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
An acquisition in the biosimilars space was the biggest deal announced in biopharma M&A during March. 1 April 2022
Pharmaceutical
Expected bad news for Amylyx Pharmaceuticals will not deter the company’s efforts to secure approval for its amyotrophic lateral sclerosis (ALS) candidate, AMX0035. 1 April 2022
Biotechnology
The UK health technology assessor the National Institute for Health and Care Excellence on Thursday advised the National Health Service in England to not provide Novartis' Piqray (alpelisib) with fulvestrant to post-menopausal women and men with a certain type of advanced breast cancer. 1 April 2022
Biotechnology
A grant of £15.9 million ($20.9 million) has been awarded to chemical producer Croda International to increase the UK’s manufacturing capacity of specialty lipids, an essential ingredient in mRNA vaccines, the government has announced today. 1 April 2022
Biotechnology
Outlook Therapeutics today said it has submitted its Biological License Application (BLA) to the US Food and Drug Administration for ONS-5010, an investigational therapy which, if approved, will be branded as Lytenava (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD). 31 March 2022
Pharmaceutical
India's TB Prevalence Survey 2019-2021, the first of its kind in the country in 55 years, has found that tuberculosis (TB) is more prevalent in India than previously thought. 31 March 2022
Pharmaceutical
German life sciences major Bayer has announced planned investments of around two billion euros ($2.22 billion) over the next three years on strengthening its global pharma production network. 31 March 2022
Biotechnology
Swiss clinical-stage biotech Numab Therapeutics and Japan’s Ono Pharmaceutical today announced that Ono has exercised its option to enter into a development and license agreement for a multispecific antibody candidate that was generated through a research collaboration between the two companies initiated in 2017. 31 March 2022
Biotechnology
French drugmaker Sanofi held an investor event this week to outline its ambitions in the immunology space, including the goal to more than quadruple sales in this space by 2030. 31 March 2022
Biotechnology
US biotech Clovis Oncology saw its shares roar up 55% to $2.55 pre-market, as it unveiled positive top-line results from the monotherapy portion of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating Rubraca (rucaparib) as first-line maintenance treatment. 31 March 2022
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biotech firm Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under review for the treatment of anemia due to chronic kidney disease (CKD). 31 March 2022
Pharmaceutical
At AMCP 2022 in Chicago, new data from Janssen, the pharma arm of Johnson & Johnson (NYSE: JNJ), support the value of switching certain people with schizophrenia onto a long-acting treatment regimen. 31 March 2022
Pharmaceutical
In view of the disruptions caused by the Russian invasion of Ukraine, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are issuing initial advice for sponsors on how to manage the conduct of clinical trials in this situation. 31 March 2022
Pharmaceutical
Specialist HIV company ViiV Healthcare, which is majority-owned by GlaxoSmithKline, says that the US Food and Drug Administration has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to 31 March 2022
Biotechnology
Shares of US biotech Adagio Therapeutics shot up more than 53% to $5.90 by late morning trading today, after it reported that the primary endpoints were met with statistical significance for all three indications in the company’s ongoing global Phase II/III clinical trials evaluating its investigational drug adintrevimab (ADG20) as a pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19. 30 March 2022
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The Ministry of Health has begun collecting data on drugs that are not produced in Russia as well as a number of “friendly” countries as part of its efforts to prevention their shortage in the domestic market, according to recent statements by an official spokesman of the Ministry and local media, reports The Pharma Letter’s local correspondent. 30 March 2022
Biotechnology
The US Food and Drug Administration (FDA) has authorized a second booster dose of either the Pfizer and BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised patients. 30 March 2022
Biotechnology
Japan’s Taiho Oncology and Taiho Pharmaceutical - both owned by Otsuka Pharmaceutical - announced today that the US Food and Drug Administration has accepted and granted priority review of the New Drug Application (NDA) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor, in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions. 30 March 2022
Pharmaceutical
Japan’s Ono Pharmaceutical has entered into a collaboration agreement with privately-held French artificial intelligence (AI) company Iktos to discover and develop novel small-molecule compounds using Iktos’ unique AI drug discovery technology. 30 March 2022
Pharmaceutical
Cabenuva (cabotegravir/rilpivirine) has been approved in the USA to treat HIV-1 in virologically suppressed adolescents who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either active ingredient. 30 March 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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