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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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Pharmaceutical
Drug pricing policy changes in the USA were signed into law as part of the Inflation Reduction Act last month in one of the most impactful acts of the Biden administration so far. 21 September 2022
Biotechnology
Aiming to delve further into the use of poly ADP-ribose polymerase inhibitor, German life sciences major Merck KGaA has linked up with a leading Italian oncology discovery organization. 21 September 2022
Biotechnology
Shares in US biopharma Spectrum Pharmaceuticals dropped by a massive 37% on Tuesday while those in Swedish biotech Oncopeptides closed 25% lower. 21 September 2022
Biotechnology
Nine months after gaining its first approval in the USA, AstraZeneca’s Tezspire (tezepelumab) has now been approved in the European Union (EU). 21 September 2022
Pharmaceutical
More clinical setbacks for the systemic vasodilator treprostinil have forced United Therapeutics to stop a late-stage trial, sending shares down 5% on Tuesday. 21 September 2022
Pharmaceutical
Specialty drugmaker Fennec Pharmaceuticals has finally achieved US approval for its medicine Pedmark (sodium thiosulfate). 21 September 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final appraisal document (FAD) recommending Brukinsa (zanubrutinib). 21 September 2022
Biotechnology
Driven by the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies among other pioneering pipeline therapies, the diabetic macular edema market is expected to more than double over the next decade. 21 September 2022
Pharmaceutical
The US Court of Appeals for the Federal Circuit (CAFC) has denied its petition to rehear the negative decision regarding the validity of US Patent No 9,187,405, covering a dosing regimen for 0.5mg of its blockbuster multiple sclerosis drug Gilenya (fingolimod), Swiss pharma giant Novartis announced this morning. 21 September 2022
Biotechnology
In an all-stock deal valued at around $53 million, Rocket Pharmaceuticals is to acquire fellow US biotech firm Renovacor. 20 September 2022
Pharmaceutical
Extending a previous accord with the US pharma giant, Israel-based CytoReason has now signed a new partnership with Pfizer to use CytoReason’s artificial intelligence technology for Pfizer’s drug development programs for a further five years. 20 September 2022
Biotechnology
Belgium’s NeuVasQ Biotechnologies, a Université Libre de Bruxelles (ULB) spin-off developing pharmaceuticals to restore blood-brain barrier function, has named Emmanuel Lacroix chief executive and company director. 20 September 2022
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Nulibry (fosdenopterin) for Injection as the first therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. 20 September 2022
Pharmaceutical
Sage Therapeutics closed up 3.8% at $42.14 on Tuesday after, along with partner Biogen, it announced new analyses from across the development program for zuranolone. 20 September 2022
Biotechnology
German biotech Evotec has been awarded a contract valued at up to $49.9 million by the US Department of Defense (DOD) for the rapid development of monoclonal antibody (MAb)-based drug product prototypes targeting plague. 20 September 2022
Biotechnology
ViroCell Biologics, a UK contract development and manufacturing organization (CDMO), has announced the appointment of Susan Nichols to its senior management team as chief business officer (CBO). 20 September 2022
Biotechnology
AstraZeneca's Evusheld (tixagevimab and cilgavimab) has been approved for a second indication in Europe. 20 September 2022
Pharmaceutical
Less than two months after Theravance Biopharma sold off rights to its share of royalties from parts of GSK’s respiratory franchise, the company announced an agreement to buy back equity from the British drugmaker. 20 September 2022
Biosimilars
In an effort to bring clarity to the use of biosimilars in Europe, health authorities have issued a statement confirming their interchangeability with reference medicines. 20 September 2022
Pharmaceutical
The European Commission (EC) has granted marketing authorization of Lupkynis (voclosporin) to treat adults with active lupus nephritis (LN). This follows the positive European Medicines Agency’s CHMP opinion announced in late July. 20 September 2022
All news
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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