Confirmation unsure for Biden health secretary nominee Xavier Becerra

 The U.S. Senate Finance Committee deadlocked on Wednesday over President Joe Biden’s nominee to head the Department of Health and Human Services, Xavier Becerra, raising questions about Democrats’ ability to overcome Republican opposition to the California attorney general.

The 14-14 party-line vote sent Becerra’s nomination to Senate Majority Leader Chuck Schumer and Senate Republican leader Mitch McConnell for further action. Under new rules to deal with the 50-50 Senate split between the two parties, either can file a motion to bypass a tied committee and bring matters straight to the Senate floor with a separate procedural vote.

Becerra’s fate will depend on Senate Democrats’ ability to stick together and support him, possibly with a tie-breaking vote by Vice President Kamala Harris.

The Finance Committee in the same session on Wednesday approved two other Biden nominees - Katherine Tai for U.S. Trade Representative and Wally Adeyemo for Deputy Treasury Secretary - by voice votes, indicating no significant opposition.

Two Finance Committee Republicans on Wednesday said they had opposed Becerra because of a lack of past healthcare experience and because of his challenges as California attorney general to HHS authorities to grant religious conscience waivers to Obamacare mandates to provide coverage for contraception.

“His qualifications to be HHS Secretary seem to be minimal beyond suing HHS,” said Senator Bill Cassidy, a Louisiana Republican who is also a physician.

Senator Mike Crapo of Idaho, the top Republican on the panel, said he opposed Becerra because of his challenges on behalf of California to HHS authorities on contraception. But both Crapo and Cassidy said they would work with Becerra to lower healthcare costs if he won confirmation.

On Tuesday, Biden withdrew the name of another nominee, Neera Tanden, to head the Office of Management and Budget. Her nomination ran aground over past divisive social media posts that targeted both Democrats and Republicans.

In Tanden’s case, Democrat Joe Manchin of West Virginia withdrew his support, citing Tanden’s past social media posts criticizing his daughter, the CEO of a health firm. His opposition made it impossible for Democrats to overcome unified Senate Republican opposition to Tanden.

A spokesman for Manchin could not immediately be reached for comment on Becerra’s nomination.

In choosing Becerra, a fellow Democrat and a Latino former congressman, Biden picked an administrator with a long record of supporting the Affordable Care Act, former President Barack Obama’s key domestic policy achievement. Biden has said he wants to improve the ACA, which relies on private insurers, rather than launch a new government-provided healthcare program.

On Tuesday, the Senate confirmed Commerce Secretary Gina Raimondo and White House Council of Economic Advisers Chair Cecilia Rouse, bringing the number of cabinet-level officials confirmed to 12 of 24.

https://www.reuters.com/article/us-usa-biden-nominees/confirmation-unsure-for-biden-health-secretary-nominee-xavier-becerra-idUSKBN2AV25I

Millions of U.S. households would not get COVID-19 payments under new Biden plan

 Millions of U.S. households who received coronavirus-relief payments under President Donald Trump would not get aid under a modified version of President Joe Biden’s $1.9 trillion aid package announced on Wednesday, analysts said.

Under a compromise with centrist Democrats in the Senate, those payments would only go to individuals who earned less than $80,000, or couples who earned less than $160,000.

The income cutoff had been set at $100,000 and $200,000, respectively, under a version of the bill passed by the Democratic-led House of Representatives on Saturday.

That means nearly 9 million fewer households would get direct payments this time around, said Kyle Pomerleau, a tax analyst with the conservative American Enterprise Institute.

The Institute on Taxation and Economic Policy calculated that those payments now would help 11.8 million fewer adults and 4.6 million fewer children than the more generous version that passed the House.

But 200 million adults and 80 million children would still see benefits, the left-leaning think tank estimated.

“For the bottom 60% of Americans, the folks who really need help, there would be basically no difference at all,” ITEP analyst Steve Wamhoff said.

The lower caps would reduce the cost of the massive package by between $13 billion and $20 billion, they said - roughly 1% of the total.

Some 162 million households received payments under the first round of payments included in the CARES Act of 2020, according to the Internal Revenue Service.

The Democratic-controlled Senate expects to open debate on the package as early as Wednesday, with a final vote for passage seen later in the week.

At a total cost of more than $400 billion, the direct aid is one of the largest elements in a sweeping aid package that also pays for vaccines and medical supplies to fight the COVID-19 pandemic, and earmarks hundreds of billions of dollars to help revive the world’s largest economy.

The pandemic has killed more than 515,000 Americans to date and thrown millions out of work.

The bill would provide payments of up to $1,400 per person, including children - a significant jump from the $1,200-per-person payments approved under the CARES Act and the $600-per-person payments Congress approved in December.

As in those earlier aid packages, the payments would be reduced for individuals earning more than $75,000 and couples earning more than $150,000. The compromise announced on Wednesday means the payments are phased out more dramatically.

https://www.reuters.com/article/us-health-coronavirus-usa-payments/millions-of-u-s-households-would-not-get-covid-19-payments-under-new-biden-plan-idUSKCN2AV2RX

Medicinova (MNOV) to discontinue development of SARS-CoV-2 vaccine for COVID-19

 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced an update on the development of a SARS-CoV-2 vaccine for COVID-19. MediciNova has conducted a careful review of its numerous development programs to determine the best allocation of resources going forward considering the stage of development, expected costs of completing clinical development, and the competitive landscape. Given the COVID-19 vaccines currently in use and other vaccines in advanced stages of development, MediciNova has decided to discontinue development of a SARS-CoV-2 vaccine for COVID-19 in order to maintain adequate resources for its other development programs which have indications with larger unmet medical needs and market opportunities.

https://www.streetinsider.com/Corporate+News/Medicinova+%28MNOV%29+to+discontinue+development+of+SARS-CoV-2+vaccine+for+COVID-19/18070632.html

Permira bids for medical device maker LivaNova

 Private equity group Permira has made a takeover bid for medical device maker LivaNova, the Financial Times reported on Wednesday, citing people familiar with the matter.

According to the report, the offer, made in mid-February, values LivaNova’s stock at more than $80 a share.

LivaNova did not immediately respond to a Reuters request for comment.

Talks are ongoing but there is no certainty that a deal will be reached, the FT report added.

LivaNova, which has a market capitalization of $3.71 billion, was created in 2015 through a merger of Cyberonics and Storin.

https://www.reuters.com/article/livanova-permira-ma-idUSL3N2L14DR

Takeda buys epilepsy treatment rights from Ovid for up to $856M

 Takeda Pharmaceutical Co will spend as much as $856 million to secure global rights from Ovid Therapeutics Inc to an experimental drug being developed to treat rare epilepsy, the companies said on Wednesday.

Takeda will be responsible for future development and commercialization of the drug, soticlestat, worldwide and Ovid will no longer have any financial obligation, the companies said in a statement.

Ovid will receive an upfront payment of $196 million at the close of the agreement, expected by the end of March, and is eligible to receive up to an additional $660 million in milestone payments.

The Japanese drugmaker entered into a collaboration agreement in 2017 with Ovid to develop and market soticlestat, which aims to treat children and adults with Dravet Syndrome and Lennox-Gastaut syndrome.

The companies in August reported results from a mid-stage study showing soticlestat met the main goal of reduction in seizure frequency.

Jazz Pharmaceuticals Plc last month agreed to buy GW Pharmaceuticals Plc in a $7.2 bln deal for its FDA-approved drug, Epidiolex, to treat seizures associated with the two syndromes.

Takeda said it plans to start late-stage studies of soticlestat in children and young adults with the two epileptic syndromes in the second quarter.

Ovid will also receive tiered royalties beginning in the low double-digits and up to 20% on sales of the drug, Takeda said.

https://finance.yahoo.com/news/takeda-buys-epilepsy-treatment-rights-120001496.html

BioXcel: Positive Update on BXCL501 for Dementia Related Agitation

 Review of TRANQUILITY data showed 30 mcg dose met statistical significance across multiple scales

Company initiated supplemental 40 mcg dose cohort to help inform clinical development strategy across the full range of dementia care settings

End of Phase 2 meeting scheduled with U.S. Food and Drug Administration (“FDA”) in Q2 2021

Pivotal Phase 3 program expected to begin in the second half of 2021

https://www.globenewswire.com/news-release/2021/03/03/2186065/0/en/BioXcel-Therapeutics-Provides-Update-on-its-BXCL501-Program-for-the-Acute-Treatment-of-Dementia-Related-Agitation.html

Ocugen’s COVID-19 Vax Partner, Bharat Biotech shares Phase 3 Interim Results of COVAXIN

 

• Data from 25,800 participants in Phase 3 trial in India, received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose.
  
  
• Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints.

https://www.globenewswire.com/news-release/2021/03/03/2186178/0/en/Ocugen-s-COVID-19-Vaccine-Co-Development-Partner-Bharat-Biotech-shares-Phase-3-Interim-Results-of-COVAXIN-Demonstrates-Efficacy-of-81.html