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 revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) for the treatment of COVID-19, to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. 7 July 2022
Pharmaceutical
It is an exciting time within the schizophrenia market as numerous monotherapies and adjunctive therapies are being developed to address some of the most important unmet needs observed with current antipsychotic treatments. 7 July 2022
Biotechnology
Biotech BeiGene has entered into a worldwide strategic collaboration with InnoRNA, a privately-held LNP-based delivery technology and mRNA drug discovery specialist. 6 July 2022
Biosimilars
The US Association for Accessible Medicines’ (AAM) Biosimilars Council has released an update on major developments in the biosimilars sector by executive director Craig Burten. 6 July 2022
Pharmaceutical
German companies Evotec and Boehringer Ingelheim have joined forces with French diagnostics firm bioMérieux to form a joint venture to fight antimicrobial resistance (AMR). 6 July 2022
Biotechnology
Privately-held US biotech Skyhawk Therapeutics has announced an exclusive worldwide collaboration agreement with French pharma major Sanofi to discover and develop novel small molecules that modulate RNA splicing for challenging oncology and immunology targets. 6 July 2022
Biotechnology
Japanese drugmaker Eisai’s shares gained almost 6% to 6,167 yen after, along with partner Biogen, it announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (BAN2401). 6 July 2022
Biotechnology
Norwegian biopharma Nordic Nanovector has provided a disappointing update on PARADIGME, its Phase IIb trial of Betalutin (177Lu lilotomab satetraxetan) in third-line relapsed and anti-CD20 refractory follicular lymphoma. 6 July 2022
Pharmaceutical
Excited by the prospect of renewed regulatory support for amyotrophic lateral sclerosis (ALS) candidate AMX0035, investors bought up shares in Amylyx Pharmaceuticals before the opening bell on Tuesday. 6 July 2022
Biotechnology
Trials of a potentially curative remedy for type 1 diabetes (T1D) will continue, after the US Food and Drug Administration lifted a clinical hold on the candidate. 6 July 2022
Biotechnology
Shares of Swiss pharma giant Roche edged up 2% to 325.35 francs this morning, after it announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio (mosunetuzumab). 6 July 2022
Biotechnology
With rapidly increasing worldwide prevalence, Alzheimer’s disease (AD) has been identified as a major global health threat by the international medical community. 6 July 2022
Pharmaceutical
Urovant Sciences has entered into an exclusive license agreement with French drugmaker Pierre Fabre to register and commercialize vibegron, trade named Gemtesa, for the treatment of overactive bladder (OAB) in certain countries. 5 July 2022
Biotechnology
Gene expression company Syros Pharmaceuticals is to acquire TYME Technologies in a deal that values the oncology-focused biotech at around $60 million. 5 July 2022
Biotechnology
Germany’s CureVa is the latest biopharma company seeking to get a share of the very large profits being made by the most successful COVID-19 vaccines and treatments. 5 July 2022
Biotechnology
Privately-held UK-based company Mogrify and Japanese drugmaker Astellas have signed a collaborative research agreement on in vivo regenerative medicine approaches to address sensorineural hearing loss. 5 July 2022
Pharmaceutical
In line with its commitment to transparency, Spanish plasma-derived medicines company Grifols has disclosed for the seventh consecutive year all payments and other transfers of value related to medicines and medical technology made to healthcare professionals and healthcare organizations in the several European countries listed within the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) scope, including Spain. 5 July 2022
Biotechnology
In a move to further expand its blood cancer research portfolio, Anglo-Swedish pharma major AstraZeneca today announced an agreement to acquire USA-based biotech TeneoTwo, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma. 5 July 2022
Biotechnology
The UK’s pricing and reimbursement agency, the National Institute for Health and Care Excellence (NICE), has issued its verdict on new atopic dermatitis treatments. 5 July 2022
Biotechnology
Myasthenia Gravis (MG) is a rare long-term chronic autoimmune condition that affects the body’s voluntary muscles.1 It occurs when antibodies such as Immunoglobulin G (IgG) attack receptors that receive nerve impulses for the muscles, eventually leading to muscle weakness and fatigue. 5 July 2022
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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
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
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