Fierce Biotech

The FDA outlined a new pathway for the expedited approval of medical devices, diagnostics and certain combination products that aim to improve upon the safety of those currently on the market.

Scientists at Vanderbilt University say they’ve found a potential way to improve the process by which the heart repairs itself after a heart attack, and it comes from an unlikely source—a compound in Roche’s library that was initially designed to treat rheumatoid arthritis.

After a whirlwind year and two quick-fire raises, cancer startup Black Diamond Therapeutics has nabbed Yumanity, Merck KGaA and SR One veterans to help head up its research work.

In this week's EuroBiotech Report, Lundbeck inks $2 billion Alder buyout, Euro biotechs raise cash and blast rocks Russian smallpox lab.

In our EuroBiotech roundup this week, Nordic Nanovector delays phase 2b readout, PPF buys big Autolus stake and Poxel shares phase 3 diabetes data. 

Centrexion Therapeutics has restarted its attempt to list on the Nasdaq. The Jeff Kindler-helmed biotech pulled the plug on a planned IPO last year but now hopes to find investors more amenable to its bid to raise money for a phase 3 pain program.

Ginkgo Bioworks has raised $290 million. The synthetic biology unicorn will use the series E funds to continue building on a cell programming platform it thinks can upend multiple industries.

New phase 2a data show Spruce's lead drug reduced the level of three hormones overproduced by patients with congenital adrenal hyperplasia, teeing it up for its next trial slated to start in 2020.

Trials for cancer drugs undertaken in Europe in the mid-2010s were flawed to such a degree as to “raise questions” over their true benefit to patients, according to a new report out this week from British science journal The BMJ.

About 10 months after first announcing the move, Google has subsumed the healthcare-focused efforts of U.K.-based artificial intelligence firm DeepMind—and with them, its data-sharing partnerships with multiple National Health Service hospitals.

KRAS made a splash at this year’s ASCO after Amgen’s early data for first-to-clinic inhibitor AMG 510 triggered blockbuster chatter. Now one research team has early evidence that the combo could further increase KRAS inhibitors’ therapeutic effects in lung cancer.

X4 Pharmaceuticals has a new R&D chief: Renato Skerlj, Ph.D., who founded the company alongside CEO Paula Ragan, Ph.D. and biotech luminary Henri Termeer. Skerlj joins X4 from Lysosomal Therapeutics, where he led drug discovery and preclinical development efforts.

Last week, Shanghai Henlius Biotech teed up for a $477 million IPO on the Hong Kong Stock Exchange. It fell a little short when it priced on Wednesday, ultimately bagging $410 million, but still made the top five biopharma IPOs so far this year.

Amgen has tapped Adaptive Biotechnologies to deliver next-generation sequencing assays as it moves drugs toward approval. Under a four-year agreement, Adaptive’s clonoSEQ Assay will be used to assess minimal residual disease in clinical trials.

Boundless Bio was founded on a discovery that a group of cancer-driving mutations called amplifications occur in extrachromosomal DNA, or DNA that resides outside of the chromosome in cancer cells.

German pharma Bayer led One Drop’s $40 million series B round and licensed its technology for its “bio-digital efforts” in areas beyond diabetes including cancer, heart disease and women's health.

Abbott has received European approvals for two devices designed for children and infants with life-threatening heart defects—including the world’s smallest mechanical heart valve and a separate implant designed for the tiniest babies.

Using ultra-small device implants being developed by Iota Biosciences, Astellas Pharma hopes to explore new methods of delivering diagnostics and therapies that could work in concert with traditional treatments—or even replace them.

Versantis has raised a €16 million ($18 million) series B round. The Swiss biotech will use the money to gather clinical proof-of-concept data on a drug designed to clear out ammonia and other toxic metabolites that contribute to poor health outcomes in liver disease patients.

Moncef Slaoui and his colleagues at Medicxi have taken the wraps off a new oncology startup, Divide & Conquer. The biotech wants to interrupt the cell-to-cell communication that may make some solid tumors hard to treat.