Tetraphase Pharmaceuticals has announced a corporate reorganization, “in order to maximize the commercial opportunity for Xerava (eravacycline),” an antibacterial approved by the US regulator in August 2018. 13 June 2019
Cancer specialist Phoenix Molecular Designs has completed clinical trial supply manufacture for its lead program PMD-026, the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). 12 June 2019
Roche subsidiary Genentech has announced positive topline results for NOBILITY, a Phase II trial of Gazyva (obinutuzumab) for adults with proliferative lupus nephritis, a severe and potentially life-threatening manifestation of systemic lupus erythematosus (SLE). 12 June 2019
Drug manufacturers and trade groups are calling for modifications to the US Food and Drug Administration’s draft guidance on continuous manufacturing quality considerations, according to a posting by WCG Marketing Intelligence & Insights. 12 June 2019
The US cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) announced on Friday that it plans to assess the comparative clinical effectiveness and value of treatments for acute migraine. 10 June 2019
US drugmaker TherapeuticsMD has entered into an exclusive license and supply agreement with fellow women’s health specialist UK-based Theramex, to commercialize Bijuva (estradiol and progesterone capsules) and Imvexxy (estradiol vaginal inserts) outside of the USA. 8 June 2019
Today, the US Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. 3 June 2019
Japan’s Chugai has filed an application for ALK inhibitor, Alecensa (alectinib) capsule 150mg to the Ministry of Health Labor and Welfare (MHLW) for an additional indication of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma (ALK-positive ALCL). 3 June 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation for Aliqopa (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. 30 May 2019
Japan’s Shionogi has agreed terms with Italy-based Molteni Farmaceutici for the distribution and sale of Rizmoic (naldemedine) in Italy and Poland. Shionogi will help promote the therapy. 23 May 2019
US-based Sunovion Pharmaceuticals, a subsidiary of Japan’s Sumitomo Dainippon, has received Breakthrough Therapy designation for its investigational EP-363856, for the treatment of people with schizophrenia. 22 May 2019
The US Centers for Disease Control and Prevention (CDC) has announced that there have been a total of 880 measles cases reported this year. 21 May 2019
Sweden’s Oncopeptides will apply for accelerated approval in the USA for melflufen, as a therapy for people with triple-class refractory multiple myeloma, at the start of 2020. 21 May 2019
Netherlands-incorporated drugmaker Mylan has exercised an option from a 2018 distribution agreement to acquire a portfolio of prescription and over-the-
counter products from Aspen Pharmacare in, primarily, Australia and New Zealand. 20 May 2019
The number of patients who have taken part in clinical studies supported by the National Institute for Health Research (NIHR) over the last year in England is a record 870,250. 20 May 2019
David Apelian will step down as Eiger BioPharmaceuticals’ chief operating officer and executive medical officer, effective June 14, 2019, to become the chief executive at an unnamed private biotech company. 20 May 2019
The US Food and Drug Administration has approved extending the indication of Japan pharma major Takeda’s Gattex (teduglutide) for injection to pediatric patients 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). 17 May 2019
Celgene has won a positive UK reimbursement decision for Revlimid (lenalidomide) in combination with dexamethasone for multiple myeloma in certain adults, in the first-line setting. 17 May 2019
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