Biogen has announced acceptance of marketing applications of Plegridy(peginterferon beta-1a) for review by the US and EU regulatory authorities. Plegridy, a member of the interferon class of treatments, is a pegylated subcutaneous ...
Tags: Biogen, Marketing Applications
The USFDA has accepted Teva Pharmaceutical Industries' supplemental new drug application (sNDA) for reviewing Copaxone (glatiramer acetate injection) 40mg/1mL. Indicated for patients with relapsing-remitting multiple sclerosis (RRMS), the ...
Tags: Drug Application, Medicine
Biogen Idec is seeking FDA approval for Plegridy (Peginterferon Beta-1a) as multiple sclerosis (MS) medication. The company submitted a biologics license application (BLA) to the FDA for its pegylated subcutaneous injectable candidate ...
Tags: Biogen IDEC, FDA Approval
Acorda Therapeutics has obtained additional US patent for ampyra covering a range of dosage strengths. Ampyra, referred to as fampridine in some countries outside the US, is indicated for the treatment to improve walking in patients with ...
Mapi Pharma, developer of complex bulk Active Pharmaceutical Ingredients (APIs), has been granted a US patent for a long acting depot formulation of glatiramer acetate, which is under the development as a once-a-month treatment for Multiple ...
The authorities in Italy have granted commercialization approval for GW Pharmaceuticals' Sativex prescription medication. Sativex is indicated for the treatment of moderate to severe spasticity in multiple sclerosis (MS) in patients who ...
Tags: GW Pharmaceutical, Medicine
BD Medical, a division of Becton, Dickinson and Company, has introduced BD UltraSafe PLUS passive needle guard in the US. The FDA-cleared anti-needlestick safety device is developed by an anti-needlestick device company Safety Syringes, ...
Tags: Bd Medical, Needle Guard
Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has cleared Genzyme's once-daily, oral Aubagio 14mg to treat relapsing forms of multiple sclerosis (MS). The approval of Aubagio was based on safety and ...
Canbex Therapeutics has completed a 2.1m ($3.2m) fundraising round to complete early development of drug candidate to treat spasticity in multiple sclerosis (MS). The financing for the round was led by Merck Serono Ventures, the venture ...
Tags: Canbex Therapeutics, Canbex
The US Food and Drug Administration (FDA) has approved Biogen Idec's Tecfidera (dimethyl fumarate), a new first-line oral capsule for people suffering from relapsing forms of multiple sclerosis (MS). Tecfidera reduces relapses and ...
Tags: FDA, Biogen capsule, multiple sclerosis
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Genzyme's oral Aubagio (teriflunomide) for relapsing-remitting multiple sclerosis (MS). Aubagio did not ...
Domain Therapeutics SA announced today that Domain Therapeutics grants Prexton Therapeutics an exclusive option to license and develop metabotropic glutamate receptor 4 (mGluR4) Positive Allosteric Modulator (PAM) drugs targeting ...
Tags: Domain Therapeutics SA, chemical, drugs
The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS). Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such ...
Tags: FDA, biologics license application, relapsing multiple sclerosis
Biogen Idec and Elan are seeking approvals from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for first-line use of Tysabri (natalizumab) in anti-JCV antibody negative patients with multiple sclerosis (MS). ...
MRC Technology, a technology transfer charity and company, announced at the end of last year a pound 577,000 funding award from the Biomedical Catalyst. The award has been granted to MRC Technology to fund research into the role of ...