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Bayer christens $250M cell therapy ‘launch facility’ in Berkeley

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
- Source: drugdu
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- October 12, 2023
Merck’s Keytruda hits overall survival goal in early lung cancer as FDA decision nears

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
- Source: drugdu
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- October 12, 2023
New University of Bristol study to aid strep A vaccine development

The study will offer new insights into the immune system’s response to iGAS Spencer Dayman Meningitis Research has announced that scientists at the University of Bristol have begun a research project to aid in the development of a vaccine against invasive group A streptococcus (iGAS). The study will offer new and unique insights into the adaptive immune response to iGAS. iGAS is a severe infection caused by bacteria invading parts of the body, including the blood, deep muscle, fat tissues or lungs, which can lead to diseases such as meningitis and sepsis. Since April 2023, there have been 3,287 cases of iGAS in the UK, 761 of which occurred in children aged 18 years and under. There is currently no vaccine to protect individuals from group A streptococcus, which can also cause rheumatic fever and scarlet fever. Funded by Spencer Dayman Meningitis Research, scientists Dr Ana Goenka, Dr Alice Halliday ...
- Source: drugdu
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- October 12, 2023
Salipro partners with Icosagen to develop monoclonal antibody therapies

Swedish company Salipro Biotech has entered into a multi-target antibody research agreement with biotech company Icosagen. The agreement leverages Salipro’s proprietary platform technology for membrane proteins to identify drugs that target specific G protein-coupled receptors (GPCRs) and solute carrier (SLC) transporters, as per a 10 October announcement. These membrane proteins play a role in different areas such as oncology and autoimmune diseases. Estonian company Icosagen has CRO [contract research organisation] and CDMO [contract development and manufacturing organisation] capabilities, with expertise in protein production and analytics, which contributes to the drug development of monoclonal antibodies. Icosagen will utilise its QMCF technology to advance the project, based on the 10 October press release. The company’s QMCF technology is based on a proprietary mammalian expression system for producing recombinant proteins. Monoclonal antibodies have been identified by GlobalData as a key innovation area for cancer therapy, with Johnson & Johnson being the leading patent ...
- Source: drugdu
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- October 12, 2023
Q&A With David Klein, Co-Founder and CEO of Click Therapeutics

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 ...
- Source: drugdu
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- October 12, 2023
J&J’s DePuy Synthes wins FDA clearance for TriAltis tech

BY SEAN WHOOLEY [Image courtesy of DePuy Synthes] Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology. DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use. The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies. DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and ...
- Source: drugdu
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- October 12, 2023
Akero’s Phase IIb NASH Data Disappoints, Sends Stock Plummeting

By Tristan Manalac Pictured: Illustration of a damaged liver/iStock, Mohammed Haneefa Nizamudeen Results from the Phase IIb SYMMETRY study showed that Akero Therapeutics’ lead candidate efruxifermin failed to significantly reduce liver fibrosis without worsening non-alcoholic steatohepatitis, the company announced on Tuesday. In the 36-week analysis, 22% of patients treated with the 28-mg dose of efruxifermin (EFX) saw at least a one-stage improvement in liver fibrosis with no non-alcoholic steatohepatitis (NASH) worsening, whereas 24% of those given the higher 50-mg dose met this endpoint. Neither dose level was statistically better than placebo, in which group 14% of participants demonstrated at least a one-stage fibrosis improvement without disease worsening. In addition, 21% and 14% of patients in the lower and higher EFX dose groups—respectively— demonstrated NASH resolution alongside fibrosis improvement of at least one stage. These were not significantly better than the 9% rate in the placebo arm, according to Akero. Despite ...
- Source: drugdu
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- October 12, 2023
Merck Touts Keytruda Phase III NSCLC Survival Data Ahead of FDA Decision  

By Kate Goodwin Pictured: Merck headquarters/iStock, JHVEPhoto Phase III results released Tuesday showed Merck’s anti-PD-1 therapy Keytruda is the first to improve overall survival when used as a neoadjuvant and adjuvant treatment versus pre-operative chemotherapy for patients with non-small cell lung cancer, according to the company’s announcement.  In the KEYNOTE-671 trial, Keytruda plus chemotherapy was given to patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) prior to surgery. After resection, Keytruda was administered as a single agent.   While the data was not provided in Tuesday’s announcement, Merck called the trial the first Phase III to “show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB” NSCLC.  The company said results from the analysis of KEYNOTE-671 will be presented later this month at the European Society for Medical Oncology (ESMO) Congress and shared with global regulatory authorities.  Previous interim results ...
- Source: drugdu
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- October 12, 2023
Merck shares positive results for Keytruda in phase 3 bladder cancer study

Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage trial of its anti-PD-1 therapy Keytruda (pembrolizumab) in certain bladder cancer patients. The phase 3 AMBASSADOR trial has been evaluating Keytruda versus observation as an adjuvant treatment for patients with localised muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma. At a pre-specified interim analysis, Keytruda demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of disease-free survival versus observation in these patients after surgery. The safety profile of Keytruda was consistent with that observed in previously reported studies, Merck said, adding that the National Cancer Institute-sponsored study will continue to evaluate its second dual primary endpoint of overall survival. More than 82,000 people in the US are expected to be diagnosed with bladder cancer this year, and approximately 7% of bladder cancer cases are locally advanced ...
- Source: drugdu
- 138
- October 11, 2023
In cutting sales guidance, EuroAPI cites CDMO industry struggles and customers’ inventory reductions

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 ...
- Source: drugdu
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- October 11, 2023

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