The UK’s National Institute for Health and Care Excellence (NICE) has released its final appraisal document (FAD) recommending funding for the use of Elmiron (pentosan polysulfate sodium) in England. 13 November 2019
US biopharma Lipocine lost 71% of its value in the stock market on Monday as markets digested news of a third complete response letter (CRL) relating to the testosterone replacement therapy, Tlando. 12 November 2019
Japan’s Otsuka and its USA-based, indirect subsidiary Avanir Pharmaceuticals have decided to continue the clinical development program of AVP-786 (a combination of deudextromethorphan hydrobromide and quinidine sulfate) for the treatment of agitation in patients with Alzheimer’s dementia. 12 November 2019
Oncology specialist Agenus has received $10 million upfront from UroGen Pharma, in return for access to the anti-CTLA-4 antibody zalifrelimab. 12 November 2019
Therapix Biosciences, an Israeli specialty, clinical-stage pharma company focusing on the development of cannabinoid-based treatments, and Canada-based Destiny Biosciences Global yesterday announced their mutual decision to discontinue negotiations on the previously -announced proposed merger. 8 November 2019
France’s OSE Immunotherapeutics has agreed a deal with Chong Kun Dang for Tedopi, formerly known as OSE-2101, for potential registration and commercialization in South Korea. 8 November 2019
UK-incorporated Mallinckrodt today announced that Uvadex (methoxsalen) has received regulatory approval in Australia by the Therapeutic Goods Administration (TGA) for extracorporeal administration with the THERAKOS CELLEX Photopheresis System. 7 November 2019
Privately-held German drugmaker Boehringer Ingelheim has presented results from a new subgroup analyses from the Phase III INBUILD trial that showed Ofev (nintedanib) reduced the rate of lung function decline in patients with autoimmune-related interstitial lung diseases. 7 November 2019
French microbiome specialist Enterome has entered into a collaboration with the Memorial Sloan Kettering Cancer Center (MSK) to evaluate the potential of gut microbiome-derived antigens. 7 November 2019
Chinese biotech companies Ascentage Pharma and Henlius have announced a collaboration to test a combination of their drugs in chronic lymphocytic leukemia. 6 November 2019
UK Health Secretary Matt Hancock announced ambitious National Health Service (NHS) plans on Tuesday that could help to shepherd in the era of predictive and personalized healthcare. 6 November 2019
USA-based Cognate BioServices has bought Cobra Biologics for an undisclosed sum. Cobra specializes in plasmid DNA and viral vector manufacturing services. 6 November 2019
Endo International today announced that Paul Campanelli, president and chief executive has notified his intention to retire and Endo’s board of directors is implementing its CEO succession plan. 5 November 2019
Eisai has sold ex-Japan royalty rights for the investigational anti-cancer agent tazemetostat to Royalty Pharma, for $110 million upfront and up to $220 million based on marketing approvals in the USA. 5 November 2019
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