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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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Biotechnology
Swiss biotech Basilea Pharmaceutica continues its positive wave of third-quarter 2022 activity with the successful asset purchase and sub-licence agreement of its tyrosine kinase/polo-like kinase 1 (TTK/PLK1) inhibitor, BAL0891, to SillaJen (Kosdaq:215600), a South Korean biotech. 24 September 2022
Biotechnology
Ionis Pharmaceuticals’ shares were down 6.6% pre-market today, after the company released new data on its hypercholesterolemia candidate ION499 that failed to impress its development partner. 23 September 2022
Biotechnology
Developed by UK pharma major AstraZeneca, Ultomiris (ravulizumab) has been approved in Europe for a new indication. 23 September 2022
Pharmaceutical
Privately-held Swiss company Ferring Pharmaceuticals and its subsidiary Rebiotix look set to achieve a notable first for the industry. 23 September 2022
Pharmaceutical
The UK Chancellor of the Exchequer today announced at the mini-Budget the Long-Term Investment for Technology & Science (LIFTS) competition. 23 September 2022
Biotechnology
A deeper look at late-stage research conducted by Biogen suggests a more positive outlook for its amyotrophic lateral sclerosis (ALS) candidate tofersen. 23 September 2022
Biotechnology
US biopharma Spectrum Pharmaceuticals was 16% down during pre-market trading on Friday, exacerbating Tuesday’s 37% decline. 23 September 2022
Biotechnology
Despite trying to put a positive spin on another regulatory setback for French biopharma company DBV Technologies’ peanut allergy candidate, battered investors sent the firm’s stock down 12% to less than $2 in pre-market trading. 23 September 2022
Biotechnology
Inventiva, which is making solid progress with its candidate for the highly challenging non-alcoholic steatohepatitis (NASH) indication, saw its shares shoot up more than 25% to 5.06 euros yesterday, after the French biotech announced a lucrative licensing deal for its drug lanifibranor in China. 23 September 2022
Pharmaceutical
UK-based GSK’s latest deal has defied the long-term trend among big pharma companies to move investment away from the high-risk, low returns antibiotic space. 22 September 2022
Biotechnology
An Expert View from Georgi Makin, Editor, Phacilitate. 22 September 2022
Pharmaceutical
As with any big pharma company, Swiss giant Novartis periodically holds events to inform shareholders and other interested parties on its updated strategy and optimism for future drug sales. 22 September 2022
Generics
There was positive news from US pharma giant Merck & Co this morning, with respect to patent litigation relating to its blockbuster diabetes drug franchise. 22 September 2022
Biotechnology
Shares of US pharma major Eli Lilly edged up 1.4% to $300.68 pre-market today, on the news that its RET kinase inhibitor Retevmo (selpercatinib) had received a second approval in the USA. 22 September 2022
Biotechnology
Investors are jittery after the sudden departure of French drugmaker Servier from a collaboration in oncology with San Francisco’s Allogene Therapeutics. 22 September 2022
Pharmaceutical
More data from Novo Nordisk’s ONWARDS program show positive results for the firm’s new once-weekly insulin product, insulin icodec. 22 September 2022
Biotechnology
Shares of US biotech Sesen Bio (Nasdaq: SESN) tumbled nearly 33% to $0.45 by close of trading yesterday, after it revealed a plan to merge with privately-held Carisma Therapeutics. 22 September 2022
Pharmaceutical
USA-based Adamis Pharmaceuticals saw its shares plunge as much as 42% yesterday, after releasing disappoint trial results of its COVID-19 treatment candidate. 22 September 2022
Biotechnology
Coeptis Therapeutics has raided the nearby University of Pittsburgh in the latest step towards realizing the company’s aim of disrupting conventional treatment paradigms. 21 September 2022
Biotechnology
A drug candidate that Japan’s largest drugmaker Takeda Pharmaceutical pretty much decided to discontinue back in 2015, has now been out-licensed in a deal that could earn the firm nearly $300 million should it prove successful, albeit with a modest upfront payment. 21 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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