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According to the American Society of Health System Pharmacists, 323 drugs are currently experiencing shortages in the United States, the highest number the organization has seen since it began recording drug shortages in 2001. These include chemotherapies, ADHD medications, oxytocin and more. And the threat of shortages has a chance to be exacerbated further, at least in the short term, due to pending bipartisan legislation in both houses called the BIOSECURE Act,. If enacted, it might prevent American companies from working with key Chinese biotech contractors like WuXi AppTec, WuXi Biologics and MGI Tech. Stock prices have fallen significantly for these companies since the bill was introduced, and drug companies have warned investors that passage of the bill could have manufacturing impacts as well as cause delay in clinical trials.
Defenders of the bill say that this will ultimately improve competition – and decrease reliance on China. “We have seen this play before with Huawei and America’s telecoms sector. This bipartisan and bicameral bill will ensure U.S. taxpayer funds do not advance efforts by BGI and other [Chinese Communist Party]-backed companies to put Americans at long-term risk,” bill cosponsor Senator Bill Hagerty (R-TN) said in a press release when the bill was introduced.
So far it’s not clear whether the bill will pass this year, and what the ultimate legislation will look like. But given that pharmaceutical supply chains are complicated and involve years-long contracts (not to mention regulatory approvals), attorneys in the healthcare sector have been advising clients to start preparing to make changes. Industry trade group Biotechnology Innovation Organization announced it would support the legislation last month after initially opposing it, as the group walks the tightrope between trying to allay shortages but also support American manufacturing. The group expressed its desire to “work with Congress and the White House to develop policies and legislation that align with and advance a vibrant biotechnology industry for the United States and its allies.”
Meet The Billionaire-Owned Company Making Injectors For Blockbuster Drugs Like Ozempic
SHL Medical
The runaway success of weight loss drugs took the markets by storm last year, spurring huge stock gains for drugmakers like Novo Nordisk, which makes Wegovy and Ozempic. Most patients take them at home in weekly injections, using plastic, pen-like devices known as autoinjectors, filled with the liquid medication and fitted with a tiny needle as wide as two human hairs.
As demand for the drugs soars, so does the need for those devices. That growth has now minted a new billionaire: Roger Samuelsson, the 60-year-old Swedish cofounder of Switzerland-based SHL Medical, one of the world’s largest manufacturers of autoinjectors. Forbes estimates he’s worth $3 billion, largely thanks to his 69% stake in the company he cofounded in 1989.
Pipeline & Deal Updates
Multiple Sclerosis: Genentech released new data from the phase III trial of its relapsing, remitting MS treatment ocrelizumab as a subcutaneous injection. The data showed that patients had “near complete suppression” of brain lesions and relapses for nearly a year after receiving the twice-yearly shot of the drug. The intravenous version of the drug was approved by the FDA in 2017.
Healthcare IT: Accenture Federal Services will be acquiring Cognosante, a health IT provider for several federal agencies, for an undisclosed amount.
Biomanufacturing: Fujifilm Diosynth announced that it will be investing $1.2 billion to expand its manufacturing facility in North Carolina.
Artificial Intelligence: Analytics startup Kontakt.io, which develops software for healthcare systems to optimize operations, announced it has raised a $47.5 million investment led by Goldman Sachs to expand its AI capabilities.
Psoriasis: Teva and Alvotech announced that the FDA has approved Selarsdi, a biosimilar to Stelara, for the treatment of psoriasis and psoriatic arthritis.
New ‘One-And-Done’ Vaccine Method Could Protect Infants—From Covid, Flu—With Just A Single Shot, Study Suggests
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Researchers are pitching a new vaccine method for infants that offers continued protection with just a single dose, even if the virus mutates, according to a new study that could set the stage for “universal vaccines.”
Other Healthcare News
UnitedHealth Group estimated the total impact of the cyberattack on its Change Healthcare unit will cost the company between $1.35 billion and $1.6 billion in 2024.
A late-stage trial of Eli Lilly’s weight loss drug Zepbound showed promising results in treating sleep apnea symptoms.
The European Union’s drug regulator said there is no evidence linking diabetes and weight loss drugs like Ozempic and Wegovy to an increase in suicidal thoughts.
The CDC said there is no evidence to suggest Covid vaccines could cause sudden cardiac death and other heart problems in young people.
The U.S. Supreme Court allowed Idaho to enforce a controversial ban on gender-affirming care to minors while the law is being appealed.
Across Forbes
Meet The Skydiving Billionaire With Sky-High Returns
TikTok Mishandled The Data Of Hundreds Of Top American Advertisers
Green Hydrogen’s Hype Hits Some Very Expensive Hurdles
What Else We are Reading
AI traces mysterious metastatic cancers to their source (Nature)
New Long Covid trials aim to clear lingering virus—and help patients in dire need (Science)
