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enGene to Initiate BLA Submission by Year End and Reports New LEGEND Data in Bladder Cancer

On November 11, clinical-stage non-viral genetic medicines company enGene (Nasdaq: ENGN) announced updated results from the pivotal Cohort 1 of its Phase 2 LEGEND trial of detalimogene voraplasmid, which are expected to form the basis for a Biologics License Application (BLA) with the U.S. FDA. The cohort enrolled 125 patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. As the data matured, the primary endpoint of complete response at any time improved to 56% from 54%, while the key secondary endpoint of the Kaplan-Meier estimate of duration of response of at least 12 months improved to 43% from 25%, and median duration of response improved to 10.1 months from 8.6 months. On safety, only 2% of patients experienced a serious treatment-related adverse event, with no Grade 4 or Grade 5 events reported. Following a pre-BLA meeting, the company aligned with the FDA on the efficacy-evaluable population ...
- Source: drugdu
- 42
- November 12, 2026
CorMedix to Acquire Heron Therapeutics’ Commercial Assets for $145 Million in Cash and Stock

On November 11, CorMedix announced a definitive agreement to acquire substantially all assets of Heron Therapeutics, including a portfolio of four commercial-stage products. The transaction is expected to be immediately accretive to earnings and free cash flow and significantly diversify the company’s revenue base within hospital and acute care settings. The acquired portfolio includes four FDA-approved products—ZYNRELEF, APONVIE, CINVANTI and SUSTOL—which collectively generated approximately $150 million in trailing 12-month net revenue. The upfront consideration consists of $145 million in cash and approximately 14.6 million shares of CorMedix common stock. Heron is also eligible for up to $55 million in earn-out payments tied to 2028 net sales of ZYNRELEF. CorMedix anticipates $45 million to $60 million in annualized operating cost synergies by the end of 2027 through its existing commercial infrastructure. The acquisition is expected to close in the first quarter of 2027, subject to Heron stockholder approval and other customary ...
- Source: drugdu
- 42
- November 12, 2026
MaxCyte to Acquire Akron Bio for $151.8 Million, Expanding Across the Cell Therapy Manufacturing Workflow

On November 11, cell-engineering company MaxCyte announced a definitive agreement to acquire Akron BioProducts from affiliates of Arcline Investment Management for total consideration of $151.8 million. The transaction is expected to close before the end of 2026, subject to customary closing conditions. Headquartered in Boca Raton, Florida, Akron supplies GMP-grade reagents and ancillary materials used throughout the cell therapy manufacturing workflow, including electroporation, expansion and cryopreservation. Its products are embedded in customers’ validated manufacturing processes and regulatory submissions, supported by drug master files (DMFs) referenced in INDs and BLAs. The combination is expected to nearly double MaxCyte’s revenue base and, through Akron’s products, expand MaxCyte into the viral ex-vivo cell therapy market. The combined business will be embedded in the workflow of five approved therapies and support more than 100 clinical programs. Under the terms, MaxCyte will pay $105.0 million in cash at closing, subject to customary adjustments, plus 20,639,733 ...
- Source: drugdu
- 36
- November 12, 2026
Hunan Warner’s Metformin and Empagliflozin Tablets (I) Approved, Deemed to Pass Consistency Evaluation

On the evening of November 10, Hunan Warner Pharmaceutical (688799) announced that it had recently received a Drug Registration Certificate for metformin and empagliflozin tablets (I), issued by the National Medical Products Administration (NMPA). The product, with approval number H20266500, contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin per tablet. It was approved as a Class 4 chemical drug under the new registration classification and is deemed to have passed the generic quality and efficacy consistency evaluation. Used alongside diet control and exercise, metformin and empagliflozin tablets (I) are indicated for adults with type 2 diabetes already treated with empagliflozin and metformin hydrochloride, to improve their glycemic control. Source: http://finance.eastmoney.com/a/202611103927450284.html
- Source: drugdu
- 36
- November 12, 2026
Revenue increased fourfold, yet 35% of employees were laid off.

Layoffs are often interpreted as a sign of operational pressure, pipeline setbacks, or tight cash flow. However, Agios Pharmaceuticals ‘ Q3 2026 financial report presents a stark contrast: quarterly product revenue reached $55.4 million, more than quadrupling year-over-year ; at the same time, the company announced it would cut more than 100 R&D positions by the end of the year, equivalent to a reduction of more than 35% in its R&D team. These figures are indeed eye-catching when put together, but when broken down, they do not indicate that a company is in trouble. Rather, they are more like a biotech company ‘s phased transformation from “burning money on R&D” to “commercial profitability”. The surge in revenue isn’t due to a sudden increase in R&D personnel, but rather because the core product has entered the commercialization and mass production phase. Agios’ revenue growth primarily comes from mitapivat, an oral pyruvate ...
- Source: drugdu
- 35
- November 12, 2026
Johnson & Johnson officially announces major collaboration.

On November 10, Johnson & Johnson Medical Technology officially announced that it has signed a cooperation agreement with Jiangsu Changyida Medical Technology Co., Ltd. (hereinafter referred to as Changyida) to deepen cooperation on the next-generation blood flow diverting mesh stent Qiangyida PLUS. Deepening cooperation Why is it favored by giants? With four separate agreements signed over three years, the collaboration between Johnson & Johnson and Changyida is progressing in depth. Looking back on the collaboration, the partnership has achieved several significant milestones. In 2023, Johnson & Johnson partnered with Clindam for the first time to jointly develop the Clindam FlowGuard Mesh Stent , which was successfully launched in 2024. The product features a nickel-titanium alloy structure woven with four platinum-tungsten radiopaque wires, enabling excellent conformal adhesion and allowing for delivery to small diameter systems (0.017mm). It also boasts a closed-end design. Building on the success of the first product, the ...
- Source: drugdu
- 35
- November 12, 2026
BrightGene reports positive Phase III results from two BGM0504 diabetes trials

On the evening of November 11, BrightGene reported that BGM0504, an injectable dual GLP-1 and GIP receptor agonist developed by its Suzhou subsidiary, met the objectives of two Phase III trials. The monotherapy and combination trials both used change from baseline in HbA1c at week 32 as the primary endpoint. The monotherapy trial enrolled 227 Chinese adults with type 2 diabetes whose blood glucose remained inadequately controlled after diet and exercise interventions. At week 32, mean HbA1c fell by 2.20 and 2.60 percentage points with 5 mg and 10 mg, respectively, versus 0.51 points with placebo. Both doses were statistically superior to placebo. The combination trial enrolled 553 Chinese adults whose blood glucose remained inadequately controlled on metformin alone or with a sulfonylurea. The comparator was semaglutide 1.0 mg once weekly. At week 32, mean HbA1c fell by 2.41 percentage points with BGM0504 10 mg and 1.95 points with semaglutide. ...
- Source: drugdu
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- November 12, 2026
Tianjin Pharmaceutical wins China approval for histidine API

Tianjin Pharmaceutical (600488) announced on the evening of November 11 that China’s National Medical Products Administration had approved its marketing application for histidine active pharmaceutical ingredient (API). The application was submitted and accepted in November 2024, and supplementary materials were filed from December 2025 to March 2026. China’s Center for Drug Evaluation lists the API as status A, indicating approval for use in marketed formulations. The company invested approximately RMB 1.47 million in the project. Histidine is an essential amino acid used in amino acid infusions and combination formulations. The filing cited IQVIA data showing that global sales of oral and injectable formulations containing histidine, including single ingredient and combination products, were US$2.223 billion in 2024 and US$2.131 billion in 2025. Before the approval, the company had 25 amino acid APIs in its domestic portfolio. Source: https://finance.eastmoney.com/a/202611123928798819.html
- Source: drugdu
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- November 12, 2026
EXPO SALUD

Organiser：FISA S.A. Exhibition Company, Santiago, Chile Time：November 10-12, 2026 Address：San Diego Convention Center Corporation, 111 West Harbor Drive, San Diego, CA 92101 Exhibition hall：SAN DIEGO CONVENTION CENTER Product range: Medical Devices and Instruments‌: Medical electronic instruments, medical ultrasound instruments, medical X-ray equipment, medical optical instruments, clinical laboratory analysis instruments, dental equipment and materials, operating room equipment and appliances, emergency room equipment and appliances, diagnosis and treatment room equipment and appliances, disposable medical supplies, medical dressings and hygiene materials, various surgical instruments, medical health care equipment and supplies, traditional Chinese medical instruments and rehabilitation aids, hemodialysis equipment, anesthesia and respiratory equipment ‌Medical Consumables‌: Operating room gowns, shoes, gloves, various medical scalpels, forceps, scissors, dental grinding tools, bone grinding tools, drilling tools, microscopes, small electronic instruments, disposable supply consumables, cotton textiles, disposable syringes, blood transfusion sets, band-aids, masks, bandages, stethoscopes, toolboxes, work uniforms, medical suitcases, gloves, syringes, blood transfusion sets ‌Rehabilitation ...
- Source: drugdu
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- November 12, 2026
Tigermed to Privatize Frontage at HK$2.37 per Share, a ~59.1% Premium, and Divest Overseas Lab Business

After trading hours on November 9, 2026, Tigermed (300347.SZ; 03347.HK) announced that it intends to sell its controlling interest in subsidiary Frontage Holdings (01521.HK) and divest its overseas laboratory services business. The transaction comprises a privatization and a separation. Its wholly owned subsidiary Hongkong Tigermed, together with CRL and Dr. Li Song, established SanRex as the acquisition vehicle to privatize Frontage by way of a scheme of arrangement. SanRex is a consortium in which Tigermed holds a 53.4% stake. The cancellation price is HK$2.37 per scheme share, representing a premium of approximately 59.1% over Frontage’s closing price of HK$1.49 on the preceding trading day. Upon completion of the privatization, Frontage will become a wholly owned subsidiary of SanRex and its listing will be withdrawn from the Hong Kong Stock Exchange. The privatization will be followed by a separation: consortium member CRL (Charles River Laboratories, NYSE: CRL) will hold Frontage’s target ...
- Source: drugdu
- 84
- November 10, 2026

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