I recently participated in IndustryWeek’s Production Pulse livestream on a panel that discussed the manufacturing stories that drove 2023 and what that means for 2024.
Prepping for this panel got me thinking: what have been the biggest issues in pharma this year? Here are a few that topped my list:
Controlling costs of modern therapies
This conversation usually starts with cell and gene therapies, simply because they come with the largest price tags. If the future hope is to move these therapies beyond the rare disease, small patient population indications into larger patient groups (for example, sickle cell disease), something must be done to address costs because current payment models in the U.S. will struggle to support therapies that cost multiple millions per dose.
Solving this problem is a multi-pronged effort: better policies in place, new reimbursement models — but how this has manifested on the manufacturing side is a push to get drug manufacturers to get costs down as low as possible.
Whether it's optimizing facility design, more efficient clinical trials or using computational and AI advancements to streamline development and production, there’s been an overall push to increase efficiency and reduce waste.
Continued public focus on drug prices
Drug pricing has been in the public and political crosshairs for years, and as we move into an election year, the pressure is only going to increase. Because drug pricing is not well understood by those outside the industry, a big component to this is a push for more transparency.
On the state level, the industry could see stricter Drug Price Transparency (DPT) laws. These laws inform the public which pharma manufacturers are increasing prices, why they are doing so, by how much, and how often. Some refer to it as “shame and blame” system.
The industry will also have to face federal involvement. A big issue this year has been the portion of the Inflation Reduction Act which looks to lower prescription drug costs by allowing Medicare to negotiate prices with drug companies and by putting a cap on drug prices. If the prices of certain drugs covered under Medicare rise at a rate that exceeds inflation, drugmakers have to pay a rebate to the government.
There was immediate backlash from the pharma industry. Merck was the first to formally challenge the law. The drugmaker argued the program is unconstitutional. According to Merck, the Fifth Amendment requires the U.S. government pay “just compensation” if it takes property for public use — but the IRA allows the government to obtain innovations without providing fair value for them. J&J, Astellas Pharma and BMS have subsequently filed similar suits.
The Centers for Medicare & Medicaid Services unveiled the initial 10 medications designated for Medicare price negotiations in accordance with the IRA back in August and this will take effect in 2026.
FTC turns up the heat
Speaking of government oversight, back in 2021, the Federal Trade Commission vowed to take a more aggressive stance on pharma mergers and it has followed through this year.
The FTC filed a lawsuit early this year to attempt to block Amgen's $27.8 billion buyout of Horizon — the deal eventually closed in October after Amgen agreed to some of the FTC's settlement terms. The agency also took aim at Pfizer’s $43 billion acquisition of Seagen, that deal finally closed earlier this month after Pfizer agreed to donate royalties from one of the drugs in question. More recently, we saw Sanofi back out of a $755 million licensing deal with Maze Therapeutics after the FTC moved to block the acquisition of a Pompe Disease drug.
The long-reaching impacts of platinum-based chemotherapy shortages have dominated headlines as of late, shining a bright light on what has been an ongoing issue in U.S. health care for over a decade.
Drug shortages are complex and driven by a variety of causes, among them business decisions, natural disasters, ingredient and packaging supply constraints, quality issues and regulatory actions.
The broad public health issue, which has been prioritized by regulators, health care industry groups and lawmakers on both sides, has once again found its way to the President’s desk. In November, President Biden announced that he will invoke the Defense Production Act to encourage the manufacture of essential medicines in the U.S. and mitigate drug shortages.
What were your takeaways from 2023? And what can the industry expect in 2024? Let us know! –Karen Langhauser
BMS closes the year on a high note
The holiday season hasn't slowed Bristol Myers Squibb's deal-making.
Earlier this week, BMS announced its plan to acquire RayzeBio in a $4.1 billion cash deal, aiming to establish a presence in the rapidly growing radiopharmaceutical sector. RayzeBio's focus on actinium-based radiopharmaceuticals, different from existing Lutetium-177-based drugs, offers potential advantages, including increased efficacy and more precise targeting.
Earlier this month, BMS finalized its largest antibody-drug conjugate (ADC) deal of the year, signing a license and collaboration agreement with SystImmune. The agreement, valued at up to $8.4 billion, centers around a potentially groundbreaking bispecific ADC targeting both EGFR and HER3.
And just a few weeks before that, the pharma giant acquired Karuna Therapeutics, a specialist in psychiatric and neurological treatments, in a $1.4 billion deal.
Dr. Samit Hirawat, BMS' Chief Medical Officer of Drug Development, emphasized that this acquisition positions the company in a promising and swiftly expanding area for solid tumor treatment. RayzeBio, founded in August 2020, boasts a well-funded pipeline with its lead program, RYZ101, in phase 3 development for gastroenteropancreatic neuroendocrine tumors and early-stage development for small cell lung cancer and other tumor types. — Andrea Coronaa