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
The contract development and manufacturing organization (CDMO) AGC Biologics and RoosterBio, a supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media and bioprocess development services, have announced a strategic partnership. 17 August 2022
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration today announced the execution of a joint development agreement (JDA) — among Johnson & Johnson unit Janssen Pharmaceutica, Japan’s Otsuka, TB Alliance and the Bill & Melinda Gates Medical Research Institute — supporting the progression of two investigational tuberculosis (TB) combination treatment regimens into Phase II clinical development. 17 August 2022
In the UK, the National Institute for Health and Care Excellence (NICE) has given a positive reimbursement decision for AbbVie’s Rinvoq (upadacitinib). 17 August 2022
The US Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 17 August 2022
CNS specialist Lundbeck was trading 12% lower by mid-afternoon Wednesday after presenting its financial results for the first half of the year. 17 August 2022
The UK government has initiated formal consultations with the European Union, with the aim of finalizing UK participation in EU science and research programs. This follows persistent delays by the EU in implementing the agreement reached under the Trade and Cooperation Agreement (TCA). 17 August 2022
The European Investment Bank (EIB) is providing 22 million euros ($22.4 million; above 100 million polish zlotys) in financing to Ryvu Therapeutics, Poland’s largest biotech firm that is focusing on novel small molecule therapies that address unmet medical needs in oncology. 17 August 2022
Ideaya Biosciences has announced its financials for second-quarter 2022, saying it has a strong balance sheet of ~$324 million cash, cash equivalents and marketable securities as of June 30, 2022, which is anticipated to fund planned operations into 2025. 17 August 2022
Shares of French pharma major Sanofi were down 4.8% at 82.42 euros this morning, after it announced the discontinuation of the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). 17 August 2022
As President Joe Biden signs the Inflation Reduction Act into law, drugmakers in the USA are poring over the likely impact on drug prices, and how best to respond to its enactment. In this episode, we take a quick look at the Act’s provisions, and the likely impact on drugmakers, with Stephanie Kennan from political consultancy McGuireWoods. 17 August 2022
US biotech Viridian Therapeutics has commenced an underwritten public offering of $175 million of shares of its common stock and series B preferred stock. 16 August 2022
Big pharma has come knocking at the door of Orna Therapeutics, a biotech launched a few years ago by MIT alumni with the goal of developing a new kind of RNA therapeutic. 16 August 2022
USA and Israel-based-BrainStorm Cell Therapeutics is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). 16 August 2022
As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022
Deerfield Management is to take a stake in Swiss firm ADC Therapeutics, an antibody-drug conjugate company based in Lausanne, as the company restructures its obligations. 16 August 2022
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022
During much of the last two years, due to the COVID-19 pandemic and the movement restrictions that were imposed, US Food and Drug Administration inspections of manufacturing facilities were seriously limited and resulted in a large number of delays in new drug approvals. 16 August 2022
Japanese pharma major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor andY Welfare (MHLW) for the osteoporosis treatment Edirol (eldecalcitol) Tablet (0.5µg/0.75µg). 16 August 2022
US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022
UK pharma major AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 16 August 2022