PharmaBiz

Gilead reaps huge HCV sales, payer fury

Gilead reaps huge HCV sales, payer fury

By

Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also reaped blockbuster sales for Gilead.

Panel votes against painkiller

Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."

Bayer drug gets orphan label

Bayer drug gets orphan label

By

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

Valeant bids $47B for Allergan

Valeant bids $47B for Allergan

By

The deal would bring Allergan's Botox and Juvederm under the same roof as Restylane.

Sarepta plans for 2015 drug review

Sarepta plans for 2015 drug review

By

The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.

GSK allegations build in Jordan and Lebanon

GlaxoSmithKline says it is investigating allegations of employee misconduct. The company said in a statement that the allegations have numbers "very similar to those reported by other companies in our sector."

Generic Celebrex is coming

Pfizer and Teva's settlement puts generic Celebrex on the market by December.

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

By

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Researchers say Tamiflu a waste of money

Complete data sets have prompted researchers to say Tamilflu and Relenza fail at their key reason for being: preventing flu pandemics.

Merck looks poised to challenge Gilead

Merck looks poised to challenge Gilead

By

Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.

Halozyme pancreatic drug study on FDA hold

Halozyme pancreatic drug study on FDA hold

By

The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.

Louisiana sends Takeda $9-billion Actos bill

The drugmaker is accused of burying cancer risks associated with the diabetes medication.

FDA won't review Afrezza until July

The regulator has put off the inhaled insulin's PDUFA date by three months.

Alkermes to submit schizophrenia med this year

Phase-III results prompted the drugmaker to pursue a third-quarter filing.

Sun Pharma to buy Ranbaxy

The announcement will create the fifth largest generics drug maker, reports Reuters.

Roche seals two deals in one weekend

The Swiss drugmaker has scooped up Oryzon's experimental acute myeloid leukemia treatment and private Massachusetts diagnostics firm IQuum.

GSK reportedly being investigated for Mideast behavior

WSJ's sources say allegations of misconduct are similar to those leveled against the company in China.

ViiV adds Tivicay to UN patent pool

The GSK-Pfizer-Shionogi joint venture said it will add HIV med Tivicay to a United Nations patent pool, cutting its price for developing countries and granting access for generics firms.

GSK stops lung-cancer vaccine trial

The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

SCOTUS to hear out Teva on Copaxone delay

The Israel-based drugmaker will try to extend the MS treatment's patent life until September 2015.

Lilly Alimta patent extended to 2022

Lilly Alimta patent extended to 2022

By

A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

By

At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.

New OTC Nexium approved

The FDA has approved a 24-hour version of Pfizer's heartburn medication.

J&J gets out of diagnostics

The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.

Massachusetts bans Zohydro

The Bay State is saying no to the controversial prescription painkiller.

Amgen's PSCK9 shows rare disease potential

Amgen's PSCK9 shows rare disease potential

By

The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.

Possible Zohydro competitor surfaces

Possible Zohydro competitor surfaces

By

A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.

Celebrex patent loss to inflict EPS pain, but little more

Celebrex patent loss to inflict EPS pain, but little more

By

Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.

Nexavar fails recurrence target

Nexavar fails recurrence target

By

Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.

Email Newsletters