Dive Brief: Medtronic agreed to buy EOFlow, a company based in South Korea that makes a tubeless, disposable insulin pump on a patch. The company will make a public tender offer to acquire all of EOFlow’s outstanding public shares for 971 billion South Korean won ($738 million). The purchase will allow Medtronic to compete with Insulet, which has gained market share with its tubeless insulin pumps, and Tandem Diabetes Care, which agreed last year to buy patch pump-maker AMF Medical. Dive Insight: Medtronic, with a warning letter recently lifted from its U.S. diabetes business, aims to bring new products to market. The company plans to integrate its new insulin dosing algorithm, which is used in the 780G pump, with EOFlow’s pump. “We’ve never lost faith in our technology,” Medtronic CEO Geoff Martha said on a Thursday earnings call, adding that “the patch segment is a good segment and we ...
Just as biopharma’s M&A prospects seemed to be improving, the U.S. antitrust watchdog is putting a damper on dealmaking. The U.S. Federal Trade Commission has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, the agency said Tuesday. By a unanimous vote among the three Democrat commissioners, the agency is seeking a temporary restraining order and preliminary injunction to prevent the transaction from closing. In an alarming sign for biopharma M&A scrutiny to come, the FTC argues Amgen could leverage its existing product portfolio to “entrench the monopoly positions” of Horizon meds for thyroid eye disease and chronic gout. The antitrust challenge marks the first time that the FTC has reached beyond specific product overlaps in its reviews and instead focused on companies’ past behaviors around drug pricing. It’s an approach that the agency has threatened to implement since 2021 but has only now reared its ...
An Astellas Pharma drug that treats hot flashes and night sweats from menopause is now approved by the FDA, a regulatory decision that makes the therapy the first one that hits a particular central nervous system target to ease the symptoms of this change in life. The Friday approval of the drug, fezolinetant, covers the treatment of moderate-to-severe vasomotor symptoms caused by menopause. Tokyo-based Astellas will market the once-a-day pill under the brand name Veozah. In an email, the company said the new drug will carry a wholesale price of $550 for a 30-day supply. Astellas expects Veozah will become available within three weeks. Menopause brings a decline in the production of estrogen and progesterone. The resulting hormonal imbalance can affect the way the body regulates body temperature, leading to hot flashes, the sudden and intense feelings of warmth. While hormone therapy is standard treatment for such vasomotor symptoms, ...
CTI Biopharma has something many biotech companies aspire to achieve—revenue. Sales of its approved cancer drug are growing, but commercialization comes with costs as does development of the molecule for additional indications. CTI expects it will need to raise money, but the dismal financial conditions mean fundraising prospects for any biotech company could remain challenging for the foreseeable future. Enter Swedish Orphan Biovitrum (Sobi), the Stockholm-based rare diseases biopharmaceutical company. Sobi has agreed to acquire CTI in a cash deal that values the Seattle-based biotech at $1.7 billion. According to the terms of the deal, Sobi will pay $9.10 for each share of CTI, which represents an 89% premium to the stock’s price before the deal was announced Wednesday. The heart of the acquisition is Vonjo, a drug for myelofibrosis, a rare bone marrow cancer that impairs the production of red blood cells. Last year, the FDA granted accelerated approved ...
Six months after Gilead got a smackdown in the United States for its drug to treat hepatitis delta virus (HDV), bulevirtide has scored a regulatory win in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given bulevirtide a thumbs up for patients with HDV and compensated liver disease. If the European Commission signs off on the entry inhibitor, it will become the only authorized treatment for HDV in Europe. Known commercially as Hepcludex, the drug received conditional approval in Europe three years ago. Since then, a phase 3 trial has demonstrated the effectiveness and safety of the treatment. Gilead hoped the results of the MYR301 study—which were released in June of last year and showed significant viral declines after 48 weeks of treatment—would pave the way for approval in the U.S. But the FDA sent Gilead a complete response letter (CRL) citing manufacturing and delivery concerns. The regulator did not ask Gilead to conduct another ...
Fingerpaint Group has a mind to draw biopharma companies a clearer picture of their market access options—and now it has MYND to help it do so. By acquiring MYND Group, Fingerpaint has continued its takeover spree and added to the capabilities of its recently rebranded market access group. Healthcare marketing agency Fingerpaint moved into market access early in 2020 with the acquisition of 1798, a California-based developer of market access and commercialization support programs. Late last year, Fingerpaint dropped the 1798 name. Rebranded as Fingerpaint Market Access, the unit, which had been involved in 30 launches in the previous three years, pitched itself as an end-to-end consultancy. Now, Fingerpaint has added to its market access capabilities. MYND is a Pennsylvania-based provider of a range of market access services, spanning from market research through to the training of sales teams. The services overlap with Fingerpaint’s existing capabilities. In a statement, Bill McEllen, global president ...
Jenny Craig has alerted employees to potential mass layoffs as it begins “winding down physical operations” and hunts for a buyer, according to communications the weight-loss company sent some staffers this week. The company said it “has been going through a sales process for the last couple of months,” according to a document titled “Jenny Craig Company Transition FAQs” that was dated Tuesday and provided to NBC News. Several Jenny Craig staffers said the company alerted them in recent days about potential layoffs. The FAQ document said: “While we had to issue Warn Notices specifically for sites where we had more than 50 people potentially impacted, this will likely impact all employees in some manner. “We do not know the exact employees/groups whom will be impacted, and if any employees may be retained. As a result, we would suggest that you anticipate that your employment may ...
Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that weren’t ...
Omar Ford Quest Diagnostics is diving into a quickly growing segment of liquid biopsy with its latest M&A prospect. The Secaucus, NJ-based company announced a definitive agreement to acquire Haystack Oncology in an all-cash equity transaction. Quest will pay $300 million in cash at closing and Haystack has the potential to obtain up to an additional $150 million in performance milestones. If the deal were to close, then Quest would inherit Baltimore, MD – based Haystack’s minimal residual disease testing technology. MRD testing is a specific category of liquid biopsy that identifies circulating tumor DNA (ctDNA) in the bloodstream of patients following surgery and treatment for cancer. In a prospective, multi-institution study published in the New England Journal of Medicine in June 2022, an earlier version of the Haystack technology demonstrated the ability to better identify patients with residual disease for adjuvant chemotherapy after surgery for stage II colon cancer, thereby reducing ...
Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
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