Showing posts from July, 2019

Syapse, Pfizer enter deal to develop precision medicine in oncology

A company that uses data from various sources for the development of precision medicine programs in oncology has gained its latest pharmaceutical industry partner. San Francisco-based Syapse said Tuesday that it had signed a collaboration deal with New York-based drugmaker Pfizer that will involve using real-world data from Syapse’s network of community health system providers to understand molecular testing and treatment choices. The partnership marks the company’s third such deal with a major drug company, after it signed similar agreements with Amgen , in May of this year, and Roche , in January 2018 . “ Pfizer is on the forefront of utilizing real-world data to improve the lives of patients worldwide, and we are pleased to work with them to unlock evidence and insights that can help improve patient care and accelerate the availability of new treatments,” Syapse CEO Ken Tarkoff said in a statement. “To realize the potential of precision medicine, all of the stakeholders in the

US FDA grants breakthrough therapy designation to Lenvima plus Keytruda combination to treat patients with advanced unresectable HCC

Eisai, a leading global research and development-based pharmaceutical company and Merck & Co., Inc.,a leading global biopharmaceutical company Kenilworth, New Jersey, USA known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Lenvima, the orally available kinase inhibitor discovered by Eisai, in combination with Keytruda, Merck & Co., Inc.'s anti-PD-1 therapy, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment. This is the third breakthrough therapy designation for the Lenvima plus Keytruda combination. The first two breakthrough therapy designations for the combination were in advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI- H)/proficient mismatch repair (pMMR) endometrial carcinoma, received in January 20

Boehringer Ingelheim Acquires Cancer Vaccine Biotech in €325M Deal

The German giant Boehringer Ingelheim has acquired the Swiss company AMAL Therapeutics and its cancer vaccine technology in a deal worth up to €325M. The deal includes €225M in upfront and developmental milestone payments, as well as up to €100M in undisclosed commercial milestone payments. AMAL’s vaccine development pipeline includes five preclinical programs. The lead vaccine, intended for colorectal cancer, is expected to enter phase I trials this year. Boehringer aims to combine its own cancer immunotherapy programs with AMAL’s technology. Boehringer is targeting solid tumors that have no inflammation, making them resistant to immunotherapies including checkpoint inhibitors . AMAL’s cancer vaccine technology could help Boehringer develop ways to evoke an immune response to these cancers. “We want to pioneer new paradigms of biology-based care for cancer patients, and the technologies and expertise developed at AMAL are critical to our efforts,” stated Michel Pairet, one of Boehrin

Bayer’s move to block Natco’s colorectal cancer brand dismissed by Delhi HC

MUMBAI: The acrimonious patent-related tussles between Indian and multinational drug makers are down but not yet out. In the latest development, a division bench of the Delhi High Court dismissed an injunction petition filed by German drug maker BayerNSE -1.32 % to protect its drug Regorafenib sold under brands Stivarga, Nublexa and Resihance against Hyderabad-based drug maker Natco PharmaNSE -0.39 %. Bayer raised the objection against Natco’s brand launched under the name Regonat alleging infringement of its patent rights. The court has sent back the case to the single judge for hearing the matter afresh. The case is likely to come up for hearings later this month. Regorafenib is used to treat colorectal cancer, known to be the sixth most prevalent cancer in India. Bayer alleged its drug was granted patents in 2004 and is therefore eligible for intellectual property protection rights for 20 years. Earlier on July 5, Bayer had secured an injunction against Natco, which then appealed

US FDA approves Pfizer's oncology biosimilar, Zirabev to treat five types of cancer

Pfizer Inc announced the US FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer. “Biosimilars like Zirabev can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, global president, Pfizer Oncology. “We are proud to add Zirabev to our growing oncology portfolio for US patients living with a wide variety of tumor types.” The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of Zirabev to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparati

EMA Recommends Extension of Indications for Ramucirumab

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ramucirumab (Cyramza). The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V. The CHMP adopted a new indication as follows: “Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib”. For information, the full indications for Cyramza will be as follows : Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatm

J&J’s DARZALEX gets USFDA approval to treat multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the U.S. Food and Drug Administration (FDA) approval of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from the Phase 3 MAIA (MMY3008) clinical study, which showed that DARZALEX-Rd significantly reduced the risk of disease progression or death by 44 percent compared to treatment with Rd alone.The application received approval through the U.S. FDA's Real-Time Oncology Review (RTOR) pilot program. "Multiple myeloma can become more difficult to treat after relapse, so it is important that patients receive an efficacious upfront therapy with a goal of extending their first remission period," said Saad Usmani, M.D., FACP, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Carolin