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Dynavax Announces FDA Approval of HEPLISAV-B™ for Prevention of Hepatitis B in Adults

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
- Source: investors.dynavax
- 576
- November 13, 2017
FDA hepatitis B Heplisav-B
Guidance for Visiting Foreign Clients (Part Ⅱ)

After reading part 1 of our series Guidance for Visiting Foreign Clients you should probably know how to prepare before visiting foreign clients. In part 2 we give you more tips on how conduct your meeting for a more successful outcome.
- Source: Ddu
- 928
- November 10, 2017
clients Ddu College
Merck Receives FDA Approval of PREVYMIS™ (letermovir)

Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
- Source: finance.yahoo
- 1,118
- November 10, 2017
CMV FDA HSCT New Approvals
Novartis reports positive results from Phase III trial of Kisqali® (ribociclib) combination therapy

Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
- Source: Novartis
- 819
- November 10, 2017
breast cancer Clinical Trials Kisqali Phase
With 2-pronged filing, Novartis’ CAR-T med Kymriah aims to jump intoEurope with both feet

Novartis is blazing ahead with its bid to take its new CAR-T therapy, Kymriah, into new realms with a double-pronged approval application in Europe.
- Source: Fiercepharma
- 523
- November 10, 2017
CAR-T therapy Kymriah Novarti
FDA Announces New Policy for Genetic Testing Regulation

In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
- Source: jdsupra
- 537
- November 10, 2017
direct-to-consumer genetic risk Policy
A Chinese Province Is Sequencing One Million of Its Residents’ Genomes

Authorities in the city of Nanjing, the capital of China’s Jiangsu province, announced at the end of October that they would sequence the genes of 1 million individuals to build a genetic database of Chinese residents. This project is part of the National Health and Medicine Big Data Nanjing Center, a new data storage facility under construction in the region.
- Source: futurism
- 598
- November 10, 2017
cancer chronic gene Market Views sequence
Women who ate 2-6 daily servings had 18% lower probability of clinical pregnancy

Women who ate more fruits and vegetables containing high amounts of pesticide residue were less likely to get pregnant or have a live birth following infertility treatments, an observational study found.
- Source: medpagetoday
- 393
- November 10, 2017
infertility pesticide residue Researches
POLICY CHANGE! Only 35 Days for New Drug Approvals!

Beijing Beishengyan biological Product’s Sabin Strain Inactivated Polioviurs Vaccine (Sabin IPV), secured approval from the China Food and Drug Administration (CFDA) in August 2017. On September 29th, Sabin IPV was officially on the market, offering one more option for IPV precaution. With the exception of time for material supplements, the CFDA took only 35 days to process production, registration and application of Beishengyan’s IPV and issue a drug approval number and certificate.
- Source: Ddu
- 706
- November 10, 2017
Ddu College drug approval IPV vaccine
12 Questions to Ask BEFORE Saying “Yes” to Chemotherapy Treatment

Conventional doctors have considered chemotherapy treatment and radiation to be the standard of care for so long, they’ve lost sight of the fact that these treatments are causing cancer − not curing it.   Did they somehow miss the fact that these super toxic cancer therapies could be the reason for their repeat customers?
- Source: thetruthaboutcancer
- 677
- November 10, 2017
cancer Chemotherapy

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