Latest Pharma and Biotech News
Biotechnology
28 November 2024 Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma.
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Pharmaceutical
Positive results for nirogacestat would appear to validate Pfizer’s strategy of spinning out assets that fall outside of its strategic focus. 25 May 2022
Biosimilars
Alvotech Holdings, a privately-held Icelandic biosimilars developer, today announced positive results from a confirmatory clinical study for AVT04, the firms proposed biosimilar to Stelara (ustekinumab). 25 May 2022
Biotechnology
US microbiome company Seres Therapeutics has announced the presentation of data from its Phase III ECOSPOR III study that suggest investigational microbiome-based therapeutic SER-109 prevents recurrent C. difficile infections (rCDI) by rapidly establishing a long-lasting colony of beneficial gut microbes, which can produce fatty acids that disrupt the C. difficile lifecycle. 24 May 2022
Biotechnology
The local subsidiary of Swiss pharma giant Roche has launched its Phesgo, the first-ever fixed-dose formulation in cancer treatment to combine two monoclonal antibodies, in India. 24 May 2022
Biotechnology
USA-based gene therapy and vaccine company Ocugen has seen its shares boosted by news that the US Food and Drug Administration is to lift a clinical hold on one the firm’s coronavirus vaccine program. 24 May 2022
Generics
At the 2022 American Psychiatric Association (APA) annual meeting, Israeli generics giant Teva Pharmaceutical will present new data for Austedo (deutetrabenazine). 24 May 2022
Pharmaceutical
US neuroscience drug developer Biohaven Pharmaceutical’s shares were barely changed yesterday, despite disclosing top-line results from a Phase III clinical trial evaluating the efficacy and safety of its investigational therapy, troriluzole, in patients with spinocerebellar ataxia (SCA), that did not reach statistical significance in the overall SCA population as there was less than expected disease progression over the course of the study. 24 May 2022
Pharmaceutical
Shanghai-based Junshi Biosciences has announced positive results from a small trial of its COVID-19 antiviral, VV116, which compared its efficacy with Pfizer's Paxlovid (nirmatrelvir/ritonavir). 24 May 2022
Pharmaceutical
Prader-Willi Syndrome (PWS) awareness takes place every year in May, offering a time to reflect on the current and future treatment landscape. 24 May 2022
Generics
Piramal Pharma Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has announced that a new active pharmaceutical ingredient (API) plant at the company's site in Aurora, Ontario, Canada, has come online and successfully completed its initial production runs. 24 May 2022
Pharmaceutical
British drugmaker GlaxoSmithKline faces a higher wage bill after workers accepted an average 10.5% pay increase in return for calling off planned industrial action. 23 May 2022
Biotechnology
Highlighting the fact that there is an existing vaccine, life sciences industry analyst GlobalData has said the current monkeypox outbreak “should not be overly concerning.” 23 May 2022
Biotechnology
Privately-held Italian drugmaker Chiesi Pharmaceutical has bought global rights to a portfolio of therapeutic monoclonal antibodies (MAbs). 23 May 2022
Generics
About 100 generic medicines are set to be suspended from use in Europe, after a scientific panel of the European Medicines Agency reviewed evidence of irregularities at an Indian contract research organization (CRO). 23 May 2022
Biotechnology
At the annual European Congress of Rheumatology (EULAR 2022), presentations will include new data from two Phase III studies of bimekizumab, BE MOBILE 1 and BE MOBILE 2. 23 May 2022
Biotechnology
Canadian biotech Zymeworks today announced that its board of directors, after thorough consultation with its financial and legal advisors, unanimously determined that the unsolicited, opportunistic, proposal from an activist shareholder, Dubai-based All Blue Falcons and its affiliates to purchase Zymeworks for $10.50 per share (~$773 million in total) substantially undervalues the company and is not in the best interest of the firm and its shareholders. 20 May 2022
Pharmaceutical
Following the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meeting in May, positive opinions were issued on five novel medicinal products. 20 May 2022
Pharmaceutical
A new coalition in oncology will forge an innovative model of collaboration with the goal of boosting access to cancer medicines. 20 May 2022
Biotechnology
US cancer-focused biotech Foghorn Therapeutics yesterday announced the Food and Drug Administration (FDA) has placed the Phase I dose escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) on a partial clinical hold. 20 May 2022
Generics
The US Food and Drug Administration yesterday published a new batch of product-specific guidances (PSGs). 20 May 2022
All news
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
The currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. 29 November 2024
Pharmaceutical
Taiwan-based Formosa Pharmaceuticals (6838: TW) revealed that it has entered into an exclusive licensing agreement with Medvisis Switzerland, in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Pharmaceutical
German family-owned pain focused drugmaker Grünenthal has announced the pricing of 500 million-euro ($527.5 million) aggregate principal amount of 4.625% senior secured notes due 2031. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
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