France-based ophthalmics firm NicOx and Fera Pharmaceuticals, a privately-held, US specialty pharmaceutical company, have amended their 2015 license agreement, which granted Fera exclusive rights to develop and commercialize naproxcinod for the US market. 27 September 2018
San Francisco’s Flow Pharma has formed a joint venture in China, named Hefei Sageland Biotechnology, together with Button Capital, a cross-border investment and consulting company based in China. 26 September 2018
Chicago’s AbbVie has received approval in Canada for Venclexta (venetoclax) as a treatment for chronic lymphocytic leukemia (CLL), in combination with rituximab. 26 September 2018
An investigation from Associated Press has found that US drugmakers continue to raise drug prices, despite high profile messaging from the White House that the US Government would act to bring prices down. 25 September 2018
Kyorin Pharmaceutical has received marketing approval from Japan's Ministry of Health, Labor and Welfare for vibegron for the treatment of adults with overactive bladder (OAB) in Japan. 24 September 2018
The European Medicines Agency is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. 22 September 2018
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, for the prevention of invasive disease and pneumonia in adults. 21 September 2018
Following on previous reductions in the price of oncology drugs in China, the Shanghai government cut prices of 20 cancer drugs, effective on September 30. 19 September 2018
Astellas Pharma has launched Dafclir (fidaxomicin) for infectious enteritis, including with clostridium difficile (CD) in Japan, under the terms of a licencing agreement with Merck & Co. 18 September 2018
Lin BioScience, a drug development company targeting untreatable conditions in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration has granted Rare Pediatric Disease (RPD) designation to LBS-008, a first-in-class oral therapy for the treatment of Stargardt disease. 17 September 2018
Principia Biopharma, a startup based in southern San Francisco, has raised over $100 million in an initial public offering, kicking off trading on the Nasdaq on September 14. 17 September 2018
Japanese drug major Takeda Pharmaceutical says that it has received unconditional clearance from the State Administration for Market Regulation in China (SAMR) for the proposed $62 billion acquisition of rare diseases specialist Shire announced on May 8, 2018. 14 September 2018
The Indian health ministry on Wednesday notified a ban on 328 fixed-dose combination (FDC) drugs on safety grounds, Business Standard reports. 13 September 2018
Russia’s BIOCAD and Shanghai Pharmaceuticals Holding (SPH) have agreed a deal to build a facility in China, to manufacture drug substances. 12 September 2018
The USA’s Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the comparative clinical effectiveness and value of medications for addiction treatment (MAT) used for individuals with opioid use disorder. 12 September 2018
Cambridge, UK-based Napp Pharmaceuticals has launched flutiform k-haler, a new asthma product. The firm says it is planning further launches across Europe in the next months. 10 September 2018
Hansoh, a Chinese pharma based in Lianyungang, Jiangsu province, has applied to stage an initial public offering (IPO) on the Hong Kong exchange, reports ChinaBio today. 10 September 2018
The European Investment Bank (EIB) and Spanish drugmaker Grifols on Friday announced the signing of a new loan agreement for 85 million euros ($99 million) to advance the firm’s R&D efforts to discover new therapeutic uses for plasma proteins in the treatment of rare and chronic diseases. 8 September 2018
At its monthly meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) did not start or conclude a new referral. 7 September 2018
A new group of British Members of Parliament (MPs) and peers have written to the Chancellor urging her to protect and promote the UK’s world-leading life sciences sector in the government's first Budget, due on October 30. 17 October 2024
The US Food and Drug Administration (FDA) has updated the US label for French pharma major Sanofi’s Flublok (Influenza Vaccine) to include data from a new safety study involving pregnant women. 17 October 2024
Chengdu Baiyu Pharmaceutical yesterday announced that it has entered into an exclusive license agreement with Swiss pharma giant Novartis for a small molecule anti-tumor asset. 17 October 2024
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