The COVID-19 pandemic has underscored key weaknesses in the biopharma
industry’s complex global supply chain, and now a top adviser for the
Trump administration is calling on Congress to push for more
manufacturing in Puerto Rico.
In an interview with the Washington Examiner, White House trade
adviser Peter Navarro faulted a “broken system” that pushes
manufacturing offshore. He called on Congress to use the next round of
COVID-19 relief to incentivize manufacturing on the island territory.
Previously, a tax provision allowed U.S. companies to avoid paying
federal taxes on profits from operations in Puerto Rico, but Congress
phased that out over time, the Examiner reports. Plus, utility costs are
significantly higher there than in the U.S., which has also led to a
reduction in manufacturing. Pharma companies themselves have shuttered a
number of drug plants in Puerto Rico in recent years.
“If this crisis has taught us anything across party lines, it is that
we do indeed need to bring home the pharmaceutical supply chain, that
it is not just a public health issue, but a national security issue and
an economic security issue,” Navarro told the publication.
The Trump administration has already made moves to bolster U.S. drug
production in its response to the pandemic. The administration picked a
little-known startup, Phlow Corporation, for a $354 million contract to
produce generic meds and active pharmaceutical ingredients for COVID-19
therapies. And Monday, the government inked a $628 million deal with
Maryland biotech Emergent BioSolutions for potential COVID-19 vaccine
manufacturing.
Aside from the administration’s efforts, lawmakers are working on
their own measures to bring drug production back to the U.S., Stat reports. That’s caused pharma companies to mobilize lobbyists to push back.
https://www.fiercepharma.com/pharma/fiercepharmapolitics-trump-trade-advisor-citing-broken-system-calls-for-more-drug
Monday, June 1, 2020
Thailand races to create COVID vaccine, eyes possible medical tourism boost
Momentum is building behind Thailand’s push to create its own
coronavirus vaccine, with more manpower and resources dedicated to the
effort amid hopes it could boost medical tourism.
Thai trials of an experimental vaccine using monkeys started last month, one of at least 100 potential vaccines being developed globally. The government is hopeful it will have a cost-effective vaccine ready for next year.
Bionet-Asia, a local firm working with the government and a top Bangkok university, has put all other activities on hold and dedicated 250 personnel and all of its labs, technology and production facilities to developing a COVID-19 vaccine.
“In the case of COVID, there is a global effort to speed up
experiment, trials, to share information, share diagnostics and that’s
why we are in a position too, to move very fast,” chief executive
officer, Pham Hong Thai, told Reuters.
He said tests on animals had so far shown encouraging results and the next step would be seeking government approval for clinical trials involving humans.
With just over 3,082 cases and 57 deaths, Thailand has had some success in containing the coronavirus and eased many of its restrictions in response to low infection numbers.
It has been seven days without a case of local transmission, with all
infections this past week found among quarantined nationals returning
from overseas.
Public Health Minister Anutin Charnvirakul said it was important to channel all efforts towards the development of a vaccine and put Thailand on the medical map.
“Thailand has a good healthcare system, good medical practices. It will garner a lot of interest from tourists and investors and boost us as a medical hub,” he said.
https://www.reuters.com/article/us-health-coronavirus-thailand-vaccine/thailand-races-to-create-covid-vaccine-eyes-possible-medical-tourism-boost-idUSKBN2382BW
Thai trials of an experimental vaccine using monkeys started last month, one of at least 100 potential vaccines being developed globally. The government is hopeful it will have a cost-effective vaccine ready for next year.
Bionet-Asia, a local firm working with the government and a top Bangkok university, has put all other activities on hold and dedicated 250 personnel and all of its labs, technology and production facilities to developing a COVID-19 vaccine.
He said tests on animals had so far shown encouraging results and the next step would be seeking government approval for clinical trials involving humans.
With just over 3,082 cases and 57 deaths, Thailand has had some success in containing the coronavirus and eased many of its restrictions in response to low infection numbers.
Public Health Minister Anutin Charnvirakul said it was important to channel all efforts towards the development of a vaccine and put Thailand on the medical map.
“Thailand has a good healthcare system, good medical practices. It will garner a lot of interest from tourists and investors and boost us as a medical hub,” he said.
https://www.reuters.com/article/us-health-coronavirus-thailand-vaccine/thailand-races-to-create-covid-vaccine-eyes-possible-medical-tourism-boost-idUSKBN2382BW
Twist Bio joins COVID-19 therapy development alliance
Privately held Proteona announces that Twist Bioscience (TWST +0.4%) has joined an
international alliance led by Proteona aimed at developing neutralizing
antibody therapies against COVID-19 for vulnerable immunocompromised
patients.
Twist has developed a highly parallel
silicon-based DNA synthesis platform that enables the manufacture of
millions of “oligos” of different lengths with a high degree of accuracy
that can be used to optimize therapeutic IgG antibodies.
Proteona has developed single-cell proteogenomics technology
that enables the simultaneous screening of antibodies targeting
multiple viral variants. In COVID-19, it is analyzing blood samples from
recovered patients and screening for B cells that produce neutralizing
antibodies against SARS-CoV-2. Identified candidates will be optimized
for possible therapeutic use.
https://seekingalpha.com/news/3579102-twist-bio-joins-covidminus-19-therapy-development-allianceAbbVie files marketing applications for new use of Rinvoq
AbbVie (ABBV -1.6%) has submitted marketing applications
in the U.S. and Europe seeking approval to use Rinvoq (upadacitinib) 15
mg for the once-daily treatment of adults with active psoriatic
arthritis.
The JAK inhibitor is currently approved in both territories for rheumatoid arthritis.
https://seekingalpha.com/news/3579165-abbvie-files-marketing-applications-for-new-use-of-rinvoqCelyad up 9% on positive data on non-gene edited CAR T therapy
Ultra-thinly traded micro cap Celyad (CYAD +9.0%) is up on more than double normal volume, albeit on turnover of only 39K shares, in reaction to updated data from a Phase 1 clinical trial, alloSHRINK, evaluating CYAD-101 in patients with metastatic colorectal cancer (mCRC). The results were virtually presented at ASCO.
CYAD-101 is a non-gene edited allogeneic CAR T
therapy designed to avoid graft-versus-host disease (GvHD) via the use
of a technology called TIM (T cell receptor inhibitory molecule) that
knocks down the immune response responsible for GvHD.
15 patients with relapsed/refractory mCRC who
progressed after chemo are enrolled, each receiving three consecutive
doses of CYAD-101 concurrently with FOLFOX chemo.
No evidence of GvHD has been observed after 44
injections of CYAD-101. Two patients showed partial responses while nine
experienced stable cancer implying a disease control rate of 73%
(n=11/15).
Enrollment in an expansion cohort assessing CYAD-101 (1B cells/infusion) following FOLFIRI chemo should commence in Q4.
#ASCO20
https://seekingalpha.com/news/3579061-celyad-up-9-on-positive-data-on-non-gene-edited-car-t-therapyAlnylam to host webcast on Illuminate-A study of lumasiran on June 7
Alnylam Pharmaceuticals (ALNY -0.9%) will discuss full results from the ILLUMINATE-A Phase 3 study of lumasiran in a webcast conference call on Sunday, June 7, at 8:30 am ET.
The clinical data will be presented at the
European Renal Association-European Dialysis and Transplant Association
International Congress being held June 6-9 as a virtual event.
https://seekingalpha.com/news/3579031-alnylam-to-host-webcast-on-illuminate-study-of-lumasiran-on-june-7Sensus Healthcare up after it rejects buyout offer at $4/share
Sensus Healthcare (SRTS +13.0%) had received an unsolicited offer to acquire all the outstanding shares at a price of $4/share, in cash.
Following consideration by and at the direction of its Board of Directors, Sensus rejected the offer.
https://seekingalpha.com/news/3579043-sensus-healthcare-up-13-after-rejects-buyout-offer-4-share
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