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  • FDA hikes GDUFA fees

    The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

  • Study: Almost one-third of adults are getting their flu shots after-hours

    LOS ANGELES — A study published Monday evening by the Annals of Family Medicine found that 30.5% of adults seeking vaccinations did so during the evening (17.4%), on the weekend (10.2%) or on a holiday (2.9%), such as Columbus Day or Veterans Day. The study also found that the patients who most likely received vaccinations during these times were younger (less than 65 years old), male, residing in urban areas and without chronic conditions — groups with historically lower vaccination rates. 

  • Biosimilars score a win

    The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

  • Celgene drug approved for metastatic pancreatic cancer

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Celgene for treating patients with pancreatic cancer that has spread to other parts of the body, the agency said Friday.

    The FDA announced the approval of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) for patients with late-stage forms of the disease. The drug is a chemotherapy treatment already approved for treating breast and lung cancers.

  • Otsuka to buy Astex for $886 million

    TOKYO — Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

    Astex, based in Dublin, Calif., uses a drug-discovery system known as fragment-based drug discovery, which enables rapid discovery and development of compounds for target proteins implicated in diseases and works by evaluating binding of target proteins with small molecules through 3D structural analysis. Astex developed and launched the chemotherapy drug Dacogen (decitabine), currently sold by Eisai.

  • ViiV Healthcare expands funding for HIV/AIDS organizations in South

    RESEARCH TRIANGLE PARK, N.C. — A joint venture founded by GlaxoSmithKline and Pfizer focused on treatments for HIV has expanded its support of community organizations in the South.

  • Aptalis Pharma launches H. pylori treatment

    BRIDGEWATER, N.J. — Aptalis Pharma has launched its 10-day drug therapy for treating a gastrointestinal bacterial infection and ulcer condition, the company said.

    Aptalis announced the launch of Pylera 10 Day Therapy PAK (bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride). The drug is approved for use in combination with the proton-pump inhibitor omeprazole in patients with Helicobacter pylori infection and duodenal ulcer disease that is either active or has a history of occurring within the past five years, for eradicating H. pylori.

  • Study questions drug-discount programs

    NEW YORK — Over the last few years, many drug makers have offered coupons and co-payment-assistance programs as a way to reduce patients' out-of-pocket spending on medications, but a new study questions whether they really reduce spending in the long run and whether they're even legal.

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