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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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Biotechnology
GSK subsidiary Sierra Oncology has returned rights for oncology candidate SRA737 to the CRT Pioneer Fund (CPF), a joint initiative between commercialization and development company Cancer Research Technology and the European Investment Fund. 12 October 2022
Biotechnology
Denmark-based clinical-stage firm Evaxion Biotech, which specializes in the development of AI-driven immunotherapies, announced that its new chief executive Per Norlén joined the company on October 3. 12 October 2022
Biotechnology
US precision oncology start-up Tavros Therapeutics and Vividion Therapeutics, a biopharma company that was snapped by German pharma major Bayer last year, have entered into a collaboration to discover or target four oncology targets across an initial five-year term. 12 October 2022
Biotechnology
Boston-based Albireo Pharma, a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, closed more than 14% higher after Tuesday’s trading. 12 October 2022
Pharmaceutical
Japanese pharma major Astellas today released positive 52-week results from the Phase III SKYLIGHT 4 clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 12 October 2022
Biosimilars
Inflation across Europe has now risen above 10%. As a result, this has increased the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. 12 October 2022
Pharmaceutical
Positive early stage data bode well for DICE Therapeutics' goal of developing a novel oral therapeutic for the treatment of psoriasis. 12 October 2022
Pharmaceutical
The global general anesthesia drugs market is anticipated to reach a valuation of $6.7 billion by 2032, with sales growing at a stagnant CAGR of 3.4% from 2022 to 2032, according to Future Market Insights. 12 October 2022
Pharmaceutical
Swiss pharma giant Roche today announced new two-year data showing that its Evrysdi (risdiplam) improved or maintained motor function in people with spinal muscular atrophy (SMA), a progressive neuromuscular disease that can be fatal. 12 October 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy). 11 October 2022
Biotechnology
Results from early stage research into AstraZeneca’s coronavirus vaccine has poured cold water onto hopes that a nasally-administered form of the jab could be developed soon. 11 October 2022
Biotechnology
Reports hinting that Michelle McMurry-Heath’s days as president and chief executive of the Biotechnology Innovation Organization (BIO) might be numbered have circulated in recent days. 11 October 2022
Biotechnology
Shares of Ginkgo Bioworks were down 3.6% at $2.78 today, despite the company announcing a deal with US pharma giant Merck & Co to engineer a crucial component of up to four enzymes for use as biocatalysts in Merck's active pharmaceutical ingredient (API) manufacturing efforts. 11 October 2022
Biotechnology
Oxford, UK-based start-up Ochre Bio, an innovator in chronic liver disease drug development, yesterday announced the successful close of $30 million in Series A financing. 11 October 2022
Biotechnology
Dutch rare disease specialist Pharming has moved a step closer to marketing authorization for leniolisib in Europe. 11 October 2022
Biotechnology
Neumora Therapeutics, a US clinical-stage biotech focussed on brain diseases through the integration of data science and neuroscience that came out of stealth in July last year with $500 million financing, has added to its cash pile announcing today the close of a $112 million Series B financing. 11 October 2022
Biotechnology
The UK’s BioIndustry Association (BIA), the trade body for innovative life sciences, has welcomed a one-year extension to the European Commission Decision Reliance Procedure (ECDRP). 11 October 2022
Pharmaceutical
German pharma major Bayer had a boost for its Kerendia (finerenone), a non-steroidal mineralocorticoid receptor antagonist, with an important endorsement for the drug’s use. 11 October 2022
Biotechnology
Positive Phase III trial results evaluating the investigational use of Dupixent (dupilumab) in children aged one to 11 years with active eosinophilic esophagitis (EoE) were presented today at United European Gastroenterology (UEG) Week 2022. 11 October 2022
Biotechnology
Singapore-based TauRx Pharmaceuticals, a company that claims to be the global leader in tau-based research in Alzheimer’s disease, recently reported positive progress for the firm's lead investigative oral drug hydromethylthionine mesylate (HMTM). The drug was found to be effective in improving cognition in patients with early Alzheimer’s disease (AD). 11 October 2022
All news
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
Pharmaceutical
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. 27 November 2024
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