The European Medicines Agency (EMA) is set to review a bid for breast cancer candidate trastuzumab deruxtecan, an HER2-directed antibody drug conjugate (ADC). 8 July 2020
French drugmaker Sanofi appears keen to mitigate any shock about its pandemic-hit second quarter results, which are due to be presented on July 29. 7 July 2020
The World Health Organization (WHO) on Saturday accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms. 4 July 2020
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. 25 June 2020
Epidarex Capital, a transatlantic life science venture firm, today announced the closing of Epidarex Capital III UK LP (the Fund) at £102.1 million ($126 million). 22 June 2020
The US Food and Drug administration yesterday issued a guidance for industry entitled, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” 18 June 2020
Family-owned German pharma major Boehringer Ingelheim today said that Dr Wolfgang Baiker, US country managing director, president and chief executive, will retire after 31 years of committed service to the company on July 31, 2020. 15 June 2020
Simcere Pharmaceutical has applied for an initial public offering (IPO) in Hong Kong to raise $500 million, part of which will go to R&D for cancer and CNS treatments, according to the prospectus. 11 June 2020
Chinese pharma Hengrui and its Japanese peer Oncolys Biopharma have terminated their partnership on the potential solid tumor treatment telomelysin (OBP-301), an oncolytic virus. 10 June 2020
Arena Pharmaceuticals chief medical officer Chris Cabell will assume the position of R&D head, following the departure of Preston Klassen for a CEO role at another company. 9 June 2020
Rare disease specialist Amryt has inked a distribution agreement for Myalepta (metreleptin) with Baar, Switzerland-based firm Swixx BioPharma. 3 June 2020
Sanofi has named four new leaders to its Executive Committee, completing previously announced changes to further simplify the company’s leadership team. 29 May 2020
Lyon, France-based MaaT Pharma has appointed Savita Bernal as chief business officer, replacing Jean-Marc Renard, who will continue to advise the company. 28 May 2020
China's medicines regulator the Center for Drug Evaluation (CDE) re-opened its office on Monday, after months-long lockdown during the COVID-19 pandemic. 26 May 2020
Mitsubishi Tanabe Pharma (MTPC) today announced that its subsidiary in Thailand has obtained regulatory approval for Tenelia (teneligliptin hydrobromide hydrate) 20mg tablets for a treatment agent for type 2 diabetes mellitus from the country’s Food and Drug Administration, following the completion of the approval application procedure. 25 May 2020
In a letter to World Health Organization (WHO) director general Tedros Adhanom Ghebreyesus, US President Donald Trump, who last month suspended US funding to the agency, threatened to make this temporary freeze permanent and reconsider the USA’s membership altogether. 19 May 2020
More than 50 independent pharmacies have filed a class action lawsuit against OptumRx, a division of UnitedHealth Group, alleging that the company failed to comply with state pharmacy claims reimbursement law. 15 May 2020
ViiV Healthcare, the specialist HIV company majority owned by GSK, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). 16 October 2024
Jaguar Health today announced the US launch of Gelclair, the only Food and Drug Administration (FDA)-approved mucoadhesive on the market indicated for the management of pain caused by oral mucositis 16 October 2024
Netherlands-based life sciences venture capital firm Forbion has raised more than 2 billion euros ($2.2 billion) across its two newest funds. 16 October 2024
The American Lung Association Research Institute has announced a $22 million research investment in 2024, marking one of the largest lung health research programs in the USA. 16 October 2024
US pharma major Eli Lilly has announced a strategic collaboration with two UK government departments and the devolved nations to tackle significant population health challenges, including exploring new models to better care for people living with obesity. 16 October 2024
TenNor Therapeutics, a Suzhou-based clinical-stage biotech company, has announced the initial closing of a series E financing round, raising over 300 million yuan ($41 million). 16 October 2024
Switzerland-based Novocure saw its shares rise 10% yesterday and leap a further 24% to $22.05 pre-market, after the company received a new US regulatory approval for its key product Optune Lua. 16 October 2024
Shares of Spanish drugmaker PharmaMar leapt more than 28% to 63.70 euros today, after it announced positive clinical trial findings for its combo lung cancer treatment, under development with USA-based Jazz Pharmaceuticals, which rose 4.2%. 15 October 2024
Novartis has discontinued an early Phase II trial of LTP001 in idiopathic pulmonary fibrosis (IPF). The company confirmed that the decision was not related to safety, with no issues emerging in the study. 15 October 2024
US pharma major Eli Lilly has announced plans to invest around 1.5 billion renminbi ($206 million) into expanding its manufacturing facility in Suzhou, China. 15 October 2024
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
French biopharma company Inventiva has announced financing of immediately 94.1 million euros ($103 million) and up to 348 million euros, subject to satisfaction of specified conditions. 15 October 2024
India's Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. 14 October 2024
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators. 14 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024