The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024
UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024
Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024
Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T cell therapies. 26 January 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its January 2024 meeting, but rejected two others. 26 January 2024
Osivax, a French biopharma developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, has named Nicola Groth its new chief medical officer (CMO). 26 January 2024
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of KarXT (xanomeline tartrate/trospium chloride) drug KarXT, from Karuna Therapeutics for the treatment of schizophrenia. 26 January 2024
The US Food and Drug Administration (FDA) has provided an update on its review of the New Drug Application (NDA) for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 26 January 2024
Shares of Dutch biotech LAVA Therapeutics shot up 43% to $2.23 by close of trading on Thursday, after it revealed a clinical trial collaboration and supply agreement with US pharma giant Merck & Co. 26 January 2024
In early December, the USA’s Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. 26 January 2024
The UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved a four-dose version (covering a month’s treatment) of the diabetes and weight management medicine Mounjaro (tirzepatide) - Mounjaro KwikPen. 26 January 2024
Products from biotech major Gilead Sciences appear twice on a US Food and Drug Administration (FDA) list of six cell therapies that are to carry black box warnings about the risk of T-cell malignancies. 25 January 2024
Cellular Origins, a part of TTP Company, focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies, today announced the appointment of Peter Crossley as chief operating officer (COO). 25 January 2024
Korean immuno-oncology company CanariaBio has taken a stock market battering following the failure of its Phase III trial of oregovomab, an antibody targeting CA125, for ovarian cancer patients. 25 January 2024
Belgian cell therapy biotech BioSenic will, for the first time, share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. 25 January 2024
The European regulatory filing for Acarizax (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation 25 January 2024
UK-based dermatology company SkinBioTherapeutics is to acquire the issued share capital of Dermatonics, a specialist in innovative topical and dermatological products in the skincare and woundcare space. 25 January 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin, submitted by Montreal, Canada-based Theratechnologies . 25 January 2024
San Diego, USA-based precision cancer medicines developer Kura Oncology saw its shares rocket more than 46% to $19.62 yesterday it announced a $150 million oversubscribed private placement. 25 January 2024
Earlier this week, ArriVent Biopharma filed for an IPO, following several other young biotechs giving notice they planned to take the plunge in 2024. 25 January 2024