July - September 2021
FDA Revises Labeling of Biogen’s Alzheimer’s Drug to Emphasize Early Treatment
The Food and Drug Administration, under heavy criticism over its decision last month to approve Biogen’s Alzheimer’s drug Aduhelm, has revised the medicine’s prescribing information in an effort to focus treatment to the type of patients who were included in clinical testing. The FDA’s June 7 approval of Aduhelm was made more controversial by the agency’s decision to clear the drug for broad use, even though Biogen’s studies only
enrolled patients with mild Alzheimer’s. Under the FDA’s initial approval of Aduhelm, patients in the United States would be eligible for treatment, despite Biogen never having studied the drug in patients in later stages of disease.
Related Cos., CareMax Partner Up to Develop Senior Health Centers in Underserved Communities
Related Cos., one of the largest owners of affordable housing in the U.S., is acquiring as much as a 9% stake in healthcare provider CareMax Inc. as part of its plan to develop scores of senior health centers in underserved urban communities throughout the U.S. Related, a developer of office buildings, malls and upscale apartments as well as affordable housing, will act as an investor, adviser, developer and, in some cases, landlord of CareMax
health centers. As part of the deal, Related will buy $5 million in CareMax stock and receive warrants to purchase up to 8 million shares at $11.50 a share.
FDA Approves First Biosimilar to Top-Selling Eye Drug Lucentis
The U.S. Food and Drug Administration on Monday approved the first biosimilar version of Lucentis, a blockbuster biologic drug for age-related macular degeneration and two other eye conditions. The biosimilar, called Byooviz, was developed by Samsung Bioepis and will be sold by partner Biogen when patents protecting Lucentis expire next year. Byooviz is the second biosimilar to be approved in the U.S. in 2021 after the agency cleared Mylan and Biocon’s Semglee as interchangeable with Sanofi’s Lantus. The FDA approved three
biosimilars last year and to date has approved 31 of the copycat drugs.
Startup EQRx to Take Drug Price Mission Public through $1.8B SPAC Deal
EQRx, a startup with lofty ambitions to develop competitors to top-selling drugs at much reduced prices, will go public through a merger with a blank-check company backed by the biotech venture firm Casdin Capital and the hedge fund Corvex Management. The deal, announced Friday by EQRx and the special-purpose acquisition company CM Life Sciences II, will give EQRx access to $1.8 billion in new funds, dramatically increasing the
resources it has on hand to support a business plan. EQRx’s business plan remains unproven, however. It is unclear how well EQRx can deliver on its promise of cheaply developing dozens of other drugs as good as, or better than, established medicines.
Merck Wins Approval for Cancer Drug Acquired in 2019 Biotech Buyout
Merck & Co. on Friday said it has won Food and Drug Administration approval for a targeted cancer drug it acquired two years ago in a $1 billion buyout of biotech Peloton Therapeutics. The drug, which will be sold as Welireg, is cleared to treat several types of tumors that are associated with a rare genetic condition called von Hippel-Lindau disease, or VHL. In a small clinical trial of 61 people with VHL-associated cancer, treatment with Welireg shrank tumors in the kidney, nervous system and pancreas. Welireg is the first drug of its type to win FDA approval, Merck said in a August 16 statement.
Pandemic Special Enrollment Period Led to Record Number of ACA Enrollees
More than 2.8 million people signed up for healthcare coverage during the special enrollment period for Affordable Care Act plans that ran from February 15 through August 15, putting the number of people enrolled in an ACA plan at its highest level ever, according to a release from HHS. The American Rescue Plan passed earlier this year also expanded premium tax credits and helped drive down premiums — over 90% of those who
enrolled during the SEP saw their premiums reduced, and 48% of new HealthCare.gov enrollees pay $10 or less a month in premiums after tax credits, according to the release. Existing enrollees have also benefited, saving an average of $67 a month on premiums, according to HHS
Pfizer Stocks Cancer Drug Pipeline with $2.3B Deal for Trillium
Pfizer is building up its pipeline of experimental cancer medicines, announcing a deal to buy the Cambridge, Massachusetts-based biotech Trillium Therapeutics for nearly $2.3 billion. The acquisition marks a dramatic turnaround for Trillium, which was worth less than $50 million at the start of last year. Under deal terms, Pfizer agreed to pay $18.50 per share of the biotech, valuing the company at a premium of more than 200% to the stock’s closing price on Friday. By buying Trillium, Pfizer gains access to two drugs in early stages of clinical testing for a range of blood cancers, like lymphoma, as well as certain solid tumors.
Google Disbands Health Unit as Chief Departs for Cerner
Google is dissolving its health division, Google Health, after three years as the head of the unit, David Feinberg, departs to become CEO of health IT vendor Cerner. Google is splitting its health projects and teams across several other divisions of the company. Alphabet’s Google created the Google Health division in 2018 to bring its health initiatives under a single umbrella. The Mountain View, California-based company remains committed to healthcare and will continue to invest in the space, but the goal of the reshuffling is to put its teams in the areas that make the most sense for its projects.
Business Groups Withdraw Suit Challenging Health-Price Transparency Rule
The U.S. Chamber of Commerce and a Texas affiliate withdrew a suit filed to block parts of a federal rule requiring insurers and employers to disclose prices they pay for healthcare services and drugs. The withdrawal came after the Biden administration delayed enforcement of provisions of the rule that were the focus of the suit. The suit, which was filed against the U.S. Department of Health and Human Services and other federal agencies
on August 10, claimed provisions of the rule, which required disclosure of prices for healthcare services and drugs in machine-readable files, went beyond federal authority and could raise healthcare costs. Enforcement of some provisions of the rule was delayed to July 1, 2022, from January 1, 2022. Enforcement of a requirement to disclose drug prices was delayed indefinitely pending new rule making.
Headspace, Ginger to Merge, Creating $3B Mental Health Company
Meditation and mindfulness startup Headspace and on-demand mental healthcare app Ginger have announced plans to merge into a single company, called Headspace Health, valued at $3 billion. The two startups focused on mental health and wellness have each raised more than $200 million in venture funding from investors. As Headspace Health, the two companies will offer support for mental health symptoms from anxiety to depression
to more complex diagnoses, selling direct to consumers and to employers and health plans. Financial terms of the deal, which is expected to close in the fourth quarter this year, were not disclosed.
BioMarin Wins European Approval to Sell Drug for Dwarfism
BioMarin Pharmaceutical can sell its drug for dwarfism in Europe after regulators there granted a market authorization, two months following the European Medicines Agency’s endorsement of the California biotech company’s treatment. BioMarin’s drug, which it will sell under the brand name Voxzogo, is the first medicine to be made available in Europe for achondroplasia, the most common cause of dwarfism. Under an access plan with authorities in France, BioMarin plans to charge roughly $300,000 per patient per year.
FDA Approves First-of-Its-Kind Stroke Rehabilitation System
The U.S. Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve stimulation (VNS). The Vivistim System is not approved for use outside of its intended use to stimulate the vagus nerve during chronic ischemic stroke
rehabilitation therapy for moderate to severe loss of upper extremity function. It should not be used in patients with vagotomy, which is surgical removal of part of the vagus nerve.