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.
A new collaboration in autoimmune disorders has been launched between Chicago-based AbbVie and another American company, HotSpot Therapeutics. 6 December 2022
Danish pharma major Novo Nordisk announced last month that the company had experienced a growth in the sales of Ozempic (semaglutide), which is indicated for type 2 diabetes (T2D). 6 December 2022
UK-based respiratory disease specialist Pulmocide today announced it has raised $52 million in a Series C extension round led by new investors Pictet Alternative Advisors and Vivo Capital. 6 December 2022
French firm Valneva has presented positive antibody persistence data 12 months after vaccination with a single dose of its chikungunya vaccine candidate, VLA1553. 6 December 2022
Ireland and USA-based natural killer (NK) cell therapy biotech ONK Therapeutics has named Bruce McCreedy as chief scientific officer (CSO). 6 December 2022
Shares of La Jolla USA-based biotech Equillium were up 12% to $1.85 in pre-market trading, on news of a lucrative licensing deal with Japan’s Ono Pharmaceutical. 6 December 2022
In a challenging environment for biotech finance, Australian needle-free treatment specialist Vaxxas has raised new money for its COVID-19 vaccine - a sign of its potential in the growing market for seasonal coronavirus protection. 6 December 2022
While autologous CAR-T cell therapies have upended the treatment landscape for people with blood cancer, associated toxicities have limited access for many people. 6 December 2022
US clinical-stage cancer focused biotech Mirati Therapeutics has announced preliminary results from the KRYSTAL-7 Phase II trial and KRYSTAL-1 Phase Ib cohort evaluating adagrasib (400mg twice daily) concurrently combined with Merck & Co’s blockbuster drug Keytruda (pembrolizumab) in patients for the treatment of first-line non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation across all PD-L1 subgroups. 6 December 2022
The US Food and Drug Administration (FDA) has approved a second indication for Brexafemme (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC). 6 December 2022
Further adding new talent to its management team, LifeMine Therapeutic, a US start-up searching the fungal biosphere for genetically-encoded small molecules (GEMs), today announced the appointment of Dr Elliot Ehrich as chief medical officer and executive vice president of translational science, and of Lata Jayaraman as executive vice president and head of biology. 6 December 2022
Despite its multiple negative impacts, the COVID-19 pandemic had the more positive effect of showing that having a strong and innovative research-based pharmaceutical industry is crucial, as the sector was able to mobilize quickly to produce effective vaccines. 5 December 2022
Research from industry analyst GlobalData has highlighted the extent to which the market capitalization of the largest biopharmaceutical firms has declined in the last quarter. 5 December 2022
Patients have been dealt a major blow after the first ever treatment for AL amyloidosis, a rare incurable condition, was rejected by the UK’s National Institute for Health and Care Excellence (NICE). 5 December 2022
Australia’s Mayne Pharma Group has signed an exclusive license agreement with TherapeuticsMD for three branded women’s health products and a portfolio of prenatal vitamins in the USA. 5 December 2022
Swiss contract development and manufacturing organization (CDMO) Lonza today announced the start of new mid-scale manufacturing assets at its active pharmaceutical ingredients (API) manufacturing center in Nansha, China. 5 December 2022
Swiss biotech firm Idorsia (SIX: IDIA) has won marketing authorization in its home country for a new insomnia med, Quviviq (daridorexant). 5 December 2022
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
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024