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Generics
The European Commission has informed US health care giant Johnson & Johnson (NYSE: JNJ) and Swiss drug major Novartis (NOVN: VX) of its objections regarding an agreement - often called a pay-for-delay deal - concluded between their respective Dutch subsidiaries relating to fentanyl (brand name Duragesic), a strong pain-killer. 1 February 2013
Biotechnology
Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) says that it has terminated its collaboration with CureTech for the development of an experimental cancer. Teva entered into agreements with CureTech in 2006. Teva intends to book a noncash net charge of $109 million as a result of the impairment of its investment in CureTech. 1 February 2013
Pharmaceutical
New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list the anesthesia reversal agent sugammadex (Bridion, from US pharma giant Merck & Co; NYSE; MRK) in Section H of the Pharmaceutical Schedule (the national Preferred Medicines List (PML), subject to the restrictions outlined below, from July 1, 2013, through a provisional agreement with the US firm's local subsidiary Merck Sharp & Dohme as follows: 30 January 2013
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) says it is expanding its operations into South Africa, with the filing of its two products - Halaven (eribulin) for metastatic breast cancer and Fycompa (perampanel) for epilepsy - to The Medicines Control Council (MCC). 30 January 2013
Biotechnology
French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme says that the US Food and Drug Administration has accepted for standard review the company's supplemental Biologics License Application (sBLA) file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the US launch of once-daily, oral Aubagio (teriflunomide). 28 January 2013
Pharmaceutical
Global drugs behemoth Pfizer (NYSE: PFE) last week released a batch of new clinical trial data relating to three already marketed products, the smoking cessation agent Chantix (varenicline), the antidepressant Pristiq (desvenlafaxine succinate) and overactive bladder drug Toviaz (fesoterodine fumarate). 27 January 2013
Pharmaceutical
US drugmaker Allergan (NYSE: AGN) has entered into a definitive merger agreement to acquire 100% of the shares of fellow USA-based MAP Pharmaceuticals (Nasdaq: MAPP) for a price of $25.00 per share, a 60% premium over MAP's closing stock price on the Nasdaq Stock Market of $15.58 on January 22, and represents a total equity value of around $958 million, on a fully-diluted basis. 24 January 2013
Generics
US generic and specialty drugmaker Watson Pharmaceuticals (NYSE: WPI) says that it has completed the acquisition of Belgium-based Uteron Pharma for $150 million in cash up front, and up to $155 million in potential future milestone payments. 24 January 2013
Pharmaceutical
Impax Pharmaceuticals, the branded products division of Impax Laboratories (Nasdaq: IPXL), revealed on Monday that the US Food and Drug Administration had issued a complete response letter regarding the New Drug Application for Rytary (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the USA. There was no impact on the firm's shares as US markets were closed yesterday. 22 January 2013
Pharmaceutical
US drugmaker Allergan (NYSE: AGN) says that the US Food and Drug Administration has approved its Botox (onabotulinumtoxinA), best known as an anti-wrinkle preparation, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication. 21 January 2013
Biotechnology
The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says the US Food and Drug Administration has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations. 17 January 2013
Pharmaceutical
A team of researchers from Canada's Universite Laval, CHU de Quebec, and UK pharma giant GlaxoSmithKline (LSE: GSK) has discovered a way to stimulate the brain's natural defense mechanisms in people with Alzheimer's disease. This major breakthrough, details of which are presented this week in an early on-line edition of the Proceedings of the National Academy of Sciences (PNAS), opens the door to the development of a treatment for Alzheimer's disease and a vaccine to prevent the illness. 16 January 2013
Pharmaceutical
Confirming expectations announced when Pfizer (NYSE: PFE) revealed its $680 million acquisition of NextWave Pharmaceuticals (The Pharma Letter October 23, 2012), the US drugs behemoth said that Quillivant XR (methylphenidate hydrochloride) CII for extended-release oral suspension is now available in the USA for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR, NextWave's lead product, is the first once-daily, extended-release liquid methylphenidate for ADHD and is now available by prescription. 15 January 2013
Pharmaceutical
At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) assessed available data related to safety concerns over Merck & Co's (NYSE: MRK) cholesterol drug Tredaptive, Pelzont and Trevaclyn - identical medicines containing the active ingredients nicotinic acid and laropiprant - and recommended that the marketing, supply and authorizations of these medicines be suspended across the European Union. 13 January 2013
Pharmaceutical
The US Food and Drug Administration yesterday announced it is requiring the manufacturers of Ambien, Ambien CR (both from French drug major Sanofi - Euronext: SAN), Edluar, from Sweden's Meda (OMX: MEDA A), and Zolpimist from Novadel, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses of the drug. 11 January 2013
Pharmaceutical
The overall global market for drugs to treat Parkinson's disease will reach a value of $3.43 billion in 2016, according to a new report for business information provider Visiongain, covering the 2013 to 2023 period. 10 January 2013
Pharmaceutical
US drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) says it has acquired Zacharon Pharmaceuticals, a privately-held biotechnology company based in San Diego focused on developing small molecules targeting pathways of glycan and glycolipid metabolism. 8 January 2013
Pharmaceutical
USA-based Illumina (Nasdaq: ILMN), recently the subject of a failed takeover bid by Swiss drug major Roche (ROG: SIX), has signed a definitive agreement to acquire Verinata Health, a provider of non-invasive tests for the early identification of fetal chromosomal abnormalities, for consideration of $350 million plus up to $100 million in milestone payments through 2015. 8 January 2013
Biotechnology
Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) fell as much as 8% to $138.05 in pre-market trading yesterday, after the company reported top-line results of EMPOWER, a Phase III trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS), showing that the drug did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival. The stock partially recovered to close down 1.4% at $147.86. 4 January 2013
Biotechnology
USA-based Repligen (Nasdaq: RGEN) saw its share jump 5.6% to $6.63, after the company revealed it has signed an exclusive worldwide licensing agreement with global drugs behemoth Pfizer (NYSE: PFE) to advance its spinal muscular atrophy (SMA) program, originally in-licensed from Families of SMA (FSMA). 4 January 2013
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Pharmaceutical
New York-based Mind Medicine, a company developing MM120, a form of LSD (lysergide d-tartrate), for mental health conditions, has announced the appointment of Gregg Pratt, as chief regulatory and quality assurance officer. 19 November 2024
Biotechnology
Last week saw US pharma major AbbVie release disappointing Phase II trial results on its emraclidine in schizophrenia, which benefited Bristol Myers Squibb. Also on the research front, Germany’s Merck KGaA and Abbisko’s pimicotinib showed positive results in tenosynovial giant cell tumor (TGCT). M&A news saw German BioNTech punting $800 million upfront to acquire China based oncology focused Biotheus. Also of note, US drugmaker Halozyme Therapeutics made an unsolicited takeover bid for Evotec, valuing the German firm, at around 2 billion euros. 17 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Biotechnology
Swiss clinical-stage biopharma AC Immune saw its shares gain 8% to $3.38 in US trading this morning, after it released positive interim safety and immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Pharmaceutical
Digital therapeutics company GAIA has announced the signing of a licensing agreement for attexis with fellow German firm MEDICE Arzneimittel Pütter. 14 November 2024
Biotechnology
Cambridge, USA-based Vesalius Therapeutics has entered into a multi-target strategic alliance with the UK’s GSK to discover and develop novel treatments for Parkinson's disease, and another undisclosed neurodegenerative indication. 13 November 2024
Biotechnology
Neurogene has announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase I/II open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. 13 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Pharmaceutical
The Parkinson’s disease (PD) therapeutic landscape is heavily genericized, leaving substantial unmet needs in neuroprotective and disease-modifying therapies (DMTs), says data and analytics company GlobalData in an overview of ongoing PD research.. 11 November 2024
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