27 September 2024 Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector.
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
US biotech major Amgen rolled out senior executives and a swish presentation in providing an update on two of its drugs in Phase III trials this week. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
German drug discovery company Evotec has entered a technology development partnership with Danish drugmaker Novo Nordisk in cell therapy. 26 September 2024
Recently-created by US biotech incubator Flagship Pioneering, Abiologics has announced the appointment of Maria-Chiara Magnone as its chief scientific officer. 26 September 2024
LEO Pharma has presented late-breaking data on the DELTA FORCE trial for Anzupgo (delgocitinib) cream as a potential treatment for adult patients with moderate to severe chronic hand eczema (CHE). 26 September 2024
Binnopharm Group, leading drug producer in Russia via its affiliate Alium, and Indian pharm major Dr Reddy's Laboratories today announced the signing of a deal that will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet (ciprofloxacin) and Levolet (levofloxacin) brands from Dr Reddy’s in Russia, Uzbekistan and Belarus. 21 February 2022
Shares in US genetic medicines company Homology Medicines were set to open 37% lower on Monday following the release of bad news since Friday’s close. 21 February 2022
Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically-significant and clinically-meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy. 21 February 2022
Japanese drugmaker Ono Pharmaceutical says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma. 21 February 2022
The bipolar disorder market is expected to grow from $4.1 billion in 2020 to $4.9 billion by 2030 across the eight major markets (8MM: the USA, France, Germany, Italy, Spain, UK, Japan and Canada) at a compound annual growth rate (CAGR) of 1.7%. 21 February 2022
Shares of UK respiratory disease focussed biotech Synairgen plunged more than 85% to 25.04 pence this morning, after it announced that the international Phase III SPRINTER trial of SNG001 in patients hospitalized with COVID-19 did not meet its primary or key secondary efficacy endpoints. 21 February 2022
A Phase III trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis, marking a rare, albeit minor, set-back for the blockbuster monoclonal antibody (MAb). 21 February 2022
South Korea’s Celltrion Healthcare announced new data sets on the SC formulation of infliximab, Remsima (CT-P13) in IBD, at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022. 21 February 2022
Danish dermatology specialist LEO Pharma has appointed Brian Hilberdink new executive vice president and president of LEO Pharma Inc in the USA, effective March 14, 2022. 21 February 2022
The US Food and Drug Administration has lifted its clinical hold on the Investigational New Drug (IND) application to evaluate the vaccine candidate, BBV152, known as COVAXIN outside the USA, that was submitted by Ocugen. 21 February 2022
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial. 20 February 2022
German life sciences and pharma company Merck KGaA late on Friday revealed that the European Commission (EC) has approved once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 19 February 2022
Chinese biopharma firm Innovent Biologics has announced that its experimental anti-PCSK9 antibody, named IBI306, has come up trumps in two Phase III trials in China. 18 February 2022
The annual generic drug approvals by the US Food and Drug Administration have been falling since 2020, with 737 generics approved1 in fiscal year 2020 and 6792 in fiscal year 2021 – the latter being the lowest in five years. 18 February 2022
German life sciences major Bayer was trading nearly 2% higher on Friday afternoon after the presentation of positive data from the Phase III ARASENS trial of darolutamide (Nubeqa) in metastatic hormone-sensitive prostate cancer (mHSPC). 18 February 2022
Japan’s largest drugmaker Takeda today announced the first six-month interim analysis results from INSPIRE, in which clinical remission was observed in 65% of patients in both cohorts who were evaluated at six months. 18 February 2022
Sweden-headquartered contract development and manufacturing organization Recipharm is on the M&A path again, having announced its intention earlier this month to acquire Portuguese CDMO GenIbet, today it revealed two more buys. 18 February 2022
Kate Corke, partner and Christina Tennant, senior counsel at Farrer & Co, provide an Expert View on real estate for the UK’s life sciences sector. 18 February 2022
The launch of generic versions of Bristol Myers Squibb’s blockbuster multiple myeloma drug Revlimid (lenalidomide) in Europe have been announced by two companies today. 18 February 2022