Pharma News

Aurinia Pharmaceuticals Inc. , a clinical stage biopharmaceutical company focused on the global immunology market, announced that it has received the final End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug Administration Division of Pulmonary, Allergy and Rheumatology Products. The minutes are consistent with the preliminary responses that were issued to the Company prior to the meeting which took place on October 25, 2016.

Daiichi Sankyo Company, Limited  and DarwinHealth announced a strategic partnership to use quantitative systems biology-based algorithms and novel, validated approaches focused on tumour checkpoints - a new class of cancer targets - to help prioritize investigational compounds in the Daiichi Sankyo Cancer Enterprise pipeline for clinical development.

Alvogen, the next generation pharmaceuticals company, has launched the first generic equivalent to Tamiflu (oseltamivir phosphate) capsules in the United States.

CDSCO decided to abolish practice of pre-inspection by State Licensing Authority & Central Licensing Authority for issuing Form 29 License to manufacture drugs for purposes of examination, test or analysis for biological products (Vaccines & r-DNA products).

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Sun Pharmaceutical Industries Ltd and its subsidiaries and Israel-based Moebius Medical have entered into an exclusive worldwide licensing deal to further develop MM-II, a novel pharmaceutical candidate for the treatment of pain in osteoarthritis.

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Soligenix, Inc.,  a late-stage biopharmaceutical company, announced SGX942 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy.

Novartis announced initial topline results from two pivotal phase III clinical studies evaluating the safety and efficacy of pegpleranib in combination with Lucentis (ranibizumab) for the treatment of neovascular age-related macular degeneration (nAMD). Studies OPH1002 and OPH1003, sponsored by Ophthotech Corporation, did not meet the primary endpoint of superiority for the pegpleranib and ranibizumab combination therapy, measured as best corrected visual acuity (BCVA) in terms of additional letter gains over ranibizumab monotherapy. At month 12, patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement in study OPH1002 and a 9.91 letter BCVA improvement in study OPH1003. Patients treated with ranibizumab alone showed a 9.82 letter BCVA improvement in the OPH1002 study and a 10.36 letter BCVA improvement in the OPH1003 study.

AstraZeneca and its global biologics research and development arm, MedImmune,  announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.

Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, has received FDA 510(k) clearance for its ExactVu micro-ultrasound system.