Swedish immunology company InDex Pharmaceuticals today announced that after more than seven years as chief executive, Peter Zerhouni has decided to leave his position. 11 April 2022
In a Stock Exchange filing on April 8 by the US biotech, Kaleido Biosciences said that its board of directors had voted to immediately wind-down and cease all of the company’s ongoing operations, sending the firm’s shares down 75% to $0.36. 8 April 2022
The European Commission (EC) has expanded the marketing authorization for French pharma major Sanofi’s Dupixent (dupilumab) in the European Union. 7 April 2022
US biotech major Gilead Sciences has announced the formal opening of an office focused on developing new pediatric formulations for its portfolio of medicines in Dublin, Ireland. 6 April 2022
The European Medicines Agency has announced that general, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorization holders are increasing by 0.3% and 5.3% as of April 1, 2022, to reflect the inflation rate adjustments of 2020 and 2021, respectively. 5 April 2022
Vifor Pharma has announced full results from its Phase-IIIb DIAMOND trial showing that Veltassa (patiromer) allowed patients to achieve long-term potassium control, reduced the risk of recurrent hyperkalemia and prolonged optimized and guideline recommended renin-angiotensin aldosterone system inhibitor (RAASi) therapy. 4 April 2022
A New Jersey federal judge has tossed a qui tam lawsuit accusing Bayer Corp. and Johnson & Johnson of defrauding federal insurance programs through antibiotic labeling shortfalls, ruling that the complaints need more specifics in order to advance, according to Law360. 4 April 2022
The trade association representing the Belgian pharmaceutical industry has urged authorities to resume discussions on forging “a new pact,” a goal originally outlined as part of the federal coalition agreement of 30 September, 2020. 4 April 2022
Orient EuroPharma has signed a deal with the US branded and generic drugmaker Currax Pharmaceuticals to bring the weight control drug Contrave (naltrexone/bupropion) to the Taiwan market as soon as in the second half of 2022. 1 April 2022
Biogen has submitted the final study protocol for the confirmatory Phase IV ENVISION trial, a requirement of the Accelerated Approval of Aduhelm (aducanumab), for review. 31 March 2022
Japanese drugmaker Daiichi Sankyo has transferred its marketing authorization of the synthetic broad spectrum antibacterial agent Cravit Tablets/Injection (levofloxacin) in China to YaoPharma. 31 March 2022
Israeli generics giant Teva Pharmaceutical Industries says that its US subsidiary has reached an agreement with the Attorney General of Florida that settles the state’s and its subdivisions opioid-related claims. 31 March 2022
Indian drug major Sun Pharmaceutical Industries has entered into an exclusive patent licensing agreement with Danish CNS specialist Lundbeck to market and distribute its own version of vortioxetine in India. 30 March 2022
Germany’s BioNTech, which has jumped into the limelight from near obscurity through the development of the most successful COVID-19 vaccine (Comirnaty) with US pharma giant Pfizer (NYSE: PFE), today reported financial results for the three months and full year ended December 31, 2021 and provided an update on its corporate progress. 30 March 2022
The Journal of Clinical Endocrinology & Metabolism has published positive results from the Phase III LINC 4 study of Recordati’s Isturisa (osilodrostat) in patients with Cushing’s disease. 29 March 2022
The Cystic Fibrosis Foundation announced an award for up to $15.9 million in additional funding to USA-based Eloxx Pharmaceuticals to expand clinical studies of ELX-02, a potential therapy for people with CF who have nonsense mutations, with the news lifting the firm’s shares by 8.5% to $0.52 by mid-day trading. 29 March 2022
Santhera Pharmaceuticals and ReveraGen BioPharma have started a rolling new drug application submission for vamorolone in the USA, after a successful pre-NDA meeting in late 2021. 29 March 2022
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic. 3 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 3 October 2024