Shares of Karyopharm Therapeutics skyrocketed more than 36 percent after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s Xpovio for treating multiple myeloma.
We are on the verge of a medical renaissance, a period of accelerated progress in the treatment and management of rare diseases. This reawakening also brings with it challenges that we must grapple with.
Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.
Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.
The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.
The U.S. FDA accepted a New Drug Application and granted Priority Review for Genentech’s baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older.
Clovis Oncology Inc. today announced that the European Commission authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.
Ipsen Receives Approval from European Commission for Xermelo for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy
Approvals, Biopharma, Carcinoid Syndrome, Carcinoid Syndrome Diarrhea, European Commission, First-In-Class, Tryptophan Hydroxylase InhibitorsIpsen today announced that the European Commission approved Xermelo (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Special Feature – First Year After Launch: The specialties win again
Ankylosing Spondylitits, Antipsychotics, August 2017, Autoimmune Diseases, Biotech, Blockbusters, Breast Cancer, CDK 4/6 Inhibitors, First Year After Launch special feature, First-In-Class, Hepatitis C, Luteinizing Hormone-Releasing Hormone (LHRH) Agonists, New Drug Applicationa, New Molecular Entities, Plaque Psoriasis, Potential Blockbusters, Product Launches, Psoriatic Arthritis, Specialty Medicines, TherapeuticsJust like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
