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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Biotechnology
Japan’s SanBio Group has announced that SB623 met the primary endpoint and demonstrated a trend toward maintaining the improvement of function and activities of daily living in the final, one-year analysis of the Phase II STEMTRA trial, which evaluated the efficacy and safety of SB623 compared to sham surgery in patients with chronic motor deficit from traumatic brain injury (TBI). 8 April 2022
Biotechnology
Ireland-headquartered Jazz Pharmaceuticals has entered into a licensing agreement under which it has acquired exclusive global development and commercialization rights to Werewolf Therapeutics’ investigational WTX-613 molecule. 7 April 2022
Pharmaceutical
The Novo Holdings portfolio company ReViral has been acquired by US pharma giant Pfizer for up to $525 million in total dieal value. 7 April 2022
Pharmaceutical
The European pharma industry has commissioned a report on drug affordability which highlights its message that overall expenditure on therapies has remained stable. 7 April 2022
Biotechnology
Today Germany’s Merck KGaA and US pharm giant Pfizer announced that, following a successful appeal of the prior negative Final Appraisal Document (FAD), the UK’s National Institute for Health and Care Excellence (NICE) has overturned its decision and now recommends the immunotherapy Bavencio (avelumab) as a maintenance treatment option in eligible adult patients with locally advanced or metastatic urothelial carcinoma (UC), also known as bladder cancer. 7 April 2022
Pharmaceutical
The Russian Ministry of Health has prepared a list of 39 anticancer drugs that are likely to be in short supply in the country due to ongoing military conflict between Ukraine and Russia and Western sanctions imposed on Russia, reports The Pharma Letter’s local correspondent. 7 April 2022
Biotechnology
The news just keeps on coming on Sanofi and Regeneron’s immunology blockbuster Dupixent (dupilumab). 7 April 2022
Pharmaceutical
Shares of Texas, USA-based vaccines developer Vaxxinity were up more than 3% to $4.49 pre-market today, as it revealed that the Coalition for Epidemic Preparedness Innovations (CEPI) will co-fund the ongoing global pivotal Phase III clinical trial of Vaxxinity's next generation UB-612 COVID-19 vaccine candidate as a heterologous - or 'mix-and-match' - booster dose. 7 April 2022
Pharmaceutical
French firm Abionyx Pharma has reported positive interim results from an open-label Phase IIa trial of its acute kidney injury (AKI) candidate CER-001. 7 April 2022
Biotechnology
The third of a series of Industry Leader pieces from biological reagent supplier and service provider Sino Biological. 7 April 2022
Biotechnology
Chinese clinical-stage biotech Shenzhen Pregene Biopharma and CellPoint, a Dutch cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), have entered an exclusive license agreement for the development and commercialization of PRG-1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the USA. 7 April 2022
Biotechnology
The European Center for Disease Prevention and Control (ECDC) and European Medicines Agency’s (EMA) COVID-19 task force (ETF) have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population. 7 April 2022
Generics
Widely researched and resourced during the early stages of the COVID-19 pandemic, repurposing has shown its worth in an emergency. Facilitating repurposing beyond the pandemic promises sustainable developments and patient centric health outcomes in a range of therapy areas, comments Medicines for Europe, the trade group that represents generic and biosimilars drugmakers in the region. 7 April 2022
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca and Merck & Co’s Koselugo (selumetinib) for use by the National Health Service (NHS) in England. 6 April 2022
Pharmaceutical
US company Citius Pharmaceuticals today reported top-line results from the pivotal Phase III trial of I/ONTAK (E7777; denileukin diftitox)), an engineered interleukin (IL)-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). 6 April 2022
Pharmaceutical
The US Food and Drug Administration has just approved Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorders in adults. The drug was developed by Connecticut, USA company BioXcel Therapeutics. 6 April 2022
Biotechnology
Tetraneuron, a Spanish biotech taking a multifactorial approach to Alzheimer's through gene therapy, is to start a new round of financing. 6 April 2022
Biosimilars
Iceland-based Alvotech Holdings today announced the resolution of all intellectual property disputes with AbbVie in Europe and selected markets outside of Europe, related to its AVT02 biosimilar candidate. 6 April 2022
Biotechnology
Swiss pharma giant Novartis today announced the US Food and Drug Administration has granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. 6 April 2022
Biotechnology
The latest results from the Phase III CHAMPION-MG trial open-label extension showed that Ultomiris (ravulizumab-cwvz) demonstrated long-term efficacy in adults with anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis (gMG). 6 April 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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