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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
A stark warning on UK access to innovation has been issued by the Association of the British Pharmaceutical Industry (ABPI). 20 October 2022
Biotechnology
US messenger RNA (mRNA) Moderna today announced new clinical data on its bivalent Omicron-containing booster, mRNA-1273.214, demonstrating its superiority of the biotech’s original COVID-19 vaccine Spikevax. 19 October 2022
Pharmaceutical
The recent European Commission’s (EC) approval of Eli Lilly’s (NYSE: LLY) Mounjaro (tirzepatide) for treating type 2 diabetes (T2D) is of paramount interest, and not only for T2D patients, as it could address vital unmet needs for other GIP/GLP-1 receptor agonist–treated diseases, including obesity. 19 October 2022
Biotechnology
A crucial milestone is coming up next month for French ophthalmology company Nicox. 19 October 2022
Biotechnology
An exclusive licensing agreement has been reached between Jazz Pharmaceuticals and Zymeworks, granting the former extensive development and commercialization rights to zanidatamab. 19 October 2022
Biotechnology
New Jersey, USA-based rare disease drug developer PTC Therapeutics saw its shares close down 11% yesterday and fall a further almost 12% to $43.00 pre-market today, after it revealed it has paused US enrollment in a Phase II study of PTC518 in Huntington's disease. 19 October 2022
Biotechnology
Spanish plasma-derived medicines company Grifols ( today announced that its drug Tavlesse (fostamatinib) has a been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments. 19 October 2022
Biotechnology
UK-based Nucleome Therapeutics, a spinout from Oxford University founded with the aim to unlock the non-coding regulation of the genome for human health, has closed an oversubscribed £37.5 million ($42.4 million) Series A financing round. 19 October 2022
Pharmaceutical
Shares in Texan protein expert Salarius Pharmaceuticals fell back by as much as 45% on Monday, after the firm said it was pausing a key trial of its lead candidate. 19 October 2022
Biotechnology
Cambridge, USA-based clinical-stage biotech Synlogic has announced positive top-line data from its Phase II Synpheny-1 study in phenylketonuria (PKU). 19 October 2022
Pharmaceutical
US healthcare giant Johnson & Johnson was trading around 0.5% lower at lunchtime on Tuesday. 18 October 2022
Biotechnology
German biotech Abalos Therapeutics has announced the appointment of Thomas Bogenrieder as chief medical officer (CMO). 18 October 2022
Pharmaceutical
A broad set of mechanisms of action (MOAs) are being explored by drug developers in dry eye syndrome (DES), analysis from GlobalData shows. 18 October 2022
Biotechnology
Bolstering its presence in the gene therapy sector, US pharma major Eli Lilly today announced it is acquiring Akouos, a precision genetic medicine company that is developing a portfolio of first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss. 18 October 2022
Biotechnology
After several setbacks in its product development and partnering deals in the last few years, US oncology focussed biotech AVEO Oncology has agreed to be acquired by South Korea’s LG Chem. 18 October 2022
Pharmaceutical
Hungary-based Gedeon Richter has announced the UK launch of Drovelis (estetrol (E4]/ drospirenone (DRSP)) as a combined oral contraceptive. 18 October 2022
Pharmaceutical
US neurological diseases specialist Acorda Therapeutics saw its shares go stratospheric yesterday, after it revealed it has been awarded $16.5 million by an arbitral panel following a dispute with Ireland-incorporated drugmaker Alkermes over licensing royalties for the multiple sclerosis drug Ampyra (dalfampridine). 18 October 2022
Biotechnology
Gilead Sciences has won European approval for Yescarta (axicabtagene ciloleucel) for the treatment of certain adults with different kinds of large B-cell lymphoma (LBCL). 18 October 2022
Biotechnology
Shares of US messenger RNA (mRNA) therapeutics and vaccines maker Moderna closed up almost 4% at $139.25 yesterday, after it announced that the company and Gavi, the Vaccine Alliance, have mutually agreed to cancel remaining pending orders under the current COVID-19 vaccine supply agreement for 2022. 18 October 2022
Pharmaceutical
Swiss pharma giant Roche today reported that third-quarter 2022 revenues fell 6% to 14.74 billion Swiss francs ($14.84 billion), below market expectations of about 15.5 billion francs. 18 October 2022
All news
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
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
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