A review of recent litigation from Sara Koblitz, a director at Hyman, Phelps & McNamara, provides reason to think that so-called skinny-labeled drugs will continue to be an option for generics manufacturers. 12 January 2022
At the 40th Annual JP Morgan Healthcare Conference, Servier’s new USA-based business, Servier Pharmaceuticals, has highlighted its successes, pointing to a near-20% growth in revenues. 11 January 2022
Japan-based Sosei Group and the life sciences arm of Google-parent company Alphabet, USA-based Verily, have entered into a strategic research collaboration. 7 January 2022
UK-based iron deficiency specialist Shield Therapeutics has entered into an exclusive licence agreement for Accrufer/Feraccru (ferric maltol) with KYE Pharmaceuticals in Canada. 6 January 2022
Boston, USA-based Odyssey Therapeutics, a biotechnology company pioneering next generation precision immunomodulators and oncology medicines, today announced that it has acquired Rahko, a leading quantum machine learning company. 6 January 2022
ONK Therapeutics, an Ireland-headquartered innovative NK cell therapy platform company, today announced the closing of its $21.5 million Series A financing, led by current investors Acorn Bioventures and ALSHC, who were joined by Cormorant Asset Management. 6 January 2022
Ares Trading, an affiliate of Merck KGaA, has exercised a fourth licensing option with oncology company F-star Therapeutics, to develop another bispecific program under an ongoing immuno-oncology collaboration. 5 January 2022
Rare diseases company Amryt has announced that The Lancet Diabetes & Endocrinology has published full results of a global Phase III trial that compared Mycapssa (oral octreotide capsules) to long-acting injectable somatostatin receptor ligands for maintenance of biochemical response in patients with acromegaly. 4 January 2022
The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 years of age and older. 3 January 2022
There was a flurry of activity in US biotech Biogen stock since yesterday, after the Korea Economic Daily reported on Wednesday that local firm Samsung Biologics had been approached by the US firm to buy its shares, in a deal which could be valued at more than $42 billion. 30 December 2021
The US Food and Drug Administration has determined that Eagle Pharmaceuticals has maintained its 180 days of marketing exclusivity for its recently approved abbreviated new drug application (ANDA) for vasopressin. 30 December 2021
Merck & Co, known as MSD outside the USA and Canada, and Ridgeback Biotherapeutics have announced that Japan’s Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. 29 December 2021
Israel-based Oramed Pharmaceuticals says that its subsidiary, Oravax Medical, has signed a cooperation and purchase agreement with Vietnam-based Tan Thanh Holdings Investment to pre-purchase Oravax’ oral COVID-19 vaccine, currently in development. 29 December 2021
A new licensing agreement between Durect Corporation and Innocoll Biotherapeutics grants the latter exclusive development and commercialization rights to Posimir (bupivacaine). 23 December 2021
Deciphera Pharmaceuticals today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Qinlock (ripretinib) in the UK for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. 21 December 2021
The US Food and Drug Administration has approved German drug major Bayer’s Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism (VTE), or blood clots that form in the veins, and reduce the risk of VTE recurring in pediatric patients from birth to younger than 18 years who have received at least five days of injectable or intravenous treatment for blood clots. 21 December 2021
Swiss biopharma Helsinn Group and Xediton Pharmaceuticals, a Canada-based specialty pharma company with a strong presence in products in oncology, have announced the signing of an exclusive license and distribution agreement in Canada for Truseltiq (infigratinib). 20 December 2021
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