Pharmaceuticals/Biotech

The Lead

Drug Firms Find Profits In Niche 'Orphan Drugs'

January 25, 2012 9:25 am | by Matthew Perrone, AP Health Writer | News | Comments

The so-called orphan drugs include extra patent protections, higher pricing and a streamlined review process by FDA.

GSK Undeterred By Human Genome 'Poison Pill'

May 18, 2012 10:10 am | News | Comments

GlaxoSmithKline says it will persist with its bid to take over U.S. company Human Genome Sciences despite the target's new 'poison pill' defense.

FDA OKs Generic Versions Of Plavix

May 18, 2012 8:46 am | by Linda A. Johnson, AP Business Writer | News | Comments

Patients taking the popular blood thinner Plavix now have the option of getting a less-expensive pill, following the approval of the first generic versions in the U.S.

Antibiotic Linked With Rare But Deadly Heart Risk

May 17, 2012 8:55 am | by Lindsey Tanner, AP Medical Writer | News | Comments

Study found that an antibiotic widely used for bronchitis and other common infections seems to increase chances for sudden deadly heart problems.

FDA Clears New Bristol-Myers Squibb Plant

May 15, 2012 2:41 pm | News | Comments

Bristol-Myers Squibb Co. said Tuesday the FDA approved a new manufacturing plant where the company will produce its rheumatoid arthritis drug Orencia.

Kentucky Court To Hear Diet Drug Suit In June

May 14, 2012 11:11 am | News | Comments

Court will hear an appeal from a group of people who say that a $42 million judgment awarded to them from their one-time attorneys should be reinstated.

Alere Skids On Expected Recall, Federal Subpoena

May 11, 2012 2:23 pm | News | Comments

Shares of the medical diagnostics company slipped after it announced that the government was concerned over its marketing and quality-control testing.

Seven Success Criteria For Hiring A GMP Consultant

May 11, 2012 1:33 pm | by The QA Pharm | Blogs | Comments

There is nothing worse than throwing a bunch of consultants at a problem without knowing the boundaries of the project or defining the expected results. Unfortunately, it happens all the time. It ends in frustration for all parties involved. A formal scope of work (SOW) helps both the client and the consultant to set expectations of each other, and agree on basic assumptions that are critical to success.

Omnicare Pays $50 Million To Settle DOJ Case

May 11, 2012 12:52 pm | News | Comments

The company said there were no allegations that drugs were illegally diverted to someone without prescriptions and no patients were harmed.

Two Molecular Biologists Get $500K Medical Prize

May 11, 2012 9:29 am | News | Comments

The two men performed pioneering research on how cells express their genetic information at The Rockefeller University in New York City.

FDA Panel Backs Pill To Block HIV Infection

May 11, 2012 8:53 am | by Matthew Perrone, AP Health Writer | News | Comments

The first drug shown to prevent HIV infection won the endorsement, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

Company Recalls Nebraska Lethal Injection Drug

May 10, 2012 9:24 am | by Grant Schulte, Associated Press | News | Comments

Naari AG asked Nebraska officials to quarantine its supply of sodium thiopental because it was "illegally diverted" from its supply chain.

GlaxoSmithKline In Takeover Bid For Human Genome

May 9, 2012 9:10 am | News | Comments

GlaxoSmithKline has tabled an offer to take over U.S. drug maker Human Genome Sciences Inc. which values the target at nearly $2.6 billion.

China To Reinvestigate Human Flesh Capsule Claims

May 8, 2012 9:18 am | News | Comments

South Korean officials say they seized smuggled capsules containing powdered remains of dead babies, which some believe can cure a variety of diseases.

Abbott Labs Settles $1.5B Dispute Over Drug Claims

May 7, 2012 1:03 pm | by Pete Yost, Associated Press | News | Comments

Attorneys general from across the country alleged that Abbott marketed its anti-seizure drug Depakote for unapproved uses.

Contract Manufacturing And Recalls

May 7, 2012 12:18 pm | by Mike Rozembajgier, Vice President of Recalls, StericycleExpertRECALL | Articles | Comments

Pharmaceutical companies face increased competition to meet consumer demand, which means tighter and more complex deals with contract manufacturers.

NIH, Companies Aim To Teach Old Drugs New Tricks

May 3, 2012 2:08 pm | by Lauran Neergaard, AP Medical Writer | News | Comments

Pfizer, AstraZeneca and Eli Lilly & Co. are dusting off two dozen old drugs that failed to treat one disease but might treat another.

Impax Labs Falls On Weak Sales, New FDA Warning

May 2, 2012 9:27 am | News | Comments

The FDA recently issued a Form 483, which said inspectors found problems in Impax's quality control laboratory.

Pfizer Profit Falls On Generic Lipitor

May 1, 2012 7:45 am | News | Comments

Pfizer said that its first-quarter profit fell 19 percent, mainly because new generic competition to its blockbuster cholesterol pill cut U.S. sales by 15 percent.

US Approves Antibiotic To Treat, Prevent Plague

April 30, 2012 9:38 am | by the Associated Press | News | Comments

The Johnson & Johnson antibiotic is able to cure a vast majority of the rare bacterial infections, which could be use as a potential bioterrorism agent.

Merck Wins Suit Blocking Generic Cholesterol Drugs

April 30, 2012 8:50 am | News | Comments

Merck won two patent infringement lawsuits against a generic drug maker seeking to make copycat versions of its lucrative cholesterol pills, Zetia and Vytorin.