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EY’s John Babitt provided a mid-year 2022 update on medtech investment trends, and the outlook for the industry going into 2023 in this commentary for In Vivo.
After a runaway 2021 and a strong if bumpy Q1 2022, all health care product sectors underwent an investment dip in Q2, says Silicon Valley Bank. Healthtech in Europe remained a stand-out performer.
European payers and health technology appraisal organizations have warned that their decision making is being increasingly hampered by evidence gaps. Some solutions may lie in the better use of existing mechanisms, such as scientific advice and managed entry agreements, while others could be introduced through the overhaul of the EU pharmaceutical legislation.
During Q2, biopharma merger and acquisition value reached $25.4bn and drew in $27.3bn in potential deal value from alliances. Device company M&A values reached $2.7bn, while in vitro diagnostic firms and research tools players completed M&A activity that totaled $534.3m.
Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.
A balanced policy environment that can support biosimilar competition is needed to allow the drugs to flourish in the US, says Amgen’s executive director of marketing and global biosimilars commercial lead Chad Pettit.
Drug manufacturers have been feeling the crunch from global supply chain issues, but the FDA will accept no excuses when it comes to quality and safety. How can manufacturers prepare for proposed changes to quality measurement requirements?
During Q2, biopharmas brought in an aggregate $12.5bn in financing and device company fundraising totaled $3.7bn; while in vitro diagnostic firms and research tools players raised $720m.
Offering a challenging but blossoming free market model, strong academic institutions and an excellent track record in patents, the Swiss Biotech industry is one to watch.
Pfizer social media announcement that it’s seeking full approval for the oral COVID antiviral raise questions about where the line is on promotion versus other communications, FDA’s ability to regulate pharma on social media, and the unique considerations of promotion under EUAs.
Six $1B+ alliances were penned in June. Topping the list was a potential $4.26M deal between Immatics and Bristol Myers Squibb for the development of multiple allogeneic off-the-shelf TCR-T and/or CAR-T programs. The companies seek to develop two BMS-owned programs and both firms will have an option to develop up to four additional programs each. The programs will utilize Immatics’ ACTallo proprietary allogeneic gamma delta T cell-derived adoptive cell therapy platform. BMS contributes its suite of next-generation technologies as well as its oncology drug development expertise. Bristol Myers Squibb was also involved in the top June M&A by deal value. The company entered into an agreement to acquire Turning Point Therapeutics in an all-cash transaction with an equity value of $4.1B. Founded in 2013 as TP Therapeutics, Turning Point has advanced a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis. Its lead asset, repotrectinib, is a next-generation, potential best-in-class tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer and other advanced solid tumors. Repotrectinib has been granted three Breakthrough Therapy designations from the US FDA. BMS expects the therapy to be approved in H2 2023 and become a new standard of care for patients with ROS1-positive NSCLC in the first-line setting. Turning Point also has several other clinical-stage oncology candidates in addition to multiple discovery programs. Financing reached $5.2bn in biopharma, $498m in device, and $311m in diagnostics.
In Vivo's Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in June 2022. Data provided by Biomedtracker.
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