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Wednesday, January 24, 2024

Twist Expands Express Genes Rapid Synthesis Service

Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced the expansion of Twist Express Genes, a new leading gene synthesis service with an order to shipping turnaround starting at five business days1, to include larger DNA preparations up to 1 milligram.

The Express Genes offering, initially launched in November 2023, now extends to larger midiprep (10μg to 100 μg) and maxiprep (100μg to 1mg) DNA preparations. As with Twist standard speed Clonal Genes, all Twist Express Genes are NGS-verified as clonally perfect.

https://www.businesswire.com/news/home/20240124209204/en/

Biogen cut to Neutral from Buy by UBS

 Target to $276 from $311

https://finviz.com/quote.ashx?t=BIIB&ty=c&ta=1&p=d

GSK in Agreement on Elegen’s Cell-Free DNA Production Tech

 

  • Multi-year collaboration allows GSK to leverage Elegen’s cell-free synthetic DNA production technology.
  • Agreement provides Elegen up to $35 million in near-term financial and development support and fees, in addition to sales of ENFINIA DNA and a potential equity investment in Elegen by GSK.
Elegen, a leader in DNA manufacturing innovation, today announced a collaboration and licensing agreement with GSK (LSE/NYSE: GSK) to enable its use of Elegen’s proprietary cell-free DNA manufacturing technology in the development of GSK’s vaccines and medicines.

The terms of the agreement include upfront fees and purchase commitments of Elegen’s ENFINIA DNA to support GSK’s development of medicines and vaccines, including RNA vaccines. Elegen is also eligible to receive both near-term milestone payments relating to the development of new product features and a potential equity investment in Elegen by GSK.

Commercially launched in March of last year, ENFINIA DNA delivers NGS-verified, high-complexity, clonal-quality, linear DNA up to 7kb in as fast as seven business days. Unlike conventional synthesis of mRNA from linearized plasmid DNA, Elegen’s DNA is produced entirely cell-free, with the potential to enable a seamless transition from discovery to clinical scale-up under GMP. This technology may save significant time and substantial resources spent iteratively cloning, linearizing and purifying plasmid DNA as well as generating master cell banks. Elegen’s innovation in cell-free DNA manufacturing technology represents a significant leap forward that could power the next generation of mRNA, cell and gene therapies.

This collaboration follows the Early Access Program launched by Elegen in May of last year that offered DNA of longer length and higher complexity to select customers. “Over the past year dozens of customers, including multiple top 10 biopharma, have validated the unprecedented speed, length, accuracy and complexity of our cell-free DNA manufacturing technology,” said Matthew Hill, Ph.D., Elegen founder and CEO. “GSK recognizes the importance of a reliable, turnkey supply of DNA for a variety of applications for which speed, accuracy and quality of DNA synthesis are essential. This collaboration will expand our offering to include the clinical production of genetic medicines potentially including mRNA, cell and viral gene therapies.”

https://www.businesswire.com/news/home/20240124105579/en/

Boeing, Not Spirit, Mis-Installed Door Plug That Blew Out; Insider Whistleblower Says

 ...and the hits keep coming for Boeing.

An anonymous self-described Boeing insider told the Seattle Times that Boeing's 737 production system is described as “a rambling, shambling, disaster waiting to happen.”

Specifically, the whistleblower said that the fuselage panel that blew off an Alaska Airlines jet earlier this month was removed for repair then reinstalled improperly by Boeing mechanics on the Renton final assembly line

China "Unexpectedly" Cuts Required Reserve Ratio In Desperate Bid To Contain Market Collapse

 In a move many said was very long overdue, this morning China which has paradoxically waited too long until deflation reigns across the country, said it will cut the required reserve ratio (RRR) by 50bps within two weeks and hinted at more support measures to come, which while coming largely in time with the easing ahead of the lunar new year was an unusually early disclosure that shows mounting urgency across President Xi Jinping’s government to shore up the economy and halt a $6 trillion stock-market rout. The cut was announced unexpectedly by People’s Bank of China Governor Pan Gongsheng during a press conference on Wednesday in Beijing and sends a new signal that officials are eager to curb the stock-market selloff, while also stepping up support for the broader economy.

The RRR, which determines the amount of cash banks have to keep in reserve, will be lowered by 0.5% on Feb. 5 to provide 1 trillion yuan ($139 billion) in long-term liquidity to the market, the People’s Bank of China’s Governor Pan Gongsheng told reporters at a briefing.

Theratechnologies CRL for F8 Formulation of Tesamorelin sBLA

 

  • FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity
  • CRL does not impact commercial availability of EGRIFTA SV®, the F4 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV and lipodystrophy
https://www.biospace.com/article/releases/theratechnologies-receives-complete-response-letter-crl-from-the-fda-for-the-f8-formulation-of-tesamorelin-sbla/

Annovis Bio Refines Timeline for Parkinson’s Phase III Study Data Announcement

 Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, has announced a postponement in the Phase III study data release for buntanetap in Parkinson’s Disease. This adjustment is due to ongoing data cleaning efforts to ensure the accuracy and reliability of the study results.

“We acknowledge the ongoing anticipation for the Phase III data announcement initially set for the end of January 2024. However, the delivery of the cleaned data is now delayed as we work to provide the most accurate results by ensuring the process is conducted diligently and thoroughly," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "During this period, the Company remains blinded to the data, and the statistical analysis is yet to be performed. We understand your potential frustration with the required extension, and we want to stress that our focus is on delivering results that are trustworthy. We are working hard to provide them to you very soon."

The Company is dedicated to maintaining open communication and will continue to provide updates for Parkinson’s Phase III study results in a timely and informative manner.

About the Phase III Trial
This study is a Phase III, randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients on top of their standard of care. Patients were treated with buntanetap (10 mg or 20 mg) or placebo for 6 months. The study was initiated in August 2022 with a record pace of full enrollment in just nine months and a total of 616 screened, 523 randomized and 471 completed patients across 67 sites (43 in the United States and 24 in the European Union).   Screen failure (15%) and drop out (9.9%) rates were below projections.

https://www.biospace.com/article/releases/annovis-bio-refines-timeline-for-parkinson-s-phase-iii-study-data-announcement/