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

FDA mulls new incentives to stem antimicrobial resistance

The agency is working to smooth approval pathways for new products, while proposing changes to reimbursement to account for limited use.

By Suzanne Elvidge • June 13, 2018

CMS sets goals to tackle opioid crisis

The plan calls for greater data transparency, as well as use of a Medicare heat map to pinpoint areas that can benefit from targeted safe prescribing efforts.

By Meg Bryant • June 12, 2018

AbbVie, Roche win key US approval for blood cancer drug

Venclexta, when paired with Rituxan, is now cleared for second-line treatment of two related types of leukemia, positioning the drug behind Imbruvica.

By Ned Pagliarulo • June 11, 2018

EMA moves forward with Amsterdam relocation

The board of the EU's medicines agency signed off on a plan to keep business moving as the agency moves from London post-Brexit.

By Suzanne Elvidge • June 11, 2018

'Patient-focused' drug development guidance coming, FDA chief says

Speaking at the BIO International convention, FDA Commissioner Scott Gottlieb also laid out his vision to balance workloads among therapeutic areas.

By Lisa LaMotta • June 8, 2018

BIO18: FDA to issue guidance on cell and gene therapy in July

Commissioner Scott Gottlieb also said the industry needs to move toward continuous manufacturing of these treatments.

By Lisa LaMotta • June 7, 2018

FDA lays out biosimilar guidance for agency meetings

One aim of the draft guidance is to speed biosimilars' path to market by improving communication with the regulator. 

By Suzanne Elvidge • June 6, 2018

First Neulasta biosimilar headed to US market

The FDA has approved Mylan and Biocon's copycat pegfilgrastim, putting even more pressure on the already weakening Amgen franchise.

By Jacob Bell • June 6, 2018

FDA puts illegal opioid websites on notice, issues warning letters

Commissioner Scott Gottlieb said the effort is one piece of a broader effort to crack down on opioids sold online and shipped by mail.

By David Lim • June 6, 2018

AMA trumpets physician efforts in opioid epidemic fight

The doctors' group said opioid prescriptions are down while prescription drug monitoring program queries are up.

By Les Masterson • June 1, 2018