Today the US Food and Drug Administration published the draft guidance for industry “A Risk-Based Approach to Monitoring of Clinical Investigations -- Questions and Answers.” 14 March 2019
HitGen and Sun Pharma Advanced Research Company (SPARC) are to collaborate to identify novel small molecule leads for targets of interest. 14 March 2019
Sanofi has successfully priced an offering of 2 billion euros ($2.26 billion) of notes, a move which the company says is aimed at lowering its average cost of debt and extending the average maturity of its debt. 14 March 2019
The US Food and Drug Administration has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, says the drug’s maker Aerie Pharmaceuticals. 13 March 2019
Mitsubishi Tanabe has announced positive topline results from two pivotal Phase III trials of MT-6548 (vadadustat) in certain people with anemia due to chronic kidney disease (CKD). 13 March 2019
With Brexit day on the horizon, Gavin Davidson, pharma analysts at analytics firm GlobalData, offers his views as to how this will impact the pharma sector. 12 March 2019
Singapore-based ASLAN Pharmaceuticals and South Korea’s BioGenetics have expanded a strategic collaboration related to ASLAN003, agreeing a new commercialisation deal. 11 March 2019
UK and USA-based company EUSA Pharma has announced that Fotivda (tivozanib) has been included in the new European Society of Medical Oncology (ESMO) clinical practice guidelines for renal cell carcinoma (RCC). 8 March 2019
Chiesi has successfully expanded the label for Trimbow (BDP/FF/G) in Europe, recognising its effect on exacerbations and symptoms in people with moderate to severe chronic obstructive pulmonary disease (COPD). 7 March 2019
The global nasal drug delivery systems market size is expected to reach $67.99 billion by 2025, expanding at a compound annual growth rate (CAGR) of 6,5%, according to a new report by Grand View Research. 7 March 2019
Japan’s Otsuka Pharmaceutical has launched Selincro nalmefene hydrochloride) 10mg tablets, a therapeutic drug treatment to reduce alcohol consumption in alcohol-dependent patients in Japan. 6 March 2019
European CNS specialist Neuraxpharm has appointed Dan Furrer as head of corporate marketing. Mr Furrer will lead the creation of a “global marketing centre of excellence” for the firm. 6 March 2019
Spain’s largest drugmaker Almirall has entered into a definitive agreement with Celling Biosciences, based in Austin (Texas), to divest ThermiGen for an undisclosed amount. 5 March 2019
Sweden’s Hansa Biopharma says that the European Medicines Agency has accepted the company's Marketing Authorization Application (MAA) for review of Idefirix (imlifidase). 1 March 2019
Japanese drugmaker Taisho Pharmaceutical has sought to increase its stake in Vietnam-based Duoc Hau Giang Pharmaceutical JSC beyond the current 35% share. 1 March 2019
Rare diseases company Amryt Pharma has announced an update on its Phase III EASE trial for AP101 as a potential treatment for epidermolysis bullosa (EB). 28 February 2019
There were 31 new prescription drugs registered by Australia’s Therapeutic Goods Administration (TGA) in 2018, compared to 34 in 2017 and 41 in 2016. 28 February 2019
Shionogi has announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin. 17 October 2024
Sanofi has entered into an agreement with Orano Med, a subsidiary of the Orano Group, to advance the development of radioligand therapies for rare cancers. 17 October 2024
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