A panel of European Medicines Agency recommended against granting marketing approval to Portola Pharmaceuticals Inc.’s oral blood thinner, saying the benefits of the drug did not outweigh risks.
Deal activity is rampant as Big Pharma gobbles up next-generation medicines and technologies to help overcome maturing pipelines and biosimilar threats.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
A panel of European Medicines Agency recommended approval for GlaxoSmithKline’s two-drug regimen to treat HIV, the virus that causes AIDS.
Amicus Therapeutics announced that Japan’s Ministry of Health, Labour and Welfare approved the oral small molecule pharmacological chaperone Galafold capsules 123mg (migalastat).
Novartis announced that the U.S. Food and Drug Administration expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.
U.S. regulators approved Seattle Genetics Inc.’s Adcetris as part of a chemotherapy cocktail to treat advanced Hodgkin’s lymphoma in newly diagnosed patients.
Arena Pharmaceuticals Inc.’s shares rose 34 percent after the company released positive top-line results from its Phase II trial of etrasimod in ulcerative colitis.
A supplemental New Drug Application was accepted by the U.S. FDA for Pfizer and partner Astellas Pharma’s Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
A U.S. Food and Drug Administration decision to slap a clinical hold on Solid Biosciences’s experimental gene therapy treatment for Duchenne muscular dystrophy sent share prices plunging.
The U.S. FDA accepted Merck & Company’s supplemental Biologics License Application and granted Priority Review for Keytruda (pembrolizumab) in advanced cervical cancer.
Shares of Advaxis Inc. were down more than 21 percent in after the company announced that the U.S. FDA halted a Phase I/II trial that uses an AstraZeneca Pharmaceuticals LP drug following the death of a patient.
AcelRx Pharmaceuticals intends to resubmit a New Drug Application for Dsuvia (sufenetanil sublingual tablet) for pain in Q2 2018 after receiving a Complete Response Letter in October 2017.
Pfizer Inc.’s Xeljanz should be approved to treat patients with moderate to severe ulcerative colitis, a chronic bowel disease, a U.S. Food and Drug Administration advisory committee concluded.
Shares of Theratechnologies and TaiMed Biologics jumped after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.
Bristol-Myers Squibb Co. said the U.S. Food and Drug Administration approved a four-week dosing schedule for its cancer drug Opdivo.
The U.S. FDA accepted for review the supplemental BLA of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.
Shares of Portola Pharmaceuticals fell more than 27 percent after the company announced a delay of several months for possible regulatory approval of its factor Xa inhibitor antidote AndexXa.
The U.S. Food and Drug Administration approved ZTlido, Sorrento Therapeutics Inc.’s non-opioid painkiller patch for nerve pain related to shingles.
The European Medicines Agency is following in the footsteps of the U.S. Food and Drug Administration with plans to help pharma companies win approval for novel Alzheimer’s drugs.
U.S. health regulators rejected Celgene Corp.’s application seeking approval of a key multiple sclerosis drug due to insufficient data, the company said.