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 European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC). 1 March 2023
Shanghai Junshi Biosciences had more positive news, this time on its monoclonal antibody (MAb) candidate ongericimab, adding to the successful trials results for its toripalimab in breast cancer last week. 1 March 2023
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted that available data is adequate to support the safety and effectiveness of the respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF, from US pharma giant Pfizer. 1 March 2023
In a second financing within one year, China-based Oricell Therapeutics has announced the close of a $45 million Series B1 investment round. This adds to the $125 million Series B fund that was raised in July 2022. 1 March 2023
The Association of the British Pharmaceutical Industry (ABPI) has attempted to show that there is a better way than the existing Voluntary Pricing and Access Scheme (VPAS). 1 March 2023
US generic drug-focussed drugmaker Viatris has announced that, as it prepares to enter Phase 2 of its previously revealed strategic plan in 2024, the appointment of pharma veteran Scott Smith to lead the execution of that plan as Viatris' new chief executive (CEO), effective April 1, 2023. 28 February 2023
Werner Baumann, chairman of the board of management at the German life sciences major Bayer, presented his final set of annual financial results on Tuesday. 28 February 2023
US precision medicines company Frontier Medicines today announced the addition of Christo Shalish to the leadership team as senior vice president (SVP) and head of business development. 28 February 2023
Sino-American biotech BeiGene yesterday reported financial results, showing that revenues for the fourth quarter and full year 2022 was $380.1 million, missing consensus estimates of $345 million by 2%, and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. 28 February 2023
New York-based central nervous system (CNS) specialist Axsome Therapeutics has hit a regulatory snag in the development of AXS-05 (dextromethorphan/bupropion). 28 February 2023
The Biologics License Application (BLA) for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. 28 February 2023
US CNS specialist Aptinyx saw its shares plunge more than 56% to $0.26, after it released Phase II clinical study results evaluating the effects of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. 28 February 2023
Russia may be facing a shortage of erectile dysfunction drug Viagra (sildenafil) – once the best-selling medicine in the country- due to the recent announcement by the USA’s Viatris about the suspension of supplies to the drug to the Russian market. 28 February 2023
The Dutch business of Rhythm Pharmaceuticals has acquired Xinvento, a Netherlands-based biotech focused on therapies for congenital hyperinsulinism (CHI). 27 February 2023
The need to guarantee a new regulatory category for ‘value-added medicines’ has been proposed by the Asociación Española de Medicamentos Genéricos (AESEG), the Spanish trade group representing generic and biosimilar medicine manufacturers. 27 February 2023
Even as the US Food and Drug Administration’s (FDA) director of drug quality Carmelo Rosa recently emphasized the need for Indian pharmaceutical companies to continually strive to manufacture drugs of the highest quality, both domestically and internationally, the Indian government has gone into overdrive to ensure that the impeccable standards of its regulatory mechanisms can be maintained over the long-term, reports The Pharma Letter’s India correspondent. 27 February 2023
Minister for Health Stephen Donnelly’s decision to publish the Mazars Report has been welcomed by the Irish Pharmaceutical Healthcare Association (IPHA). 27 February 2023
Indian generic drug major Dr Reddy's Laboratories saw its shares dip 1.2% to 4,411 rupees, as it revealed it has entered into a definitive agreement to acquire the US generic prescription product portfolio of Australia-based Mayne Pharma. 27 February 2023