The US Food and Drug administration has announced the availability of a guidance for industry, titled “Control of N-Nitrosamine Impurities in Human Drugs.” 2 September 2020
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. 1 September 2020
Ionis Pharmaceuticals has agreed to buy all outstanding shares of Akcea Therapeutics, approximately 24%, for $18.15 per share in cash. 1 September 2020
In the latest update on countries negotiating with pharma over access to unapproved COVID-19 vaccines, Japan is said to be talking to Moderna over acquiring 40 million doses of its mRNA candidate. 28 August 2020
Californian genome engineering firm Synthego has raised $100 million in a series D financing led by new investor Wellington Management, bringing total private funding to more than $250 million. 28 August 2020
Beximco Pharmaceuticals is to collaborate with the Serum Institute of India to become the exclusive supplier of AstraZeneca’s COVID-19 vaccine in Bangladesh, should the product be approved. 28 August 2020
Hong Kong-based Jacobson Pharma has signed a letter of intent with a subsidiary of Shanghai Fosun Pharmaceutical to market and supply up to 10 million doses of BioNTech’s BNT162 mRNA-based vaccine. 27 August 2020
Indian drugmaker Lupin and Netherlands-based Mylan have announced the launch of Nepexto, a biosimilar of Amgen’s Enbrel (etanercept), in the German market. 27 August 2020
Indian drugmaker Intas Pharmaceuticals has developed COVID-19 specific hyperimmune globulin and has received authorization from the Drug Controller General of India to conduct a clinical trial. 26 August 2020
Dutch gene therapy company uniQure today announced the appointment of Ricardo Dolmetsch, as president, research and development, effective September 14, 2020. 25 August 2020
German’s Merck KGaA says that the US Food and Drug Administration has accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally-dosed tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). 25 August 2020
Despite today announcing that the first volunteers have been enrolled in the Phase II portion of its ongoing clinical trial in the USA and Australia to evaluate the immunogenicity and safety of its COVID-19 vaccine candidate, US clinical-stage biotech Novavax’ shares were down more than 14% at $117.87 by late-morning trading. 24 August 2020
Japanese drugmaker Daiichi Sankyo has announced the publication of real-world data on the use of Lixiana (edoxaban) in patients with atrial fibrillation (AF) in the cardiology journal, European Heart Journal - Cardiovascular Pharmacotherapy. 21 August 2020
A pair of Russia’s leading microbiologists will tell the world about the differentiating characteristics of the Sputnik V vaccine for COVID-19 on Thursday. 20 August 2020
The European Commission has approved, under the EU Merger Regulation, the acquisition of sole control of Gehe Pharma Handel GmbH, Gehe Immobilien GmbH & Co. KG and Gehe Immobilien Verwaltungs-GmbH (“Gehe”) by Alliance Healthcare Deutschland, all of Germany. 20 August 2020
Privately-held Harbour BioMed and its and its partners Utrecht University and Erasmus Medical Center have announced a new research collaboration with Viroclinics-DDL and Kiadis Pharma. 19 August 2020
Australia's Prime Minister Scott Morrison said on Tuesday said that the country has signed a deal with AstraZeneca to secure a potential COVID-19 vaccine, joining a growing list of countries lining up supplies of the drug, as reported London South East. 19 August 2020
CARE (Corona Accelerated R&D in Europe), a new consortium supported by the Innovative Medicines Initiative (IMI) public-private partnership, has announced its launch to accelerate the discovery and development of urgently needed medicines to treat SARS-CoV-2, the virus that causes COVID-19. 18 August 2020
Swedish Orphan Biovitrum (also known as Sobi) announced today that Ravi Rao has been appointed head of research and development (R&D), as Milan Zdravkovic leaves for new opportunities outside the company. 18 August 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