27 September 2024 Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector.
Shares of German pharma major Bayer were up 4.6% at 30.45 euros after it released positive early trial results for its Parkinson’s disease candidate. 27 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
CNS specialist Lundbeck has announced data from the TALISMAN natural history study, as well as additional data from the AMULET trial, of amlenetug, in multiple system atrophy (MSA) at the International Congress of Parkinson's Disease and Movement disorders in Philadelphia, USA. 27 September 2024
Repair Biotechnologies, a company developing therapies to reverse atherosclerotic plaque, has entered into a collaboration with Genevant Sciences, a specialist in nucleic acid delivery technology. 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
Chicago, USA-based ARCH Venture Partners revealed it has closed the ARCH Venture Fund XIII, a venture capital fund with more than $3 billion to support the founding and growth of early-stage biotechnology companies. 27 September 2024
US virology and immunology company Enanta Pharmaceuticals has given further weight to its claims to have the leading portfolio of potent respiratory syncytial virus (RSV) replication inhibitors 27 September 2024
Sage Therapeutics has announced that Biogen has terminated its partnership on the SAGE-324 program, following the recent failure of the drug in a Phase II study for the treatment of essential tremor. 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
USA-based biotech funder and incubator Flagship Pioneering yesterday unveiled Mirai Bio, a company pioneering the first open end-to-end platform for the biotech industry to enable the co-creation of fully optimized genetic medicines. 27 September 2024
Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector. 27 September 2024
US drugmaker AbbVie has announced positive topline results from its pivotal Phase III TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. 26 September 2024
Evaxion Biotech has entered into an option and license agreement with MSD (tradename of Merck & Co outside of the USA and Canada), for two pre-clinical vaccine candidates. 26 September 2024
Danish CNS specialist Lundbeck and US privately-held biotech Iambic Therapeutics today announced a strategic research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine. 26 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Pfizer (NYSE: PFE) has announced the withdrawal of Oxbryta (voxelotor), a treatment for sickle cell disease (SCD), from all global markets. 26 September 2024
Adrian Tombling, partner and life sciences sector specialist at European intellectual property firm, Withers & Rogers, offers an Expert View on why patents are not the real barrier and why we need them to guard the human race against the risks posed by COVID-19 mutations or future pandemics. 4 January 2022
Denmark’s Genmab and privately-held Dutch biotech Synaffix have signed a license agreement providing Genmab broad access to Synaffix’ ADC technologies. 4 January 2022
Shares of PTC Therapeutics were up 6.9% to $42.58 by close of trading on Monday, ahead of formally announcing that Waylivra (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. 4 January 2022
Privately-held Oncoheroes Biosciences is to acquire certain development rights to Allarity Therapeutics’ candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor. 4 January 2022
Advicenne, a French firm specializing in rare renal diseases, has signed an exclusive distribution agreement with Swedish pharma company FrostPharma for the commercialization of Sibnayal (potassium citrate/potassium hydrogen carbonate). 4 January 2022
Shares of Swiss biotech Santhera Pharmaceuticals were up 15.4% at 1.50 Swiss francs by early afternoon, after it revealed an exclusive license agreement with China-based rare diseases specialist Sperogenix Therapeutics. 4 January 2022
Shares in New York-based rare disease firm Applied Therapeutics have fallen by a third, after the company said it would put a US regulatory bid on hold. 4 January 2022
The US Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No 9,187,405 covering a dosing regimen for Gilenya (fingolimod). 4 January 2022
US autoimmune drug developer Kyverna Therapeutics has entered into exclusive, worldwide licenses with the National Institutes of Health (NIH) for intellectual property related to a novel clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties uniquely suited for use in autoimmune diseases. 4 January 2022
South Korean Celltrion Group’s shares edged up 1.8% to 200,000 Korean won in early trading on Monday, after it released results for its COVID-19 cocktail therapy candidates including neutralization data against the Omicron variant. 4 January 2022
As another wave of coronavirus infections swamp India, the country has stepped up its efforts to fight the disease and has cleared two new vaccines and one anti-COVID drug for restricted use. 2 January 2022
Novavax closed down 7.6% at $143.07 on Friday, despite announcing that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the US Food and Drug Administration for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. 1 January 2022
US specialty pharma company Xeris Biopharma saw its share leap nearly 30% to $3.15 post-market on Thursday, after it announced that the US Food and Drug Administration had approved its Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 31 December 2021
The UK subsidiary of US pharma giant Pfizer today announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Great Britain for the supply and use of PF-07321332/ritonavir for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe disease. 31 December 2021
Bermuda-based Kiniksa Pharmaceuticals saw its shares drop more than 15% after it announced that the Phase III portion of the Phase II/III trial of mavrilimumab in COVID-19-related acute respiratory syndrome (ARDS) did not meet the primary efficacy endpoint. 31 December 2021
In the USA, a New York jury on Thursday found that Israel-based Teva Pharmaceutical Industries’ US subsidiary contributed to a crisis of opioid abuse in the Empire State, but also placed a small portion of the blame for the epidemic on the state. 31 December 2021
US CNS-focussed biotech Amylyx Pharmaceuticals yesterday revealed that the US Food and Drug Administration has accepted for review its New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). 30 December 2021
USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021
Ever increasing investments are being made in artificial intelligence, as drugmakers spy an opportunity to drive efficiencies and spur innovation. In this episode, we discuss an exciting new collaboration between pharmaceutical majors in the field of AI. 30 December 2021
Bangladeshi generics and active ingredients maker Beximco Pharmaceuticals today announced the launch of the world's first generic version of Pfizer’s COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir tablets, co-packaged for oral use), which was granted emergency use authorization (EUA) by the US Food and Drug Administration on December 22, 2021. 30 December 2021