Pharma News

The discovery of penicillin has led to a sharp decline of syphilis around the world, except in Africa. In a new study, Prof. Chris Kenyon of the Antwerp Institute of Tropical Medicine (ITM) describes the different rates of decline of syphilis around the world. This week the European Centre of Disease Prevention and Control (ECDC) also published its latest figures on syphilis in Europe.

Profound Medical Corp. announced that it has been granted Investigational Device Exemption (“IDE”) approval from the U.S. Food and Drug Administration (“FDA”), for a multicenter Pivotal Clinical Trial (“Pivotal Trial”). The objective of this trial is to evaluate the efficacy of the TULSA-PROTM System in patients with localized prostate cancer.

Pain Therapeutics, Inc. announced that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), tentatively scheduled for Friday, August 5, 2016.  This is intended to be a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.

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Roche announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecentriq® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

Genmab A/S announced that the Phase III POLLUX study (MMY3003) of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p < 0.0001).  Patients who received treatment with daratumumab in combination with lenalidomide and dexamethasone had a 63% reduction in risk of their disease progressing, compared to those who did not receive daratumumab. The median PFS for patients treated with daratumumab in combination with lenalidomide and dexamethasone has not been reached, compared to an estimated median PFS of 18.4 months for patients who received lenalidomide and dexamethasone alone.

Hormone therapy, gynecological disorders, and musculoskeletal disorders in women are the prime areas of focus in the women's health disorder therapeutics market. BCC Research reveals in its new report that the market represents one of the most attractive markets in the global pharmaceutical industry.

The latest advances in technology such as high-throughput screening and rapid diagnostics are keying growth in the life sciences tools and reagents market. BCC Research reveals in its new report that these and other innovations are spurring development of efficient, user-friendly and affordable scientific techniques and products.

Millennium Dental Technologies (MDT) is pleased to announce a first-of-its-kind 510(k) clearance from the Food and Drug Administration (FDA) for periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® protocol.

Mission Pharmacal Company announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for over-the-counter liquid Potassium Iodide Oral Solution USP. The solution is a ready to use thyroid blocking medication that can be used by all ages in the event of a nuclear emergency.

Roche announced that Alecensa® , an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK-inhibitor.