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Thursday, March 2, 2023

Taiwan military to get $619 million U.S. arms boost as China keeps up pressure

 The United States has approved the potential sale of $619 million in new weapons to Taiwan, including missiles for its F-16 fleet, as the island reported a second day of large-scale Chinese air force incursions nearby.

The arms sales are likely to further sour already tense ties between Washington and Beijing, which has repeatedly demanded such deals stop, viewing them as unwarranted support for democratically governed Taiwan, an island China claims as its own territory.

The Pentagon said on Wednesday the U.S. State Department has approved the potential sale to Taiwan of arms and equipment that includes 200 anti-aircraft Advanced Medium Range Air-to-Air Missiles (AMRAAM) and 100 AGM-88B HARM missiles that can take out land-based radar stations.

"The proposed sale will contribute to the recipient's capability to provide for the defence of its airspace, regional security, and interoperability with the United States," it said in a statement.

Taiwan's defence ministry said the missiles would help "effectively defend the airspace to deal with threats and provocations from the Communist military" and would bolster defence stockpiles.

Raytheon Technologies and Lockheed Martin are the principal contractors, it added. China has sanctioned both companies for selling Taiwan weapons.

China's Foreign Ministry said it was "firmly" opposed to the planned sale, adding that the United States should stop arms sales to and military contacts with Taiwan.

CHINESE AIR FORCE INCURSION

Taiwan has complained for the past three years or so of stepped-up Chinese military activities near the island as Beijing seeks to assert its sovereignty claims.

Taiwan reported on Thursday a second day of large-scale Chinese air force incursions into its air defence identification zone, with its defence ministry saying that during the last 24 hours it had spotted 21 aircraft.

China has said its activities in the area are justified as it seeks to defend its territorial integrity and to warn the United States against "colluding" with Taiwan, despite the anger this causes in Taipei.

Santhera Submits Marketing Authorization Application to UK MHRA for Vamorolone in Duchenne

  Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

In parallel to the MAA submission to the UK MHRA, Santhera is currently preparing an application to include vamorolone for the treatment of DMD in the Early Access to Medicines Scheme (EAMS) in the UK. The aim of the EAMS is to provide patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization, when there is a clear unmet medical need.

https://www.biospace.com/article/releases/santhera-submits-marketing-authorization-application-to-the-uk-mhra-for-vamorolone-in-duchenne-muscular-dystrophy-/

Sanofi, Sobi: Positive topline results from pivotal phase 3 study of in children under 12 with haemophilia A

 

  • Primary endpoint was met with no factor VIII inhibitors detected, confirming the safety profile of efanesoctocog alfa in previously treated patients under 12 years of age
  • The completion of XTEND-Kids represents the final milestone needed for regulatory submission in the EU

MorphoSys Stops Work and Operations on Pre-Clinical Research

  MorphoSys AG (FSE:MOR)(NASDAQ:MOR) today announced that the company will stop work and operations on its pre-clinical research programs to optimize its cost structure. While the data from these pre-clinical programs are promising, MorphoSys would need to make substantial investments to bring these programs into the clinic. As a result, MorphoSys will reduce its workforce at the company's headquarters in Planegg, Germany, by approximately 17%. This action, along with other steps taken over the past year, enables MorphoSys to focus resources on its mid- to late-stage oncology pipeline.

https://www.biospace.com/article/releases/morphosys-stops-work-and-operations-on-pre-clinical-research-programs/

Pentagon Admits Russia Captured American Weapons In Ukraine

 by Kyle Anzalone via The Libertarian Institute,

American weapons provided to Ukraine have been captured by Russia on the battlefield, a top Department of Defense official told Congress on Tuesday. Over the past year, Washington has provided Kiev with nearly $45 billion in military aid. 

Undersecretary of Defense for Policy Colin Kahl claimed Moscow was capturing American weapons and selling them on the black market. “Our assessment is if some of these systems have been diverted it’s by Russians who have captured things on the battlefield, which always happens,” he said. 

After Russian forces invaded Ukraine just over a year ago, the Joe Biden administration began providing Kiev with unprecedented weapons transfers. The US has provided Ukraine with $44.3 billion in military assistance from January 24, 2022, to January 15, 2023, according to The Kiel Institute for the World Economy. 

Kahl went on to assert that “no evidence” has surfaced to suggest Kiev was responsible for the weapons finding their way to the black market

In the early months of the war, CNN reported that the US lacked oversight over the arms sent to Ukraine. A source told the outlet in April, “we have fidelity for a short time, but when it enters the fog of war, we have almost zero. It drops into a big black hole, and you have almost no sense of it at all after a short period of time.”

That same month, Jonas Ohman, founder and CEO of Blue-Yellow, a Lithuania-based organization that has been meeting with and supplying frontline units with military aid in Ukraine told CBS News, “All of this stuff goes across the border, and then something happens, kind of like 30% of it reaches its final destination.” 

In May, the Washington Post reported Ukraine is infamous for black market weapon sales. “The US government is well aware of the country’s challenges with weapons proliferation, though it has been vague in describing the precautions it’s taking,” the outlet wrote. 

Kahl was confronted by Congressman Matt Gaetz over the weapons ending up in the hands of neo-Nazis. Gaetz cited a 2018 article from Global Times that found American arms were being used by the Azov Battalion, a neo-Nazi militia that was absorbed into Ukraine’s national guard. Kahl dismissed Gaetz’s question by asserting the claim was “Beijing’s propaganda.”

The Azov Battalion has been photographed with Western-made anti-tank weapons. In March, NEXTA tweeted, “A shipment of NLAW grenade launchers and instructors from #NATO countries arrived in Kharkiv. The Azov regiment was the first to learn about new weaponry.” The post included photos of Ukrainian soldiers wearing Nazi patches on their uniforms. 

In July, the Stimson Center – an American organization – warned US arms could flow to “avowed neo-Nazis.” “[The Azov Battalion’s] role in key Ukrainian theatres creates risks that arms could be diverted to Azov troops in contravention of US law,” the report said. 

Kahl claimed the weapons are tracked by Ukraine with scanners provided by Washington, and the data is transferred to American officials at the embassy in Kiev. He added the officials complete some inspections outside of the embassy. 

Additionally, Kahl discussed the White House’s strategy for its proxy war in Ukraine. He said the Department of Defense does not believe Russian forces will make significant territorial gains in the coming months. “You may see small portions of territory change hands in the coming weeks and months.” He told Congress, “I do not think that there’s anything I see that suggests the Russians can sweep across Ukraine and make significant territorial gains anytime in the next year or so.”

He explained that the Biden administration was committed to arming Ukraine, though the timetable for providing fighter jets was at least a year and a half. Kahl added that the price tag to provide Kiev with F-16s was $11 billion and the fighter jet was not one of Ukraine’s “top three priorities.”

https://www.zerohedge.com/military/pentagon-admits-russia-captured-american-weapons-ukraine

OptionCare sells 13M shares for Walgreens

 Option Care Health, Inc. (“Option Care Health” or the “Company”) (NASDAQ: OPCH) announced today that an affiliate of Walgreens Boots Alliance, Inc. (the “Selling Stockholder”) has agreed to sell 13,000,000 shares of the Company’s common stock at a price to the public of $30.75 per share in an underwritten secondary offering. The offering is expected to close on March 3, 2023, subject to customary closing conditions. The Company will not receive any proceeds from the offering.

https://finance.yahoo.com/news/option-care-health-announces-pricing-014800106.html

Valneva covid vax shelf life was recently extended to 21 months from 18 months

 On February 23, 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the use of VLA2001 in adults 18 to 50 years of age as a booster dose to be given at least seven months following primary vaccination (the second dose) with VLA2001 (homologous booster dose) or with an adenoviral vector COVID-19 vaccine (heterologous booster dose).

Valneva also provided an update on its pivotal Phase 3 Study COV-Compare (VLA2001-301). In this study, neutralizing antibodies on Day 208 (six months after the second dose of the primary vaccination with VLA2001) were non-inferior compared to the active comparator AZD1222, an adenoviral vector vaccine. The fold decline of neutralizing antibodies over six months after a second vaccination with VLA2001 was similar to the active comparator, and less pronounced than for other licensed COVID-19 vaccines2,3. The T-cell response against the spike protein elicited upon vaccination with VLA2001 was in the same range as for the active comparator. Moreover, T-cell reactivity against the nucleocapsid and membrane protein was induced upon vaccination with VLA2001.

Additionally, results from VLA2001-304, a Phase 3 study in older adults, 56 years of age and above, showed that VLA2001 was well tolerated by these participants when administered as a two-dose or three-dose immunization, thus confirming the previously reported favorable safety profile of VLA20014. In this age group, a two-dose vaccination with VLA2001 was inferior in terms of geometric mean titers and seroconversion rates compared to younger adults aged 30 years and above. After two doses, immunogenicity in older adults was at a level which could be correlated with 60-70% vaccine efficacy against ancestral SARS-CoV-25. A third dose of VLA2001 further increased immunogenicity in participants aged 56 years and above to the titers associated with vaccine efficacy of >90% against ancestral SARS-CoV-26,7.

Finally, VLA2001’s shelf life was recently extended to 21 months compared to 18 months previously. The Company will continue to submit data to further extend it.

https://finance.yahoo.com/news/valneva-provides-clinical-regulatory-updates-060000933.html