clinical trial requirements.

Five things for pharma marketers to know: Friday, October 3

Five things for pharma marketers to know: Friday, October 3

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Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep

Pacira gets OPDP opioid promotion Warning Letter

Pacira gets OPDP opioid promotion Warning Letter

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The FDA's Office of Prescription Drug Promotion says Pacira's promotional materials for Exparel are "extremely concerning," but the drugmaker tells investors the fuss is probably because opioids have been getting a lot of attention lately.

Advocates want FDA's Hamburg out

The reason: opioids.

Five things for pharma marketers to know: Friday, September 19

Five things for pharma marketers to know: Friday, September 19

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Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.

Novo seeks liraglutide obesity indication

Novo seeks liraglutide obesity indication

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An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.

Merck scores first US PD-1 approval

Merck scores first US PD-1 approval

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The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).

FDA sanctions don't kill a business

Bloomberg reports that India's Wockhardt has become an M&A target.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.

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.'"

FDA tackles women's sexual health

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

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.

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.

FYI: FDA habla español

The FDA issued a Warning Letter over unapproved drug claims published in Spanish.

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.

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Avastin pockets another Priority Review label

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

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.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

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The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

Researchers give FDA social media advice

Researchers give FDA social media advice

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Researchers from Boston Children's Hospital, Harvard Medical School and Brigham and Women's Hospital are offering a bit of internet advice for the Food and Drug Administration: do more.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year

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Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.

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