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Biotechnology
Shares of PTC Therapeutics were up 6.9% to $42.58 by close of trading on Monday, ahead of formally announcing that Waylivra (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. 4 January 2022
Biotechnology
Shares of Swiss biotech Santhera Pharmaceuticals were up 15.4% at 1.50 Swiss francs by early afternoon, after it revealed an exclusive license agreement with China-based rare diseases specialist Sperogenix Therapeutics. 4 January 2022
Biotechnology
Shares in New York-based rare disease firm Applied Therapeutics have fallen by a third, after the company said it would put a US regulatory bid on hold. 4 January 2022
Biotechnology
US autoimmune drug developer Kyverna Therapeutics has entered into exclusive, worldwide licenses with the National Institutes of Health (NIH) for intellectual property related to a novel clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties uniquely suited for use in autoimmune diseases. 4 January 2022
Biotechnology
Bermuda-based Kiniksa Pharmaceuticals saw its shares drop more than 15% after it announced that the Phase III portion of the Phase II/III trial of mavrilimumab in COVID-19-related acute respiratory syndrome (ARDS) did not meet the primary efficacy endpoint. 31 December 2021
Biotechnology
US CNS-focussed biotech Amylyx Pharmaceuticals yesterday revealed that the US Food and Drug Administration has accepted for review its New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). 30 December 2021
Biosimilars
USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021
Pharmaceutical
Russian drugmaker ChemRar Group says that its Avifavir (favipiravir) drug is effective against various variants of SARS-CoV-2 (coronavirus), including Delta and Omicron, as it affects the highly conservative and mutation-resistant replication systems of RNA virus (RdRp) via three complementary mechanisms, resulting in complete blockade of the viral infection. 27 December 2021
Pharmaceutical
US cancer-focussed firm Karyopharm Therapeutics has entered into an exclusive licensing agreement whereby privately-held Italian drugmaker Menarini will commercialize Nexpovio (selinexor), Karyopharm’s first-in-class, oral selective inhibitor of nuclear export (SINE) compound, in Europe and other key global territories. 24 December 2021
Pharmaceutical
A new strategic research tie-in between Aarvik Therapeutics and ArriVent Biopharma will see the firms working together to develop an undisclosed oncology-focused drug candidate. 24 December 2021
Biosimilars
With the recent launch of the Avastin (bevacizumab) biosimilar in China, Henlius, the biotech arm of Fosun Pharma, now has four biosimilars under its belt. However, the Shanghai-based firm is eager to shake off the image of a biosimilars supplier. 22 December 2021
Biotechnology
Novartis announced today that it entered into a definitive agreement to acquire all of the outstanding share capital of the UK-based ocular gene therapy company Gyroscope Therapeutics, which was formed in 2016 and co-funded by Syncona. 22 December 2021
Biotechnology
Clearly French pharma major Sanofi’s appetite for M&A has not been satisfied yet, as the company today announced its sixth acquisition this year. 21 December 2021
Pharmaceutical
Topical dermatology specialist DermBiont has raised $28 million in a series A financing, at the same time as acquiring clinical-stage biotech Chromaderm. 21 December 2021
Generics
Swiss drugmaker Vifor Pharma and its partner American Regent, Daiichi Sankyo’s US subsidiary, today announced that they have reached settlement agreements with Mylan Laboratories, part of Viatris, the newly-formed generics power-house resulting from the merger of Mylan and Pfizer, and Sandoz, which is about to be spun out of Novartis, that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the US Food and Drug Administration to market a generic version of Injectafer (ferric carboxymaltose). 20 December 2021
Biotechnology
The US Food and Drug Administration (FDA) has approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, said Belgo-Dutch clinical-stage immune-oncology biotech argenx. 20 December 2021
Biotechnology
Ipsen and fellow France-based Genfit have entered into a long-term strategic partnership for global collaboration between the two companies. 18 December 2021
Pharmaceutical
The UK’s National Institute of Heath and Care Excellence (NICE) has published its final technology appraisal guidance (TAG) for Ontozry (cenobamate), a treatment for focal onset seizures in uncontrolled epilepsy from Arvelle Therapeutics, a unit of privately-held Italian drugmaker Angelini Pharma. 16 December 2021
Biotechnology
Switzerland-based clinical-stage immune-oncology company Anaveon has agreed a 110 million Swiss francs ($120 million) Series B financing led by incoming investor Forbion, corner-stoned by founding investor Syncona, also joined by existing investor Novartis Venture Fund, as well as new investors, Cowen Healthcare Investments (a division of Cowen Investment Management), Pfizer Ventures and Pontifax. 16 December 2021
Pharmaceutical
Swedish biotech firm Calliditas Therapeutics late yesterday announced that the US Food and Drug Administration has approved Tarpeyo (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. 16 December 2021
Biotechnology
Epitopea, a UK and Canada-based cancer immunotherapeutics company, has partnered with nucleic acid delivery specialist Genevant Sciences to develop new RNA-based therapies targeting proprietary tumor antigens. 20 December 2024
Pharmaceutical
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
Pharmaceutical
Privately-held Xcovery Holdings, an oncology-focused pharma company, has announced that the US Food and Drug Administration (FDA) has approved Ensacove (ensartinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 19 December 2024
Biotechnology
Privately-held biotech Ottimo Pharma today announces the completion of a Series A financing round of over $140 million. 19 December 2024
Biotechnology
Safi Biotherapeutics, a specialist in stem-cell derived red blood cell products, has received Rare Pediatric Disease designation and Orphan Drug designation from the US regulator. 19 December 2024
Biotechnology
BioAge Labs today announced a multi-year research collaboration with Swiss pharma giant Novartis, with the news pushing the US biotech’s shares up 6.1% to $4.35 by early afternoon. 18 December 2024
Pharmaceutical
Marking its second deal this month alone, Novo Nordisk has entered into a multi-year collaboration with Massachusetts, USA-based Photys Therapeutics to develop novel proximity-based therapeutics for a cardiometabolic disease target. 18 December 2024
Biotechnology
Cara Therapeutics and Tvardi Therapeutics have announced a definitive agreement to merge, creating a new entity under the Tvardi name. 18 December 2024
Pharmaceutical
SiteOne Therapeutics has announced the completion of a $100 million series C financing, led by Novo Holdings, with participation from OrbiMed, Wellington Management, Mission BioCapital, and others. 18 December 2024
Biotechnology
Flagship Pioneering-founded genome engineering biotech Tessera Therapeutics today announced an investment of up to $50 million from the Bill & Melinda Gates Foundation to develop curative, globally accessible in vivo genetic therapies for sickle cell disease. 18 December 2024
Biotechnology
San Francisco-based Indapta Therapeutics, a privately held start-up developing next-generation cell therapies, has raised $22.5 million in a new financing round. The firm raised over $50 million in series A funding in 2022. 18 December 2024
Biotechnology
French CNS specialist Theranexus saw its shares leap more than 34% to 0.65 euros as it revealed a license and supply agreement with Exeltis to commercialize TX01, its novel formulation of a compound already approved in the indication for the treatment of rare neurological diseases. 18 December 2024
Biotechnology
Shares in US biopharma Viridian Therapeutics shot up by 21% on Monday. 17 December 2024
Biotechnology
US antivirals giant Gilead Sciences today revealed it has entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets with Californian biotech Terray Therapeutics. 17 December 2024
Pharmaceutical
Swedish biotech company Inify Laboratories has raised approximately 135 million kroner ($12.3 million) through a private placement, supporting a planned expansion into the UK. 16 December 2024
Biotechnology
Dewpoint Therapeutics and ConcertAI have announced the first phase of their translational oncology partnership, aligned around the former company's latest drug candidate, DPTX3186. 16 December 2024
Biotechnology
Bicycle Therapeutics, a UK-headquartered pharma company developing a new class of therapeutics based on its proprietary bicyclic peptide technology, closed a third lower on Friday. 16 December 2024
Biotechnology
In a filing with the US financial regulator, German mRNA specialist BioNTech has noted the lifting of a partial clinical hold on its PRESERVE-003 trial. 16 December 2024
Biotechnology
VectorY Therapeutics, a Netherlands-based biotech focused on neurodegenerative diseases, has appointed Jim Scibetta as chief executive officer. 16 December 2024
Biotechnology
Sino-American biotech BeiGene has announced it has entered into a global licensing agreement with China’s CSPC Zhongqi Pharmaceutical Technology for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. 13 December 2024
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