Pharma News

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.

Biotage, a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, is pleased to announce the launch of Biotage SNAP Bio C18 and Biotage SNAP Bio C4 cartridges - a new range of high performance flash cartridges with wide pore media (300 Å) for reversed phase purification of peptides and other larger molecules.

AstraZeneca and Eli Lilly and Company announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase I trials as a potential disease-modifying treatment for Alzheimer’s disease (AD). This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase III trials.

Roche announced that the US Food and Drug Administration (FDA) has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy.