27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
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
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
For the fourth quarter of 2020, Biogen has reported revenues of $2.8 billion, hitting most analysts’ forecasts on the nose and bringing the total for the year to $13.4 billion. 3 February 2021
UK pharma major GlaxoSmithKline and German biotech firm CureVac today announced a new 150 million-euro ($180.5 million) collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. 3 February 2021
New York-based biopharma Immunovant lost 42% of its value in Tuesday’s trading after announcing a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401. 3 February 2021
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Beovu (brolucizumab) as an option in the National Health Service (NHS) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults. 3 February 2021
A primary analysis of Phase III clinical trials indicates that COVID-19 Vaccine AstraZeneca - formerly known as AZD1222 - is safe and effective more than 22 days after the first dose. 3 February 2021
Feeling the effects of the coronavirus pandemic, Californian biotech Amgen reported mixed results for the final quarter of 2020, with rising revenues but declining profits. 3 February 2021
Life sciences investment group Abingworth has announced the final closing of its latest transatlantic venture fund, Abingworth Bioventures 8 (ABV 8) at $465 million. 3 February 2021
In a second research collaboration this year, privately-held US DNA-encoding specialist X-Chem has entered into a research collaboration and license agreement with Swiss pharma giant Roche’s subsidiary Genentech. 3 February 2021
French vaccines developer Valneva today reported that the UK government has exercised its option to order a further 40 million doses of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, for supply in 2022. 2 February 2021
Japan’s Ono Pharmaceutical has entered into a license agreement with US clinical-stage oncology company Ribon Therapeutics for RBN-2397, Ribon’s PARP7 (Poly ADP-ribose polymerase 7) inhibitor in Phase I clinical development for the treatment of cancer. 2 February 2021
China’s Clover Biopharmaceuticals is to begin a global Phase II/III trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum. 2 February 2021
Coherus BioSciences’ shares gained 12% yesterday, after it announced a collaboration with Shanghai Junshi Biosciences for the development and commercialization of toripalimab, the Chinese firm’s anti-PD-1 antibody, in the USA and Canada, which could be worth as much as $1.1billion to the latter. 2 February 2021
Findings from the Phase III KEYNOTE-598 trial show that combining Keytruda (pembrolizumab) with another immunotherapy, Yervoy (ipilimumab), failed to improve outcomes in first-line non-small cell lung cancer (NSCLC). 2 February 2021
A rolling review of Roche and Regeneron Pharmaceuticals’ COVID-19 treatment, REGN-COV2, has been initiated by the European Medicines Agency (EMA). 2 February 2021
US biotech major Gilead Sciences and Gritstone Oncology have entered into a collaboration, option and license agreement to research and develop a vaccine-based immunotherapy as part of Gilead’s efforts to find a curative treatment for human immunodeficiency virus (HIV) infection. 1 February 2021
Cambridge, UK-based Avacta Group today announced that AffyXell Therapeutics, the joint venture with South Korean drugmaker Daewoong Pharmaceutical, has closed a Series A venture capital investment of $7.3 million to further develop its pipeline of next generation cell and gene therapies. 1 February 2021
Clinical-stage German biotech CureVac’s shares were up more than 10% in pre-market New York trading today, after it announced initiating the set-up of manufacturing capabilities for its3 COVID-19 vaccine, CVnCoV, with contract manufacturer Rentschler Biopharma. 1 February 2021
The Indian pharmaceutical sector is set to grow three-fold in the next decade, according to the country's Economic Survey. COVID-19 appears to have presented both an opportunity and a challenge for India to emerge as the 'pharmacy of the world', reports The Pharma Letter’s India correspondent. 1 February 2021