Industry News

- Read more about Novogen Submits IND Application To The USFDA for Contrail In Ovarian Cancer
Australian oncology-focused biotechnology company Novogen Ltd announced that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for Cantrixil (TRX-E-002-1) in ovarian cancer.
- Read more about Acacia Pharma show Positive Pivotal Phase 3 Trial result of BAREMSIS
Acacia Pharma show Positive Pivotal Phase 3 Trial result of BAREMSIS
Acacia Pharma Group plc, the supportive care company developing products for US and international markets, announces positive results from a pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (“PONV”).
- Read more about Study: Pfizer’s VYNDAQEL long term therapy Slowed Progression of Rare Neurodegenerative Disease
Pfizer Inc. announced the publication of a new post-hoc analysis of data from three studies of VYNDAQEL in patients with mild transthyretin familial amyloid polyneuropathy (TTR-FAP). The analysis, which included patients with the Val30Met mutation treated over varying periods of up to 5.5 years, showed that treatment with VYNDAQEL initiated during the early stage of the disease resulted in minimal neurological disease progression and in preservation of body weight, which often declines as the disease progresses. VYNDAQEL was well tolerated with no new safety signals observed.
- Read more about Gaumard launch OMNI 2 touch-screen wireless interface
Gaumard Scientific Company announced the launch of OMNI 2, a touch-screen wireless interface that transforms training with value-priced simulators and skills trainers into an easy, intuitive tap-and-go experience.
- Read more about FDA Advisory Committee Review BLA of Dynavax’s HEPLISAV-B
Dynavax Technologies Corporation announced that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.
- Read more about Dr Reddy’s completes acquisition of eight products from Teva
Dr Reddy’s Laboratories has successfully completed the previously announced acquisition of eight Abbreviated New Drug Applications (ANDAs) in the US from Teva Pharmaceutical Industries and an affiliate of Allergan plc.
- Read more about ADMA Biologics Receives Complete Response Letter from FDA for Pending BLA
ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD).
- Read more about Sun Pharma & Almirall inked in for Tildrakizumab in Europe for Psoriasis
Sun Pharmaceutical Industries and Almirall signed a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.
- Read more about e-Pharmacy to Provide Growth Opportunities for Pharma Companies : Frost & Sullivan
The launch was followed by an intense panel discussion on the importance of the concept of e-Pharmacies and the deliberations on the need of guidelines / policies to ensure legitimate players delivering the benefits of the model to consumers, thereby, enabling wider access to medicines and improving public health. The panel’s participants included officials from the Ministry of Health & Family Welfare, Central Drugs Standard Control Organization, World Health Organization (WHO), and consumer activists. The event witnessed an engaging discussion between the concerned stakeholders of the Government as well as the industry.
- Read more about Immunicum submits IND application to FDA for ongoing phase II-trial in the United States
Immunicum announced that the Company has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the U.S. The application is requesting approval to treat kidney cancer patients in the U.S. with Immunicum’s lead cancer immune primer, INTUVAX®, in its ongoing MERECA (MEtastatic REnal cell CArcinoma) phase II-trial.