Two fitusiran Phase 3 studies published in The Lancet and The Lancet Haematology highlight potential to address unmet needs across all types of hemophilia
Both Phase 3 studies achieved their primary and secondary endpoints; fitusiran prophylaxis demonstrated significant and clinically meaningful improvements in bleed protection across all hemophilia populations, presented at ASH 2021
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that it has paid the total principal amount due of $402.5 million under its 0.625% Convertible Senior Notes due 2023 (2023 Notes), in addition to payment of the remaining outstanding interest due of $1.3 million. Following the repayment, the 2023 Notes are no longer outstanding. The repayment of the 2023 Notes at maturity was financed primarily with available cash on hand and, to a lesser extent, through a borrowing under the Company’s existing credit line agreement.
https://finance.yahoo.com/news/supernus-announces-repayment-convertible-notes-200500495.html
California's vast amount of agricultural land is facing a significant issue due to a series of atmospheric rivers in recent months, which have saturated fields to the point where planting crops has become difficult.
"It's just too damn messy and muddy to create a quality pack. You don't want a bunch of mud on the produce," Christopher Valdez, president of the Grower-Shipper Association of Central California, told USA Today.
More than a dozen powerful storms later, 78 trillion gallons of water has been dumped on California, reversing a multi-year drought in a matter of months. Now the agricultural powerhouse state, producing about a third of the country's vegetables and three-quarters of its fruits and nuts, faces planting delays due to washed-out fields
According to USA Today, the planting delays experienced by California's 69,000 farms may disrupt the supply of vegetables and fruits.
In some instances, farmers have delayed plantings since January. Valdez noted:
"I don't expect there will be shortages, but there will be some gaps."
California is the top-producing state of figs, table grapes, kiwis, nectarines, peaches, persimmons, plums, and pluots. The wet, cool weather is expected to slow plant development this spring.
Additionally, California produces around 90% of the country's processed tomatoes and over a quarter of the global total. The current challenge is that fields are too wet for transplanting greenhouse tomato seedlings, resulting in delays for the next crop cycle.
It's still being determined whether shortages will occur and lead to increased supermarket prices. The economic impact is already hitting farmers and field workers.
"We're talking about workers who aren't getting jobs, and their homes may also have been flooded," said Daniel Sumner, a professor of agricultural economics at the University of California, Davis.
California consistently faces challenges in producing crops, no matter if it's wet or dry. It may be a good idea to consider starting your own garden as a precaution against potential supply disruptions that could emerge later in the year.
https://www.zerohedge.com/weather/too-dam-messy-flooded-california-farmland-delays-plantings
As tick season kicks in across the country, the executive director of the University of Massachusetts Amherst-based New England Center of Excellence in Vector-Borne Diseases (NEWVEC) and his team have completed research that offers a promising lead in the fight against Lyme disease.
The study, published recently in the journal Vector-borne and Zoonotic Diseases, demonstrates that the blood of the white-tailed deer kills the corkscrew-shaped bacterium that causes Lyme disease, a potentially debilitating illness. The Centers for Disease Control and Prevention (CDC) estimates that each year some 476,000 people are diagnosed with and treated for Lyme, the most common vector-borne disease in the U.S.
"Deer are vitally important to the survival of deer ticks, but they are not involved with transmitting the Lyme bacteria, Borrelia burgdorferi," explains senior author Stephen Rich, professor of microbiology. "We've known for some time that ticks taken from white-tailed deer are not infected, and we speculated that something about the deer prevented those ticks from becoming infected. But until publication of our paper, no one had done the experiment to show that deer blood -- specifically the serum component of white-tailed deer blood -- kills Lyme."
The results of the study may one day lead to new strategies and approaches for Lyme disease prevention and treatment, says lead author Patrick Pearson, a Ph.D. student in NEWVEC, whose upcoming doctoral examination focuses in part on this research.
"In these experiments we determined that white-tailed deer serum kills theLymebacterium. The next important question will be to understand exactly how deer blood kills Lyme bacteria," Pearson says.
The research is one project of NEWVEC, which was funded by the CDC last year with a $10 million award to prevent and reduce tick- and mosquito-borne diseases in New England. NEWVEC aims to bring together academic communities, public health practitioners, residents and visitors across the Northeast, where Lyme infections are concentrated.
The Lyme disease bacterium is passed to juvenile blacklegged (Ixodes scapularis) deer ticks from mice the arthropods feed on. The infected ticks then pass the bacterium on to humans when they feed on people.
"We are the accidental host," Rich says. "The ticks that bite us are actually looking for a deer because that's where they breed. Without the deer, you don't have ticks. But if you had only deer, you wouldn't have any Lyme."
To carry out their experiment, the researchers obtained blood serum from a semi-captive white-tailed deer herd at Auburn University in Alabama. The deer were believed to have no exposure to ticks and the bacteria that causes Lyme disease.
The researchers then grew the Lyme disease germ in test tubes and added the deer serum. "And lo and behold, it killed the bacteria," Rich says. "Whatever it is in the deer that's killing the germ is part of the innate immune system, a part of the immune system that precedes antibodies."
Pearson adds, "The Lyme bacterium has proteins on its surface that protect it from the human innate immune system. Deer blood is somehow different such that Lyme bacteria are apparently unable to protect themselves from the innate immune system of white-tailed deer."
The next research step is to determine the precise mechanisms in deer blood that kill the bacteria.
"We'd like to determine if it's something we can induce in humans," Rich says. "Or maybe we could use this somehow to our advantage to reduce the incidence of Lyme disease in the wild."
Journal Reference:
While Merck & Co.’s Seagen merger wasn't fated to be, the companies’ clinical courtship in cancer has blossomed into a swift approval at the FDA.
Monday, the U.S. drug regulator blessed the combo of Seagen and Astellas Pharma’s antibody-drug conjugate Padcev and Merck’s PD-1 king Keytruda as an initial therapy for adults with locally advanced or metastatic urothelial cancer (la/mUC). The accelerated approval specifically tees up the combo for patients who don’t qualify for cisplatin-based chemotherapy, Seagen and Astellas said in a Monday release.
There are between 8,000 to 9,000 bladder cancer patients with locally advanced or metastatic disease who fall under that cisplatin-ineligible category in the U.S., Ahsan Arozullah, M.D., M.P.H., head of oncology development at Astellas, said in a statement.
Padcev won its original approval in the U.S. under the FDA’s accelerated approval pathway, which it has since converted into a full, traditional green light. As a monotherapy, the antibody-drug conjugate is cleared for use in la/mUC patients who received prior treatment with a PD-1 or PD-LI inhibitor like Keytruda, plus a platinum containing chemotherapy in the neoadjuvant/adjuvant metastatic setting. The therapy is also approved for patients who are ineligible for cisplatin-containing chemotherapy who’ve previously received one or more prior lines of therapy.
For Seagen, the approval should help the cancer specialist grow on the commercial front. Last summer, SVB’s senior biotech analyst Andrew Berens projected Padcev will reach $7.7 billion in peak sales.
Merck & Co. is set to benefit from the approval as well, with the regulatory nod poised to extend Keytruda’s patent protection in the la/mUC indication out past 2027.
To keep hold of the accelerated nod, meanwhile, Seagen and Astellas must verify the Padcev-Keytruda combo’s clinical merits in the confirmatory trial EV-302.
The FDA based its approval on positive results from two cohorts in the partners’ phase 1b/2 study EV-103, which saw patients on the combination reach a 68% confirmed overall response rate (ORR). Of that sum, 12% of patients enjoyed a complete response, versus 55% who charted a partial one.
Padcev plus Keytruda for la/mUC carries a boxed warning for serious skin reactions, plus warnings about the potential for high blood sugar, inflammation of the alveoli in the lungs/interstitial lung disease, nervous system damage, eye disorders, and infusion site leakage, plus toxicity to embryos and fetuses in the womb.
Throughout much of 2022, industry watchers held their breath in anticipation of Merck's Seagen-buyout-that-wasn't.
After that proposed deal reportedly stalled on the bargaining table, Pfizer swooped in to steal Seagen for $43 billion in March.
The League of Women Voters of New York State filed a federal lawsuit Wednesday against the state’s Board of Elections, seeking to postpone the June 28 primary for statewide offices.
Along with two voters, the organization claims the board used congressional maps that a state judge threw out to determine if candidates’ petitions to join the primary were successful.
Under New York election laws, parties may nominate candidates for the primary at conventions. Those who do not get nominated that way can submit petitions to get on the ballot. However, those aspiring candidates must get 500 signatures from registered voters in at least half of the state’s congressional districts.
The lawsuit said the board certified primary candidates on May 4, a week after the New York State Court of Appeals upheld a lower court’s ruling that the new 26-district map featured districts unfairly tilted toward Democrats.
The new map of congressional districts is expected to be released on Friday.
Besides moving the primary to Aug. 23 - the same date as the primary for the new congressional districts - the league and other plaintiffs want the deadline extended for circulating petitions for statewide offices.
“The State Board of Elections, apparently with the support of the leaders of both major political parties, put in place a deliberately exclusionary electoral regime for statewide offices designed to limit further competition in the primary and from independent candidates in the general election,” Laura Ladd Bierman, executive director of the league, said in a statement.
Efforts were unsuccessful, at time of this publishing, to get a response from the Board of Elections.
Petra Gopfert, one of the plaintiffs in the case, said she wants to vote for former Gov. Andrew Cuomo in either the gubernatorial or lieutenant governor primary.
Cuomo resigned from office last August after a report found several women’s sexual harassment complaints against him to be credible. Cuomo disputed the report but left office saying he did not want it, and a likely impeachment, to be a distraction as the state recovered from COVID-19.
“It is not satisfactory to me that I might be able to vote for Mr. Cuomo as an independent or a write-in,” Gopfert stated in her affidavit. “If I were to do that – vote for him as an independent or a write-in in the general election – I would be deprived of my ability to support Mr. Cuomo as the standardbearer for the Democratic party, and to express my support for the Democratic party in the general election.”
Loulise Erskine, the other plaintiff in the case, stated in her affidavit that she wants to vote for Paul Nichols in the Democratic primary for governor.
Nichols did not make the primary ballot. Over the weekend, he and two other people filed a state lawsuit in Manhattan seeking to move all primary elections to Aug. 23.
Vice Chancellor Nathan Cook of the Delaware Chancery Court said the purchase agreement "clearly and unambiguously" left Merck liable for claims related to products, including Dr. Scholl's foot powder, sold before the transaction closed.
The companies face potentially billions of dollars of liability from lawsuits by consumers alleging that asbestos contained in talc-based products such as Dr. Scholl's caused cancer.
Merck claimed that its liability ended on Oct. 1, 2021, seven years after the transaction closed, and sued Bayer after the German company refused to assume liability.
But the judge called Bayer's interpretation of the purchase agreement "the only reasonable one," and said letting Merck "dump" cases would give the Rahway, New Jersey-based company an incentive to prolong or stall lawsuits.
"Nothing in the (agreement) indicates that the parties intended Bayer to assume liability for all of Merck's actions for the period during which it formulated, marketed, and sold the products" at issue, Cook wrote in a 37-page decision.
Merck did not immediately respond to requests for comment. Bayer did not immediately respond to a similar request.
The $14.2 billion purchase also included Merck's Claritin allergy medicine and Coppertone sunscreen lines.
Bayer separately inherited liability for litigation over whether the weedkiller Roundup causes cancer when it spent $63 billion in 2018 to buy Monsanto.
In June 2020, Bayer agreed to settle much of that litigation for $10.9 billion. As of February 2023, about 109,000 of the 154,000 claims it faced had been settled or deemed ineligible.
The case is Merck & Co v. Bayer AG, Delaware Chancery Court, No. 2021-0838.
