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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.
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Biotechnology
French CAR T-cell specialist Cellectis has been cleared to continue the Phase I MELANI-01 trial of UCARTCS1 in multiple myeloma. 19 November 2020
Biotechnology
Newly-formed Ireland-based SynOx Therapeutics, a clinical stage biopharmaceutical company, today announced the closing of a 37 million euros ($44 million) Series A financing co-led by HealthCap and Medicxi and joined by investors Forbion and Gimv. 19 November 2020
Biotechnology
US pharma major Eli Lilly has announced that the National Institute for Health and Care Excellence (NICE) has recommended Emgality (galcanezumab) as an option for the prevention of migraine in adults with episodic and chronic migraine in England and Wales. 18 November 2020
Biotechnology
Chiasma was trading 4% higher in the opening minutes on Wednesday. 18 November 2020
Biotechnology
There was more good news on the COVID-19 vaccine front on Wednesday with Pfizer and BioNTech announcing the final efficacy analysis in their ongoing Phase III study of their mRNA-based COVID-19 vaccine candidate, BNT162b2. 18 November 2020
Biotechnology
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency). 18 November 2020
Biotechnology
Tuesday was a share-splitting day for US biotech BrainStorm Cell Therapeutics. 18 November 2020
Biotechnology
The post-registration trials of the peptide antigens-based EpiVacCorona vaccine against COVID-19, developed by the State Research Center of Virology and Biotechnology "Vector," have begun in Russia, head of the Russian Federal Service for the Oversight of Consumer Protection and Welfare Anna Popova said on Tuesday during an online symposium dedicated to COVID-19 research, the state TASS news agency reported. 18 November 2020
Biotechnology
D3 Bio, a biotech focused on oncology and immunology, has launched with a $200 million Series A financing. 17 November 2020
Biotechnology
US pharma major Eli Lilly’s monoclonal antibody (MAb) bamlanivimab is unlikely to face payer pushback, despite its broad label, after recent Food and Drug Administration emergency use authorization (EUA), experts told Manasi Vaidya, pharma writer for the investigative news team at data and analytics company GlobalData. 17 November 2020
Biotechnology
While much of the world’s focus is on what pharma can do to end the coronavirus pandemic, the rest of the industry is continuing its work ensuring innovative medicines reach those most in need. 17 November 2020
Biotechnology
The European Commission has announced a deal with CureVac, securing up to 225 million doses of the firm’s coronavirus vaccine, with an option for 180 million more doses. 17 November 2020
Biotechnology
The US regulator has said a submission from Bristol Myers Squibb for lisocabtagene maraleucel (liso-cel) will be delayed. 17 November 2020
Biotechnology
Just as Pfizer and BioNTech did a week ago, Moderna has presented positive Phase III findings from an mRNA COVID-19 vaccine trial. 16 November 2020
Biotechnology
UK-based respiratory disease discovery biotech Synairgen has announced the publication of data from the SG016 trial in The Lancet Respiratory Medicine journal. 16 November 2020
Biotechnology
US biotech Gilead Sciences and Danish diabetes giant Novo Nordisk today announced encouraging results from a Phase II proof-of-concept trial of a cocktail of their liver disease candidates, under a 2019 collaboration. 16 November 2020
Biotechnology
Seed Therapeutics, a BeyondSpring spin-off focused on discovering and developing “molecular glues” to degrade disease-causing protein previously believed to be undruggable, has entered into a research collaboration and license agreement with Eli Lilly to discover and develop new chemical entities (NCEs) that could produce therapeutic benefit through targeted protein degradation (TPD). 14 November 2020
Biotechnology
On Friday, the Food and Drug Administration granted accelerated approval for Keytruda (pembrolizumab), in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. 14 November 2020
Biotechnology
Japan’s largest drugmaker Takeda Pharmaceutical today announced the final results from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study Open-label Extension (OLE), showing that Takhzyro (lanadelumab-flyo) helped prevent and reduce the frequency of hereditary angioedema (HAE) attacks long term in patients 12 years of age and older who received treatment for a mean (standard deviation) duration of 29.6 (8.2) months. 13 November 2020
Biotechnology
Russia has agreed terms for South Korean biotech GL Rapha to produce 150 million doses per year of its home-grown coronavirus vaccine, Sputnik V. 13 November 2020
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Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Biotechnology
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
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
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
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
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Biotechnology
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
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