Author: yourbiotech
The US Food and Drug Administration (FDA) approved a record-breaking 71 new medicines in 2023. There were one or two controversial decisions and a slight drop in first-in-class approvals. But overall, the numbers may help assuage concerns of a more restrictive regulator following 2022’s sub-40 approval tally and signal a back-to-business FDA following the official end of the US COVID-19 public health emergency in May. Small-molecule New Drug Application (NDA) approvals outnumbered Biologics License Application approvals in 2023, but only just: 48% of new approvals were biologics, a share beaten just once, in 2022. This reflects the continued march of new biologic…
A bill in the U.S. Congress targeting Chinese biotech companies may end up being more “narrowly tailored”, the U.S. lawmaker who proposed it said on Friday, adding that he was cautiously optimistic something could be passed this year. A congressional committee focused on China introduced a bill late last month that would restrict federally funded medical providers from allowing China’s BGI Group, WuXi Apptec and other biotech firms from accessing genetic information about Americans. The proposed legislation has sparked a sell-off in WuXi shares. “I’m actually cautiously optimistic that we can get something done,” Republican Congressman Mike Gallagher, chair of…
Capsida Biotherapeutics (“Capsida”) today announced that Peter Anastasiou, Chief Executive Officer, will present a corporate update at the Evercore ISI 2024 Emerging Biotech Conference which is being held virtually February 28-29, 2024. About Capsida BiotherapeuticsCapsida Biotherapeutics is an integrated gene therapy company developing treatments for rare and common diseases across all ages. Capsida’s new class of engineered adeno associated virus (AAV)-based delivery technologies enables a broad range of therapeutic modalities, including DNA, RNA, gene editors, vectorized antibodies and other genetic cargoes, to be systemically delivered to specific organ systems while simultaneously limiting exposure to non-targeted organs. Capsida’s proprietary capsid engineering and broad…
In this photo released by China’s Xinhua News Agency, staff members work in an inflatable COVID-19 testing lab provided by Chinese biotech company BGI Genomics in Beijing, June 23, 2020.(via AP) Biotechnology promises to revolutionize everyday life, with scientists and researchers using it to make rapid advances in medical treatment, genetic engineering in agriculture and novel biomaterials. Because of its potential, it has caught the attention of both the Chinese and US governments. Bills have been introduced in the House and Senate to bar “foreign adversary biotech companies of concern” from doing business with federally funded medical providers. The bills…
U.S. lawmakers are raising alarms about what they see as America’s failure to compete with China in biotechnology, warning of the risks to U.S. national security and commercial interests. But as the two countries’ rivalry expands into the biotech industry, some say that shutting out Chinese companies would only hurt the U.S. Biotechnology promises to revolutionize everyday life, with scientists and researchers using it to make rapid advances in medical treatment, genetic engineering in agriculture and novel biomaterials. Because of its potential, it has caught the attention of both the Chinese and U.S. governments. Bills have been introduced in the House and…
More biotech companies filed for bankruptcy in 2023 than any year since 2010, underscoring a brutal year defined by layoffs, company closures and pipeline reprioritizations, according to data from S&P Global Market Intelligence. 2023 eclipsed all other years by far, with 18 companies filing for protection compared to eight in 2022, which had previously held the record as the highest bankruptcy year. The year kicked off with Sorrento Therapeutics filing Chapter 11 amid a legal battle with billionaire Patrick Soon-Shiong and his immunotherapy biotech NantCell. The company had $235 million in debt and had run out of options. Sorrento had…
Entertainment Network (India), the operator of FM radio channel Radio Mirchi, on Tuesday reported a 21% increase in total revenue to Rs 140 crore.The company’s EBITDA stood at Rs 44.3 crore, showing a 36.4% rise on year-on-year basis, primarily driven by topline growth. ENIL announced profit after tax of Rs 21.6 crore for Oct-Dec quarter, marking a 108% jump.The digital segment contributed Rs 11.4 crore to the revenue, making up 13% of total radio revenues. Additionally, ENIL invested Rs 6.2 crore in strengthening its digital presence, the company said.The international business was seen to be stable with EBITDA of over Rs 2.3 crore during the quarter
The U.S. should review Chinese biotech firm WuXi AppTec and its affiliate WuXi Biologics (HK:2269) for sanctions, a bipartisan group of lawmakers told top Biden administration officials on Monday. In a letter dated Feb. 12 and seen by Reuters, the lawmakers told Treasury Secretary Janet Yellen, Defense Secretary Lloyd Austin and Commerce Secretary Gina Raimondo that the global pharmaceutical giant’s links to China’s Communist Party and military threatened U.S. national security. The letter, signed by the Republican chair and Democratic ranking member of the House select committee on China, Representatives Mike Gallagher and Raja Krishnamoorthi, and Senators Gary Peters and Bill…
A new biotech company that aims to harness the immune system to treat a range of skin diseases will launch on Monday with $100mn in seed financing. Alys Pharma, based in Boston and Geneva, has been founded by Medicxi, the European healthcare investment fund, with six university scientists who together have a substantial minority shareholding in the company. New technology — particularly the application of immunology — is transforming dermatology from a low-margin pharmaceutical backwater into a fast-growing, high-value market, said Francesco De Rubertis, executive chair of Alys. “We are poised to become a leader in immuno-dermatology, with a broad…
The past year saw a string of pipeline cuts and downsizing plans strike the biotech job market. Have layoffs spooked young professionals looking for a way into the industry, and does the employment landscape seem to be looking up this year? Employment in the life sciences industry had hit a record 2.1 million jobs in the U.S. at the beginning of 2023, according to a report by CBRE. But this came after a decline in employment growth in 2022, owing to soaring interest rates and retreating investors. And then, a contagion of layoffs took over the biotech sector last year. Now, the industry…