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
Israeli generics giant Teva Pharmaceutical Industries announced today the appointment of Eric Hughes as executive vice president, global R&D and chief medical officer. 1 July 2022
Pharmaceutical
Angion Biomedica saw its shares close down 33% on Thursday and fall a further 6% to $1.07 pre-market today, after the US company announced it will discontinue the Phase II JUNIPER study of ANG-3070 in patients with primary proteinuric kidney diseases. 1 July 2022
Pharmaceutical
Rumors of a mega Merck & Co acquisition have been swirling round in recent weeks, and while the potential takeover of Seagen has not yet happened, a few noteworthy deals have been announced during June. 1 July 2022
Biosimilars
Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines 1 July 2022
Pharmaceutical
Ireland-domiciled American drugmaker Endo International looks set to enter bankruptcy, after the firm failed to make an interest payment. 1 July 2022
Biotechnology
Danish biotech company Genmab has announced its intent to submit a biologics license application (BLA) to the US Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of 2022. 1 July 2022
Biotechnology
The US Food and Drug Administration (FDA) yesterday issued a warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. 1 July 2022
Biotechnology
Oncology is the therapeutic area with the greatest weighting in BB Biotech's portfolio and it could deliver the most significant commercial breakthroughs in the not all-too-distant future, alongside its investments in the field of mRNA technology, according to Dr Daniel Koller, head of PM for Switzerland-based investment company. 1 July 2022
Biotechnology
Blueprint Medicines has announced strategic financing collaborations with Sixth Street and Royalty Pharma worth $1.25 billion. 30 June 2022
Generics
This week Kelly Del Dotto, principal at USA-based patent firm Fish & Richardson P.C., provides context on the all-important Orange Book. 30 June 2022
Biotechnology
The US Food and Drug Administration (FDA) has placed Phase III studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis on partial clinical hold, said French pharma major Sanofi. 30 June 2022
Pharmaceutical
India's drug regulator seems to be taking into account the views of the domestic drug industry, which urged the Central Drugs Standards Control Organization (CDSCO) to consider extending the fast-track approval process adopted during COVID-19 to non-Covid drugs as well. Apart from domestic majors, multinational pharma companies, with their vaccines and drugs, also stand to benefit, reports The Pharma Letter’s India correspondent. 30 June 2022
Generics
Generics giant Teva Pharmaceutical Industries is pushing hard to make its viewpoint known as the European Commission (EC) draws up new legislation for medicines in Europe. 30 June 2022
Biotechnology
Today, Swiss pharma giant Novartis (NOVN: VX) announced results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status. 30 June 2022
Biotechnology
AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) is performing well in the Phase III AEGEAN trial, top-line results show. 30 June 2022
Biotechnology
Chicago-based ARCH Venture Partners has announced the closing of a $2.975 billion fund to invest in the creation, development and funding of early-stage biotech companies. 30 June 2022
Pharmaceutical
Effective July 1, uninsured people living with diabetes in the USA be able to obtain one or multiple Sanofi insulins from the French pharma major’s Insulins Valyou Savings Program with a valid prescription for a total of $35 for a 30-day supply. Previously, the program offered a 30-day supply of Sanofi insulins for $99. 30 June 2022
Biotechnology
Japanese drugmaker Kyowa Kirin has added a new target to a collaboration with Synaffix, aimed at developing antibody-drug conjugates. 30 June 2022
Pharmaceutical
The pharmaceutical industry is facing the prospect of an increase in disputes in the coming months. A combination of recent events such as the pandemic, the changes arising from Brexit and the war in Ukraine have all had an impact on supply lines. The energy crisis and other economic conditions are contributing to inflationary pressures across the board. 30 June 2022
Biotechnology
US pharma giant Pfizer and German partner BioNTech announced a new vaccine supply agreement with the US government to support the continued fight against COVID-19. 30 June 2022
All news
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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