Approvals - GoINPHARMA
Tuesday, 16 October 2018 - 19:49

Approvals

Green light to Bluebird’s gene therapy in Europe

Biotech Bluebird has announced today that EMA has accepted the Marketing Authorization Application (MAA) for its LentiGlobin-based  investigational treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. The authorization reflects the excellent clinical data delivered by…

FDA approves Teva’s Ajovy (migraine)

Teva Pharmaceuticals yesterday announced that FDA has approved Ajovy (fremanezumab) for the prevention of migraine. Ajovy is an anti-peptide monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), designed for episodic migraine and chronic migraine prevention in adults. Fremanezumab is…

New approval for Merck & Co.’s Keytruda in Europe

Merck & Co.’s immunotherapy Keytruda keeps winning approvals for new indications. Indeed, it was yesterday approved in Europe, in combination with chemotherapy, for non-small-cell lung cancer (NSCLC). Keytruda is the first inhibitor of  PD-1 receptors to be approved for NSCLC, both…

Gilead’s Yescarta (CAR-T) obtains marketing approval in Europe

Gilead announced today, before trading started in Wall Street, that the European Commission has granted marketing approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with DLBCL (diffuse large B cell lymphoma) and PMBCL (primary mediastinal B-cell lymphoma)….

European Commission approves Xarelto for new indication

Germany-based Bayer has obtained a significant approval by the European authorities, which have given the green light to Xarelto (rivaroxaban) to prevent thrombosis in patients with coronary artery disease (CAD) and periphery artery disease (PAD). The first country where Xarelto…

FDA approves Brainsway’s transcranial magnetic stimulator

Israel-based Brainsway has obtained FDA approval for its non-invasive transcranial magnetic stimulation device (Deep TMS) for the treatment of obsessive-compulsive disorder (OCD) in adults, a condition affecting approximately 2 billion people in the US, according to estimates. Brainsway’s shares have…

Merck & Co’s Keytruda obtains approval for NSCLC

Merck & Co.’s immunotherapy Keytruda has received the green light as a first-line treatment, in combination with chemotherapy, for metastatic non-squamous, non-small-cell lung cancer. The approval reflects the positive results from the Phase III KEYNOTE-189 clinical trial, testing the combination…

BMS’ Opdivo obtains FDA approval for SCLC

It is a great momentum for Bristol-Myers Squibb group: immunotherapy Opdivo (nivolumab) was approved by FDA last Friday for small-cell lung cancer (SCLC) in patients already treated twice, but with no therapeutic benefit. The approval reflects positive clinical results from…

FDA approves Pfizer’s Xtandi for specific prostate cancer type

Astellas and Pfizer on Friday jointly announced that FDA has approved a New Drug Application for Xtandi (enzalutamide) for a highly aggressive prostate cancer type (CRPC). The approval reflects the positive clinical data delivered by the drug during the Phase…

H1 record-results for M&A pharmaceutical activity

The pharmaceutical industry has recently undergone a sea change: indeed, in H1 2018, the M&A transaction volume rose to 1893, that is an increase of 128 transactions compared to H1 2017. Transaction value went from da $209bn (H12017) to $238bn…

Aurobindo receives FDA approval for Ibuprofen capsules

Owing to a lacking availability of Ibuprofen, FDA approved Indian Aurobindo Pharma’s manufacture of Ibuprofen capsules. A few weeks ago, BASF informed that production of Ibuprofen at its Bishop-Texas plant has been suspended until September. This led to a shortage…

FDA about to approve first cannabis-derived medicine

Next week the FDA could approve the first cannabis-derived medicine. Such drug, named Epidiolex, contains cannabinoids and has been produced by British GW Pharmaceuticals. It has been tested to treat two specific types of infantile epilepsy. Even though many analysts…

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…