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
The US Food and Drug Administration is looking to raise the issue of drug shortages, in an attempt to boost the resilience and effectiveness of drugmakers in ensuring continuity of supply. 20 May 2022
Biotechnology
French specialty vaccine company Valneva has confirmed that the European Medicines Agency (EMA) has accepted the filing of a marketing authorization application (MAA) for Valneva’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. 20 May 2022
Pharmaceutical
The leading Australian trade body for the pharmaceutical industry, Medicines Australia, said it has alerted “hundreds of key stakeholders to get ready to engage” in the next government review of the country’s health technology assessment (HTA) system. 20 May 2022
Biotechnology
German pharma major Bayer has ended a collaboration with Atara Biotherapeutics, which was based around its novel allogeneic EBV T-cell platform. 20 May 2022
Biotechnology
Positive Phase III trial results from Belgian pharma major UCB’s two clinical trials in its generalized myasthenia gravis (gMG) program will enable it to become a key future player in the MG market, with both zilucoplan and rozanolixizumab expected to enter the market next year. 20 May 2022
Biosimilars
India’s Biocon Biologics and US-headquartered Viatris have launched their Abevmy (bBevaczumab) in Canada. 20 May 2022
Pharmaceutical
Genetic differences among racial and ethnic populations can lead to differences in the safety and efficacy of drugs across these populations. The US Food and Drug Administration approves medical products based on evidence from clinical trials and so participants in clinical trials should adequately represent the population intended to use the product. 20 May 2022
Pharmaceutical
Shares of Denmark’s Zealand Pharma closed up more than 15% at 96.00 kroner, after it announced positive data from its Phase III trial of dasiglucagon in pediatric patients with congenital hyperinsulinism (CHI), a rare pediatric disease that affects mainly newborns, infants and toddlers. 19 May 2022
Biotechnology
Massachusetts, USA-based biotech incubator Flagship Pioneering announced the unveiling of a new company – Sonata Therapeutics – to develop novel medicines for a wide range of serious diseases based on understanding and re-engineering the cellular microenvironment. 19 May 2022
Pharmaceutical
Privately-held Swiss drugmaker Helsinn Group has announced the appointment of Dr Melanie Rolli as group chief operating officer (COO), effective June 1, 2022. 19 May 2022
Pharmaceutical
British targeted medicine company Redx Pharma has raised a total of £35 million ($43 million) in a share placement, with both new and existing institutional investors participating in the funding round. 19 May 2022
Pharmaceutical
In an exclusive for TPL, Clover Biopharmaceuticals’ president of global R&D, Nicholas Jackson, has contributed his thoughts on what the COVID-19 pandemic has taught us. 19 May 2022
Pharmaceutical
Danish vaccine developer Bavarian Nordic revealed today that it has secured a contract with an undisclosed European country to supply its Imvanex smallpox vaccine in response to new cases of monkeypox evolving during May 2022. 19 May 2022
Biotechnology
US clinical-stage biotech Enanta Pharmaceuticals saw its shares tumble yesterday, and fall 16% to $38.49 pre-market today, after it reported disappointing top-line results for RSVP, its Phase IIb study evaluating EDP-938, a potent N-protein inhibitor, in otherwise healthy adults with community-acquired respiratory syncytial virus (RSV). 19 May 2022
Biotechnology
The top 20 global biotech firms by market capitalization experienced a positive first quarter, despite an increasingly volatile economic backdrop, according to research from GlobalData. 19 May 2022
Pharmaceutical
German firm Fresenius Kabi, a specialist in medicines and technologies for infusion, transfusion and clinical nutrition, has recruited Brandee Pappalardo as senior vice president and chief medical officer for North America. 19 May 2022
Pharmaceutical
The local subsidiary of Danish diabetes care giant Novo Nordisk, the sponsor of semaglutide (Ozempic) solution for injection pre-filled pen, notified the Therapeutic Goods Administration (TGA) of a shortage of both strengths of semaglutide (Ozempic) products due to an unexpected increase in consumer demand. 19 May 2022
Biotechnology
In the USA, the National Institute of Allergy and Infectious Diseases (NIAID) has awarded $67.5 million to a consortium of researchers working on pandemic preparedness. 19 May 2022
Pharmaceutical
Germany’s Evotec and Spanish skin health specialist Almirall today announced a multi-target alliance in medical dermatology. 19 May 2022
Generics
Along with all the other medicines supply problems that the country has recently encountered, Russia is now facing a shortage of anti-HIV drugs, despite a significant increase of their procurements by the state in recent years, reports The Pharma Letter’s local correspondent. 18 May 2022
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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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