28 November 2024 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.
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine. 26 February 2020
Under a January 2017 agreement, Japanese drug major Takeda Pharmaceutical has now taken up its option to acquire PvP Biologics, following the conclusion of a Phase I proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease. 26 February 2020
With stocks reeling over safety concerns for blindness medicine Beovu (brolucizumab), Swiss pharma giant Novartis has begun an external review into the product. 26 February 2020
US biotech Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that Kalydeco (ivacaftor) will be available to eligible patients with cystic fibrosis (CF) in New Zealand from March 1. 26 February 2020
A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. 26 February 2020
UK-based biotech Bicycle Therapeutics has entered into a strategic collaboration agreement with Swiss pharma giant Roche’s Genentech subsidiary, a to discover, develop and commercialize novel Bicycle-based immuno-oncology (I-O) therapies. 25 February 2020
US biotech NGM Biopharmaceuticals yesterday announced positive preliminary top-line results for its liver disease candidate aldafermin, sending the firm’s shares rocketing 23.5% to $20.00 in heavy volume by Monday mid-morning, having jumped as much as 41%. 25 February 2020
The US Food and Drug Administration has granted priority review for the supplemental New Drug Application (sNDA) to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 25 February 2020
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. 24 February 2020
The US regulator has approved Trulicity (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in certain adults with type 2 diabetes. 24 February 2020
Successful Danish biotech company Genmab (Nasdaq: GMAB) said late Friday that its chairman, Mats Pettersson, has decided to step down from the post on March 26, when his election period expires. 24 February 2020
Danish CNS specialist Lundbeck late on Friday revealed that Vyepti (eptinezumab-jjmr) has been approved by the US Food and Drug Administration for the preventive treatment of migraine in adults and will be available in April 2020. 22 February 2020
Bristol-Myers Squibb has announced the approval of Opdivo (nivolumab) for unresectable advanced or recurrent esophageal cancer in Japan. 21 February 2020
The US Food and Drug Administration has accepted for Priority Review the Biologics License Application (BLA) for the investigational AAV5 gene therapy Valrox (valoctocogene roxaparvovec) for adults with hemophilia A submitted by California-based biotech BioMarin Pharmaceutical. 21 February 2020
US health technology assessor the Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the comparative clinical effectiveness and value of treatments for cystic fibrosis. 21 February 2020
Agenus has unveiled data from pre-planned interim analyses, including for a combination of the checkpoint blocker balstilimab and the anti-CTLA-4 agent zalifrelimab. 20 February 2020
Privately-held German immune-oncology firm Immatics Biotechnologies has entered into a strategic collaboration agreement with UK pharma major GlaxoSmithKline to develop novel adoptive cell therapies targeting multiple cancer indications. 20 February 2020
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
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
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
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
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
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
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
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
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
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
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
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
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
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Company Spotlight
Acadia Pharmaceuticals (Nasdaq: ACAD) is a leading pharmaceutical company with a focus on bringing life-changing therapies to patients suffering from CNS diseases.