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Pharmaceutical
27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Pharmaceutical
The Russian drug market will reach a value of $35 billion by 2024, despite the ongoing military conflict between Russia and Ukraine and the ever-tightening sanctions pressure on Russia, according to calculations by experts from the Russian consulting company in the field of pharmaceuticals SBS Consulting, report The Pharma Letter’s local correspondent. 20 September 2022
Biotechnology
Danish diabetes care giant Novo Nordisk has entered into a definitive agreement to acquire Forma Therapeutics, a US clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders, whose shares rocketed up 48% to $19.84 on the news. 19 September 2022
Biotechnology
US biotech bluebird bio has had a rocky ride in gaining US approval for its Skysona (elivaldogene autotemcel), but the US Food and Drug Administration (FDA), having earlier this year extended the review period for the product, on Friday granted authorization for the gene therapy. 19 September 2022
Biotechnology
Adding to approvals of Vabysmo (faricimab) in the major markets of the USA and Japan earlier this year, Swiss pharma giant Roche has now gained marketing clearance for the drug from the European Commission (EC) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). 19 September 2022
Pharmaceutical
Ambitions are soaring for the UK’s pharma and biotech industry on the back of record investment but can it be sustained in the absence of workers with critical STEM skills? MHA’s Yogan Patel looks at strategies for attracting and retaining talent in an Expert View piece. 19 September 2022
Biotechnology
French biotech firm Genfit has entered into an exclusivity agreement to acquire Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases. 19 September 2022
Biosimilars
Sandoz, the generic and biosimilar medicines unit of Novartis, which the Swiss pharma giant last month said it would hive off into a new publicly traded company, today announced further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab. 19 September 2022
Pharmaceutical
Pharma companies continue to evaluate novel ways to increase their return on investment and generate shareholder value, basic earnings per share (EPS), plus stock price. Historically, pharma has pursued mergers and acquisitions to undermine R&D and drive growth. 19 September 2022
Biotechnology
Last month, Belgo-Dutch autoimmune diseases specialist argenx announced the European Commission (EC) approval of Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 19 September 2022
Biotechnology
Significant news last week included US pharma major Bristol Myers Squibb gaining Food and Drug Administration approval for its TYK2 inhibitor Sotyktu (deucravacitinib) for the treatment of plaque psoriasis. Shares of US biotech Akero skyrocketed last Tuesday when it released very positive Phase IIb results for its efruxifermin in the treatment of non-alcoholic steatohepatitis (NASH). Also, US pharma giant Pfizer released impressive new Phase III data on its pentavalent vaccine for meningococcal disease. US biotech Gilead Sciences last week entered into a settlement with several generic drugmakers relating to copy versions of its HIV drugs Descovy and Odefsey. 18 September 2022
Biotechnology
Following approval from the US regulator in March this year, on Friday Bristol Myers Squibb revealed that the European Commission has also cleared its fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. 17 September 2022
Biotechnology
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim results from a well-watched Phase I trial early Friday. 16 September 2022
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) today released its list of recommended novel medicines and one biosimilar for approval following its September 2022 meeting. 16 September 2022
Biosimilars
The Initiative for Medicines, Access, and Knowledge (I-MAK), a campaign group seeking to drive down the cost of medicines, has taken aim at pharma firms’ protection of their patents. 16 September 2022
Biotechnology
Japanese medium-sized drugmaker Asahi Kasei Pharma yesterday revealed it has acquired the exclusive distribution rights in Japan for two products developed by Swedish Orphan Biovitrum. 16 September 2022
Biotechnology
Efforts on the part of New York pharma major Pfizer to become a vaccines giant took another step forward on Thursday, with positive results from a trial in meningitis. 16 September 2022
Biotechnology
Looking to cement its lead in the treatment of rare blood disorders, AstraZeneca has lifted the lid on positive results for a new add-on therapy for its blockbuster C5 inhibitor franchise. 16 September 2022
Pharmaceutical
The World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline, which now conditionally recommends Veklury (remdesivir) for the treatment of patients with severe COVID-19, now continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization. 16 September 2022
Pharmaceutical
US agencies the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND). 16 September 2022
Pharmaceutical
A state-of-the-art research and development facility, using world-class medical research to find solutions for a range of serious illnesses, has opened in West Auckland. 16 September 2022
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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
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
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. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
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