How one hedge fund manager plans to take on big pharma patents

Kyle Bass, who founded Hayman Capital Management in Dallas, predicted the subprime mortgage crisis and gained fame, fortune, and respect. Now, he is taking on pharma firms with "questionable" patents.

By Nicole Gray • Jan. 9, 2015

Tensions with pharma run high as UK's Cancer Drugs Fund cuts expenses

While the UK has long depended on the Cancer Drugs Fund (CDF) to pay for oncology treatments that are not covered under the National Health Services, the CDF is overwhelmed and cutting back.

By Nicole Gray • Jan. 9, 2015

Finally approved: FDA says 'yes' to Impax's Parkinson's drug

After a string of setbacks, Impax finally got an FDA approval for Rytary.

By Nicole Gray • Jan. 9, 2015

Siga ordered to pay $113M to PharmaAthene in smallpox case

The ruling is widely considered to be a good thing for Siga. 

By Nicole Gray • Jan. 8, 2015

Namenda controversy continues as Actavis awaits court decision

Actavis has suggested that if the current injunction stands, it could reduce sales in the Namenda franchise by as much as 15% in 2016.

By Nicole Gray • Jan. 8, 2015

UPDATE: Novartis Neupogen biosimilar takes yet another step toward FDA approval

A U.S. advisory panel to the FDA recommended approval of Novartis/Sandoz's biosimilar of Amgen's Neupogen, Zarxio, (filgrastim) just days after FDA staff announced a similar recommendation.

By Nicole Gray • Jan. 8, 2015

FDA grants drug makers 'track and trace' reprieve until May

The Drug Supply Chain Security Act (DSCSA) was slated to go into effect on January 1, but the FDA has issued drug manufacturers a reprieve until May 15. 

By Nicole Gray • Jan. 7, 2015

Pharma companies unite to fight CA drug take-back program

Citing water contamination and drug abuse concerns, Alameda County enacted a drug take-back program in 2012. But pharma companies are being forced to bear the financial burden—and now they're fighting back.

By Nicole Gray • Jan. 7, 2015

Salix CEO Logan becomes second C-suite casualty of inventory spat

The wholesale inventory irregularities reportedly also scuttled a potential deal with Allergan.

By Sy Mukherjee • Jan. 6, 2015

Massachusetts mulls legal action over marketing practices for pain drugs

Massachusetts is claiming that pain drug makers use misleading marketing practices.

By Nicole Gray • Jan. 5, 2015

An 18-year record: FDA approved 41 drugs in 2014

Last year, the FDA approved 41 first-of-a-kind drugs (including 15 drugs for orphan diseases), signaling a high level of industry innovation and regulatory efficiency.

By Nicole Gray • Jan. 5, 2015

Japan first nation to approve potential Novartis blockbuster Cosentyx

And the US will likely not be far behind. 

By Nicole Gray • Jan. 5, 2015

UPDATED: FDA grants BMS's novel Opdivo accelerated approval for advanced melanoma

More than three months before its PDUFA date.

By Sy Mukherjee • Dec. 22, 2014

FDA approves Cubist's novel antibiotic Zerbaxa for complicated infections

Zerbaxa, developed by Cubist, is intended to treat complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) in adults. It's the 4th new FDA-approved antibacterial this year.

By Nicole Gray • Dec. 22, 2014

FDA unexpectedly approves AZ's Lynparza for advanced ovarian cancer

The approval of Lynparza (olaparib) represents a significant step forward in treating BRCA-associated reproductive cancers.

By Nicole Gray • Dec. 22, 2014

UPDATED: Express Scripts snubs Gilead, will only offer AbbVie's new hep C pill

Viekira Pak won FDA approval on Friday. Now, the largest U.S. pharmacy benefits manager is choosing AbbVie over Gilead, striking an exclusive deal to offer the new treatment at a discount to patients.

By Sy Mukherjee • Dec. 19, 2014

Controversial pay-to-delay deals on the decline in the EU

That's according to a report from European regulators.

By Nicole Gray • Dec. 19, 2014

14 pharmacy execs arrested, 2 charged with murder over 2012 meningitis deaths

Two pharmacists from the New England Compounding Center, including owner Barry Caden and head pharmacist Glenn Chin, have been charged with 25 counts of 2nd degree murder in seven states.

By Nicole Gray • Dec. 18, 2014

FDA approves Novartis/Alcon's Xtoro for swimmer's ear

The FDA has approves an important new treatment option for acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus, a condition commonly known as swimmer's ear.

By Nicole Gray • Dec. 18, 2014

The US Patent Office just gave a big gift to biopharma companies

Just in time for the holidays!

By Nicole Gray • Dec. 17, 2014

Historic: FDA approves first-ever system to cut blood transfusion infections

Cerus Corp's Intercept Blood System could make transfusions safer by reducing the risk for transmitting infections like HIV and hepatitis via plasma.

By Sy Mukherjee • Dec. 17, 2014

FDA forces Pfizer to put another warning on antipsychotic Geodon

The FDA has warned the public that Geodon (ziprasidone) has been associated with a condition known as DRESS, which can cause fever, rash, and swelling in multiple vital organs.

By Nicole Gray • Dec. 17, 2014

FDA approves two new plasma-based tests, expands use of a third

December has been a good month for plasma-based diagnostics. And in an unprecedented move, the FDA granted a waiver for the availability of a rapid screening for syphilis in order to expand testing.

By Nicole Gray • Dec. 16, 2014

Senate bill would give 15 years' data exclusivity to drugs for unmet needs

The Dormant Therapies Act would offer an important incentive for pharma companies developing new therapies for unmet medical needs.

By Nicole Gray • Dec. 16, 2014

Indian Supreme Court rejects Bayer's bid to block cheap cancer generic

The generic version of Nexavar (sorafenib), used to treat kidney and liver cancers, will cost just $173 per month versus $5,500 for the branded version.

By Nicole Gray • Dec. 15, 2014