PharmaBiz

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

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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

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The FDA has issued draft guidance that funds FDA inspection of some drug compounders.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

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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

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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

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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

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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

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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

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

Biogen, Eisai in Alzheimer's pact

Biogen Idec and Eisai said they will collaborate on and co-market two of Eisai's clinical candidates for Alzheimer's disease.

Sanofi seeks to revive Kynamro launch

Sanofi seeks to revive Kynamro launch

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Kynamro's slow start, coupled with competition, has prompted Sanofi to add sales reps.

Bayer acquires Chinese consumer co.

Bayer bought China-based Dihon Pharmaceutical Group, which specializes in traditional Chinese medicine consumer goods.

Ranbaxy shuts two sites

The drugmaker says the voluntary measure was out of an abundance of caution.

FDA seeks flexible OTC review process

The agency says is it time to update the onerous decades-old review process.

Forest acquisition whets M&A appetite

Bloomberg reports that Teva has sparked interest as a takeover target.

Industry wary of new German pricing rule

Germany's price transparency requirement has the industry worried other markets will demand lower prices.

Actavis buys Forest, bolsters specialty biz

Actavis buys Forest, bolsters specialty biz

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The drugmaker, hitherto known for its generic expertise, says the purchase could mean that half its future revenue will come from branded, specialty drugs.

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