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.
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Biosimilars
Deficiencies identified by the US Food and Drug Administration (FDA) at Icelandic biosimilar firm Alvotech’s Reykjavik facility have resulted in a second complete response letter (CRL) for AVT02, its copy of Humira (adalimumab). 30 June 2023
Biotechnology
Dublin, Ireland-headquartered protein specialist Prothena has published results from the Phase III VITAL trial in a journal of the American Society of Hematology (ASH). 30 June 2023
Pharmaceutical
To ensure the effective implementation of India's National Rare Disease Policy-2021, the Delhi High Court has formed a five-member National Rare Diseases Committee to ensure that the policy benefits reach the ultimate patients. 30 June 2023
Biotechnology
Cancer giant Bristol Myers Squibb has secured a new European approval for its checkpoint blocker Opdivo (nivolumab), in non-small cell lung cancer (NSCLC). 30 June 2023
Pharmaceutical
Canada-headquartered Aurinia Pharmaceuticals saw its shares leap more than 17% to $10.77 in pre-market trading, after it said that its board of directors has initiated an exploration of strategic alternatives. 30 June 2023
Biotechnology
The US Food and Drug Administration yesterday approved Lantidra (donislecel), the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. 30 June 2023
Pharmaceutical
China's National Medical Products Administration (NMPA) has recently launched a nationwide drug safety consolidation and enhancement campaign to establish a solid foundation for drug safety. 30 June 2023
Biotechnology
US pharma major Eli Lilly is to acquire Sigilon Therapeutics, a biopharma company seeking to develop functional cures for patients with a range of acute and chronic diseases. 29 June 2023
Pharmaceutical
BioXcel has presented positive top-line results for TRANQUILITY II, a Phase III trial of BXCL501, its orally dissolving film formulation of dexmedetomidine under investigation for the acute treatment of Alzheimer’s disease-related agitation. 29 June 2023
Pharmaceutical
A decades-long program to develop the first new vaccine for pulmonary tuberculosis in a century has received a half-billion dollar funding boost. 29 June 2023
Biotechnology
Chinese biotech Laekna has listed on the main board of Hong Kong’s stock exchange. 29 June 2023
Pharmaceutical
Italy’s privately-held Italfarmaco Group has taken another pivotal step towards approval of its proprietary histone deacetylase (HDAC), givinostat, in Duchenne muscular dystrophy (DMD). 29 June 2023
Biotechnology
Lars Petersen has been named as the new president and chief executive officer (CEO) of FUJIFILM Diosynth Biotechnologies, a Japanese contract development and manufacturing organization (CDMO), and subsidiary of FUJIFILM Corp, effective immediately. 29 June 2023
Pharmaceutical
US clinical stage biotech RenovoRx saw its shares leap 30% to $2.90 in pre-market activity, after it released positive interim Phase III data showing an 8-month improvement in progression-free survival (PFS) for patients on RenovoGem (intra-arterial administration of gemcitabine) in locally advanced pancreatic cancer. 29 June 2023
Biotechnology
French pharma major Sanofi hosted a Vaccines Investor Event today, when it reaffirmed its ambition to deliver more than 10 billion euros ($10.9 billion) in annual vaccines sales by 2030, driven by core franchises of influenza, meningitis, and pediatric vaccines, with the addition of RSV. 29 June 2023
Pharmaceutical
An Expert View from Chris Blanchette, Novo Nordisk, Kathy Lang, PRECISIONheor, Ross Maclean, Precision Value & Health. 29 June 2023
Pharmaceutical
Traders have taken a downbeat view of Cognition Therapeutics’ prospects, with top-line results from a Phase II trial shaking confidence in the firm’s Alzheimer’s research. 29 June 2023
Pharmaceutical
The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). 29 June 2023
Biotechnology
San Diego, USA-based biotech AvantGen has appointed of Jordon Wang as its new chief operating officer (COO) and senior vice president of technology development. 29 June 2023
Biotechnology
BlueRock Therapeutics, a wholly-owned subsidiary of German life sciences company Bayer, can boast that bemdaneprocel, its neuronal stem cell therapy for Parkinson’s disease, is the first to show positive results in a Phase I study. 28 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
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