Monday, 23 April 2018 - 2:56
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Approvals

New FDA approval for US-based biotech Ultragenyx

The Novato, California-based biotech Ultragenyx yesterday announced, before Wall Street opened, that its investigational therapy Crysvita (burosumab) has obtained the FDA approval for the treatment of X–Linked Hypophosphatemia (XLH), a rare condition. XLH is a serious disease affecting bones, which…

Good news for Teva at last: generic to Lialda launched

Good news are coming from Teva at last: the Israeli-based pharmaceutical group has announced it has launched the generic version of Lialda (mesalamine) 1.2g in the US. Mesalamine is indicated for the treatment of ulcerative colitis, a disorder affecting over…

Eli Lilly keeps momentum: new approval for Verzenio

Eli Lilly maintains momentum: FDA has approved Verzenio (abemaciclib)  in combination with an aromatase inhibitor (AI) for the treatment of some breast cancer types. The approval reflects the positive results from the Phase III MONARCH 3 trial, which has demonstrated…

Puma Biotechnology’s breast cancer therapy not approved in Europe

Neratinib, Puma Biotechnology’s treatment for early-stage breast cancer in patients with HER2 genetic mutation, has not been approved by EMA. The decision contrasts with the already received approval by FDA. EMA Committee for Medicinal Products for Human Use (CHMP) has…

New FDA approval for AstraZeneca’s Imfinzi

FDA has approved the cancer drug Imfinzi for the treatment of stage III lung cancer on patients who have already been treated with chemotherapy and radiation therapy. The approval reflects the positive data from the Pacific clinical trial. Analysts believe…

Johnson & Johnson’s Erleada approved for prostate cancer treatment

Johnson & Johnson has obtained the FDA approval for Erleada (apalutamide) in patients with non-metastatic 
prostate cancer, developing despite hormonal therapy. In fact, Erleada is the first treatment approved for this cancer type. Erleada enters into direct competition with Xtandi…

Good news for Vertex again: Symdeko approved as cystic fibrosis treatment

Vertex has reported that the FDA has approved Symdeko (tezacaftor/ivacaftor and ivacaftor) that, once on the market, will cost $292,000 annually and will contribute $100-200m to the group’s financial results as early as this year. Vertex’s management expects the group…

Novo Nordisk’s Ozempic approved also in Europe

Denmark-based Novo Nordisk yesterday announced that the European Commission has approved Ozempic (semaglutide) for the treatment of type-2 diabetes as a once-weekly treatment in a Multi-Dose Pen. Novo Nordisk expects to launch Ozempic in Europe in H2 2018. Ozempic has…

Gilead’s Biktarvy (HIV) approved

FDA has granted Gilead approval for its novel drug Biktarvy, for the treatment of HIV. Biktarvy combines the novel inhibitor bictegravir with Gilead’s molecules emtricitabine and tenofovir alafenamide. It is a once-daily treatment–a regimen tested in as many as 4…

New developments for Roche’s novel autism therapy

FDA has granted Breakthrough Therapy designation to Roche’s RG7314 investigational therapy (balovaptan), developed by the Switzerland-based group for the treatment of autism. Balovaptan is a V1A receptor antagonist, which has already shown efficacy against autism in various clinical trials. Roche’s…

Roche granted approval for ocrelizumab (multiple sclerosis) in Europe

Roche has announced that the European Commission has granted a marketing authorization to ocrelizumab, for the treatment of patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. The European Commission has considered the positive results from the…

Roche’s and Bayer’s strategies compared

If we compare the pipelines and M&A activities of Germany-based Bayer and Switzerland-based Roche, it is clear that the strategies developed by the two groups have much in common.  Bayer signed on November 14th an agreement with Loxo Oncology worth…

Fresenius closer and closer to marketing biosimilars

Fresenius yesterday took the opportunity to demonstrate to investors and shareholders that purchasing Merck KGaA’s biosimilars portfolio has been a wise decision. Indeed, Fresenius Kabi yesterday submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for its biosimilar…

FDA accepts BLA for Teva’s fremanezumab

Teva Pharmaceutical today has announced that FDA has accepted its BLA (Biologics License Application) for fremanezumab, an anti-CGRP monoclonal antibody for the preventive treatment of migraine. Additionally, the Administration has granted Fast Track Designation to the product for the prevention…

Positive momentum for Indivior continues

Good news for Indivior, which yesterday announced it has been granted approval by FDA for RBP-7000, its new schizophrenia investigational therapy. Indivior’s shares increased over 10% at the beginning of the month (London), reflecting the approval of Sublocade, a treatment…

New developments fostered by “digital drugs”

Digital drugs are becoming a reality: indeed, FDA few weeks ago  approved Otsuka Pharmaceutical’s Abilify, an antipsychotic drug including a built-in sensor, developed by  Proteus Digital Health, expected to help patients with depression maintain the necessary regularity in taking the…

FDA approves Roche’s Hemlibra, novel therapy for hemophilia A

Roche has announced that FDA has approved Hemlibra (emicizumab) for routine prophylaxis in adults and children with haemophilia A with factor VIII inhibitors.  Approximately 30% of haemophilia A patients can develop inhibitors against factor VIII replacement therapies. This puts them…

Biosimilar to Humira developed by Boehringer Ingelheim approved in Europe

The European Medicines Agency (EMA) has approved Boehringer Ingelheim’s Cyltezo, biosimilar to AbbVie’s blockbuster Humira. The Agency has recently approved the biosimilar to Humira developed by Amgen as well, which will be marketed as of October 2018 as Amgevita. The…

New regulation prohibits fentanyl in the US

The US Department of Justice has prohibited marketing and owning fentanyl, a highly addictive synthetic opioid, 50 times more potent than heroin and 100 times more potent than morphine. The decision reflects an increase in opioid consumption in the US….

Germany-based Aicuris obtains FDA approval for antiviral

Aicuris is a young pharmaceutical company, established in 2006 as a spin-off of Bayer, headquartered in Wuppertal (Germany), exclusively focusing on developing novel antiviral and antibacterial agents for the treatment of severe infectious diseases. The company this week has reached…

FDA approves Merck & Co.’s Previmis

Merck & Co. has announced that FDA has approved Previmis (letermovir) once daily (for oral use and injection for intravenous infusion). The product is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult patients who have to undergo…