Topic:

Regulatory

Latest Headlines

Latest Headlines

Medtronic: Proposed U.S. Treasury tax inversion regs won't have an impact

Medtronic has assured its investors, again, that moves by the U.S. Department of Treasure to block tax inversions will not have any material impact on it. Its latest statement is in response to temporary regulations on inversions and proposed regulations on earnings stripping that were released earlier this week by the Treasury Department.

Celltrion's Remicade biosim kneecapped Merck in Europe. Can it do the same to J&J; in the U.S.?

The FDA has officially green-lighted the Remicade biosimilar Inflectra, a med from South Korea's Celltrion and Pfizer's Hospira. But will the knockoff be able to capture the same kind of market share from Johnson & Johnson that it's been stealing in Europe from Merck & Co.? Depends who you ask.

Drug price cuts in Japan sink in though details sparse

Domestic and foreign drugmakers in Japan may cut spending on R&D; as the scope of mandated price cuts for reimbursed products kicks in--suggesting that future investments are at stake.

South Korea's Celltrion gets U.S. FDA nod for Remicade biosimilar Inflectra

The hits keep coming for South Korean biosimilar makers with Incheon-based Celltrion snapping up a U.S. FDA approval for a biosimilar of Johnson & Johnson's Remicade, which follows crosstown rival Samsung Bioepis getting an endorsement from the EMA for its version of the drug, Flixabi.

UPDATED: Celltrion, Pfizer win landmark FDA OK for a biosimilar of J&J;'s blockbuster Remicade

The FDA has approved Celltrion's biosimilar version of Johnson & Johnson's Remicade, cracking open a big market for one of the world's top blockbusters.

ConforMIS withdraws FDA submission for iTotal Hip, to resubmit in second half

Personalized 3-D printed joint implants may seem like a no-brainer. But troubled small-cap ConforMIS has struggled to dig in its heels since a $135 million IPO last June. Last fall, the implant maker faced a recall due to packaging problems. And now the FDA has forced its hand on a regulatory submission for a hip implant--causing it to withdraw the application in the face of unanticipated questions.

UPDATED: FDA nitpicks Shionogi's head lice copay voucher over 'false and misleading' claims

Things are getting hairy for New Jersey-based pharma Shionogi and its head lice treatment Ulesfia. The FDA is chastising the company for putting out a copay coupon that talks up the lotion's benefits without warning patients about its risks.

American Optometric Association takes beef with eye test app to FDA

The American Optometric Association (AOA) is hopping mad at eye test maker Opternative for allegedly marketing its product without proper approvals, and now the group wants the FDA to jump into the fray. The AOA is urging regulators to take legal action against Opternative for selling a test that leads to an eyeglass or contact lens prescription without an in-person exam by an eye care professional.

Intercept surges as FDA review hesitates on endorsing OCA data, but doesn't hate it

FDA staffers reviewing Intercept's data on obeticholic acid (OCA) for rare cases of primary biliary cirrhosis noted that the drug clearly hit a key goal in the study after finding the safest dose for patients. But the panel of outside experts scheduled to meet on Thursday will be charged with considering whether its impact on the single biomarker for the disease--a surrogate for transplant-free survival--is sufficient for an approval, with data lacking on another biomarker and lingering concerns about potential liver damage.

Gilead gains next-gen HIV approval from FDA as it looks to beat back competition

Gilead Sciences has notched up yet another HIV therapy approval as touted blockbuster Descovy gains the nod from the U.S. regulator.