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Good morning. At the start of this week, one of my colleagues lamented that we weren’t seeing the flood of news we’d typically expect around this time of year. It seems he may have spoken too soon — let’s get into all the news we have this morning.
The need-to-know this morning
- Belgian firm Galapagos NV said it would split itself into two companies, with the brand-name biotech aiming to prioritize its oncology efforts. The other company, an as-yet-to-be-named branch now known as SpinCo, plans to build up a pipeline through transactions. SpinCo was established with about $2.5 billion in cash from Galapagos.
- Sana Biotechnology reported very early data on a potentially curative therapy for Type 1 diabetes.
- Jasper Therapeutics reported preliminary results from a mid-stage study of its drug briquilimab in patients with chronic hives.
- Viking Therapeutics announced the start of a mid-stage study of its oral obesity treatment.
A looming patent cliff could fuel JPM deal-making
The annual J.P. Morgan Healthcare Conference is prime time for companies to court potential M&A and licensing deals. And at this year’s gathering, there will be even greater pressure to find a good match, as the pharmaceutical industry faces one of the largest patent cliffs in recent history.
Between now and 2033, the patents on dozens of brand-name medications including Keytruda, Eliquis, and Jardiance will expire, with drug companies standing to lose more than $400 billion in revenue. (By comparison, the last major patent cliff that hit the industry, in 2011, jeopardized around $250 billion in drug revenue.)
One of the primary ways companies navigate a patent cliff is to acquire startups and new drugs. As a result, many experts anticipate pharma ramping up M&A activity in 2025, starting at the J.P. Morgan conference next week.
“I think people need to buckle up, because it’s already twice as frothy and could get even more,” said an attorney who specializes in M&A.
Read more from STAT’s Allison DeAngelis and Adam Feuerstein.
Califf looks back on his term and worries about the new FDA era
Departing FDA Commissioner Robert Califf sat down with STAT in a wide-ranging interview ahead of the arrival of the new Trump administration. He defended the FDA’s record under his leadership, praised the progress that has been made in changing the way the agency regulates food, and expressed worries about the impact of the coming Trump administration.
“I’m a political appointee, and the election didn’t go as I hoped it would, and given the statements that have been made by various people who are in contention for key posts, I have a lot of reason to be concerned,” he said.
Califf also echoed the fears of other critics of the Trump administration, saying brain drain in the government was a legitimate worry: “It’s already happening. I mean, we’re seeing an increase in early retirements and loss of good people.”
Read more from STAT’s Matt Herper.
Startup launches with neuro candidates from Denali
A new company called Tenvie Therapeutics launched today with several neuroscience drug candidates acquired from Denali Therapeutics.
The startup has raised $200 million from ARCH Venture Partners — one of Denali’s early investors — as well as F-Prime Capital, Mubadala Capital, and others.
Tenvie’s launch highlights the considerations that startups, and neuroscience companies, in particular, must make in tough capital markets. While Tenvie is a preclinical company for now, executives anticipate its initial financing will allow it to advance into human trials and gather Phase 1 data, if not more. Lately, more and more biotechs are launching with drug candidates that they’ve licensed or acquired from other firms, and rapidly moving into clinical trials.
Read more from STAT’s Allison DeAngelis.
Medicare gains advantage in negotiating on Ozempic
The FDA approved generic versions of older GLP-1 drugs exenatide and liraglutide in November and December. While those treatments don’t work as well as semaglutide (the scientific name of Ozempic and Wegovy), their much lower costs could give Medicare leverage to push for lower prices for semaglutide, experts said.
Experts expect that semaglutide will to be among the next 15 drugs up for price negotiation. Medicare will announce that list by Feb. 1, and the negotiated prices will take effect in 2027.
The law doesn’t stop Medicare from using inferior drugs as comparators for negotiating prices; the program used inferior drugs as therapeutic comparators during the first round of negotiations.
Read more from STAT’s John Wilkerson.
East Asians under-represented in biopharma leadership
From STAT’s Usha Lee McFarling: Despite working in high numbers in the biopharma industry, East Asian Americans are absent from the top leadership positions in the field’s largest companies, according to a report being released today by ELEVAATE, a non-profit dedicated to advancing East Asian Americans in biopharma.
The report analyzed publicly traded drug companies with market capitalizations of over $500 million and found that East Asians held 7% of C-suite roles among all companies, but among the industry’s largest companies, they held just 2.5% of C-suite roles, and 1.2% of board seats. (Asian Americans make up an estimated 25% of the pharmaceutical workforce, of which ELEVAATE estimates about 7% to 13% is East Asian.)
In the largest drug companies, only four of 160 C-suite positions were held by East Asians and none was a CEO. Of those who were CEOs of smaller companies, half were founders of their own companies, a background less common for white CEOs who were more often selected by boards.
The report echoes other findings about Asian Americans within science in recent years — notably, they receive major research awards at lower rates and are less likely to hold leadership positions in academic medicine.
More reads
- Pfizer executives descend on Donald Trump’s Mar-a-Lago for planning meeting, Financial Times
- Using lab-grown human mini-brains, scientists find links between head trauma, herpes, and Alzheimer’s, STAT