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Fylnetra[sup.™] (pegfilgrastim-pbbk), a biosimilar to Neulasta[sup.®] (pegfilgrastim), has been made available by Amneal. The Food and Drug Administration (FDA) approved Fylnetra, a leukocyte growth factor, based on data demonstrating a [...]

Byline: Our Bureau Global pharma major, Lupin Limited announced that the US FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing [...]

Drug prices, as you may have heard, are kind of high. But price growth has slowed after sharp spikes in 2014 and 2015, leading analysts to believe that all the [...]

BeyondSpring, a global biopharmaceutical company, announced that its lead asset, first-in-class agent Plinabulin, has received the Breakthrough Therapy Designation (BTD) for the chemotherapy-induced neutropenia (CIN) indication from both the US [...]

H.C. Wainwright analyst Joseph Pantginis raised the firm's price target on BeyondSpring to $46 from $30 and reiterates a Buy rating on the shares after the company announced interim results [...]

BeyondSpring announced that the Phase III PROTECTIVE-2 trial, which examines the safety and efficacy of plinabulin plus Neulasta versus Neulasta monotherapy, met the primary endpoint of preventing severe neutropenia, which [...]

BeyondSpring announced that two Company abstracts were accepted at this year's American Society of Clinical Oncology Virtual Scientific Program. Both abstracts evaluate BeyondSpring's lead late-stage asset, Plinabulin, alongside Neulasta, a [...]

Byline: Our Bureau Biocon and Mylan have launched Fulphila, a biosimilar to Neulasta (pegfilgrastim). Fulphila is approved by Health Canada to decrease the incidence of infection, as manifested by febrile [...]

Net loss attributable to the company was $14.7 million and $54.9 million for the fourth quarter and full-year 2018, compared to $7.8 million and $91.8 million for the fourth quarter [...]

BeyondSpring presented new clinical results from its Study 106 program in the prevention of chemotherapy induced neutropenia for its lead asset Plinabulin at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. The [...]

BeyondSpring announced new clinical results from its Study 106 program for lead asset Plinabulin, which demonstrates that combining Plinabulin with Neulasta not only improves overall efficacy for chemotherapy-induced neutropenia, or [...]

BeyondSpring announced that the Phase 3 portion of its pivotal Study 105, evaluating its lead asset, Plinabulin, in the 105 enrolled patients treated with docetaxel chemotherapy, has met its primary [...]

BeyondSpring presented clinical trial data on its lead asset, Plinabulin, during a poster and oral presentation at the 2018 European Society for Medical Oncology, or ESMO, Congress. The data showed [...]

BeyondSpring announced positive top line Phase 2 data from its Study 106 evaluating Plinabulin in combination with Neulasta, versus Neulasta monotherapy, for the prevention of chemotherapy-induced neutropenia, or CIN, and [...]

Mylan and Biocon announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen's [...]

The European Medicines Agency this morning provided a positive opinion on Coherus Biosciences' version of Neulasta, Citi analyst Mohit Bansal tells investors in a research note. This is positive news [...]

The Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Udenyca, intended to reduce the duration [...]

Jefferies analyst Michael Yee says Mylan (MYL) priced its biosimilar to Amgen's Neulasta at a 33% discount to the gross price of branded Neulasta. While the discount is slightly more [...]

Jefferies analyst Michael Yee notes that Mylan's (MYL) Neulasta biosimilar Fulphila will launch in the coming weeks, which poses a risk for Amgen (AMGN), but he tells investors in a [...]

HIGHER: Twitter (TWTR), up 4% after S&P selected the stock to replace Monsanto (MON) in the S&P 500... Mylan (MYL), up 4% after the FDA approved Fulphila, Mylan's biosimilar to [...]

Morgan Stanley analyst David Risinger said FDA approval of Fulphila, Mylan's (MYL) biosimilar to Amgen's (AMGN) Neulasta, should be a 'substantial and durable' profit opportunity and could 'reignite' Mylan's upward [...]