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
Florida-based central nervous system (CNS) specialist Relmada Therapeutics has announced positive results from a late-stage trial of REL-1017. 21 September 2023
Following a favorable recommendation form the European Medicines Agency’s advisory committee on July, the European Commission (EC) has now granted marketing authorization in the European Union (EU) for Indian drugmaker Biocon’s Yesafili, a biosimilar of Eylea (aflibercept). 21 September 2023
UK-based Oxford Biomedica, a contract development and manufacturing organization (CDMO), is in talks to buy ABL Europe from family-owned French holding company Institut Mérieux in an all-share transaction. 21 September 2023
Italian drugmaker Menarini has secured European approval for Orserdu (elacestrant) as a monotherapy for the treatment of certain people with advanced or metastatic breast cancer. 21 September 2023
In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1 21 September 2023
The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for Neffy (epinephrine nasal spray) in the treatment of allergic reactions (Type I), including anaphylaxis for adults and children ≥30 kg. 21 September 2023
Precision medicine specialist Rezo Therapeutics has appointed Nadir Mahmood as chief executive officer, replacing co-founder Nevan Krogan, who has held the role on an interim basis. 20 September 2023
According to a statement from China’s National Health Commission (NHC), mpox will now be treated under a higher level of threat protocol, after hundreds of new cases were detected in the country. 20 September 2023
The past year has been one of ups and downs for Blueprint Medicines Corporation, a US precision medicines company developing therapies for people with cancer and blood disorders. 20 September 2023
Japanese biopharma firm PeptiDream saw its share rise almost 5% to 1,714 yen, after it revealed a potentially lucrative licensing deal with US biotech Genentech. 20 September 2023
The share of foreign pharmaceutical companies in the segment of public procurement in Russia reached 63%, the highest figure in the last six years, according to latest market statistics in Russia and local media, reports the Pharma Letter’s local correspondent. 20 September 2023
Privately-held genome-scale drug discovery company Orionis Biosciences today revealed a multi-year collaboration with Genentech, the US biotech subsidiary of Swiss pharm giant Roche, to discover novel small molecule medicines for challenging targets in major disease areas, including oncology and neurodegeneration. 20 September 2023
Swiss pharma firm Acino has acquired M8 Pharmaceuticals, a specialty biopharmaceutical company focused on licensing, marketing, and distributing innovative and established medicines in Mexico and Brazil. 20 September 2023
Gene therapy company Orchard Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. 20 September 2023
Belgian drugmaker UCB is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis. 20 September 2023
US pharma major Eli Lilly has revealed it suing spas, wellness centers and compounding pharmacies selling unapproved and compounded versions of its type 2 diabetes drug Mounjaro (tirzepatide). 20 September 2023
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma. 20 September 2023
A shortening cash runaway and a lack of near-term “value creation prospects” have forced some difficult decisions for Californian cancer firm Kinnate Biopharma. 20 September 2023