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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
La Jolla, California-based immunology specialist Equillium and Metacrine have entered into a definitive merger agreement whereby Equillium will acquire Metacrine in an all-stock transaction, edging the latter’s shares up 2.7% to $0.47 by close of trading on Tuesday. 7 September 2022
Biotechnology
STORM Therapeutics, a UK biotech discovering and developing small molecule therapies targeting RNA modification enzymes for oncology and other diseases, has announced the appointment of Gerald McMahon as president, chief executive and board director. 7 September 2022
Biotechnology
The latest in a series of Industry Leader pieces from biological reagent supplier and service provider Sino Biological. 6 September 2022
Biotechnology
The US Food and Drug Administration has lifted a clinical hold on research into SRP-5051, a candidate under development by rare disease company Sarepta Therapeutics. 6 September 2022
Biotechnology
US biopharma Iveric Bio has announced positive top-line results from GATHER2, the company’s second Phase III trial of Zimura (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). 6 September 2022
Biotechnology
New findings from the XALOC program support the real-world effectiveness of UK pharma major AstraZeneca’s Fasenra (benralizumab) in the management of patients with severe eosinophilic asthma (SEA), showing reductions in annualized asthma exacerbation rate (AAER), improvements in asthma control and the ability to achieve clinical remission. 6 September 2022
Pharmaceutical
Confirming an earlier reimbursement decision, leading PARP blocker Lynparza (olaparib) has not been recommended for regular use in England and Wales, dealing a blow to people with prostate cancer. 6 September 2022
Biotechnology
Nodus Oncology, a novel biotech company focused on developing first and best-in-class molecules inhibiting novel DNA damage response (DDR) targets, has launched with seed funding from Cumulus Oncology and announced a partnership with the Lead Discovery Center (LDC). 6 September 2022
Generics
The retiring Roger Scarlett-Smith is to be replaced as head of UK at Germany’s STADA Arzneimittel (SAZ: Xetra) by Rudolf Bär. 6 September 2022
Biotechnology
Dutch antibody-drug conjugate (ADC) specialist Synaffix and Germany’s Emergence Therapeutics today announced they have entered into a licensing agreement, providing Emergence access on a target-specific basis to Synaffix’ proprietary antibody drug conjugate (ADC) technologies comprising GlycoConnect, HydraSpace and SYNtecan E linker-payload. 6 September 2022
Biotechnology
CanSino Biologics has announced that the National Medical Products Administration of China (NMPA) has granted the company emergency use authorization for its recombinant COVID-19 vaccine (Adenovirus Type 5 Vector) for Inhalation, trade name Convidecia Air, to be used as a booster dose. 6 September 2022
Biotechnology
UK-based biotech PhoreMost, which is dedicated to ‘Drugging the Undruggable’ disease targets, today announced it has entered into a multi-project target discovery collaboration with Swiss pharma giant Roche. 6 September 2022
Biotechnology
Avance Clinical, an Australian clinical research organization CRO) for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies. 6 September 2022
Pharmaceutical
The Drugs for Neglected Diseases initiative (DNDi) has announced Dr Luis Pizarro as its new executive director, who will replace Bernard Pécoul, who has served in the role for almost 20 years. 5 September 2022
Biotechnology
Dammam Valley, based in the Kingdom of Saudi Arabia, in partnership with other investment partners, announced they are to acquire a majority stake in Germany’s Arcensus GmbH. 5 September 2022
Pharmaceutical
Phase III data from the InPedILD trial, which assessed the pharmacokinetics (dosing) and safety profile of Ofev (nintedanib) in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD), German family-owned pharma major Boehringer Ingelheim announced today. 5 September 2022
Biotechnology
Chinese biotech Hutchmed is continuing its transition from a development stage company into a global commercial organization, according to analyst Trinity Delta. 5 September 2022
Pharmaceutical
Shares of Israel-headquartered PolyPid closed down more than 73% on Friday, and a further 9% to $1.43 in after-hours trading, as the company revealed disappointing results for its lead drug candidate. 5 September 2022
Pharmaceutical
Pharma exports from Sweden have increased sharply during the first half of this year, figures show. 5 September 2022
Pharmaceutical
The likelihood of approval for the amyotrophic lateral sclerosis (ALS) candidate AMX0035 appeared to fade on Friday, following the release of downbeat briefing papers from the US regulator. 5 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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