Dive Brief The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age. The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval. Dive Insight In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and ...
Merck KGaA has signed a licensing agreement worth over €1.4bn with Jiangsu Hengrui Pharmaceuticals for the rights to its next-generation PARP1 inhibitor HRS-1167 outside of China. The deal also includes an option for an exclusive licence for its Claudin-18.2 antibody drug conjugate (ADC), SHR-A1904. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping, Merck said, adding that the candidate is currently in phase 1 clinical development and “has the potential to be used as a monotherapy and as part of a combination therapy for treating a wider range of patients”. Danny Bar-Zohar, global head of research and development and chief medical officer for the Healthcare business of Merck KGaA, said: “This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage ...
In a company press release, Actym Therapeutics announced that it has extended its Series A financing round with an additional close of $25.5 million, bringing the total Series A amount raised to $59.5 million. Co-led by Boehringer Ingelheim Venture Fund and Illumina Ventures, with GKCC LLC as a new investor, the new capital is expected to enable ACTM-838 into first-in-human oncology trial. “We have advanced the STACT platform and defined a value-building clinical pathway that will allow us to translate our deep understanding of the tumor microenvironment into a novel approach to an effective and safe cancer treatment,” said Christopher Thanos, PhD, CEO, co-founder, Actym Therapeutics. “We value the continued commitment from our current investors and welcome GKCC LLC into the syndicate. Through their combined support, we aim to bring innovative therapies to patients across multiple solid tumor indications.” Image Credit: Adobe Stock Images/Carlos Montes Published on: October 19, 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
Almirall and EpimAb Biotherapeutics have announced a bispecific antibody partnership worth up to $210m. The agreement will give dermatology-focused Almirall a licence to utilise EpimAb’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate, develop and commercialise bispecific antibodies. Almirall will have exclusive global rights for any resulting products and, in exchange, EpimAb is eligible to receive milestone payments totalling up to $210m plus royalties on net sales. Karl Ziegelbauer, executive vice president, research and development, and chief scientific officer of Almirall, said the agreement was “an important step” towards the company’s ambition to develop new biologics in the dermatology field. EpimAb’s FIT-Ig platform generates bispecific antibodies using only the basic structural parts of monoclonal antibodies without adding any complex changes. The company has so far focused the technology within the oncology space and currently has five clinical-stage assets being evaluated for indications including non-small cell lung cancer (NSCLC), gastrointestinal cancer and multiple ...
Dive Brief The European Commission on Thursday ordered Illumina to unwind its 2021 acquisition of liquid biopsy-maker Grail, establishing deadlines for the company to follow as well as potential penalties for non-compliance. The commission in September 2022 prohibited Illumina from buying Grail, maker of a blood-based early cancer detection test, over concerns that the merger would stifle innovation in the emerging market. Illumina and Grail completed the $8 billion deal anyway, in an alleged breach of EU merger control rules. Illumina, which is appealing the EC’s decision, said in a statement Thursday that it was reviewing the order. Dive Insight Illumina has been expecting the EC’s divestment instructions while maintaining that the commission does not have jurisdiction over the merger. The gene-sequencing industry leader is appealing the jurisdictional issue with the European Court of Justice. The company has said it will pursue parallel paths, working to divest Grail according to ...
KYV-101 designed as a CD19 CAR T-cell therapy. Image Credit: Adobe Stock Images/Trsakaoe Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). “We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” said Peter Maag, PhD, CEO, Kyverna Therapeutics. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their ...
Mike Hollan Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. David Klein CEO and co-founder Click Therapeutics FDA recently released draft guidelines regarding the use of software as a medical device (SaMD), which determines when the software should be included on the drug’s label. David Klein, CEO of Click Therapeutics, spoke with Pharmaceutical Executive about the impact these guidelines could have on the industry. Pharmaceutical Executive: What work are you doing with SaMD? David Klein: We are a science led biotech and tech company developing SaMD to be prescription treatments. That includes prescription digital therapeutics and discovering developing them in a way where they could potentially work independently or in conjunction with pharmacotherapies in order to lead to better clinical and economic outcomes. PE: The FDA just issued some updated guidelines regarding SaMD, how do you think the industry will ...
Flush with business during the COVID pandemic, the CDMO industry is struggling to adjust in the aftermath. Case in point is EuroAPI, which has slashed its projected revenue growth in 2023 from a range of 7% to 8% to a new window of 3% to 5%. The Sanofi drug ingredients spinoff also has dropped its estimated earnings growth from between 12.5% and 13.5% to range of 9% to 11%. During a conference call on Monday, CEO Karl Rotthier chalked the changes up to pricing pressures resulting from lower inflation, coupled with “inventory reduction programs implemented by some of our customers.” Rotthier also mentioned the “biotech funding crisis.” He said that more than 20 of the company’s projects have been delayed, reduced in scope or halted altogether. The board of EuroAPI has begun to conduct a strategic review of its operating model. The company’s midterm view of its prospects from 2023 ...
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