A £650 million ($802 million) war-chest to fire up the UK’s life sciences sector and drive forward the government’s priority to grow the economy has been unveiled by the Chancellor of the Exchequer Jeremy Hunt today. 26 May 2023
Hefei Tianhui Biotechnology (HTIT) has recently submitted a marketing authorization application (MAA) in China for the world’s first oral insulin for type 2 diabetes (T2D). 26 May 2023
Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. 26 May 2023
The UK’s Medicines and Healthcare products Regulator Agency (MHRA) today announced that new regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the USA. 26 May 2023
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 2023
US pharma giant Pfizer is to present data on more than 15 drugs—including six early pipeline assets—at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6. 25 May 2023
Anglo-Swedish drugmaker AstraZeneca is lining up the big-hitters from its cancer drug portfolio for next week’s American Society of Clinical Oncology (ASCO) Annual Meeting. 25 May 2023
Japanese drugmaker Daiichi Sankyo today announced that Vanflyta (quizartinib) has been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive, with the news surprisingly pushing the firm’s shares down 4.4% to 4,582 yen 25 May 2023
PTC Therapeutics’ stock plummeted 19.6%, ending the regular session at $46.95, after it revealed top-line results from the MOVE-FA Phase III trial of vatiquinone in patients with Friedreich ataxia. 25 May 2023
The European Union must improve its biosimilar medicines policy to increase equity of access and bring much needed savings to healthcare budgets, says Medicines for Europe, the trade group that represents makers of generic and biosimilar medicines in the region. 25 May 2023
Prime Minister Fumio Kishida has announced the government of Japan's pledge to contribute $200 million to the Global Health Innovative Technology Fund (GHIT Fund). 25 May 2023
USA-based ClearPoint Neuro a global therapy-enabling platform company providing navigation and delivery to the brain, saw its shares rise 3% to $8.15 pre-market today, on news of a multi-year license agreement with Belgium’s largest pharma company, UCB, to partner on drug delivery platforms for UCB’s gene therapy portfolio. 25 May 2023
Shares of US oncology drugmaker Mirati Therapeutics closed down 4% on Wednesday and were a further 8.7% lower at $40.01 in pre-market activity today, after it revealed that the SAPPHIRE study did not meet its primary endpoint of overall survival (OS) at the final analysis. 25 May 2023
The leading trade body for the British pharmaceutical industry has appointed a new president, current Pfizer UK managing director Susan Rienow. 25 May 2023
German generics major STADA Arzneimittel today revealed that, following a six-day inspection, the US Food and Drug Administration (FDA) has approved the STADA-controlled entity as a manufacturing and storage site for Retacrit (epoetin alfa-epbx) drug substance, at the Norbitec biologics facility in Uetersen, Germany. 25 May 2023
A new proposal from the US Department of Health and Human Services (HHS) is proposing steps to further drive down prescription drug costs in Medicaid, building on the Biden administration’s widespread efforts to lower medicine prices. 24 May 2023
Boston, USA-based cell and gene therapy incubator ElevateBio has raised $401 million in a series D financing round led by AyurMaya Capital Management Fund. 24 May 2023
UK headquartered Biodexa Pharmaceuticals, a company developing treatments for metastatic brain cancers, has signed non-binding letter of intent to potentially acquire Varian Biopharmaceuticals, a private US precision oncology company developing novel therapeutics for the treatment of cancer. 24 May 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