 |
|
|
|||||
In Novo Nordisks legal fight against dozens of U.S. pharmacies and companies selling cheaper copies of its weight-loss drug Wegovy, one name remains conspicuously absent: Hims & Hers. The high-profile telehealth company continues to sell compounded versions of Wegovy at lower prices, testing the limits of federal restrictions on such copies and contributing to weaker sales growth for Novo. In June, Novo accused Hims of violating its intellectual property and endangering patients, scrapping a brief arrangement enabling them to sell Wegovy directly to consumers and raising expectations of litigation. A Novo spokesperson said the Danish drugmaker was not ruling out further legal action after announcing new lawsuits against 14 small pharmacies, telehealth providers and weight-loss clinics this week, but declined to comment on Hims. The drugmaker has filed more than 130 cases in 40 U.S. states. A spokesperson for Hims defended personalization of medicines as the future of healthcare, saying patients and providers use their platform to make clinical decisions. “Investors are happy to see Novo getting more aggressive on the litigation front, but remain puzzled as to why they havent confirmed that they are filing or have filed litigation against Hims yet,” said Barclays analyst Emily Field. Legal experts say Novos expanding litigation against smaller telehealth players could add pressure on a company like Hims to negotiate a settlement or help the drugmaker test out strategies. At the same time, the fact that Novo and Hims had a prior collaboration may complicate legal action. “Business happens in the shadow of the law,” said Robin Feldman, a professor at UC Law San Francisco who has written books on the pharmaceutical industry and its intellectual property battles. “Sometimes companies file against smaller players as a shot across the bow, a way to rattle the larger players.” The U.S. Food and Drug Administration set a May 22 deadline for compounding pharmacies to cease mass-producing copies of Wegovy, a practice allowed only when a drug is in shortage. Hims says it still offers personalized versions of Wegovy, in doses not manufactured by Novo, that better suit individual patient needs. The telehealth provider argues that individualized dosing remains legal under compounding rules. Compounding laws are just vague enough to allow for different interpretations, and the interpretation that matters that of the courts has not been provided to our knowledge, said TD Cowen analyst Michael Nedelcovych.Novos cases against smaller compounders could shape how courts interpret those boundaries, said Gaston Kroub, a partner at patent litigation firm Kroub, Silbersher & Kolmykov. This is an untested set of affairs, said Kroub. If you want to train for a heavyweight championship fight, you start sparring with lighter opponents.In addition to trademark infringement, Novo has accused pharmacies of steering people toward compounded Wegovy by interfering with the relationship between clinicians and patients.Josh Gerben, an intellectual property attorney, said the fact that Hims and Novo had a prior business relationship will complicate any claim Novo could bring. Maggie Fick and Diana Novak Jones, Reuters
Category:
E-Commerce
New Jersey-based DermaRite Industries has announced a voluntary recall of individual lots of soap and skincare products due to microbial contamination, which has been identified as Burkholderia cepacia, the company said last week. The bacterium can cause serious and life-threatening infections. The Food and Drug Administration (FDA) published a recall announcement on August 9. Impacted products include over-the-counter (OTC) antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers. The following products are included in the recall: OTC Healthcare antiseptic lotion soap DermaKleen OTC External Analgesic DermaSarra OTC Antimicrobial foam soap KleenFoam OTC Antiseptic cleanser PeriGiene The FDA recall notice includes a list of impacted products with their lot numbers, expiration dates, reorder numbers, product descriptions, and product labels. The recalled products were distributed nationwide in the United States and Puerto Rico. You can also find full-color images of the impacted product labels on DermaRite’s website. The company says it has not received any reports of adverse events related to the recall. Bacterial infection could cause life-threatening sepsis According to a “risk statement” published by DermaRite, the contaminated products may be used by immunosuppressed individuals and people caring for immunosuppressed individuals. Burkholderia cepacia can cause serious, life-threatening infections, according to the Centers for Disease Control and Prevention (CDC). While healthy individuals with minor skin lesions are only likely to experience local infections, people with weakened immune systems are more at risk. For immunosuppressed individuals, the infection is more likely to spread into the bloodstream and could lead to life-threatening sepsis. Sepsis can cause extensive inflammation throughout the body and cause tissue damage, organ failure, and death. Consumers should destroy impacted products DermaRite alerted distributors and customers to the voluntary recall by email and told them to examine their inventory and destroy all affected products immediately. If you have questions about the recall, contact Mary Goldberg by calling 973-569-9000 x104 Monday through Friday, 9:00 am to 5:00 pm EST or by emailing voluntary.action@dermarite.com. If you have experienced problems related to using the impacted products, contact a healthcare provider. Report any adverse reactions experienced as a result of using these products to the FDAs MedWatch Adverse Event Reporting program. You can file a report online, download a reporting form, or call 1-800-332-1088 to request a reporting form to submit by fax or mail.
Category:
E-Commerce
Michigan Gov. Gretchen Whitmer met privately in the Oval Office with President Donald Trump to make a case he did not want to hear: The automotive industry he said he wants to save was being hurt by his tariffs.The Democrat came with a slide deck to make her points in a visual presentation. Just getting the meeting Tuesday with the Republican president was an achievement for someone viewed as a contender for her party’s White House nomination in 2028.Whitmer’s strategy for dealing with Trump highlights the conundrum for her and other Democratic leaders as they try to protect the interests of their states while voicing their opposition to his agenda. It’s a dynamic that Whitmer has navigated much differently from many other Democratic governors.The fact that Whitmer had “an opening to make direct appeals” in private to Trump was unique in this political moment, said Matt Grossman, a Michigan State University politics professor.It was her third meeting with Trump at the White House since he took office in January. This one, however, was far less public than the time in April when Whitmer was unwittingly part of an impromptu news conference that embarrassed her so much she covered her face with a folder.On Tuesday, she told the president that the economic damage from the tariffs could be severe in Michigan, a state that helped deliver him the White House in 2024. Whitmer also brought up federal support for recovery efforts after an ice storm and sought to delay changes to Medicaid.Trump offered no specific commitments, according to people familiar with the private conversation who were not authorized to discuss it publicly and spoke only on condition of anonymity to describe it.Whitmer is hardly the only one sounding the warning of the potentially damaging consequences, including factory job losses, lower profits and coming price increases, of the import taxes that Trump has said will be the economic salvation for American manufacturing.White House spokesman Kush Desai said no other president “has taken a greater interest in restoring American auto industry dominance than President Trump.” Trade frameworks negotiated by the administration would open up the Japanese, Korean and European markets for vehicles made on assembly lines in Michigan, Desai said.But the outreach Trump has preferred tends to be splashy presentations by tech CEOs. In the Oval Office on Wednesday, Apple CEO Tim Cook gave the president a customized glass plaque with a gold base as Cook promised $600 billion in investments. Trump claims to have brought in $17 trillion in investment commitments, although none of those numbers has surfaced yet in economic data.Under his series of executive orders and trade frameworks, U.S. automakers face import taxes of 50% on steel and aluminum, 30% on parts from China and a top rate of 25% on goods from Canada and Mexico not covered under an existing 2020 trade agreement. That puts America’s automakers and parts suppliers at a disadvantage against German, Japanese and South Korean vehicles that only face a 15% import tax negotiated by Trump last month.On top of that, Trump this past week threatened a 100% tariff on computer chips, which are an integral part of cars and trucks, though he would exclude companies that produce chips domestically from the tax.Whitmer’s two earlier meetings with Trump resulted in gains for Michigan. But the tariffs represent a significantly broader request of a president who has imposed them even more aggressively in the face of criticism.Materials in the presentation brought by Whitmer to the meeting and obtained by The Associated Press noted how trade with Canada and Mexico has driven $23.2 billion in investment to Michigan since 2020.General Motors, Ford, and Stellantis operate 50 factories across the state, while more than 4,000 facilities support the auto parts supply chain. Altogether, the sector supports nearly 600,000 manufacturing jobs, forming the backbone of Michigan’s economy.Whitmer outlined the main points of the materials to Trump and left copies with his team.To Grossman, the Michigan State professor, a key question is whether voters who expected to be helped by tariffs would react if Trump’s import taxes failed to deliver the promised economic growth.“Everyone’s aware that Michigan is a critical swing state and the auto industry has outsized influence, not just directly, but symbolically,” Grossman said.AP VoteCast found that Trump won Michigan in 2024 largely because two-thirds of its voters described the economic conditions as being poor or “not so good.” Roughly 70% of the voters in the state who felt negatively about the economy backed the Republican. The state was essentially split over whether tariffs were a positive, with Trump getting 76% of those voters who viewed them favorably.The heads of General Motors, Ford and Stellantis have repeatedly warned the administration that the tariffs would cut company profits and undermine their global competitiveness. Their efforts have resulted in little more than a temporary, monthlong pause intended to give companies time to adjust. The reprieve did little to blunt the financial fallout.In the second quarter alone, Ford reported $800 million in tariff-related costs, while GM said the import taxes cost it $1.1 billion. Those expenses could make it harder to reinvest in new domestic factories, a goal Trump has championed.“We expect tariffs to be a net headwind of about $2 billion this year, and we’ll continue to monitor the developments closely and engage with policymakers to ensure U.S. autoworkers and customers are not disadvantaged by policy change,” Ford CEO Jim Farley said on his company’s earning call.Since Trump returned to the White House, Michigan has lost 7,500 manufacturing jobs, according to the Bureau of Labor Statistics.Smaller suppliers have felt the strain, too.Detroit Axle, a family-run auto parts distributor, has been one of the more vocal companies in Michigan about the impact of the tariffs. The company initially announced it might have to shut down a warehouse and lay off more than 100 workers, but later said it would be able to keep the facility open, at least for now.“Right now it’s a market of who is able to survive, it’s not a matter of who can thrive,” said Mike Musheinesh, owner of Detroit Axle. Joey Cappelletti and Josh Boak, Associated Press
Category:
E-Commerce
All news |
||||||||||||||||||
|
||||||||||||||||||