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Biotechnology
Japanese drugmaker Chugai, which is majority owned by Roche, On Friday revealed that Zenyaku Kogyo has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), for an additional dosage and administration of an anti-CD20 monoclonal antibody Rituxan (rituximab) intravenous injection 100mg and 500mg, which is co-marketed by both companies, for chronic idiopathic thrombocytopenic purpura (ITP) in children. 23 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
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Australia’s CSL Limited plans to shut down its Californian R&D facility focused on cell and gene therapies by January 2025, signaling a shift away from ex vivo lentiviral-based technology. 19 November 2024
Biotechnology
Cellular immunotherapy specialist Fate Therapeutics soared as much as 73%, and closed up 12.45 at $2.27 yesterday, after it released early-stage data on its FT819 in lupus. 19 November 2024
Pharmaceutical
US antiviral giant Gilead Sciences on Friday unveiled two-and-a-half-year interim analysis from the ongoing Phase III ASSURE study of its Livdelzi (seladelpar). 16 November 2024
Pharmaceutical
French drugmaker Ipsen announced late-breaking data for Iqirvo (elafibranor 80mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE study at the American Association for the Study of Liver Disease (AASLD) congress. 16 November 2024
Biotechnology
Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024
Biotechnology
Shares of US genetic meds company MeiraGTx Holdings were up 7% at $7.12 in early trading after it announced important developments along with its third-quarter 2024 financials, reporting a $0.54 per share loss. 13 November 2024
Biotechnology
Dutch firm Argenx and China’s Zai Lab have received an approval from the National Medical Products Administration (NMPA) for Vyvgart Hytrulo (efgartigimod alfa). 13 November 2024
Pharmaceutical
AstraZeneca and Merck & Co announced that their jointly developed drug Koselugo (selumetinib) has shown positive outcomes in the KOMET Phase III trial. 12 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program, according to Sarah Wicks and James Valentine at US law firm Hyman, Phelps & McNamara. 11 November 2024
Biotechnology
Sarepta Therapeutics has announced it will cease development of SRP-5051, an experimental drug for Duchenne muscular dystrophy, citing safety issues, feedback from the Food and Drug Administration, and the shifting Duchenne treatment landscape. 11 November 2024
Pharmaceutical
Research results featured heavily in the news last week, first with Viking Therapeutics releasing promising early-stage data for its investigational medicine VK2738 at the ObesityWeek meeting. US biotech Beam Therapeutics released early-stage data on its sickle cell disease candidate BEAM-101. Also of note, Arcus Biosciences and Gilead Sciences announced promising Phase III results for their TIGIT inhibitor domvanalimab in combination with zimberelimab. Denmark’s Novo Nordisk released financial results that attracted interest. 10 November 2024
Pharmaceutical
Italian pharma major Recordati saw its shares dip 3.75% to 50.10 euros this morning, despite posting a set of strong financial results. 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Biotechnology
The global market for Duchenne muscular dystrophy (DMD) therapeutics is projected to grow by $4.4 billion between 2024 and 2028, fueled by artificial intelligence and strong demand for new treatments. 7 November 2024
Pharmaceutical
US drugmaker Sarepta Therapeutic saw its shares gain 2.4% to $127.97 as it reported financial results for the third quarter 2024. 7 November 2024
Pharmaceutical
Among major pharmaceutical news stories last week were Johnson & Johnson’s upbeat presentation on its R&D pipeline at an investors review day, as well as the announcement that Amgen was filing a Biological License application for its new migraine drug, more data on Shire’s rare disease candidate lanadelumab and Ionis’ inotersen. 21 May 2017
Biotechnology
Typically, when the US Food and Drug Administration approves an expansion of the indication for a drug, it means that additional clinical data have shown the drug can safely and effectively treat patient populations other than those for which it was originally intended. 19 May 2017
Biotechnology
Britain's largest pharma company GlaxoSmithKline has published results from a Phase III trial of mepolizumab as a treatment for EGPA, a rare inflammatory disease. 18 May 2017
Biotechnology
Ireland-incorporated Shire was trading 1.5% higher at £480.35 as Thursday’s markets prepared to close after announcing positive Phase III results with lanadelumab. 18 May 2017
Biotechnology
By expanding the approved use of Kalydeco (ivacaftor) in cystic fibrosis (CF), the US Food and Drug Administration (FDA) has tripled the number of rare gene mutations that the drug can now treat. 18 May 2017
Biotechnology
After releasing top-line results from a Phase III study into lead candidate inotersen, Ionis Pharmaceuticals saw its share price dip around 8%, as concerns over the drug’s side effects outweighed news that the trial had reached its primary endpoints. 16 May 2017
Biotechnology
The death of Henri Termeer, former chief executive of trailblazing biotech company Genzyme, has prompted a wave of tributes from across the industry. 16 May 2017
Biotechnology
The Food and Drug Administration has expanded a previously granted Breakthrough Therapy designation (BTD) for setmelanotide, a novel melanocortin-4 receptor (MC4R) agonist from Boston, USA-based biotech firm Rhythm Pharmaceuticals. 13 May 2017
Pharmaceutical
The rise in the share price of France’s neurodegenerative diseases specialist Pharnext has eased off as investors mull over a deal which is set to earn the company 20 million euros ($21.7 million). 11 May 2017
Biotechnology
US drugmaker Alexion Pharmaceuticals took a 3.4% hit to its share price on Monday, reducing its value to $124.48, after news that Brazilian police had raided its Sao Paolo offices in a sales practices probe. 9 May 2017
Pharmaceutical
The US Food and Drug Administration on Friday approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. 6 May 2017
Biotechnology
New York-based Ovid Therapeutics listed on the Nasdaq stock exchange today, pricing its initial public offering of 5 million shares at $15 each. After its first morning’s trading, the price had fallen about 10%. 5 May 2017
Biotechnology
The venture capital arms of Swiss giants Novartis and Roche have invested heavily in a French biotech startup called Vivet Therapeutics. 4 May 2017
Biotechnology
US clinical-stage biotech company bluebird bio yesterday announced that it has entered into worldwide license agreements around its proprietary lentiviral vector platform with two leading European pharma companies. 3 May 2017
Pharmaceutical
Ireland-headquartered rare diseases specialist Shire reported a 110% leap in first-quarter 2017 total revenues to $3.57 billion, boosted by its $32 billion acquisition last year of Baxalta, and at the top end of analysts’ forecasts. Sales excluding legacy Baxalta were up 11% to $1.8 billion. 2 May 2017
Biotechnology
Britain's largest pharma company GlaxoSmithKline is investing $139 million in its biopharmaceutical manufacturing site in Maryland, USA, to support growing demand for Benlysta (belimumab). 2 May 2017
Pharmaceutical
The past week was dominated by dozens of first-quarter financial results from both European and US biotech and pharma majors, including Biogen, Celgene, Eli Lilly, Novartis and Roche. However, there were also some interesting new drug approvals, including that of BioMarin Pharmaceuticals’ Brineura as the first product to gain Food and Drug Administration approval for a form of the rare Batten disease, as well as the first new liver cancer drug approval – Bayer’s Stivarga – in more than a decade. 30 April 2017
Pharmaceutical
The criteria of Australia’s Orphan Drug Program, which provides an incentive for sponsors to bring medicines for a small population to market that might otherwise not be available in Australia, have not been reviewed in almost 20 years and changes to the Program are required to ensure that it is still fulfilling its intended purpose. 30 April 2017
Biotechnology
The US Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. 28 April 2017
Biotechnology
A 22% increase in its net revenue was reported by US biotech Vertex Pharmaceuticals in its financial results for the first quarter of 2017 compared to the same period of 2016. 28 April 2017
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