Latest Pharma and Biotech News
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27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 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
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
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Biotechnology
US cancer metabolism specialist Agios Pharmaceuticals late Friday announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. 19 October 2020
Biotechnology
On Friday, Pfizer chairman and chief executive Albert Bourla issued an ‘open letter’ aiming to provide greater clarity around the development timelines for Pfizer and partner Germany’s BioNTech’s COVID-19 vaccine, known as BNT162b2, and when it might be submitted for review by the US Food and Drug Administration. 17 October 2020
Biotechnology
Shares in Spanish drugmaker PharmaMar were more than 6% higher on Friday afternoon. 16 October 2020
Biotechnology
US biotech major Gilead Sciences has announced findings from multiple studies in Asian population that evaluated the safety and efficacy of switching to once-daily, single tablet regimen, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) from baseline regimens. 16 October 2020
Biotechnology
Chugai Pharmaceutical says it has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for risdiplam, an oral survival motor neuron-2 (SMN2) splicing modifier, for the treatment of spinal muscular atrophy (SMA). 16 October 2020
Biotechnology
Belgium-based biotech Galapagos, along with partner French independent drugmaker Servier, reported that no signal of activity was observed in the top-line results in their ROCCELLA Phase II trial of GLPG1972/S20186. 16 October 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma (cHL). 15 October 2020
Biotechnology
Health Canada has approved Luxturna (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. 15 October 2020
Biotechnology
With the objective of expanding its R&D efforts in pain and neurodegeneration, US pharma major Eli Lilly today announced that it acquiring privately-held US biotech Disarm Therapeutics, which is creating a new class of disease-modifying therapeutics for patients with axonal degeneration. 15 October 2020
Biotechnology
Japanese drugmaker Otsuka and its member company Astex Pharmaceuticals have announced top-line results of the ASTRAL-2 and ASTRAL-3 clinical studies. 15 October 2020
Biotechnology
US biopharma Vertex Pharmaceuticals has announced that the Phase II study of VX-814 in alpha-1 antitrypsin deficiency has been discontinued based upon safety and pharmacokinetic data. 15 October 2020
Biotechnology
On Wednesday, the US Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn; REGN-EB3), a mixture of three monoclonal antibodies, as the first FDA-cleared treatment for Zaire ebolavirus (Ebola virus) infection. 15 October 2020
Biotechnology
The European Medicines Agency has confirmed that mRNA-1273, a vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure, said the vaccine’s developer. 14 October 2020
Biotechnology
Eli Lilly has become the latest drugmaker to announce a pause to its Phase III COVID-19 trial, albeit that this one is for a therapeutic rather than a vaccine. 14 October 2020
Biotechnology
Boehringer Ingelheim and UK-based Oxford BioTherapeutics (OBT) said today that they are building on their successful partnership and are establishing a new alliance to discover additional selective targets for strategic cancer indications to deliver first-in-class treatments for cancer patients. 14 October 2020
Biotechnology
US artificial intelligence (AI) to gene therapy focussed biotech Dyno Therapeutics has signed a collaboration and license agreement with Roche. 14 October 2020
Biotechnology
AffaMed Therapeutics today announced a definitive merger agreement with fellow Shanghai, China-based biopharmaceutical company EverInsight Therapeutics. 14 October 2020
Biotechnology
Israeli firm RedHill Biopharma saw its shares move up 3.9% to $10.35 by midday yesterday, after it announced collaborations with two specialist pharmaceutical manufacturers in Europe and Canada to ramp-up manufacturing of opaganib. 14 October 2020
Biotechnology
Californian company Gossamer Bio lost more than a third of its market value in Tuesday morning’s trading. 13 October 2020
Biotechnology
A pivotal Phase III trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged six to 11 years with uncontrolled moderate-to-severe asthma. 13 October 2020
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