PharmaFocus Today – Page 9 – media

BioNTech’s mRNA Cancer Vaccine BNT113 Falls Short of Primary Endpoint in Phase 3 Trial

On October 13, BioNTech announced the first top-line results of its AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) for its mRNA cancer immunotherapy candidate BNT113 . Unfortunately, BNT113 in combination with pembrolizumab as first-line treatment for unresectable recurrent or metastatic HPV16-positive, PD-L1-positive head and neck squamous cell carcinoma failed to meet the first of the dual primary endpoints—progression-free survival —and did not statistically demonstrate a significant improvement over pembrolizumab monotherapy. Following the announcement, BioNTech’s stock price fell by about 6% during trading, casting a shadow over market enthusiasm for the mRNA tumor vaccine sector once again. It is important to note that this setback does not equate to a complete failure of the trial. The independent data monitoring committee recommends that the trial proceed as planned and that the second dual primary endpoint—overall survival—be assessed. According to the pre-specified statistical design of the trial, even if the progression-free survival (PFS) endpoint ...
- Source: drugdu
- 220
- October 16, 2026
Foghorn Therapeutics’ Collaboration Terminated by Eli Lilly; Company to Lay Off 40% of Its Workforce

recently announced that Eli Lilly has terminated its collaboration with the company . The core SMARCA2 selective inhibitor FHD-909 failed to demonstrate the efficacy required to advance to the expansion phase in Phase I dose escalation, and the related SMARCA2 degrader project has also been discontinued. Following the announcement, Foghorn’s stock price plummeted, falling by more than 40% at one point during the day , leaving its market capitalization at only about $130 million. As a result, Foghorn’s board of directors approved a restructuring plan that would reduce its workforce by about 40% , bringing the total number of employees down to about 65, in order to extend its cash runway to the second half of 2029. Why did a four-year collaboration end so suddenly? Why was the cooperation terminated? The key to understanding Eli Lilly’s “return” lies in understanding the decision-making logic of MNCs in the early stages of ...
- Source: drugdu
- 181
- October 16, 2026
Visara (USA) Acquires Overseas Rights to Haite Bio’s HT006.2.2 Eye Drops

On October 13, 2026, Haitai Bio (300683.SZ) announced that it had signed an exclusive cooperation and licensing agreement with Visara, Inc., a US company, regarding the HT006.2.2 eye drop project. According to the agreement, Visara will obtain exclusive rights outside of Greater China to develop, commercialize, manufacture, contract manufacture, use, sell, offer for sale, import, export, and otherwise utilize the licensor and licensed products of HT006.2.2 eye drops. HT006.2.2 eye drops are a recombinant human nerve growth factor (rhNGF) ophthalmic formulation independently developed by the company with independent intellectual property rights, targeting tropomyosin receptor kinase A (TrkA) and p75 neurotrophic factor receptor (p75NTR). Visara will pay the company an upfront payment of US$7 million plus recent milestone payments. Depending on the progress of clinical development and commercialization, Haitai Bio will also be entitled to receive milestone payments related to research, registration, and commercialization up to a maximum of US$104 million. ...
- Source: drugdu
- 195
- October 16, 2026
Asia Pacific Pharmaceutical’s Shengyao Guangyan Obtains a New Acne Drug Technology Achievement from Quzhou Fudan Research Institute

On October 13, 2026, Zhejiang Shengyao Guangyan Pharmaceutical Co., Ltd. (hereinafter referred to as “Shengyao Guangyan”), a wholly-owned subsidiary of Asia Pacific Pharmaceutical (002370.SZ), signed a “Letter of Intent for Cooperation on Innovative Drug Technology Transaction” with Quzhou Fuda Biomedical Innovation Research Institute (hereinafter referred to as “Quzhou Fudan Research Institute”), intending to introduce all the technological achievements of the Class 1.1 small molecule innovative drug “a BODIPY photosensitizer for acne treatment” held by Quzhou Fudan Research Institute . The target project of this collaboration is a Class 1.1 small molecule innovative drug, “A BODIPY-type photosensitizer for acne treatment,” belonging to the cutting-edge field of photodynamic therapy. It is currently in the PCC (preclinical candidate compound) stage, with one Chinese patent application filed. The indication is acne and other applications. The transaction consideration includes a total of RMB 25 million for R&D and approval milestone payments, a total commercialization milestone ...
- Source: drugdu
- 129
- October 16, 2026
Zelgen Submits a Marketing Application in China for Gecacitinib in Ankylosing Spondylitis

On October 14, 2026, Zekjing Biotechnology (688266.SH) announced that it had submitted a third marketing application for gecacitinib to the National Medical Products Administration for the treatment of active ankylosing spondylitis. Gecacitinib is a novel JAK inhibitor independently developed by the company, which owns the intellectual property rights to the product. Previously, the drug had been approved for marketing by the National Medical Products Administration for two indications: the treatment of intermediate- to high-risk myelofibrosis and severe alopecia areata in adults. The myelofibrosis indication has been included in the 2025 National Reimbursement Drug List. Ankylosing spondylitis is an arthritis characterized by long-term inflammation of the spinal joints, typically manifesting as inflammation of the sacroiliac joints and spinal entheses. The Chinese market for ankylosing spondylitis drugs is projected to reach RMB 17 billion by 2025, with a compound annual growth rate of 12.1% from 2020 to 2025. Source: https://mp.weixin.qq.com/s?__biz=MzA5Njc0MTAxOQ==&mid=2650033491&idx=2&sn=0acfe69713aae899421bc4c8d33101c2&chksm=89939f3bf89bb9f002129378fbe4bfc53f860
- Source: drugdu
- 99
- October 16, 2026
Teva Announces U.S. FDA Approval of WELTRUZA™ (olanzapine) Extended-Release Suspension for Injection

WELTRUZA™ (olanzapine) extended-release suspension for injection is the first and currently the only approved long-acting olanzapine injection (LAI) for the treatment of schizophrenia in adults, administered subcutaneously once a month; treatment requires no loading dose, no oral medication supplementation, and no post-injection monitoring. This approval is based on the results of the pivotal Phase III SOLARIS study. The study showed that WELTRUZA improved overall symptoms, significantly reduced disease severity, and improved individual and social functioning; its systemic safety profile was consistent with that of oral olanzapine.¹ As Teva continues to advance its global “Pivot to Growth” strategy, it will further fulfill its commitment to innovation in the field of patient-centered neuroscience and continue to build a differentiated portfolio of long-acting injectable products. On October 9, Teva Pharmaceutical Industries (NYSE and Tel Aviv Stock Exchange: TEVA) announced that WELTRUZA™ (olanzapine) extended-release suspension for injection has been approved by the U.S. Food ...
- Source: drugdu
- 140
- October 16, 2026
CPHI Milan 2026 Recap | What Did Drugdu.com Bring Back from Milan?

From October 6–8, Drugdu.com attended CPHI Milan 2026, meeting with overseas buyers, pharmaceutical companies, and industry partners at Booth 20C65. For Drugdu.com, this was more than simply another overseas exhibition. Every day, product searches, supplier discovery, inquiries, sourcing requests, and overseas promotion all happen online. At the exhibition, those activities became much more tangible. Some visitors were looking for specific products and suppliers. Others wanted to explore new business channels, while some companies sat down with us to discuss overseas markets and promotion plans. After three days in Milan, the most important question for us was not how many people visited the booth. It was: What did we actually bring back from Milan? From Online Data to Real Conversations One interaction at the exhibition stood out to our team. A visitor from Costa Rica came to the Drugdu.com booth and mentioned that he regularly uses Drugdu.com to search for industry ...
- Source: drugdu
- 187
- October 9, 2026
Novo Nordisk and Nanexa Ink Up to €1.165B Long-Acting Delivery Deal for Obesity and Diabetes

On September 25, Swedish pharma company Nanexa announced an exclusive global license and collaboration agreement with Novo Nordisk, leveraging Nanexa’s PharmaShell atomic layer deposition technology for up to five peptide programs. Novo Nordisk gains exclusive global rights to develop and commercialize up to five peptide programs in obesity and type 2 diabetes using PharmaShell. Nanexa receives an undisclosed upfront payment, up to €1.165B in development, regulatory and commercial milestones, plus royalties. The deal further strengthens Novo’s obesity pipeline through long-acting delivery beyond GLP-1. Source: https://www.biobucks.co/biotech-bdl-tracker-2026
- Source: drugdu
- 248
- September 29, 2026
siRNA Biotech ADARx Raises $446M in 2026’s Third-Largest Biotech IPO

On September 24, San Diego-based siRNA therapeutics company ADARx Pharmaceuticals priced an upsized IPO of 26.25 million shares at $17.00 per share (top of the $15-$17 range), raising $446.3 million—the third-largest biotech IPO of 2026. Shares began trading on Nasdaq on September 25 under ticker ADRX. ADARx’s lead asset onvuzosiran targets hereditary angioedema (HAE), with topline data from the pivotal Phase 3 STOP-HAE trial expected by late 2027. Partner AbbVie also invested approximately $89 million in a concurrent private placement, taking a 4.9% stake. The IPO underscores continued capital market enthusiasm for RNAi therapeutics in 2026. Source: https://www.globenewswire.com/news-release/2026/09/24/3368818/0/en/adarx-pharmaceuticals-announces-pricing-of-upsized-446-3-million-initial-public-offering.html
- Source: drugdu
- 243
- September 29, 2026
Merck and Eisai’s Welireg Plus Lenvima Approved by FDA for Previously Treated Advanced Kidney Cancer

On September 25, Merck (MSD) and Eisai announced FDA approval of Welireg® (belzutifan), an oral HIF-2α inhibitor, in combination with Lenvima® (lenvatinib), for adults with advanced renal cell carcinoma (ccRCC) with a clear cell component previously treated with a PD-1 or PD-L1 inhibitor. The approval is based on the LITESPARK-005 Phase 3 study, which showed the Welireg+Lenvima combination reduced the risk of disease progression or death by 30% versus cabozantinib. This provides a new all-oral option for patients after immunotherapy failure. Source: https://www.merck.com/news/welireg-belzutifan-plus-lenvima-lenvatinib-reduced-the-risk-of-disease-progression-or-death-by-30-compared-to-cabozantinib-in-certain-previously-treated-patients-with-advanced-renal-ce/
- Source: drugdu
- 228
- September 29, 2026

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