Biotech Innovations, FDA Approvals, and Pharma Export Milestones: Your Weekly Roundup

The Weekly Roundup newsletter curates the top five - deals, pipeline, funding, and news from the past week.

The complete list is available here: Industry Updates

🤝Deals and Collaborations

1️⃣ Juno Pharmaceuticals acquires Omega Laboratories, becoming one of the largest specialty generic injectable businesses in Canada with domestic manufacturing capabilities. The acquisition solidifies Juno's ability to improve drug supply to support healthcare systems. //Read more

2️⃣ Melinta Therapeutics and Xediton Pharmaceuticals announce licensing agreement to commercialize four novel anti-infective products, BAXDELA (delafloxacin), KIMYRSA (oritavancin), ORBACTIV (oritavancin), and VABOMERE (meropenem and vaborbactam), in Canada. Xediton will be responsible for their registration and commercialization. //Read more

3️⃣Tiakis Biotech AG and Northway Biotech successfully transfer and expand manufacturing capabilities for Tiprelestat, an anti-inflammatory and tissue-protective drug being developed for the prevention of postoperative complications, COVID-19, and pulmonary arterial hypertension. //Read more

4️⃣ EyePoint Pharmaceuticals announces sale of YUTIQ to Alimera Sciences for $82.5M in cash plus royalties. Alimera will receive global rights to YUTIQ, excluding China, Hong Kong, Taiwan, Macau, and Southeast Asia, which are exclusively licensed to Ocumension Therapeutics. //Read more

5️⃣ Asieris Pharmaceuticals deepens strategic partnership with UroViu to develop an integrated diagnosis and treatment platform for bladder cancer. Asieris will use patented technology with optical imaging agents to research non-white light imaging technology for the diagnosis and postoperative monitoring of Non-Muscle Invasive Bladder Cancer. //Read more

⏫ Pipeline and Approvals

1️⃣ AbbVie announces FDA approval of RINVOQ® (upadacitinib) for the treatment of moderately to severely active Crohn's disease in adults who have had an inadequate response or intolerance to one or more TNF blockers. This is the seventh FDA approval for RINVOQ, which is now indicated in both ulcerative colitis and Crohn's disease across rheumatology, dermatology, and gastroenterology. //Explore further

2️⃣ Krystal Biotech receives FDA approval for VYJUVEK, the first-ever redosable gene therapy for Dystrophic Epidermolysis Bullosa (DEB), a rare genetic disease affecting the skin and mucosal tissues. VYJUVEK is a topical gel that restores the COL7A1 gene, and is the only medicine available in the US for DEB patients. //Explore further

3️⃣ FDA approves AbbVie and Genmab's Epkinly, a best-in-class blood cancer drug, for treating DLBCL. Epkinly is a CD20xCD3 T-cell engager, and belongs to a class of drugs including Roche's Lunsumio and glofitamab, Regeneron's candidates, and a J&J-Xencor partnership. //Explore further

4️⃣ FDA clears Beta Bionics' iLet ACE automated insulin pump and dosing decision software for people 6 years of age and older with type 1 diabetes. The iLet Bionic Pancreas is formed when combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM). The system uses an algorithm to determine and command insulin delivery. //Explore further

5️⃣ Bausch + Lomb wins its first FDA approval for Miebo drops, the first treatment to directly target tear evaporation in dry eye disease. The drug addresses an unmet need for millions of patients in the U.S. //Explore further

💰 Funding

1️⃣ Ensoma closes Series B extension, with a total round of $135M. The company is creating smart immune cell medicines using the power of multiple immune cell types. //Learn more

2️⃣ Ensoma raises $135M to develop smart immune cell medicines for hard-to-treat tumors, harnessing the power of multiple immune cell types. //Learn more

3️⃣ Biotech startup Ray raises $100M to develop vision-restoring gene therapies. The funding will help advance the lead program for retinitis pigmentosa, a degenerative retinal disease, into clinical testing within the next year. //Learn more

4️⃣ Coherent Bio closes B round with $100M to advance the clinical development of its bi-targeting XDC drug pipeline for breast cancer, solid tumors, and prostate cancer. //Learn more

5️⃣ BlueSemi to raise $10M in Series A funding to scale up EYVA, a medical device that monitors five important body vitals within 60 seconds. The funds will be used to advance the development of EYVA, which measures blood pressure, heart rate, ECG, oxygen level, and average glucose levels (HbA1c). //Learn more

📰 Interesting News

1️⃣ Article lists 5 innovative biotech startups, including Eagle Genomics, Ginkgo Bioworks, Bionaut Labs, Gelesis, and Motif FoodWorks, that are poised to change our everyday life. //Find out more

2️⃣ India's pharma exports cross $25.3B, with drugs, formulations, and biologics accounting for 70-75% of the overall exports, and bulk drugs and drug intermediates accounting for 18-20%. Vaccines, Ayush and herbals, and surgicals make up the remaining exports from the country. //Find out more

3️⃣ Long-forgotten antibiotic, nourseothricin, may work against drug-resistant bacterial infections. Scientists have found that streptothricin-F, a less potent form of the complex molecule streptothricin-D, showed no renal toxicity in mice, making it a potential candidate for further development. Nourseothricin was discovered in the early 1940s as a naturally occurring product of soil fungus. //Find out more

4️⃣ Soft, stretchable electronic skin could reconstruct the sense of touch. A Stanford team demonstrated the use of a soft, stretchable e-skin to trigger a nerve response, with nerve-like electronic pulses moving faster with more pressure or higher temperature applied to the skin. //Find out more

5️⃣ Gene therapies and mRNA vaccines are being developed for various cardiovascular disorders, raising the possibility of a cure. However, until a cure is possible, lifestyle changes in combination with medication can still help people living with cardiovascular diseases. The future of heart treatment looks promising. //Find out more