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25 November 2024 In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards.
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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
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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
Biotechnology
US healthcare giant Johnson & Johnson has filed a supplemental Biologics License Application with the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab) to treat moderately to severely active ulcerative colitis (UC). 22 November 2024
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
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Biotechnology
US precision therapy company Blueprint Medicines’ shares dipped more than 2% to $61.62 early today, after it announced a strategic collaboration with Proteovant Therapeutics to advance novel targeted protein degrader therapies to address important areas of medical need. 28 February 2022
Biotechnology
Meletios Therapeutics, a French biotechnology company formed in 2020, announced it has signed an exclusive license agreement with the Institut Pasteur for the development of a new class of antiviral treatments. 28 February 2022
Biotechnology
South Korea’s GC Pharma saw its shares fall 6.2% to 182,000 won, after it revealed it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its Biologics License Application (BLA) for Alyglo (immune globulin intravenous (human), 10% liquid). 28 February 2022
Biotechnology
Brazil’s Oswaldo Cruz Foundation (Fiocruz), through the Immunobiological Technology Institute (Biomanguinhos), provides the first doses of the COVID-19 vaccine (recombinant) produced with the national Active Pharmaceutical Ingredient (API). 28 February 2022
Biotechnology
Among significant news last week, US biotech Synairgen’s COVID-19 therapy SNG001 missed endpoints in a Phase III study of hospitalized patients. BioNTech announced a deal with fellow German company Medigene for the discovery of cancer immunotherapeutics. Sanofi and GlaxoSmithKline have now developed Phase III clinical trial data that prepares then for regulatory filings for their investigational COVID-19 vaccine. US biotech Moderna released financial results last Thursday that were very much focussed on the performance of its COVID-19 vaccine Spikevax. Also, Amicus Therapeutics announced that its planned SPAC deal with ARYA Sciences has been terminated. 27 February 2022
Biotechnology
The US Food and Drug Administration on Friday issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome, said the drug’s developer, Reata Pharmaceuticals, whose shares fell 3.7% to $25.16 in after-hours trading. 26 February 2022
Biotechnology
Canadian biopharma company Medicago and UK pharma major GlaxoSmithKline have announced that Health Canada has granted approval for Covifenz, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). 25 February 2022
Biotechnology
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant (emapalumab) to the National Medical Products Administration of China (NMPA). 25 February 2022
Biotechnology
GlobalData has taken a look at the acute myeloid leukemia (AML) treatment landscape in China. 25 February 2022
Biotechnology
ARYA Sciences Acquisition Corp IV , a publicly traded special purpose acquisition company (SPAC) sponsored by Perceptive Advisors, announced on Thursday that, due to existing market conditions, it has mutually agreed with Amicus Therapeutics terminate their previously announced business combination agreement, effective immediately. 25 February 2022
Biotechnology
US mRNA company Moderna announced better-than-expected financial results and a $3 billion share buyback on Thursday. 24 February 2022
Biotechnology
Shares in Belgian drugmaker UCB were 5% higher as Thursday’s trading entered the home straight. 24 February 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for Spikevax (COVID-19 Vaccine, mRNA) to include use in children aged six to 11. 24 February 2022
Biotechnology
UK pharma major GlaxoSmithKline has today welcomed a decision by UK health technology assessor the National Institute for Health and Care Excellence (NICE) to issue a Final Appraisal Determination (FAD) recommending the use of Zejula (niraparib) on the National Health Service (NHS). 24 February 2022
Biotechnology
The World Health Organization (WHO), the Republic of Korea and the WHO Academy have established a global biomanufacturing training hub that will serve all low- and middle-income countries wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments. 24 February 2022
Biotechnology
US biotech Moderna has announced a distribution service agreement with Adium Pharma, a privately-held Uruguay-based pharma company, to support the commercialization of the Moderna COVID-19 vaccine, Spikevax across Latin America. 23 February 2022
Biotechnology
Spark Therapeutics, fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease that was acquired by Swiss pharma giant Roche (ROG: SIX) in a $4.8 billion deal in 2020, today announced that Ron Philip, Spark’s chief operating officer, will succeed co-founder Jeffrey Marrazzo as chief executive. 23 February 2022
Biotechnology
US drugmaker Eli Lilly has announced the launch of the Lilly Institute for Genetic Medicine with an investment of approximately $700 million to establish a facility at a new site in the Boston Seaport. 23 February 2022
Biotechnology
US ophthalmic therapy developer Kodiak Sciences, which had hoped to challenge the highly successful eye drug Eylea (aflibercept) and the current standard of care, saw its shares plunge 80% to $10.07 by mid-morning today, when it released top-line results from its randomized, double-masked, active comparator-controlled Phase IIb/III clinical trial evaluating the efficacy, durability and safety of KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular (wet) age-related macular degeneration. 23 February 2022
Biotechnology
London-listed Finnish biotech firm Faron Pharmaceuticals today announced updated survival data from Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab, Faron’s wholly-owned, novel precision cancer immunotherapy candidate, which has the trade name Clevegen. 23 February 2022
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