FDA: Page 106
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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 -
Federal judge: Actavis must keep selling older version of Alzheimer's drug
Actavis has been trying to transition Alzheimer's patients on older versions of Namenda (memantine) to a new, once-daily XR version.
By Nicole Gray • Dec. 15, 2014 -
FDA
Jazz pushing potential $1B rare disease drug through rolling NDA
Defibrotide is for patients who develop severe veno-occlusive disease, which is 80% fatal, while undergoing stem cell transplant procedures. And it's inching closer to approval.
By Nicole Gray • Dec. 15, 2014 -
Lawmakers propose new antibiotics pathway to combat superbugs
The Promise for Antibiotics and Therapeutics (PATH) Act is intended to create a "limited population" pathway for antibiotics.
By Nicole Gray • Dec. 12, 2014 -
Gavi pledges $300M to get Ebola vaccines to hard-hit countries
As soon as the World Health Organization (WHO) recommends a vaccine, GAVI, the Vaccine Alliance, will provide up to $300 million to buy vaccines for countries like Sierra Leone.
By Nicole Gray • Dec. 12, 2014 -
Compromise: Branded biologics, biosimilar firms reach hard-won agreement
Companies that manufacture branded biologics and those making biosimilars have agreed to support state legislation to allow biosimilar substitution at the pharmacy level.
By Nicole Gray • Dec. 12, 2014
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