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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
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
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
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
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
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
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
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
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
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
Hungary-based Gedeon Richter has announced the UK launch of Drovelis (estetrol (E4]/ drospirenone (DRSP)) as a combined oral contraceptive. 18 October 2022
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
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
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
Privately-held Swiss ophthalmology company Oculis and European Biotech Acquisition Corp (Nasdaq: EBAC), a special purpose acquisition company (SPAC), have entered into a definitive business combination agreement. 18 October 2022
Kineta, a privately-held immuno-oncology company, has announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co. 17 October 2022