Pharma News

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

Researchers at the Department of Clinical Medicine at the University of Bergen (UiB) have discovered that medical treatment against diabetes reduces the risk of getting Parkinson´s disease by 35 per cent.

Scientists at The Scripps Research Institute (TSRI) have made a discovery that could speed efforts to develop a successful HIV vaccine.

The scientists found that on the HIV envelope protein, at a site important for viral function, a small group of sugar molecules, known as glycans, serves as a key “anchor” for antibodies that can broadly neutralize the virus. Future candidate vaccines are therefore likely to include this glycan cluster among their specific viral targets in order to maximize the chances of stimulating an effective antibody response.

Konica Minolta, Inc. and Boston-based Invicro LLC (“Invicro”) announced that they have concluded an agreement whereby Konica Minolta will acquire Invicro, a leading provider of imaging services and software for research and drug development.

BioCryst Pharmaceuticals, Inc a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.

Roche announced that the European Commission (EC) has granted a marketing authorisation for TECENTRIQ (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. People with EGFR-activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving TECENTRIQ. This approval is based on results from the large randomised Phase III OAK study and the randomised Phase II POPLAR study.1,2 The Phase III OAKstudy showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months–4.2 months longer than those treated with docetaxel chemotherapy (median OS: 13.8 vs 9.6 months; hazard ratio [HR] = 0.73, 95% confidence interval [CI]: 0.62, 0.87).

The GlaxoSminthKline to sell it's thane based property to Oberoi Realty Limited in Rs. 555 crores. The proposed property in 60 acres located in thane, Maharashtra.

Janssen Research & Development, LLC (Janssen) presented new longer-term data from the open-label extension of the VOYAGE1 trial demonstrating consistent rates of skin clearance with TREMFYA™ treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody. The longer-term findings from the Phase 3 VOYAGE 1 study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress showed more than 80 percent of patients receiving TREMFYA™, including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira® (adalimumab) achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of clearedor minimal disease at week 100. The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of TREMFYA™, and the United States Food and Drug Administration (FDA) approval of TREMFYA™ in July.

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.

Pfizer filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J).