Latest Pharma and Biotech News
Pharmaceutical
25 November 2024 In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards.
Today's issue
Refine Search
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Pharmaceutical
Shares in US biotech major Amgen were 11% lower early on Tuesday. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Biotechnology
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Pharmaceutical
Spanish HIV focused immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa, has announced the acquisition of its investigational assets related to the HTI therapeutic HIV vaccine by US antiviral specialist Gilead Sciences. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Pharmaceutical
Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co. 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Pharmaceutical
Specialist pre-clinical contract research organization (CRO) and ion channel screening company Metrion Biosciences has announced the appointment of Lee Patterson as its new chief executive. 25 November 2024
Pharmaceutical
Levothyroxine, a widely prescribed treatment for hypothyroidism, may contribute to bone loss in older adults, according to new research presented at the Radiological Society of North America’s (RSNA) annual meeting. 25 November 2024
All news
Pharmaceutical
The European Commission has granted conditional marketing authorization for Lytgobi (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA). 6 July 2023
Pharmaceutical
The European Medicines Agency (EMA) is among the regulators to have endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA). 5 July 2023
Biotechnology
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 5 July 2023
Biotechnology
UK and USA-based biotech F-star Therapeutics, an invoX company, has entered into another collaboration with Japan’s largest drugmaker Takeda. 5 July 2023
Biotechnology
The Johnson & Johnson subsidiary Janssen has announced positive top-line results from its Phase IIb FRONTIER 1 trial of the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide, JNJ-2113, in moderate-to-severe plaque psoriasis. 5 July 2023
Pharmaceutical
Shares of Amneal Pharmaceuticals fell 13.1% to $2.70 in choppy post-market trading, after the US drugmaker revealed that the US drugmaker revealed that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the New Drug Application (NDA) for IPX203 in the treatment of Parkinson’s disease. 5 July 2023
Pharmaceutical
Chinese rare disease drug developer RareStone Group has received approval from the National Medical Products Administration (NMPA) for Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. 5 July 2023
Biotechnology
The European Commission has granted approval for the label extension of Orkambi (lumacaftor/ivacaftor), from US biopharma firm Vertex Pharmaceuticals, for the treatment of children with cystic fibrosis (CF) ages 1 to 5 July 2023
Pharmaceutical
South Korean firm SK bioscience today revealed it has signed a Memorandum of Understanding (MOU) with the Government Pharmaceutical Organization (GPO), a state pharmaceutical enterprise in Thailand, to strengthen Thailand’s vaccine infrastructure. 5 July 2023
Biotechnology
German multi-modal biotech Evotec has agreed terms for a $74 million project, building on work it has been undertaking on behalf of the US Department of Defense (DoD). 5 July 2023
Biosimilars
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today provided an update on the deal it announced last month with US pharma major Pfizer. 4 July 2023
Biosimilars
Pharmsynthez, one of Russia's leading drugmakers, is accelerating its expansion in the domestic market by investing more than 20 billion roubles ($223 million) in the building of one of Russia’s largest complexes for the production of active ingredients and finished dosage forms within the territory of the Vorotynsk Industrial Park in the Kaluga region. 4 July 2023
Pharmaceutical
Political and health leaders have signed and adopted the Nagasaki Outcomes Statement, calling for accelerated R&D, access, and delivery for neglected tropical diseases (NTDs). 4 July 2023
Generics
The Russian Ministry of Health has called on domestic drugmakers to accelerate efforts for the development and production of cheaper analogues of expensive drugs, particularly those that are used for the treatment of socially significant diseases, according to recent statements made by Sergey Glagolev, deputy head of the Ministry. 4 July 2023
Biotechnology
For many years, Britain’s pharma largest company AstraZeneca has maintained a strong presence in China, and this approach looks set to pay off. 4 July 2023
Pharmaceutical
Developing new drugs is a complex and expensive process with a high failure rate. In fact, only about one out of 250 preclinical compounds make it to FDA approval. With an average cost of $40,000 per patient in a phase three clinical trial, the financial impact of failure is staggering. 4 July 2023
Generics
Mumbai, India-based generic drugmaker Lupin Limited saw US regulatory approval for two of its copy medicines in the space of two days. 4 July 2023
Biosimilars
A life-changing treatment to prevent blindness in premature babies is to be routinely available on England’s National Health Service (NHS), it was revealed today. 4 July 2023
Biotechnology
German family-owned pharma major Boehringer Ingelheim today presented new late-breaking data from the EFFISAYIL trial showing that patients receiving the highest dose of spesolimab experienced significantly reduced generalized pustular psoriasis (GPP) flares by 84% over 48 weeks compared to placebo (hazard ratio 0.157; 95% confidence interval 0.05–0.54; p=0.0005). 4 July 2023
Pharmaceutical
Japanese drugmaker Maruho has entered into an exclusive license agreement to develop and commercialize Alchemedicine's aldehyde dehydrogenase 2 (ALDH2) activator following Maruho's exercise of the option right included in the exclusive negotiation and evaluation agreement that had already been executed between the companies. 4 July 2023
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze