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Pharmaceutical
Israel-based generics giant Teva Pharmaceutical Industries’ US subsidiary has reached an agreement with the Attorney General (AG) of Texas that settles the state’s and its subdivisions opioid-related claims. 7 February 2022
Biotechnology
Australian stem cell therapy company Mesoblast has appointed Eric Rose, since 2013 a non-executive director, to the role of chief medical officer. 3 February 2022
Biotechnology
Sweden-headquartered contract development and manufacturing organization Recipharm today announced the acquisition of GenIbet, a Portuguese CDMO, specializing in the manufacture of biological clinical trial material and novel modalities such as viral vectors, RNA and microbiome. 1 February 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir/rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. 1 February 2022
Biotechnology
Swedish immuno-oncology company Alligator Bioscience has appointed Sumeet Ambarkhane as chief medical officer. 1 February 2022
Pharmaceutical
LEO Pharma has appointed Christophe Bourdon as chief executive officer, effective from April 1 2022. 31 January 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. 31 January 2022
Pharmaceutical
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization for US pharma giant Pfizer’s oral antiviral Paxlovid (PF-07321332/ritonavir) for the treatment of COVID-19. 27 January 2022
Biotechnology
The European Commission has approved another indication for Merck & Co’s mega-blockbuster anti-PD-1 drug Keytruda (pembrolizumab), this time as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 27 January 2022
Pharmaceutical
London-based Global Blood Therapeutics (GBT) has been given a positive scientific opinion under the UK’s Early Access to Medicines Scheme (EAMS), for its sickle cell disease candidate voxelotor. 27 January 2022
Generics
Bright Way Group, the Russian investment company and pharmaceutical producer, plans to invest up to 3 billion roubles ($38 million) in the building of a large-scale pharmaceutical factory in the city of Moscow within the Technopolis Moscow special economic zone (SEZ), according to recent statements by Moscow authorities and local media reports. 26 January 2022
Pharmaceutical
Swiss biotech Idorsia and Syneos Health have extended an existing collaboration to commercialize daridorexant for the treatment of insomnia across Europe and Canada. 26 January 2022
Pharmaceutical
The US subsidiary of Italian drugmaker Chiesi Farmaceutici has announced that a post hoc analysis of the CHAMPION PHOENIX clinical trial that evaluated treatment of Kengreal (cangrelor) in patients undergoing percutaneous coronary intervention (PCI) was published in Circulation: Cardiovascular Interventions. 25 January 2022
Biotechnology
Ono Pharmaceutical’s Taiwanese subsidiary has received the additional approval of Opdivo (nivolumab) intravenous infusion 20mg, 100mg Inj, a human anti-human PD-1 monoclonal antibody, from the Taiwan Food and Drug Administration (TFDA). 25 January 2022
Biotechnology
Chinese biotech firm BeiGene has announced findings from the Phase III RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. 24 January 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) has approved a scale up of manufacturing of AstraZeneca’s Vaxzevria (previously called COVID-19 Vaccine AstraZeneca). 24 January 2022
Biotechnology
Swiss biotech Idorsia today announced the appointment of Guy Braunstein, who has served as head, global clinical development since the creation of Idorsia and before, since 2009 at Actelion, to a newly created role – chief medical officer (CMO) and affirms that he will continue to serve as a member of the Idorsia executive committee (IEC) in this new position. 24 January 2022
Biotechnology
Research conducted by Brighton, UK-based Destiny Pharma, with the cooperation of the US Department of Veterans Affairs, shows successful gut colonisation of its microbiome candidate NTCD-M3. 24 January 2022
Pharmaceutical
The US Food and Drug Administration has granted expedited approval of a supplemental new drug application (sNDA) for US biotech major Gilead Sciences’ Veklury (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. 22 January 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceuticals has obtained regulatory approval from the Ministry of Health, Labor and Welfare for the humanized anti-human interleukin (IL)-6 receptor monoclonal antibody Actemra (tocilizumab; genetical recombination) for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention). 22 January 2022
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Biotechnology
US biotech Paragon Therapeutics yesterday revealed that biotech industry veteran Susanna High has been appointed as chief executive (CEO). In this newly-created role, Ms High will lead the team’s continued efforts to propel the development of a pipeline of transformative therapies and accelerate their potential impact. 22 November 2024
Pharmaceutical
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
California-based venture capital firm Versant Ventures yesterday announced the launch of Pep2Tango Therapeutics, a start-up focused on innovative, next-generation weight loss therapies. Proceeds from the significant, undisclosed round will support development of the company’s novel unimolecular tetra-receptor agonist peptides to treat obesity and related conditions. 22 November 2024
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 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
Biotechnology
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 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
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Biotechnology
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
Biotechnology
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
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