Borealis majority owner OMV in talks with Borouge backer Adnoc
Broad outline for merger talks may be reached in coming weeks
Abu Dhabi and Austria’s OMV AG are exploring a combination of Borouge Plc and Borealis AG to create a chemicals and plastics company worth more than $30 billion, people familiar with the matter said.
The owners are discussing the potential valuation and ownership structure of a combined entity and may reach the broad outlines for formal merger negotiations in the coming weeks, according to the people. Talks have been on-and-off for several months and could still be delayed or fall apart, they said, asking not to be identified because deliberations are private.
MediWound Ltd. announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization. The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming the data are robust and similar to the company’s previous studies.
In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective, randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each.
Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC). Patients who achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure.
EscharEx uses the same active pharmaceutical ingredient (API) as the NexoBrid®, which has been approved for debridement of thermal burns in the U.S. and Europe.
Shares of Alvotech have rebounded on Monday from a minor selloff last week following the company's disclosure that approval for its drug candidate AVT02 would likely be delayed in the U.S.
The stock is up 20% at $9.30 in premarket trading. At Friday's close, shares had fallen 22% since the start of the year.
The Icelandic company said Wednesday that it had received a complete response letter from the U.S. Food and Drug Administration for a second biologics license application it submitted for AVT02, a biosimilar candidate to Abbvie's Humira.
Because approval is likely to be delayed, Alvotech said it would explore options to raise additional capital to continue advancing pipeline development in the near-term.
Shares sank by more than 8% the next day but recovered on Friday to close at $7.74.
Amneal Pharmaceuticals on Monday said it received abbreviated new drug application approvals from the U.S. Food and Drug Administration for some complex generic products.
The drug company said the approvals pertain to Medroxyprogesterone acetate injectable suspension, a generic version of Depo-Provera, and Dexmedetomidine Hydrochloride, a generic version of Precedex injection. Others include Nelarabine injection, Dapsone and Mometasone furoate nasal spray, generic versions of Arranon Injection, Aczone, and Nasonex, respectively.
The news came in tandem with Amneal's launch of an authorized generic of Xyrem oral solution CIII in the United States. The sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients seven years and older with narcolepsy.
"By adding these new medicines to our portfolio, Amneal is on track to launch more than 30 new generics products this year," said Chirag and Chintu Patel, co-chief executive officers.
China and Honduras started talks over a free trade pact on Monday, the Central American country's government announced in a post on social media, in the latest advance between the two nations and their recent diplomatic and economic opening.
Honduras economy ministry dubbed the day "historic" in a post on Twitter.
Eduardo Reina, the Honduran foreign minister, told reporters earlier on Monday that China's deputy trade minister will visit Tegucigalpa on July 6-8 to participate in trade talks.
Last month, Beijing approved Honduran imports of bananas, coffee and shrimp.
The start of trade negotiations comes after Honduras broke off its longstanding ties with Taiwan in March, and moved to establish relations with mainland China and its massive economy, the world's second-biggest.
Nearly four out of every 10 teen girls and young women in the US have an iron deficiency, which can lead to low energy and brain fog,a new study published in JAMA found.
To conduct the study, researchers at the University of Michigan Medical School analyzed blood test data collected over the last 20 years from the National Health and Nutrition Examination Survey, which is a part of the Centers for Disease Control and Prevention.
With 40% of American females aged 12 to 21 likely having an iron deficiency, those rates shot up for those who had low-BMI, were low-income and identified as black and Latina.
The research also found that one in every 17 females in the studied age group have low enough iron levels to be diagnosed with iron-deficiency anemia, which can have a great impact on one’s health if not treated properly.
The most concerning part of these statistics is that the majority of girls and women who have dangerous low levels of iron are not aware as the symptoms are common for other disorders. Standard health screenings for their age groups do not require a ferritin test, which measures iron levels.
Researchers hope that this study will lead to more ferritin tests, which measures iron levels, being ordered for teen girls and young women.Stock Photo/Getty Images Symptoms of iron deficiency include fatigue, cold extermities, hair loss, brittle nails, cognitive issues like brain fog, decreased athletic performance, shortness of breath, junk food cravings, headaches and sleep disorders.
The ferritin test is typically run most consistently on toddlers, people who are pregnant or those who have a long list of symptoms associated with anemia.
The CDC recommends anemia screening for female adolescents, who are not pregnant, and women every five to 10 years.
“Iron deficiency is an under-recognized problem with adverse impacts, but its symptoms and even those of anemia are normalized in young females,” lead author Dr. Angela Weyand, a pediatric hematologist, said in a press release.
“Why are we not screening for a condition that is highly prevalent, easily diagnosed, easily treated and associated with serious symptoms and increased risk of death if not addressed?”
Iron deficiency can lead to fatigue, cold extermities, hair loss, brittle nails, cognitive issues like brain fog, decreased athletic performance, shortness of breath, junk food cravings, headaches, sleep disorders and other conditions.iStockphoto/Getty Images
The doctor also suggested that medical professionals normalize discussing menstrual bleeding and a healthy period flow. She noted that many teens and young women may be unaware that they are experiencing abnormally heavy periods that might contribute to a drastic iron loss.
Menstruation is a common risk factor, although a quarter of the girls who have yet to begin their periods were diagnosed with an iron deficiency, the study showed.
Dr. Rachel Bercovitz, a hematologist and an associate professor of pediatrics at Northwestern University’s Feinberg School of Medicine, told NBC News that a period could be considered heavy “if you’re changing your pad or tampon more often than every four to six hours, or if you have to sleep on a towel or use overnight pads plus period underwear because you leak.”
Iron levels can be replenished by incorporating iron-rich foods into one’s diet or taking a daily iron supplement.iStockphoto/Getty Images “There are significant consequences especially in the adolescent age cohort where fatigue and poor concentration can lead to poor school performance,” she said. “And poor athletic performance can lead to changes in how girls think about exercise.”
Researchers hope that the findings will encourage medical professionals to order more ferritin tests for young female patients and recommend them to incorporate more iron-rich foods to their diet, such as leafy green vegetables, eggs, beans, meats and seafood.
Experts also advise taking an iron supplement with a glass of orange juice, which helps increase the amount of iron absorbed.
