Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
Today's issue
Refine Search
Pharmaceutical
The US Food and Drug Administration (FDA) has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review. 7 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has published briefing papers on AstraZeneca and Sanofi's Beyfortus (nirsevimab) ahead of Thursday’s meeting of the agency’s Antimicrobial Drugs Advisory Committee Meeting. 7 June 2023
Biotechnology
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
Biosimilars
The US biosimilar drug market emerged in 2015 to provide safe, effective, and more affordable alternatives to existing biologic drugs, but it has been slow to develop compared with Europe. 7 June 2023
Pharmaceutical
On Tuesday, US pharma giant Merck & Co (NYSE: MRK) filed a lawsuit in the US District Courts against the federal government alleging that the drug pricing clauses of the Inflation Reduction Act (IRA) of 2022 violates the First and Fifth Amendments to the US Constitution. 7 June 2023
Pharmaceutical
Plenty of money was spent in biopharma M&A during May, but big pharma was not necessarily the one doing the spending. 7 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) alongside chemotherapy for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. 6 June 2023
Pharmaceutical
USA-based Paratek Pharmaceuticals saw its shares leap almost 14% to $2.22 by mid-morning today, after it revealed it has entered into a definitive agreement to be acquired by Gurnet Point Capital and Novo Holdings. 6 June 2023
Biotechnology
Shares of US firm Ultragenyx Pharmaceutical and UK-based Mereo BioPharma rose in pre-market activity, up 6.5% to $54.48 and 11.4% at $1.17, respectively, after the companies released new showing that setrusumab rapidly induced bone production in osteogenesis imperfecta (OI)-affected patients. 6 June 2023
Pharmaceutical
A joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming fall 2023 vaccination campaigns has been issued today by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). 6 June 2023
Biotechnology
German CAR-T cell therapy specialist T-CURX has announced two appointments to its senior leadership team. 6 June 2023
Pharmaceutical
The Serum Institute of India and Bharat Biotech are in talks with the Mexican government for manufacturing vaccines in a deal that will help the two Indian pharmaceutical companies expand their presence in Mexico and the Latin American market. 6 June 2023
Pharmaceutical
As the final sessions of the 2023 congress of the American Society of Clinical Oncology (ASCO) draw to a close, attendees will reflect on a number of significant presentations, from both smaller biotechs and large drugmakers. 6 June 2023
Pharmaceutical
Day One Biopharmaceuticals shares leapt 33.8% to $18.19 in pre-market trading on Monday, after the company announced overall response rate of 67% and clinical benefit rate of 93% in 69 heavily pre-treated RANO-HGG evaluable patients in pediatric low-grade glioma trial. 6 June 2023
Pharmaceutical
Portuguese neuroscience specialist BIAL has announced positive results from the Phase III EPSILON trial of its innovative Parkinson’s disease therapy Ongentys (opicapone). 6 June 2023
Biotechnology
US biotech major Gilead Sciences’ recent investments into oncology - including its $11.9 billion acquisition of Kite Pharma in 2017 - have made the company one of the major players in the oncology space. 6 June 2023
Biotechnology
A post-marketing Phase IV trial to assess the efficacy and safety of Andexxa (andexanet alfa) in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial hemorrhage, is to be stopped early. 5 June 2023
Biotechnology
Along with the big pharma players showing off the potential of their cancer drugs at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), biotech companies have been making their presence felt, too. 5 June 2023
Biotechnology
Belgium’s largest pharma company UCB today revealed that its developmental treatment for adults with hidradenitis suppurativa (HS) has been granted Promising Innovative Medicine (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). 5 June 2023
Pharmaceutical
GLP1 receptor agonists (GLP1RA) are known as diabetes treatments, but recently they have also doubled as the new generation drugs for overweight/obesity. 5 June 2023
All news
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
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