The U.S. government will pay $1.95 billion to Pfizer Inc. and Biontech SE for the first 100 million doses of their jointly developed COVID-19 vaccine once Pfizer manufactures it and receives the FDA’s approval or emergency use authorization. The two companies agreed, as part of Operation Warp Speed, to begin delivering 300 million doses of a COVID-19 vaccine in 2021. The agreement includes the government’s option to buy as many as 500 million additional doses. Americans will not be charged to receive the vaccine, according to the companies. Biontech stock (NASDAQ:BNTX) was up 10% at midday Wednesday.

Wake-up call: FDA approves excessive daytime sleepiness treatment from Jazz

The FDA has approved Xywav (JZP-258), an oxybate product for treating both cataplexy and excessive daytime sleepiness in narcolepsy patients ages 7 and older, from Jazz Pharmaceuticals plc, of Dublin. It is the first approved new treatment option for the indications in more than 15 years, and the company plans Xywav’s launch by year-end. In the meantime, Jazz will implement a risk evaluation and mitigation strategy for the treatment.

China’s Sunshine Guojian prices $240M IPO on STAR, shares jump 92% on first day

HONG KONG – Looking to boost its R&D capacity, China’s Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. launched an IPO on July 22 that raised ¥1.7 billion (US$240 million) on Shanghai’s STAR market. Shares (SSE:688336) almost doubled in value on the first day of trading, closing at ¥54.10, for a gain of nearly 92%. The company sold less than 10% of its share capital, or about 61.6 million shares, at ¥28.18 per share. Sunshine Guojian is a subsidiary of 3sbio Inc., established in 2002. It specializes in developing antibodies for autoimmune, oncology and eye diseases. It has built a pipeline of 15 internally discovered drug candidates, with seven in clinical-stage development and eight in preclinical studies.

Series D round brings $135M for Encoded with Dravet syndrome gene therapy

South San Francisco-based Encoded Therapeutics Inc. banked $135 million in an oversubscribed series D financing, just as its lead asset, ETX-101, was granted orphan drug and rare pediatric disease designations by the FDA. Designed for the treatment of SCN1A+ Dravet syndrome (DS), the gene therapy will undergo trial activities that include a natural history study to better understand the progression of SCN1A+ DS, as well as first-in-human experiments. The new funds also will support progression of the company’s pipeline of gene therapies against other pediatric central nervous system disorders, Encoded said.

T3 Pharma closes $27M series C for live bacteria cancer immunotherapy

LONDON – Swiss startup T3 Pharma AG has raised CHF25 million (US$26.7 million) in a series C round, to fund a 100-patient phase I/II study of its live bacteria cancer immunotherapy. The trial, in a number of different solid tumors, will involve both intratumoral and intravenous administration, assessing the company’s lead candidate, T3P-Y058-739, as a monotherapy and in combination with immune checkpoint inhibitors. The new round, backed by existing investors Boehringer Ingelheim Venture Fund, Reference Capital SA, Wille Finance AG and private investors, closed less than a year after Basel-based T3 Pharma’s $12.1 million series B.

BIO Asia-Taiwan 2020: Emerging biotechs remain major driver for global innovation

Emerging companies continue to have a bigger role in pushing biotech innovation, and their presence is more important than ever, given the race for a COVID-19 solution. Those companies’ role in global R&D and new drug approvals was stressed by experts at the current BIO Asia-Taiwan conference. On Wednesday, Taiwan physically hosted the first large-scale international biotech conference in Asia. The gathering drew experts from all parts of the world to discuss global R&D and financing trends and outlook, as well as policy issues during and after the COVID-19 era.

Hacking indictment details 10 years of stolen trade secrets, criminal activity

The alleged activities of two Chinese hackers outlined in a federal indictment unsealed yesterday offer “concrete examples of two concerning trends,” U.S. Assistant Attorney General John Demers said. Though not a new revelation, the first is that “China is using cyber-enabled theft as part of a global campaign to 'rob, replicate and replace' non-Chinese companies in the global marketplace,” he added. The targets of that campaign are biopharma, medical device and other high-tech industries outlined in the country’s 10-year Made in China 2025 plan. The second trend is that China is turning a blind eye to criminals who are hacking, in part, for their own personal profit so long as they’re willing to help the state. According to the 11-count grand jury indictment handed down earlier this month, Chinese nationals Li Xiaoyu and Dong Jiazhi have conducted a hacking campaign for more than 10 years, targeting companies in the U.S., Australia, Belgium, Germany, Japan, Lithuania, the Netherlands, Spain, South Korea, Sweden and the U.K. In recent months, that activity has targeted companies working on COVID-19 vaccines and treatments.

Culture of scientific exchange said to be a risk factor for life science cybersecurity

The U.S. government has charged two citizens of China with cybercrime in connection with alleged hacking of research into vaccines for the SARS-CoV-2 virus, but more than one speaker on a July 22 webinar said cybersecurity risk is not just a question of software. A key problem, several speakers on the Booz Allen Hamilton webinar said, is that scientists involved in basic life science research at universities have a decidedly open approach to data sharing, a tendency that will have to change if government and industrial life science research is to remain secure in the years ahead.

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