Latest Pharma and Biotech News
Biotechnology
11 November 2024 On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics'
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Biotechnology
Norwegian clinical-stage biotech Nykode Therapeutics revealed that it has received notification from Genentech, a US subsidiary of Roche, of its decision to terminate the collaboration and licensing agreement for Nykode’s VB10.NEO cancer vaccine program. 12 November 2024
Pharmaceutical
While not everything appears rosy in one of AstraZeneca’s major markets, the company has announced a huge investment in another. 12 November 2024
Pharmaceutical
Merck KGaA today announced that the Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate (ORR) in patients with tenosynovial giant cell tumor (TGCT). The ORR for pimicotinib at week 25 was 54.0% compared with 3.2% for placebo (p<0.0001). 12 November 2024
Pharmaceutical
AstraZeneca and Merck & Co announced that their jointly developed drug Koselugo (selumetinib) has shown positive outcomes in the KOMET Phase III trial. 12 November 2024
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca beat analyst expectations with its third-quarter 2024 revenue and earnings figures. 12 November 2024
Pharmaceutical
Germany’s Bayer saw its shares tumble almost 11% to 21.76 euros this morning, as it reported level third-quarter 2024 sales while earnings declined. 12 November 2024
Pharmaceutical
Twelve leading health economists have published a paper in the Forum for Health Economics and Policy that challenges the drug pricing math used by groups like the Institute for Clinical and Economic Review (ICER). 12 November 2024
Biotechnology
French biotech DiogenX, which is focused on regenerating insulin-producing beta cells for the treatment of diabetes, today announces the appointment of Dr Klara Owen as chief medical officer. 12 November 2024
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
23andMe, a human genetics firm and consumer health innovator, has announced a major restructuring, cutting approximately 40% of its workforce. 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Biotechnology
Rubedo Life Sciences, a US biopharma developing first-in-class therapies targeting senescent cells which drive age-related diseases, has announced the appointment of Frederick C Beddingfield III, as chief executive officer and board director. 11 November 2024
Biotechnology
The combination of Merck & Co’s Keytruda (pembrolizumab) and Citius Pharmaceuticals’ Lymphir (denileukin diftitox-cxdl) showed promising preliminary results in an investigator-initiated Phase I clinical trial for cancer patients with recurrent solid tumors. 11 November 2024
article
US company IDEAYA Biosciences has exercised the option for an exclusive worldwide license for Biocytogen Pharmaceuticals’ B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate. 11 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Pharmaceutical
The US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) today launched new advertisements urging Congress to make sure savings on medicines go to patients, not middlemen. 11 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
Pharmaceutical
Aurinia Pharmaceuticals has announced a major strategic overhaul, reducing its workforce by almost half to focus on driving Lupkynis (voclosporin) growth. 11 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program, according to Sarah Wicks and James Valentine at US law firm Hyman, Phelps & McNamara. 11 November 2024
Biotechnology
Sarepta Therapeutics has announced it will cease development of SRP-5051, an experimental drug for Duchenne muscular dystrophy, citing safety issues, feedback from the Food and Drug Administration, and the shifting Duchenne treatment landscape. 11 November 2024
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Biotechnology
ViroCell Biologics, a UK contract development and manufacturing organization (CDMO), has announced the appointment of Susan Nichols to its senior management team as chief business officer (CBO). 20 September 2022
Biotechnology
AstraZeneca's Evusheld (tixagevimab and cilgavimab) has been approved for a second indication in Europe. 20 September 2022
Pharmaceutical
Less than two months after Theravance Biopharma sold off rights to its share of royalties from parts of GSK’s respiratory franchise, the company announced an agreement to buy back equity from the British drugmaker. 20 September 2022
Biosimilars
In an effort to bring clarity to the use of biosimilars in Europe, health authorities have issued a statement confirming their interchangeability with reference medicines. 20 September 2022
Pharmaceutical
The European Commission (EC) has granted marketing authorization of Lupkynis (voclosporin) to treat adults with active lupus nephritis (LN). This follows the positive European Medicines Agency’s CHMP opinion announced in late July. 20 September 2022
Pharmaceutical
The Russian drug market will reach a value of $35 billion by 2024, despite the ongoing military conflict between Russia and Ukraine and the ever-tightening sanctions pressure on Russia, according to calculations by experts from the Russian consulting company in the field of pharmaceuticals SBS Consulting, report The Pharma Letter’s local correspondent. 20 September 2022
Biotechnology
Danish diabetes care giant Novo Nordisk has entered into a definitive agreement to acquire Forma Therapeutics, a US clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders, whose shares rocketed up 48% to $19.84 on the news. 19 September 2022
Biotechnology
US biotech bluebird bio has had a rocky ride in gaining US approval for its Skysona (elivaldogene autotemcel), but the US Food and Drug Administration (FDA), having earlier this year extended the review period for the product, on Friday granted authorization for the gene therapy. 19 September 2022
Biotechnology
Adding to approvals of Vabysmo (faricimab) in the major markets of the USA and Japan earlier this year, Swiss pharma giant Roche has now gained marketing clearance for the drug from the European Commission (EC) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). 19 September 2022
Pharmaceutical
Ambitions are soaring for the UK’s pharma and biotech industry on the back of record investment but can it be sustained in the absence of workers with critical STEM skills? MHA’s Yogan Patel looks at strategies for attracting and retaining talent in an Expert View piece. 19 September 2022
Biotechnology
French biotech firm Genfit has entered into an exclusivity agreement to acquire Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases. 19 September 2022
Biosimilars
Sandoz, the generic and biosimilar medicines unit of Novartis, which the Swiss pharma giant last month said it would hive off into a new publicly traded company, today announced further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab. 19 September 2022
Pharmaceutical
Pharma companies continue to evaluate novel ways to increase their return on investment and generate shareholder value, basic earnings per share (EPS), plus stock price. Historically, pharma has pursued mergers and acquisitions to undermine R&D and drive growth. 19 September 2022
Biotechnology
Last month, Belgo-Dutch autoimmune diseases specialist argenx announced the European Commission (EC) approval of Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 19 September 2022
Biotechnology
Significant news last week included US pharma major Bristol Myers Squibb gaining Food and Drug Administration approval for its TYK2 inhibitor Sotyktu (deucravacitinib) for the treatment of plaque psoriasis. Shares of US biotech Akero skyrocketed last Tuesday when it released very positive Phase IIb results for its efruxifermin in the treatment of non-alcoholic steatohepatitis (NASH). Also, US pharma giant Pfizer released impressive new Phase III data on its pentavalent vaccine for meningococcal disease. US biotech Gilead Sciences last week entered into a settlement with several generic drugmakers relating to copy versions of its HIV drugs Descovy and Odefsey. 18 September 2022
Biotechnology
Following approval from the US regulator in March this year, on Friday Bristol Myers Squibb revealed that the European Commission has also cleared its fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. 17 September 2022
Biotechnology
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim results from a well-watched Phase I trial early Friday. 16 September 2022
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) today released its list of recommended novel medicines and one biosimilar for approval following its September 2022 meeting. 16 September 2022
Biosimilars
The Initiative for Medicines, Access, and Knowledge (I-MAK), a campaign group seeking to drive down the cost of medicines, has taken aim at pharma firms’ protection of their patents. 16 September 2022
Biotechnology
Japanese medium-sized drugmaker Asahi Kasei Pharma yesterday revealed it has acquired the exclusive distribution rights in Japan for two products developed by Swedish Orphan Biovitrum. 16 September 2022
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