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.
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
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
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
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
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
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
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
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
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
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
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
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
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
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
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
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
An ancient Egyptian medicament, developed by a family-run Slovakian firm, has been approved to help prevent heart attacks and strokes in the USA. 21 June 2023
Initial safety and immunogenicity results from a Phase III trial of Bavarian Nordic’s chikungunya virus vaccine candidate have been announced. 21 June 2023
Japan’s largest drugmaker Takeda has released full results from the pivotal Phase III ADVANCE-CIDP 1 clinical trial investigating Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) as maintenance therapy in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). 21 June 2023
The US Federal Trade Commission has filed a friend-of-the-court (amicus) brief in the US Court of Appeals for the Second Circuit, clarifying the legal standards that apply in certain antitrust cases involving the pharmaceutical sector. 21 June 2023
Privately-held Danish dermatology specialist LEO Pharma has appointed Kreesten Meldgaard Madsen as chief development officer and, effective Tuesday, he joined LEO Pharma’s global leadership team (GLT). 21 June 2023
Adcendo, a Danish biotech focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of cancers with a high unmet medical need, has appointed Lone Ottesen its chief medical officer (CMO). 20 June 2023
Healthcare cost pressures have started easing in all but one of the seven major markets in 2023, as physicians noticed a decline in the number of patients postponing or stopping treatments compared to 2022. 20 June 2023
Chinese insulin manufacturer Gan & Lee Pharmaceuticals has sold a 51% stake in its Russian joint venture Endogenix to its partner, the Russian company Pharmaktiv. 20 June 2023
The US Food and Drug Administration (FDA) has slapped a clinical hold on US biotech Arcellx’ CART-ddBCMA investigational new drug (IND) for the treatment of patients with relapsed or refractory multiple myeloma (rrMM). 20 June 2023
In a bid to expand its portfolio of immune related diseases, US pharma major Eli Lilly today announced a definitive agreement to acquire California-based immunology company DICE Therapeutics. 20 June 2023
The appointment of a new chief executive at immune-mediated disease specialist Veralox Therapeutics coincides with a fresh investment of $24 million from new and existing backers. 20 June 2023
The Delhi High Court has sought the Indian government's position regarding a petition that challenges the ban on fixed-dose combination (FDC) drugs, reports The Pharma letter’s local correspondent. 20 June 2023
CDKL5 deficiency disorder (CDD), which has an incidence of 1 in 40,000 to 60,000 newborns, is a developmental disorder caused by either the presence of a non-functional cyclin-dependent kinase-like 5 (CDKL5) protein known as serine-threonine kinase (STK9), or its complete absence.1,2 20 June 2023
Russia is preparing for a new wave of drug prices growth this year due to a new bill, designed by the national Parliament aimed at tightening a control for the activities of domestic pharmacies, The Pharma Letter’s local correspondent reports. 20 June 2023
Oxford University, UK, biotech spinout Evox Therapeutics has purchased USA-base Codiak Biosciences’ engEx-AAV technology platform, including all intellectual property rights therein, as well as secured exclusive access to certain associated engineering and manufacturing rights. 20 June 2023
Shares of Santhera Pharmaceuticals were up almost 8% at 0.97 francs in early trading, after the Swiss rare diseases company revealed a lucrative licensing deal with Catalyst Pharmaceuticals for its vamorolone in the North America. 20 June 2023
Hopes for what would be the first new antifungal based on a novel mechanism for decades have been dealt a blow by the US Food and Drug Administration. 20 June 2023