US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion of the manufacturing, storage, handling and distribution of its DCVax-L and DCVax-Direct products, with the company's long-time contract manufacturer, Cognate Bioservices. 27 January 2014
“It is vital that costs associated with regulatory processes do not become a barrier to developing and improving generic and biosimilar products or even maintaining the product in the market,” stated Beata Stepniewska, deputy director general of the European Generic Medicines Association (EGA) at the 13th EGA Regulatory & Scientific Affairs Conference, held in London on January 23-24. 27 January 2014
Considered a global clinical trial hub three years ago, India has suffered a series of setbacks, with its apex court, the Supreme Court in early 2013 revoking the Ministry of Health’s right to clear clinical trials in the country, reports The Pharma Letter’s Indian correspondent. 27 January 2014
Among a batch of positive opinions issued today by the European Medicines Agency’ s Committee for Medicinal Products for Human Use (CHMP), there was good news for UK pharma giant GlaxoSmithKline relating to Eperzan (albiglutide). 24 January 2014
There were a number of positive, and negative, opinions issued on January 24, following the monthly meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; see also separate stories for GlaxoSmithKline and Novartis). 24 January 2014
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given Swiss drug major Novartis (NOVN: VX) a positive opinion for the use of Xolair (omalizumab). 24 January 2014
The recently launched Breakthrough Therapy Designation (BTD) program in the USA, aimed at expediting development and review of drugs intended to treat a serious condition, has the potential to shorten development time considerably, according to the Tufts Center for the Study of Drug Development, which recently completed an assessment of the BTD program. 24 January 2014
As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug Administration yesterday notified Ranbaxy Laboratories that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. 24 January 2014
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today approved the use of Swiss drug major Roche’s MabThera (rituximab) for two potentially life-threatening auto-immune diseases, severe forms of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and which result in the inflammation and damage of small blood vessels and frequently involve multiple organs. 24 January 2014
Israeli drug developer BioLineRx has received notice from the US Food and Drug Administration confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the orphan status previously granted for the compound as a treatment for acute myeloid leukemia (AML). 23 January 2014
The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association yesterday commended the Washington State House and Senate for continuing to advance legislation designed to create a pathway for the substitution of interchangeable biologic medicines, or biosimilars. 23 January 2014
US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the US Food and Drug Administration for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. 23 January 2014
Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Allergan’s ophthalmic drug Restasis(cyclosporine ophthalmic emulsion) 0.05% product. 22 January 2014
The quality of clinical trial evidence used by the US Food and Drug Administration as the basis for recent approvals of novel therapeutic agents varies widely, with important implications for patients and physicians, claims a new report in the Journal of the American Medical Association (JAMA). 22 January 2014
The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted orphan drug designation (ODD) for the treatment of malignant mesothelioma by the European Commission, reports Japanese drug major Eisai. 22 January 2014
Lundbeck (LUN: CO) and Takeda Pharmaceutical (TYO: 4502) jointly announced today that Brintellix (vortioxetine) for the treatment of major depressive disorder in adults is available in pharmacies across the USA. 22 January 2014
The European Commission has approved Anglo-Swedish drug major AstraZeneca and soon to be ex-partner USA-based Bristol-Myers Squibb’s Xigduo (dapagliflozin and metformin hydrochloride) for the treatment of type 2 diabetes in the European Union. 22 January 2014
In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi’s biotech subsidiary Genzyme’s oral multiple sclerosis drug Aubagio (teriflunomide). 22 January 2014
Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from Japan’s Ministry of Health, Labor and Welfare for their new drug application for Savene (dexrazoxane) injectable for the treatment of anthracycline extravasation. 21 January 2014
Analysis showing the extent to which the UK National Health Service (NHS) is prescribing National Institute for Health and Care Excellence (NICE) recommended medicines has been published today. 21 January 2014
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024