Amid an ongoing epidemic of opioid abuse in the USA, the country’s medicines regulator has announced safety label changes for opioids aimed at ensuring their safe use. 14 April 2023
The USA’s Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of Madrigal Pharmaceuticals resmetirom and Intercept Pharmaceuticals’ obeticholic acid (OCA) for non-alcoholic steatohepatitis (NASH). 14 April 2023
A lot of topics were discussed at the 2023 China innovative medicine (device) medical conference (CMAC) held in Suzhou on April 7. Among them were real world studies, medical affairs and how to use AI to speed up discoveries. But one most talked about was the challenges for Chinese biotechs to go global. 13 April 2023
Sino-American biotech BeiGene today announced the first major step in the company’s expansion in Latin America (LATAM) with the formal opening of its office in São Paulo, Brazil. 13 April 2023
New York-based Tiziana Life Sciences, a biotech company developing breakthrough immunomodulation therapies via novel routes of drug delivery, has revealed plans to investigate intranasal foralumab for the treatment of long COVID. 13 April 2023
A draft evidence report from Boston, USA-based watchdog The Institute for Clinical and Economic Review (ICER) suggests a cost-effective price of up to $1.9 million for new sickle cell disease (SCD) therapies. 13 April 2023
Data from UCB’s Phase III studies of rozanolixizumab and zilucoplan in generalized myasthenia gravis (gMG) have been published in The Lancet Neurology. 13 April 2023
The US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients. 13 April 2023
US medicines cost watchdog the Institute for Clinical and Economic Review (ICER) has posted a Protocol outlining how it will conduct its third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. 13 April 2023
US biotech major Biogen today announced that it has exercised its option to license Denali Therapeutic’s antibody transport vehicle (ATV): Amyloid beta program (ATV:Aβ), lifting the latter’s shares up 3% in early trading. 12 April 2023
The protocol for the POSITIVE study, the first clinical study in dermatology to assess patients’ wellbeing as a primary endpoint, has been published in the British Medical Journal. 12 April 2023
As part of its aim to expand into cell therapies, Danish diabetes care giant Novo Nordisk has entered into a collaboration with a Canadian biotech that could cost it as much as $2.6 billion. 12 April 2023
South Korean biotech Genexine saw its shares gain more than 9% to 13,850 won, after, along with partner KG Bio, it released interim results of the Phase III clinical trial of GX-E4 (efepoetin alfa), a candidate for chronic kidney disease (CKD)-induced anemia. 12 April 2023
Japan’s largest drugmaker Takeda has linked up with little-known Canadian biotech Treventis for the further research, development, and commercialization of small molecules that target tau, a key protein in Alzheimer’s disease (AD). 12 April 2023
Concerns about Moderna’s post-COVID strategy have sparked a share price slide, following an ambivalent analysis from the firm’s flu vaccine program. 12 April 2023
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Spanish HIV focused immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa, has announced the acquisition of its investigational assets related to the HTI therapeutic HIV vaccine by US antiviral specialist Gilead Sciences. 26 November 2024
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co. 25 November 2024
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Specialist pre-clinical contract research organization (CRO) and ion channel screening company Metrion Biosciences has announced the appointment of Lee Patterson as its new chief executive. 25 November 2024
Levothyroxine, a widely prescribed treatment for hypothyroidism, may contribute to bone loss in older adults, according to new research presented at the Radiological Society of North America’s (RSNA) annual meeting. 25 November 2024