10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
US biotech major Gilead Sciences has announced that Stacey Ma will join the company as executive vice president, pharmaceutical development and manufacturing, and will become a member of the company’s senior leadership team, reporting to chairman and chief executive, Daniel O’Day. 3 June 2022
Japanese drug major Astellas Pharma’s subsidiary Xyphos Biosciences and Cambridge, Massachusetts-based GO Therapeutics have entered into a strategic research collaboration and license agreement to develop novel immuno-oncology therapeutics. 2 June 2022
Immatics Biotechnologies saw its American-traded shares rise just a modest 3.2% to $7.79 this morning, despite signing a multi-billion-dollar deal, albeit heavily back-loaded. 2 June 2022
Shares of Canada-based clinical-stage precision cancer drugs developer Repare Therapeutics were up 27.5% at $11.16 pre-market today, on the news of a worldwide license and collaboration agreement with Swiss pharma giant Roche for the development and commercialization of camonsertib (also known as RP-3500). 2 June 2022
China-based CNS drug developer SciNeuro Pharmaceuticals yesterday announced the execution of an exclusive, worldwide license and option agreement with UK pharma major GlaxoSmithKline. 2 June 2022
TauRx Pharmaceuticals, a company that claims to be the global leader in tau-based research in Alzheimer’s disease, has announced the unblinding of initial data from completion of the randomized portion of its pivotal Phase III trial, LUCIDITY. 1 June 2022
Belgian biotech Galapagos has announced that the UK's National Institute of Health and Clinical Excellence (NICE) has recommended the use of Jyseleca (filgotinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) when other treatments have not been successful. 1 June 2022
Sage Therapeutics rose as much as 10% to $34.81 after, along with partner Biogen, it announced that the Phase III SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. 1 June 2022
Shares of US biotech TG Therapeutics were down more than 9% at $4.35 by mid-afternoon today, after it announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application (BLA) for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (RMS). 1 June 2022
Investment in artificial intelligence (AI) is on the increase in the pharma industry due to its capacity to drive efficiencies and innovation. 1 June 2022
US pharma major Bristol-Myers Squibb has become the first foreign pharmaceutical manufacturer that has decided to leave Russia due to the ongoing military conflict and associated with the sanctions imposed on Russia. 1 June 2022
Swedish Orphan Biovitrum (Sobi) and French pharma major Sanofi have been awarded Breakthrough Therapy designation in the USA, for efanesoctocog alfa (BIVV001). 1 June 2022
With media and politicians calling attention to the problem of rising drug prices, it’s important to remember one fact: Generic and biosimilars represent the only segment of health care in the USA that consistently reduces costs, noted the USA’s Association for Accessible Medicines (AAM). 1 June 2022
Korean biosimilar company Samsung Bioepis is presenting new data on its copy of Humira (adalimumab), which is branded as Imraldi and Hadlima and also referred to as SB5, at the Annual European Congress of Rheumatology (EULAR 2022). 1 June 2022
US biotech Biohaven Pharmaceutical migraine nasal spray zavegepant is set to generate annual sales of $206.8 million in the USA following the potential approval of its new drug application (NDA), which was received by the Food and Drug Administration (FDA) last week. 1 June 2022
In a letter to shareholders, Takeda Pharmaceutical chief executive Christophe Weber has explained that drug manufacturers may be forced to cut prices in the near term. 1 June 2022
Global drugmakers and their Russian partners are losing their positions in the Russian market for anti-cancer drugs due to expiration of patent protection for a number of their drugs and their replacement by Russian-made generics, reports The Pharma Letter’s local correspondent. 1 June 2022
The USA’s Federal Trade Commission and the Department of Justice, Antitrust Division, will host a two-day virtual workshop to explore new approaches to enforcing the antitrust laws in the pharmaceutical industry. 1 June 2022
Bruised by its failure to enter the superlatively lucrative market for coronavirus shots, British drug developer GlaxoSmithKline is to spend billions boosting its vaccines business. 31 May 2022
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
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