After a ban of nearly six years, the US Food and Drug Administration has lifted an import alert on Ipca Laboratories' two units in Madhya Pradesh (MP), India, to ensure the supply of chloroquine tablets, considered to be one of the possible treatments for the coronavirus infection. 24 March 2020
Swiss firm Urovant Sciences has appointed Jim Robinson as chief executive, replacing the firm’s founding CEO Keith Katkin, who will become an advisor. 24 March 2020
Russia will need about 1.5-2.5 years in order to create a vaccine against coronavirus and launch it into a series production, according to recent statements made by Dmitry Lioznov, an acting Director of the Smorodintsev Research Institute of Influenza, one of Russia’s leading research institutions in the field of influenza treatment. 24 March 2020
Chugai Pharmaceutical says that, along with majority-owner Roche and Genentech, has filed a patent infringement lawsuit in the US District Court for the District of Delaware as follows. 23 March 2020
USA-based Valeritas Holdings today announced that the US Bankruptcy Court for the District of Delaware approved the sale of substantially all of the business to Danish biotech firm Zealand Pharma. 20 March 2020
US health technology assessor the Institute for Clinical and Economic Review (ICER) has now released a Draft Evidence Report assessing the comparative clinical effectiveness and value of obeticholic acid (Intercept Pharmaceuticals) for the treatment of non-alcoholic steatohepatitis (NASH). 20 March 2020
China has approved the country's first generic version of USA-based lung specialist United Therapeutics' Remodulin (treprostinil sodium), a treatment for the rare disease pulmonary hypertension. 19 March 2020
Novartis has picked up Japanese approval for its one-time gene therapy Zolgensma (onasemnogene abeparvovec), for spinal muscular atrophy (SMA) in young children. 19 March 2020
The European Medicines Agency issued a statement today saying it is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19). 18 March 2020
US Pharma major Bristol-Myers Squibb today announced that Elizabeth Mily has been appointed executive vice president, strategy and business development, effective March 30, 2020. 18 March 2020
Anglo-Swedish pharma major AstraZeneca today announced that Tom Keith-Roach has been appointed president of AstraZeneca UK, effective March 1. 12 March 2020
Cambridge, Massachusetts, USA-based biotech Kymera Therapeutics, which is pioneering targeted protein degradation to invent breakthrough protein degrader medicines for patients, today announced the closing of a $102 million Series C financing. 12 March 2020
The US Food and Drug Administration (FDA) is postponing all but the most mission-critical inspections outside of the USA through April, in response to the COVID-19 outbreak. 10 March 2020
Danish biotech Genmab says that Anthony Mancini will join the company on March 23 as executive vice president and chief operating officer, a newly-created position. 10 March 2020
Following the publication of a 10 million ($11.14 million) call in January, the European Commission has secured an additional 37.5 million euros for urgently needed research on new coronavirus (COVID-19) vaccine development, treatment and diagnostics. 6 March 2020
The European Commission has approved a change to the marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C virus (HCV). 6 March 2020
Cambridge, Massachusetts-based BlueRock Therapeutics has appointed Seth Ettenberg as chief scientific officer, overseeing R&D efforts based around the firm's proprietary cell and gene platform. 6 March 2020
As one of the largest healthcare services groups in Asia, Zuellig Pharma aims to strengthen its presence across Asia, saying it has acquired a controlling stake in Alliance Pharma (Cambodge), a leading healthcare distributor of Cambodia. 5 March 2020
US health technology assessor The Institute for Clinical and Economic Review (ICER) announced yesterday that it plans to postpone its ongoing assessment of bluebird bio’s LentiGlobin for the treatment of beta thalassemia. 4 March 2020
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