Wednesday, 20 June 2018 - 13:53
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Approvals

Pfizer: another biosimilar granted positive opinion by EMA CHMP

EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion about Trazimera–biosimilar to Roche’s Herceptin (trastuzumab)– recommending a marketing authorization for patients with HER2 breast cancer. Trazimera is the fourth biosimilar by Pfizer to obtain positive…

Perrigo postpones launch of generic to Teva’s ProAir

Perrigo has announced it expects the US authorities to reject an approval to the generic copy of Teva’s asthma inhaler ProAir, adding that it is unlikely that the product will be marketed in Q4 2018, as previously predicted. The company…

Janssen obtains FDA approval for Darzalex (multiple myeloma)

Janssen, part of Johnson & Johnson group, has announced it has obtained the FDA approval for Darzalex in combination with Takeda’s Velcade and prednisone as a first-line therapy against multiple myeloma. The approval reflects positive results obtained in the Phase-III…

FDA approves Tafinlar + Mekinist combo for thyroid cancer

The FDA has approved the Tafinlar (dabrafenib) + Mekinist (trametinib) combo, by Switzerland-based Novartis, for patients with anaplastic thyroid cancer that cannot be removed by surgery. This is the first therapy approved by FDA for patients with this thyroid cancer…

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…