– Company is aligned with the FDA on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –
– Comparative analytical studies anticipated to commence in Q4 2024 –
– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package –
Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone deficiency (GHD).
Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial.
Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.
“Based on our strong phase 2 clinical data reported previously for petosemtamab in HNSCC both as monotherapy and in combination with pembrolizumab, I continue to be confident that petosemtamab has the opportunity to become a new standard of care across r/m HNSCC and potentially beyond,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Our recently announced alignment with the FDA on phase 3 dose, and excellent execution to date has allowed us to promptly initiate our registration trials in 1L and 2/3L HNSCC.” \
More details of the trial can be found at clinicaltrials.gov.
US-based biopharmaceutical company Kezar Life Sciences has suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis.
The decision to suspend the trial was made following recommendations from an independent data monitoring committee (IDMC) after it had reviewed safety data from the trial.
According to the safety findings, four Grade Five (fatal) serious adverse events (SAEs) were reported during the trial in subjects enrolled in Argentina and the Philippines.
The IDMC's review indicated that three of the fatalities shared a pattern of symptoms and occurred close to the time of dosing.
https://finance.yahoo.com/m/5477554f-a83d-357a-852b-09dc038c51dd/kezar-life-sciences-suspends.html
AstraZeneca announces that the supplemental Biologics License Application (sBLA) for Enhertu has been accepted with priority review by the FDA to treat HER2-low or HER2-ultralow unresectable or metastatic breast cancer.
A federal judge said Amgen must face a proposed class action accusing the drugmaker of waiting too long to tell shareholders it might owe the Internal Revenue Service $10.7 billion for underreporting six years of taxes.
U.S. District Judge John Cronan in Manhattan ruled on Monday that shareholders plausibly alleged they were misled by Amgen's "reckless" concealing of its "enormous" potential tax liability.
Neither Amgen nor its lawyers immediately responded to requests for comment. Lawyers for shareholders led by the Detroit-based Roofers Local No. 149 Pension Fund did not immediately respond to similar requests.
Amgen's top-selling products include the osteoporosis treatment Prolia and the rheumatoid arthritis drug Enbrel.
The IRS accused Amgen of underreporting taxes from 2010 to 2015, mainly for attributing what should have been U.S. taxable income to a Puerto Rico unit that produces many of its drugs.
Though Puerto Rico is a U.S. territory, it is considered a foreign country for corporate tax purposes.
The roofers fund said Amgen's share price fell 6.5% on Aug. 4, 2021 and 4.3% on April 28, 2022 because the Thousand Oaks, California-based biotech company waited until then to disclose the tax risks.
In seeking a dismissal, Amgen said it "did not hide" the IRS' position, and had warned that the agency was becoming more aggressive in policing how companies allocated income and expenses among tax jurisdictions
CVS Health is exploring options that could include a break-up of the company to separate its retail and insurance units, as the struggling healthcare services company looks to turn around its fortunes amid pressure from investors, people familiar with the matter told Reuters.
CVS has been discussing various options - including how such a split would work - with its financial advisers in recent weeks, the sources said, requesting anonymity as the discussions are confidential.
The plan to potentially split the company's pharmacy chain and the insurance business has been discussed with the board of directors, which is yet to decide on the best course of action for CVS to pursue, the sources said, cautioning that the plans have not been finalized and CVS may opt for a different strategy.
CVS is also discussing whether its pharmacy benefits manager unit, which manages drug benefits for health plans, should be housed within the retail unit or under insurance, if it were to proceed with a separation that could result in two publicly traded companies, the sources said.
Such a move would effectively unwind CVS's landmark $70 billion takeover of healthcare insurer Aetna in 2017 and come as CVS attempts to navigate one of the most challenging periods in its six-decade history.
A CVS spokesperson declined to comment on whether it is holding talks to explore options.
"CVS’s management team and Board of Directors are continually exploring ways to create shareholder value," the spokesperson said. "We remain focused on driving performance and delivering high quality healthcare products and services enabled by our unmatched scale and integrated model."
The latest discussions come as CVS faces increasing pressure from investors such as Glenview Capital, which is said to be pushing for changes at the company to help improve its operations, after it cut its 2024 earnings outlook for a third consecutive quarter in August.
CVS, which has a market value of about $79 billion and held long-term debt of roughly $58 billion at the end of December, in August lowered its annual profit forecast to $6.40 to $6.65 per share, from its previous forecast of least $7.00 per share.
"While we view management's...adjusted EPS growth target for 2025 as attainable, we believe uncertainty around performance in 2024, as well as the outcome of CVS's 2025 Medicare Advantage bids, creates an unclear outlook for 2025 and beyond," TD Cowen analysts wrote in an Aug. 11 note.
https://finance.yahoo.com/news/exclusive-cvs-explores-options-including-230217242.html
Germany has become the first Western country to initiative an emergency evacuation of its citizens from Lebanon utilizing military transport planes amid the rapidly deteriorating security situation.
Some 110 passengers were flown out of Beirut international airport in an initial flight on a German air force A321 plane on Monday. The group included diplomats and non-essential staff from the German embassy as well as their families. German citizens who with medical conditions were also on this first flight
Essential personnel at Germany's embassy in Beirut have remained, in order to help facilitate the safe exit of the estimated 1,800 German citizens still in the country.
"German nationals who are particularly at risk due to medical circumstances are also being taken," a statement of the military transport flight.
More such military facilitated flights are likely, but a timeline is unclear at this point. There's an expectation of wider war as Israeli builds up military forces along the border for an 'imminent' ground incursion into south Lebanon.
Israel has also for the first time since 2006 begun striking targets in central Beirut. An estimated one million people throughout the country, but especially in the south, have been displaced thus far.
A German government spokesman announced Monday that "we are currently at a stage where we support the departure (of citizens) but we are explicitly not in an evacuation scenario."
The statement emphasized that "all Germans in Lebanon have been urged to leave the country since October 2023."
However, given the almost complete halt to commercial airline traffic at Beirut–Rafic Hariri International Airport, and the fact that Germany had to utilize a military flight to get its diplomats and citizens out in a first wave, it sure looks like this is the start of an evacuation scenario.
Currently the US and UK have troops positioned in nearby Cyprus, ready to help if those countries order military-assisted evacuations.
