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.
The market position of Bristol Myers-Squibb’s Abecma (idecabtagene vicleucel; ide-cel) for the treatment of relapsed or refractory multiple myeloma (RRMM), is facing a serious threat from a relatively novel class of drugs known as bispecific T-cell engagers (BiTEs), as they leverage clinical advantages such as improved duration of response to therapy and quicker administration. 27 December 2022
Research news last week featured strong Phase III results for Madrigal Pharmaceuticals’ investigational drug resmetirom in the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis, sending the firm’s share rocketing as much as 270%. Also of note, AbbVie announced that its Vraylar has gained a fourth approval from the US Food and Drug Administration, this one for major depressive disorder. On the deal-making front, Canada’s Zymeworks leapt on the news that Ireland’s Jazz Pharmaceuticals had opted into a previously announced collaboration that could be worth nearly $2 billion for the development of zanidatamab. And Germany’s Merck KGaA last Thursday revealed a new collaboration with Mersana Therapeutics using its STING platform to develop antibody-drug conjugates (ADCs). 26 December 2022
Although Amgen’s investigational drug AMG-133, it has the potential to address a key unmet need for drugs that reduce patient burden among patients with obesity. 23 December 2022
Following marketing authorization by the European Commission in August for the same indication, the US Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. 23 December 2022
Ahead of the expected December 29 action date, and adding to European approval in June, the US Food and Drug Administration (FDA) yesterday granted marketing authorization for Swiss pharma giant Roche subsidiary Genentech’s Lunsumio (mosunetuzumab-axgb). 23 December 2022
Germany’s Merck KGaA has embarked on a new research collaboration with Mersana Therapeutics (Nasdaq: MRSN), including terms for a commercial license. 23 December 2022
A draft report on amyloid beta-targeting antibodies in Alzheimer’s disease, prepared by the Boston, Massachusetts-based pricing watchdog the Institute for Clinical and Economic Review (ICER), recommends a price range below the current or anticipated cost. 23 December 2022
Following a previous rejection by the agency, the US Food and Drug Administration (FDA) has now accepted for review the Biologics License Application (BLA) resubmission for bimekizumab, filed by Belgium’s largest drugmaker UCB, for the treatment of adults with moderate to severe plaque psoriasis. 23 December 2022
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, which was developed by Kite pharma, now a subsidiary of US biotech Gilead Sciences. 23 December 2022
US health technology assessor the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of two gene therapies intended for the treatment of hemophilia A and B. 22 December 2022
While the vast majority of M&A deals announced so far this year are in the hundreds of million dollars, licensing agreements have been getting ever bigger. 22 December 2022
Bayer subsidiary Asklepios BioPharmaceutical (AskBio) has drawn attention to the role of its own adeno-associated virus technology in all US Food and Drug Administration-approved gene therapies of this type. 22 December 2022
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
In a filing with the US Securities and Exchange Commission (SEC), NGM Biopharmaceuticals has revealed its partner Merck & Co will pass on development of ophthalmic products. 22 December 2022
Roche company Genentech has won US approval for its intravenous Actemra (tocilizumab) product, for adults that have been hospitalized with COVID-19. 22 December 2022
US mRNA biotech Moderna, flush with cash due to the success of its COVID-19 vaccine Spikevax, today announced finalizing a strategic partnership with the UK government to establish a state-of-the-art mRNA research, development, and manufacturing facility in the UK. This milestone follows the agreement in principle between Moderna and the UK government, announced in June 2022. 22 December 2022
New gonadotropin-releasing hormone (GnRH) receptor antagonists being introduced to the endometriosis market, will push the sector’s value up from $1.05 billion in 2020 to $2.72 billion in 2030 across the seven major markets (7MM: the USA, 5EU [France, Germany, Italy, Spain, and the UK], and Japan). 22 December 2022
The European Commission has published a study examining the public procurement practices and their impact on medicines supply and availability. The study confirms that awarding multiple winners and using additional criteria other than price (most economically advantageous tender – MEAT criteria) would be more sustainable procurement. 22 December 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Sanofi’s SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults in Great Britain. 21 December 2022
Canada’s Zymeworks saw its shares leap 17% $8.28 today, after it revealed that Jazz Pharmaceuticals has exercised its option to continue with its exclusive development and commercialization rights to Zymeworks' zanidatamab in key markets, including the USA, Europe and Japan, under the license and collaboration agreement the drugmakers entered into in October this year. 21 December 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.