Industry Trends Archives - Medical Design Sourcing

30 biotech startups making waves

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The biotech industry is facing a reckoning in 2023. To date, roughly 100 biopharmas have cut workers this year, matching the total number of layoffs in the sector in 2022. Many biotech startups have been hit hard. The wave of job cuts comes on the heels of a biotech boom following the COVID-19 pandemic, when new biopharmas proliferated.

Against this turbulent backdrop, a select group of biotech startups have managed to sustain growth. We’ve selected 30 firms that have collectively raised nearly $8 billion. A fair share of these companies are focused on AI techniques to accelerate drug discovery while others have homed in on niche areas like gene therapies, RNA modulation and epigenetic therapies.

1. Tempus Mission: Applying AI for cancer care and beyond. With a valuation ranging in billions and high-profile partnerships, Tempus has forged high-profile partnerships as it extends i…

Regeneron agrees to spend up to $213M to acquire Decibel Therapeutics

To date, 2023 is shaping up to be a relatively brisk year for M&A deals. A recent case in point is Regeneron’s acquisition of Decibel Therapeutics. The centerpiece of the deal is DB-OTO, a gene therapy intended for patients with otoferlin-related hearing loss. The drug is in its first clinical trial. Regeneron agreed to pay $4.00 per share for Decibel stock with the potential to pay up to $3.50 per share in cash if Decibel hits agreed-upon regulatory milestones for DB-OTO in a specified time frame, bringing the total value of the deal to roughly $213 million.

Last year, Decibel touted DB-OTO’s ability to support otoferlin expression for several weeks before it plateaued. The company said the data for the drug were in line with earlier preclinical research in which mice achieved a functional recovery.

Involved in transmission of sound signals in the inner ear, the protein otoferlin is essential for hearing. Deficiency or mutations in the gene that produces o…

Illumina’s record EU fine could drive smaller M&A pharma deals

This table summarizes some of the largest fines from the European Union on companies for a variety of violations.

Illumina, the world’s largest gene sequencing company, faces a record fine from the E.U. for acquiring startup Grail without approval. The $8 billion deal closed in August 2021 despite ongoing EU. and U.S. investigations. A year later, the EU prohibited the merger, citing reduced innovation and choice. The expected $453 million fine, which would be the largest ever in the E.U. that aims to deter unauthorized deals. The chart on the right shows some of the most substantial fines in EU history.

Francis deSouza resigned as CEO and director of Illumina Inc. on June 11, 2023. The company named Charles Dadswell, senior vice president and general counsel, as interim CEO, while the board conducts a search for a new CEO.

Grail’s pioneering work on early cancer detection through blood tests pu…

Seven biologics walking the approval tightrope in 2023

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As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for the first time, as Nature reported, but sponsors face mounting scrutiny from regulators.

In the spotlight is the FDA’s Accelerated Approval program, which has faced criticism following a string of high-profile cases of post-approval confirmatory trial failures. For example, the Alzheimer’s drug aducanumab won accelerated approval despite conflicting evidence from clinical trials. Oncology is another area where negative confirmatory trials of accelerated approval drugs has been a concern.

Such developments have led the FDA to increase …

The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…