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
US biotech Adagio Therapeutics today outlined strategic initiatives for its ADG20 program, as well as research efforts to address SARS-CoV-2 and other coronaviruses. 22 February 2022
US rare liver disease-focussed biotech Albireo Pharma said today that the UK’s National Institute for Health and Care Excellence (NICE) has issued guidance that recommends Bylvay (odevixibat) for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC) in people aged six months and older. 22 February 2022
Dutch thrombotic diseases specialist TargED Biopharmaceuticals has raised 39 million euros ($44 million) in a Series A financing to accelerate development of its lead compound, Microlyse. 22 February 2022
Following a December positive opinion from the European Medicines Agency’s advisory committee, the European Commission has granted marketing authorization in the European Union (EU) for Kerendia (finerenone). 22 February 2022
Independent private equity firm dedicated to biotech and biopharma Jeito Capital today announced that it has co-led a $65 million Series A financing round in EyeBiotech Limited (EyeBio), a privately held ophthalmology biotechnology company working to deliver a new generation of therapies for eye diseases. 22 February 2022
German biotech BioNTech, which has earned billions of dollars through its COIVD-19 vaccine development with Pfizer (NYSE: PFE), is looking to expand its business into new areas. 22 February 2022
Binnopharm Group, leading drug producer in Russia via its affiliate Alium, and Indian pharm major Dr Reddy's Laboratories today announced the signing of a deal that will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet (ciprofloxacin) and Levolet (levofloxacin) brands from Dr Reddy’s in Russia, Uzbekistan and Belarus. 21 February 2022
Shares in US genetic medicines company Homology Medicines were set to open 37% lower on Monday following the release of bad news since Friday’s close. 21 February 2022
Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically-significant and clinically-meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy. 21 February 2022
Japanese drugmaker Ono Pharmaceutical says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma. 21 February 2022
The bipolar disorder market is expected to grow from $4.1 billion in 2020 to $4.9 billion by 2030 across the eight major markets (8MM: the USA, France, Germany, Italy, Spain, UK, Japan and Canada) at a compound annual growth rate (CAGR) of 1.7%. 21 February 2022
Shares of UK respiratory disease focussed biotech Synairgen plunged more than 85% to 25.04 pence this morning, after it announced that the international Phase III SPRINTER trial of SNG001 in patients hospitalized with COVID-19 did not meet its primary or key secondary efficacy endpoints. 21 February 2022
A Phase III trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis, marking a rare, albeit minor, set-back for the blockbuster monoclonal antibody (MAb). 21 February 2022
South Korea’s Celltrion Healthcare announced new data sets on the SC formulation of infliximab, Remsima (CT-P13) in IBD, at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022. 21 February 2022
Danish dermatology specialist LEO Pharma has appointed Brian Hilberdink new executive vice president and president of LEO Pharma Inc in the USA, effective March 14, 2022. 21 February 2022
The US Food and Drug Administration has lifted its clinical hold on the Investigational New Drug (IND) application to evaluate the vaccine candidate, BBV152, known as COVAXIN outside the USA, that was submitted by Ocugen. 21 February 2022
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial. 20 February 2022
German life sciences and pharma company Merck KGaA late on Friday revealed that the European Commission (EC) has approved once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 19 February 2022