FDA calls Pfizer Estring marketing misleading

The agency's Office of Prescription Drug Promotion took the pharma to task for not mentioning the product's risks.

By Suzanne Elvidge • July 3, 2018

Drug, device companies gave docs, hospitals $8.4B in 2017

Pfizer, for example, made $447 million in research-related payments last year. 

By Les Masterson • July 3, 2018

Biopharma embracing real-world evidence, report says

The industry is accelerating adoption, investment and application, according to Deloitte.

By Suzanne Elvidge • July 2, 2018

CMS to states: Medicaid must cover accelerated approval drugs

The agency explained that any treatment cleared through the accelerated approval pathway and defined as a "covered outpatient drug" must be covered.

By David Lim • June 28, 2018

Gottlieb calls out Perrigo for missed postmarket study deadline

The FDA chief took to Twitter to remind drugmakers of their responsibilities to conduct required follow-up studies. 

By Ned Pagliarulo • June 27, 2018

Global Blood bets sickle cell drug success will convince FDA

Following initial positive Phase 3 results for voxelotor, the biotech hopes to submit the drug for an accelerated approval.

By Ned Pagliarulo • June 27, 2018

Achaogen gets a yes and a no for antibiotic Zemdri

The FDA granted approval for urinary tract infections but not for blood infections, spurring a 20% stock slump.

By Suzanne Elvidge • June 27, 2018

DIA18: How much are PRVs even worth?

Evidence has shown the value of these regulatory fast passes has diminished in recent years, and may trend further downward as the market matures.

By Jacob Bell • June 27, 2018

FDA to pub surrogate endpoints used in cancer drug approvals

It's part of a broader effort to reassess how the agency evaluates treatment benefit amid rapid clinical advances. But the approach is not without critics.

By Ned Pagliarulo • Updated June 26, 2018

FDA OK's first marijuana-based drug

GW Pharma got a green light for its plant-derived cannibidiol Epidiolex in two rare forms of epilepsy, but must wait on DEA rescheduling before launching the drug.

By Lisa LaMotta • June 26, 2018

FDA creates new meeting track to improve discussions with industry

Through a program dubbed "INTERACT," the FDA aims to engage earlier with biological product makers in hopes of smoothing initial product development.

By Suzanne Elvidge • June 25, 2018

FDA pulls back biosimilar draft guide amid industry concern

The agency appears to be sympathetic to the cost concerns raised by biosimilar drugmakers, saying it will address them in future guidance.

By David Lim • June 22, 2018

FDA limits first-line bladder cancer labels for Keytruda, Tecentriq

Labels for the checkpoint inhibitors will now include a requirement for PD-L1 expression testing. 

By Suzanne Elvidge • June 22, 2018

Enthusiasm for GSK's Shingrix has supplies falling short

Despite a shortage, the 2018 supply will still be sufficient to vaccinate more patients than last year.

By Suzanne Elvidge • June 22, 2018

New drug shortages on the rise in 2017, after years of steady declines

A damaging hurricane season, along with manufacturing woes at a key plant, contributed to the uptick, even as the number of ongoing shortages dropped. 

By Suzanne Elvidge • June 21, 2018

Incyte preps Jakafi expansion into graft-versus-host disease

With positive topline results from the pivotal REACH1 study in hand, Incyte plans to file an application next quarter.

By Jacob Bell • June 21, 2018

Opioid supply levels decline in most states, report finds

States that passed laws to limit opioid prescriptions, such as Maine, appeared to have the biggest reductions.

By Suzanne Elvidge • June 20, 2018

340B audits target hospitals more than pharma, sparking lawmaker criticism

The drug discount program has become a flash point between the two industries amid changes made by the Trump administration.

By Tony Abraham • June 19, 2018

Gottlieb lays out FDA plans to speed generic reviews, spur label updates

The agency is set to launch a new review tool aimed at reducing the number of cycles of application review.

By David Lim • June 19, 2018

How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass

In submitting ALXN1210, the rare disease biotech used one of its priority review vouchers to hasten an approval decision from regulators.

By Jacob Bell • June 19, 2018

Ziopharm shares tumble as clinical hold delays CAR-T

The FDA put a halt to the company's Phase 1 trial before it even began, seeking more information on the company's manufacturing plans.

By Suzanne Elvidge • June 19, 2018

Solid finds its footing as FDA lifts trial hold

Shares rose on news the biotech will resume enrollment into a Phase 1/2 study of its experimental gene therapy for DMD.

By Ned Pagliarulo • June 18, 2018

Valeant hit with CRL for key dermatology drug

While the pharma seems hopeful of a quick resolution, the red light from the FDA is a blow to Valeant's plans to turn around its dermatology business. 

By Ned Pagliarulo • June 18, 2018

Mylan preps for rejection of Advair copy

The generic drugmaker faces another regulatory setback for its copycat version of the blockbuster GSK lung drug.

By Lisa LaMotta • June 14, 2018

FDA permits more expansive communication between drugmakers, payers

New guidance sets out the agency's thinking on what information companies can share with insurers about their products, including for unapproved uses.

By Ned Pagliarulo • June 13, 2018