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
A new formulation of Xgeva (denosumab) is the first product to be authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) via the regulator’s new International Recognition Procedure (IRP). 1 March 2024
San Diego-based BlossomHill Therapeutics, a company focused on the design and development of small molecules for cancer and autoimmune diseases, has announced the closing of a $100 million Series B financing round. 1 March 2024
More positive data for Abrysvo (respiratory syncytial virus vaccine) will support Pfizer’s position in an important new market for products targeting RSV infections. 1 March 2024
Privately-held Danish dermatology specialist LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and earnings before interest, tax, depreciation and amortization for 2023. 1 March 2024
In December 2023, the US Food and Drug Administration (FDA) released a 25-page draft guidance on Potency Assurance for Cellular and Genetic Therapy Products.1 1 March 2024
Russia is experiencing, shortage of a unique drug against repeated heart attacks - Effient (prasugrel) from the American pharma major Eli Lilly representative of the Russian Ministry of Health told the business newspaper Vedomosti, the Pharma Letter’s local correspondent reports. 1 March 2024
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
British pharma major AstraZeneca has chosen Shanghai as the location for what will become its fifth global strategic center for research and development. 29 February 2024
US gastroenterology specialist Ironwood Pharmaceuticals saw its shares plunge more than 30% to $10.50 in pre-market activity today, after it announced what it called ‘positive’ top-line results from its pivotal Phase III STARS trial. 29 February 2024
Avidity Biosciences has announced an oversubscribed $400 million private placement, with the news sending the US RNA-focussed biotech firm’s shares up 21.8% to $18.58 by mid-morning. 29 February 2024
San Diego, USA-based Kenai Therapeutics, a biotech leveraging induced pluripotent stem cell (iPSC) tech to discover and develop a platform of allogeneic neuron replacement cell therapies for neurological disorders, has raised $82 million in a Series A financing. 29 February 2024
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
Denmark-based life sciences investor Novo Holdings today announced it had launched Orbis Medicines, a leader in macrocycle drug discovery, to advance the development of next-generation oral macrocycle drugs. 29 February 2024
Swiss generics and biosimilars drugmaker Sandoz today announced that its US subsidiaries – Sandoz Inc and Fougera Pharmaceuticals - have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. 29 February 2024
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
The tides are shifting. As multinational entities such as Novartis, AstraZeneca and Sanofi recalibrate their strategies in India, spurred by intensified local competition and patent expiries, domestic pharma players like Cipla, Torrent Pharma, Eris Lifesciences, and JB Chemicals are asserting their prominence. 29 February 2024
Shares in New Jersey, USA-based Palatin Technologies fell over a third on Wednesday, after a key Phase III trial missed its efficacy goals. 29 February 2024
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions. 29 February 2024