8 October 2024 UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101.
Japanese drugmaker Shionogi (TYO: 4507) said yesterday that its Xocova (ensitrelvir fumaric acid, Code No.: S-217622), a novel anti-SARS-CoV-2 drug for COVID-19 obtained emergency regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the indication of SARS-CoV-2 infection. 23 November 2022
In a landmark regulatory first, Dutch gene therapy company uniQure (Nasdaq: QURE) has secured US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb). 23 November 2022
A new dengue vaccine, first approved in Indonesia, is to be evaluated by the US Food and Drug Administration under its Priority Review scheme. 23 November 2022
As US federal funding for COVID-19 vaccines and treatments dwindles and cases decline, the Biden administration is planning to stop paying for these products and transition to a more standard purchasing process through different health care system channels, including commercial insurers and pharmacy benefit managers (PBMs) next year. 23 November 2022
Belgium’s largest drugmaker UCB said yesterday it has resubmitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. 23 November 2022
Leading Indian and Chinese drugmakers are considering accelerating their expansion into the Russian market – in a move to fill vacant niches that appeared after the reduction of presence of Western pharmaceutical companies in recent months following the invasion of Ukraine. 23 November 2022
UK pharma major GSK has started the process of withdrawing the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf). 22 November 2022
The US Food and Drug Administration (FDA) today revealed it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). 22 November 2022
Novo Nordisk has announced plans to spend 5.4 billion Danish kroner ($750 million) on the expansion of existing facilities and the addition of a new plant in Bagsværd, Denmark. 22 November 2022
Representatives of the Russian patient community have warned about the shortage of the antiretroviral drug Eviplera (rilpivirine/tenofovir/emtricitabine), the most popular and most expensive combination drug for the treatment of HIV on the domestic market, reports The Pharma Letter’s local correspondent. 22 November 2022
Needing to keep pace with the pace of innovation set by drugmakers, the European Medicines Agency (EMA) has responded by setting up a new group. 22 November 2022
Munich, Germany-based clinical-stage biotech CatalYm said today it has successfully closed a 50 million-euro ($49 million) Series C financing round. 22 November 2022
Privately-held Swiss ophthalmology company Oculis has released positive results of the licaminlimab active-controlled, multicenter, randomized, parallel-group Phase II clinical trial assessing the effect of topical licaminlimab (OCS-02) on anterior chamber (AC) cell grade in patients with acute anterior uveitis (AAU). 22 November 2022
Franco-American biopharma Erytech Pharma revealed Monday that the company will no longer be developing its lead candidate Graspa (eryaspase), an l-asparaginase encapsulated inside donor-derived red blood cells (RBCs). 22 November 2022
German family-owned drugmaker Grünenthal today announced that Janneke van der Kamp will join the company as the new chief commercial officer (CCO), effective March 1, 2023. 22 November 2022
A decade on from the founding of The Cell and Gene Therapy Catapult (CGT Catapult), the UK-based industry accelerator is celebrating its successes. 22 November 2022
Italy-based privately-owned Angelini Industries has appointed Jacopo Andreose as chief executive (CEO) of its subsidiary Angelini Pharma. 22 November 2022
Adding to an Emergency Use Authorization (EUA) in the USA for the vaccine last month, US biotech Novavax says that Health Canada has granted expanded authorization for Nuvaxovid (COVID-19 vaccine (Recombinant protein, adjuvanted)) (NVX-CoV2373). 22 November 2022
Pharma observers of today might sometimes see Merck KGaA as somewhat smaller than its American namesake and as having been left behind by more recent arrivals on the European pharma scene. 21 November 2022
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Some two-and-a-half years after buying the Novo Holdings portfolio company ReViral and its respiratory syncytial virus (RSV) candidate sisunatovir in a deal worth up to $525 million, US pharma giant Pfizer may have signalled an early end to the pricey project. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
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Company Spotlight
A clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.