'Some wealthier Chinese say they can't afford marriage as economy slows'

 Victor Li is determined to get married soon, but like many other young Chinese grappling with an uncertain economic outlook, the well-heeled Shanghai entrepreneur isn't sure he can afford to.

"It's very expensive for us to get married, especially in a big city like Shanghai," the 32-year-old said, as he took a break from a ticketed networking event for wealthier, top university-educated singles at an upmarket Shanghai jazz bar.

"In terms of financial ability, it actually puts a lot of pressure on young people, including me."

As the world's second biggest economy slows, an increasing number of people are opting to stay single due to poor job prospects amid record youth unemployment and chronically low consumer confidence, leading to a record slump in marriage registrations in 2022.

This reluctance to tie the knot is worrying policymakers grappling with a decline in births and a rapidly aging population in a country that was once the world's most populous, and where marriage rates are closely tied to birth rates as unmarried mothers are often denied child-raising benefits.

China's fertility rate is currently one of the world's lowest, and official data on Wednesday is expected to show that the population fell for a second consecutive year, renewing concerns about the demographic decline.

Last year, President Xi Jinping said it was necessary to "actively cultivate a new culture of marriage and childrearing" to foster national development. Local governments have also announced various measures to encourage new families, including tax deductions and housing subsidies, as well as cash 'rewards' for marriages if the bride is aged 25 or younger.

Julia Meng, whose company "Julia's Events" organised the Shanghai singles event, said an increasing number of people aged 35 and older had effectively "given up" on marriage.

https://finance.yahoo.com/news/wealthier-chinese-cant-afford-marriage-084354944.html

Fujitsu has 'moral obligation' to pay Post Office victims

 A boss of Fujitsu has said the company has a "moral obligation" to contribute to compensation for sub-postmasters wrongly prosecuted as a result of its faulty IT software.

Paul Patterson, Fujitsu's Europe director, said the firm gave evidence to the Post Office which was used to prosecute innocent sub-postmasters.

He added the Post Office knew about "bugs and errors" in Horizon early on.

It comes as victims of the scandal told MPs of problems receiving compensation.

Between 1999 and 2015, more than 900 sub-postmasters and postmistresses were prosecuted for theft and false accounting after money appeared to be missing from their branches, but the prosecutions were based on evidence from faulty Horizon software.

Some sub-postmasters wrongfully went to prison, many were financially ruined. Some have since died.

It has been described as the most widespread miscarriage of justice in British history, but to date only 93 convictions have been overturned and thousands of people are still waiting for compensation settlements more than 20 years on.

Appearing before the Business and Trade select committee of MPs, Mr Patterson apologised for Fujitsu's role in what he said was an "appalling miscarriage of justice".

"We were involved from the very start," he said. "We did have bugs and errors in the system and we did help the Post Office in their prosecutions of the sub-postmasters.

"For that we are truly sorry."

Asked why Fujitsu didn't do anything about glitches in the Horizon system when the company knew about them at an early stage, Mr Patterson said: "I don't know. I really don't know."

He added: "On a personal level I wish I did know. Following my appointment in 2019 I have looked back on those situations for the company and the evidence I have seen and I just don't know."

https://sg.news.yahoo.com/fujitsu-moral-obligation-pay-post-123401524.html

Ukraine's Zelenskiy meets JPMorgan executives, other major investors in Davos

 Ukrainian President Volodymyr Zelenskiy said he met with executives of JPMorgan, the largest U.S. lender, and other major international investors on the sidelines of the World Economic Forum in Davos on Tuesday.

"It is important for us to attract private capital to the reconstruction of Ukraine. We hope that JP Morgan will help attract a large number of global investors and corporations to the Ukrainian economy," Zelenskiy said on the Telegram messaging app.

JPMorgan Chase (JPM.N) CEO Jamie Dimon, other senior JPMorgan executives and top management of BlackRock, Bridgewater Associates, the Carlyle Group, Blackstone, Dell and ArcelorMittal took part in the meeting, Zelenskiy's office said.

The economy ministry said about 100 senior executives joined the meeting, which focused on the need to bring in more private investment to help Ukraine rebuild and modernise its economy and infrastructure devastated by nearly two years of Russia's war.

Ukraine's economy performed better than expected last year with officials estimating gross domestic product growth at about 5% in 2023 after a 28.8% fall in 2022. The government expects GDP growth at 4.6% this year.

During the meeting, Zelenskiy stressed the need to develop and implement financial instruments blending both private and public capital, his office said in a statement.

Yulia Svyrydenko, first deputy prime minister and economy minister, said the government had kept up economic reforms required to improve the investment climate and make doing business easier despite Russia's invasion.

The Kyiv government was also working to expand war insurance for businesses and wanted to strengthen its air defence further, she added.

https://finance.yahoo.com/news/1-ukraines-zelenskiy-meets-jpmorgan-125506110.html

Anavex OKd for U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

 Placebo-controlled Phase 2 trial cleared by the FDA – Trial to begin in Q2 2024

Trial to include Schizophrenia validated clinical outcomes PANSS and EEG/ERP biomarkers

Trial to study positive, negative, and cognitive domains of Schizophrenia based on ANAVEX®3-71’s ability to synergistically activate both SIGMAR1 and M1 muscarinic receptors

https://www.globenewswire.com/news-release/2024/01/16/2809762/29248/en/Anavex-Life-Sciences-Announces-U-S-Phase-2-Clinical-Trial-of-ANAVEX-3-71-in-Schizophrenia.html

ANI: Approval and Launch of Indomethacin Oral Suspension, USP

 ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.

ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension. The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.

https://www.globenewswire.com/news-release/2024/01/16/2809672/0/en/ANI-Pharmaceuticals-Announces-the-FDA-Approval-and-Launch-of-Indomethacin-Oral-Suspension-USP.html

Allakos to stop further development of skin disease drug, plans job cuts

Allakos Inc said on Tuesday that it plans to discontinue the development of its experimental skin disease drug after it failed two mid-stage studies.

The company also said it aims to cut 50% of its workforce as part of a restructuring.

The company was testing its experimental drug, called lirentelimab, as a potential treatment for the skin conditions atopic dermatitis and chronic spontaneous urticaria.

The drug did not help reduce symptoms of either conditions across two mid-stage studies and failed to meet the main goals.

Shares of the drug developer were halted in premarket trading.

 https://finance.yahoo.com/news/1-allakos-stop-further-development-122735843.html

FDA Action Alert: Satsuma, Theratechnologies and Heron

 The FDA is looking at three target action dates over the next two weeks, including one for a nasal powder migraine treatment and another being proposed to treat excess abdominal fat in adults living with HIV who have lipodystrophy.

Read below for more.

Satsuma Awaits Decision for Nasal Powder Treatment for Migraine

Satsuma Pharmaceuticals is developing a dihydroergotamine (DHE) nasal powder product dubbed STS101, which it is proposing for the treatment of acute migraine. The deadline for the FDA’s decision is January 17. 

STS101’s New Drug Application (NDA), which the regulator accepted in May 2023, is backed by data from the Phase III ASCEND study, which enrolled 446 patients treated with over 10,500 doses of STS101 for up to 18 months.

In September 2022, Satsuma posted positive long-term data from ASCEND, showing that the drug could elicit freedom from pain within two hours of treatment in at least 34% of patients. STS101 was also safe in the long run, with no clinically relevant nasal or systemic safety issues. Most treatment-emergent adverse events were mild or moderate and transient. STS101’s NDA also includes data from a Phase I comparative pharmacokinetic and safety study.

If approved, STS101 would become the first DHE product tested in a randomized and placebo-controlled trial using modern outcome measures, as recommended by the FDA and the International Headache Society, according to Satsuma’s announcement of the NDA’s acceptance.

Theratechnologies Eyes Approval for New Formulation of Tesamorelin

Next week, the FDA will decide on Theratechnologies’ sBLA for its F8 formulation of tesamorelin, which it is proposing for the treatment of excess abdominal fat in adults living with HIV who have lipodystrophy. The regulator’s deadline is on January 22.

Tesamorelin is the only FDA-approved therapy in the U.S. to help cut abdominal fat in HIV-positive adults suffering from lipodystrophy. Currently, tesamorelin is approved in its F4 formulation, which is a single-vial formulation that is four times more concentrated than the original medicine, and is being sold under the brand name Egrifta SV.

The drug is a growth hormone-releasing factor analog that works by inducing the pituitary gland to secrete endogenous growth hormone, which in turn exerts its lipolytic effects to reduce abdominal fat.

The sBLA, which the company filed in September 2023, is backed by pharmacokinetic studies that have demonstrated the bioequivalence between the F8 formulation and the original F1 formulation of tesamorelin. By increasing the concentration, the F8 formulation allows for a smaller dose volume, delivered via a multiple-dose vial (MDV) that is reconstituted once per week.

If approved, the F8 formulation of tesamorelin will carry the brand name Egrifta MDV.

Heron Pushes for Expanded Use of Its Local Anesthetic

In December 2022, Heron Therapeutics filed a supplemental NDA (sNDA) for its local anesthetic Zynrelef (bupivacaine and meloxicam) extended-release solution, proposing its “greatly expanded” use in soft-tissue and orthopedic surgeries. The FDA’s verdict is due January 23.

Zynrelef is a dual-acting local anesthetic that uses a fixed dose of the anesthetic bupivacaine and a low dose of the non-steroidal anti-inflammatory drug meloxicam, which helps ease inflammation at the surgical site. According to the company’s website, this combination has been “clinically proven to better manage pain” versus the standard bupivacaine HCl solution.

Heron’s supplemental application is supported by safety and pharmacokinetic data from recently completed studies in patients undergoing C-section, abdominoplasty, spinal surgery and total shoulder arthroplasty. The totality of the data demonstrated comparable pain relief and safety to previous trials of Zynrelef, according to Heron’s news release of the sNDA’s submission.

Currently, Zynrelef is approved to induce postsurgical analgesia for up to 72 hours in adults who have undergone foot and ankle and small-to-medium open abdominal surgeries, as well as lower extremity total joint arthroplasty.

https://www.biospace.com/article/fda-action-alert-satsuma-merck-theratechnologies-and-heron/