Ad Header

PharmaLive

Slogan

The Pulse of the Pharmaceutical Industry

  • Filter By Category

  • Filter By Author

FDA Advisory Panel Gives Mixed Review to Sanofi’s Dengue Vaccine

A mixed review from a U.S. FDA panel of experts could sink the chances of a green light for Sanofi’s dengue vaccine Dengvaxia.

Read More »

EC approves Roche’s Tecentriq combo vs. lung cancer

Roche received European Commission (EC) approval for the company’s Tecentriq drug in combination with Avastin and chemo as an initial treatment for people with a specific type of lung cancer.

Read More »

Teva’s migraine drug gets EU panel nod

Teva Pharmaceutical Industries said a European Medicines Agency panel recommended approving the migraine treatment Ajovy, a drug being counted on to revive the company’s fortune.

Read More »

European Commission Approves Clovis Oncology’s Rubraca Tablets as Maintenance Treatment for Relapsed Ovarian Cancer

Clovis Oncology Inc. announced that the European Commission approved the use of Rubraca (rucaparib) for a second indication: as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Read More »

European Commission Approves Blincyto In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia

Amgen announced that the European Commission approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.

Read More »

Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for U.S. FDA Review

Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).

Read More »

EU approves AstraZeneca lung cancer immunotherapy

AstraZeneca’s immunotherapy drug Imfinzi was approved in Europe for use in lung cancer patients with inoperable disease that had advanced locally but not spread widely around the body.

Read More »

Bayer hemophilia treatment wins thumbs-up from EU panel

Bayer AG’s long-acting treatment for hemophilia A won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.

Read More »

Merck’s Keytruda chemo cocktail wins EU approval

Merck & Co.’s key cancer drug Keytruda was approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients.

Read More »

Novartis wins EU approval for blood cancer therapy Kymriah

Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.

Read More »

Ad Right Top

MedAdNews

Extensive pharmaceutical business and marketing intelligence. For back issues, please contact MDAD@kmpsgroup.com.

February 2019 Focus: Agenda 2019, Top 10 Pipelines To Watch, Value Of Pharmaceuticals, and more!

Subscribe

Ad Right Bottom