Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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Biotechnology
Japanese drugmaker Chugai Pharmaceutical said today it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 June 2023
Biotechnology
Israel-based NeuroSense Therapeutics announced in a Securities and Exchange Commission that it has entered into a collaborative evaluation agreement with a unit of US biotech major Biogen. 14 June 2023
Pharmaceutical
As a functional, practical and intelligent way to regulate medical products in today’s globalized world—especially with increasing public health needs, limited resources and demand for faster and better treatments—the use of regulatory decisions from other jurisdictions represents a powerful and effective alternative. 14 June 2023
Pharmaceutical
The Russian government plans to significantly increase public procurement of drugs against diabetes this year despite the existing shortage of funds, reports The Pharma Letter’s local correspondent. 14 June 2023
Generics
The UK subsidiary of Hungarian drugmaker Gedeon Richter today announced that full marketing and distribution rights to an oral contraceptive range of branded generics, acquired from Ireland-headquartered Consilient Health, have been transferred to the company. 14 June 2023
Pharmaceutical
India is to join an international system - the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) - that fosters cooperation between countries and regulatory authorities on good manufacturing practices (GMPs) in order to improve the quality of its medical products. 14 June 2023
Pharmaceutical
Just months after France’s Ipsen bought liver disease specialist Albireo (Nasdaq: ALBO), the company’s main product Bylvay (odevixibat) has won a new US nod. 14 June 2023
Pharmaceutical
Spanish dermatology-focused drugmaker Almirall has launched a non pre-emptive share capital increase for a total aggregate amount (including nominal value and share issue premium) of around 200 million euros, by issuing more than 24 million new ordinary shares at 8.20 euros. 14 June 2023
Pharmaceutical
French drugmaker Sanofi has placed a strong emphasis on the adoption of artificial intelligence capabilities to facilitate its internal operations. 13 June 2023
Biotechnology
Soliris (eculizumab), from the AstraZeneca subsidiary Alexion, has won a new approval in China. 13 June 2023
Biotechnology
UK-headquartered biotech Tiziana Life Sciences has announced the appointment of Dr Matthew Davis as its new chief operating officer (COO). 13 June 2023
Pharmaceutical
The Russian drug market grow may substantially this year due to the general stabilization of economic situation in the country and the existing stable demand for drugs from middle and high-priced segments of the market, The Pharma Letter’s local correspondent report. 13 June 2023
Biotechnology
Seagen has announced latest efficacy and safety results from Part C of a Phase II trial of Adcetris (brentuximab vedotin) alongside nivolumab and standard chemotherapy agents doxorubicin and dacarbazine as a frontline treatment for early-stage classical Hodgkin lymphoma (cHL). 13 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) late yesterday said it has approved Linzess (linaclotide) capsules to treat functional constipation in pediatric patients aged six to 17 years. 13 June 2023
Pharmaceutical
An initiative to regulate non-scheduled drug prices in India, which was under the Department of Pharmaceuticals (DoP) consideration, has been pushed to the back burner. 13 June 2023
Biotechnology
German radiopharmaceutical specialist ITM Isotope Technologies (ITM) has opened a new manufacturing facility for therapeutic radionuclides in its home town of Munich. 13 June 2023
Pharmaceutical
With UK pharma major GSK last month becoming the first to gain US Food and Drug Administration approval of a respiratory syncytial virus (RSV) vaccine with its Arexvy in May, following swiftly by the approval of US pharma giant Pfizer’s option Abrysvo, the battle ground is set for dominance in the sector. 13 June 2023
Biosimilars
Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines, says a leading European trade group. 13 June 2023
Pharmaceutical
The Biden administration has provided more evidence of its desire to follow rhetoric with action on lowering drug prices through the Inflation Reduction Act (IRA). 12 June 2023
Pharmaceutical
Spanish drugmaker PharmaMar and China-based Luye Pharma have revealed that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). 12 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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