Abbott
(NYSE: ABT) today announced that the U.S. Food and Drug Administration
(FDA) has approved a new trial designed to assess its Amplatzer™ Amulet™
Left Atrial Appendage Occluder for people with atrial fibrillation (AF)
– a condition in which the normal rhythm of the heart’s upper chambers
is disrupted and becomes erratic – who are at risk of stroke. The
CATALYST trial is the first-ever clinical trial comparing the
effectiveness of a left atrial appendage (LAA) closure device to a newer
class of blood thinners, known as non-vitamin K antagonist oral
anticoagulant (NOAC) drugs, which are currently the standard treatment
option for AF.
Atrial Fibrillation is the most common sustained cardiac arrhythmia,
with the prevalence in the U.S. projected to increase to 12.1 million by
2030.i In some people with AF, the LAA – a small, naturally
occurring pocket connected to the upper left chamber of the heart – can
allow blood to pool, leading to increased risk of clot formation. If
these clots become dislodged, they can travel to the brain, and cause a
stroke, with AF-related ischemic strokes nearly twice as fatal compared
to non-AF related strokes.ii, iii, iv To reduce the risk of
stroke, physicians may perform procedures to prevent blood clots from
leaving the LAA in patients with AF who are unable to take blood
thinners long-term.v, vi Delivered to the heart through a
small minimally invasive incision in the leg, the Amplatzer Amulet
device allows physicians to permanently “seal off” the LAA.
The global, multicenter CATALYST trial will compare the effectiveness
of the Abbott Amplatzer Amulet to NOACs as an alternative treatment
option in an expanded population of AF patients. Blood thinners, first
warfarin and now NOACs, are commonly the first-line therapy to reduce
the risk of ischemic stroke – the most common type of all stroke – in
patients with AF who are at an increased risk. However, risk of bleeding
events, medication expenses, narrow therapeutic window, patient
lifestyle, and medication compliance often limit blood thinner
effectiveness in clinical practice.vii, viii, ix The CATALYST
trial will randomize up to 2,650 subjects at 150 sites worldwide to
assess whether sealing off the LAA with the Amulet device may be a
viable alternative to a lifetime of these newer blood thinners.
“A device that can address a significant structural issue of the
heart via a minimally invasive procedure would be a significant step
forward for patients with atrial fibrillation eligible for long-term
NOAC therapy,” said Vivek Reddy, M.D., director of Cardiac Arrhythmia Services for The Mount Sinai Hospital in New York
and the principal investigator for the CATALYST trial. “This study is
an extremely important step in assessing the Amplatzer Amulet as an
effective non-prescription drug alternative for patients with AF who are
at an increased risk for ischemic stroke.”
The Amplatzer Amulet device received CE Mark approval in 2013 and is available in Europe and other countries that recognize CE Mark. At this time, the device is for investigational use only in the U.S.
https://www.biospace.com/article/releases/abbott-announces-first-of-its-kind-trial-to-assess-new-therapy-option-for-people-at-risk-of-stroke/
Monday, February 3, 2020
CTI Gets Accelerated Approval Pathway for Pacritinib in Thrombocytopenia
CTI BioPharma Corp.
(Nasdaq: CTIC) today announced that following a meeting with the U.S.
Food and Drug Administration (“FDA” or “the Agency”), CTI has reached
agreement on an accelerated approval pathway for pacritinib for the
treatment of myelofibrosis patients with severe thrombocytopenia
(platelet counts <50,000/µL). CTI will be amending the PACIFICA
pivotal Phase 3 trial protocol to allow for the primary analysis of SVR
rates on the first 168 patients, with an end-of-study analysis of TSS
and OS following the full enrollment of 348 patients. If the primary
endpoint of SVR is met following the planned review of data from the
first 168 patients, CTI intends to submit a New Drug Application (NDA)
under the FDA’s subpart H regulations, subject to review of all
available efficacy and safety data. Conversion to a regular approval of
pacritinib would be anticipated following the successful end-of-study
assessment of the secondary efficacy endpoints, and the completion of
post-marketing requirements.
“Since the initiation of the PACIFICA trial in September 2019,
we have been working diligently with the FDA to identify an expedited
approval pathway for pacritinib for the treatment of myelofibrosis
patients with severe thrombocytopenia,” said Adam R. Craig,
M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma.
“Severely thrombocytopenic myelofibrosis patients (platelet counts
<50,000/µL) have reduced survival and very limited therapeutic
options. Pacritinib has now demonstrated clinical benefit in this
population in three clinical trials, including two prior randomized
Phase 3 studies, so we believe that pacritinib has the potential to
change the treatment paradigm in this area of serious unmet medical
need.”
Based on the new trial design, CTI expects to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022 if the SVR data is positive. Final study efficacy data is expected in 2023.
Concurrent with this press release, CTI is announcing a $60 million rights offering. For further details, see the concurrent press release relating to the rights offering.
https://www.biospace.com/article/releases/cti-biopharma-establishes-accelerated-approval-pathway-for-pacritinib-in-treating-myelofibrosis-patients-with-severe-thrombocytopenia/
Based on the new trial design, CTI expects to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022 if the SVR data is positive. Final study efficacy data is expected in 2023.
Concurrent with this press release, CTI is announcing a $60 million rights offering. For further details, see the concurrent press release relating to the rights offering.
https://www.biospace.com/article/releases/cti-biopharma-establishes-accelerated-approval-pathway-for-pacritinib-in-treating-myelofibrosis-patients-with-severe-thrombocytopenia/
Orgenesis Agrees to Sell Masthercell Global Contract Unit
Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), today announced that Catalent Pharma Solutions has agreed to acquire
Masthercell Global, Inc., a contract development manufacturing
organization (CDMO) subsidiary of Orgenesis backed by Great Point
Partners and SFPI-FPIM. Orgenesis anticipates that it will receive
proceeds of approximately $127 million resulting from the transaction.
The transaction is expected to close during the current fiscal first
quarter of 2020. Orgenesis expects to use the net proceeds from the sale
of Masthercell to continue to grow its point-of-care cell therapy
business and to further the development of Advanced Therapy Medicinal
Products. Additional details on the transaction will be available in the
Company’s Current Report on Form 8-K filed today with the Securities
and Exchange Commission at www.sec.gov and on the Company’s website at: https://ir.orgenesis.com/all-sec-filings.
Vered Caplan, Chief Executive Officer of Orgenesis,
stated, “We are very proud of the developments and accomplishments at
Masthercell Global, which has become a best-in-class contract
development and manufacturing organization (CDMO) servicing many of the
leading cell and gene therapy companies. We are also grateful to Great
Point Partners and SFPI-FPIM for their tremendous support. Since we
completed our acquisition of Masthercell Global in 2015, the business
has grown rapidly along with this burgeoning industry. With Catalent’s
expertise and resources, we believe Masthercell Global will be well
positioned to continue on its current trajectory in order to meet the
evolving needs of the industry. We believe the resources provided to
Orgenesis by this transaction will enable us to significantly accelerate
our point-of-care (“POCare”) cell therapy platform and we look forward
to providing further updates.”
NCI grant boosts Artelo Bio
Thinly traded nano cap Artelo Biosciences (NASDAQ:ARTL) is up 60% premarket on robust volume in reaction to a $4.2M five-year NCI grant
that will fund the advancement of its fatty acid binding protein 5
(FABP5) inhibitor program. Specifically, the grant will support research
at Stony Brook University’s Institute of Chemical Biology and Drug
Discovery, in collaboration with Cold Spring Harbor Laboratory and
Artelo.
https://seekingalpha.com/news/3537263-nci-grant-boosts-artelo-bio-up-60-premarket
https://seekingalpha.com/news/3537263-nci-grant-boosts-artelo-bio-up-60-premarket
Diagnostic gear costs knock profits at Siemens Healthineers
Siemens Healthineers operating income slipped 11% in the first quarter of its financial year, despite higher revenue, as the German company sold less profitable imaging machines and incurred ramp-up costs for its new blood-testing machines.
The German maker of x-ray, ultrasound and MRI scanners said on Monday
its adjusted earnings before interest and tax declined to 484 million
euros ($536 million) in October-December.
That was below analysts’ average estimate of 568 million euros, according to a consensus posted on the company’s website.
First-quarter revenue rose 8.7% to 3.59 billion euros, slightly above expectations, the Siemens subsidiary said, adding it was maintaining its outlook for 2020 fiscal year through September, predicting growth in adjusted earnings per share of 6% to 12%.
“Profitability was negatively impacted by a temporary dip in Imaging and the guided weak margin performance in diagnostics,” the group said in a statement.
Ramp-up costs for a new line of blood- and urine-testing gear branded Atellica were inflated by the shipment of more than 600 analyzers from July to September last year, the company added.
Siemens Healthineers’ shares were down 4.6% at 1057 GMT to a three-month low, with Credit Suisse analysts saying that while the Atellica challenges had been known, weak imaging margins posed a new concern.
“The slow start to the year will leave an overhang of a guidance reduction later on in the year given the implied catch up on margins / EPS growth for the remaining quarters,” they said in a research note.
The health tech firm is pinning its hopes on Atellica automated testing machines to turn around its diagnostics division, which lags market leader Roche, but installation has proven more costly and time-consuming than initially hoped.
Faster growth is on the cards as Healthineers announced its largest Atellica order ever on Monday with U.S. lab operator Quest Diagnostics agreeing to purchase up to 120 Atellica analyzers.
The deal would translate into additional annual sales of 40 to 50 million euros over 10 years, Chief Executive Bernd Montag said in a media call
That was below analysts’ average estimate of 568 million euros, according to a consensus posted on the company’s website.
First-quarter revenue rose 8.7% to 3.59 billion euros, slightly above expectations, the Siemens subsidiary said, adding it was maintaining its outlook for 2020 fiscal year through September, predicting growth in adjusted earnings per share of 6% to 12%.
“Profitability was negatively impacted by a temporary dip in Imaging and the guided weak margin performance in diagnostics,” the group said in a statement.
Ramp-up costs for a new line of blood- and urine-testing gear branded Atellica were inflated by the shipment of more than 600 analyzers from July to September last year, the company added.
Siemens Healthineers’ shares were down 4.6% at 1057 GMT to a three-month low, with Credit Suisse analysts saying that while the Atellica challenges had been known, weak imaging margins posed a new concern.
“The slow start to the year will leave an overhang of a guidance reduction later on in the year given the implied catch up on margins / EPS growth for the remaining quarters,” they said in a research note.
The health tech firm is pinning its hopes on Atellica automated testing machines to turn around its diagnostics division, which lags market leader Roche, but installation has proven more costly and time-consuming than initially hoped.
Faster growth is on the cards as Healthineers announced its largest Atellica order ever on Monday with U.S. lab operator Quest Diagnostics agreeing to purchase up to 120 Atellica analyzers.
The deal would translate into additional annual sales of 40 to 50 million euros over 10 years, Chief Executive Bernd Montag said in a media call
https://www.marketscreener.com/news/Diagnostic-gear-costs-knock-profits-at-Siemens-Healthineers–29930248/?countview=0
Huawei, Chinese chip makers keep factories humming despite virus
Some technology firms in China have maintained operations to manufacture parts and products despite government calls in various cities and provinces for companies to halt work to help stop the spread of a new coronavirus.
Chinese telecom giant Huawei Technologies Co Ltd said on Monday it
had resumed production of goods including consumer devices and carrier
equipment, and operations were running normally.
The company restarted manufacturing after the Lunar New Year holiday in line with a special exemption that allows certain critical industries to remain in operation, despite Beijing’s call to halt all work in some cities and provinces.
The spokesman said most of the production was in , a city in the southern province of Guangdong.
Various provinces and cities in China have called for factories to halt work, though companies in certain industries can remain in operation while others can apply for an exemption
A notice in Shanghai, for example, says that business involved in producing food supplies, medical supplies or sectors relevant to the national economy.
Other companies have also kept production running, in some cases even through the New Year, in a sign of the critical importance Beijing places on its domestic tech supply chain, a subject of friction with the United States
Yangtze Memory Technologies Co Ltd (YMTC), a state-backed maker of flash memory chips based in Wuhan – the city where the virus outbreak began – confirmed that it had not ceased production.
“At present, production and operations at YMTC are proceeding normally and in an orderly manner,” a company spokesman wrote in a statement.
The spokesman said no employees had been confirmed as infection cases, and the company had enacted certain isolation measures and partitions to ensure the safety of employees.
State media reported that the chip maker did not cease operations over the Lunar New Year holiday.
Meanwhile, Semiconductor Manufacturing International Corp (SMIC) also kept production running through the holiday break.
In a post on social media, the company said it organised a work group before the holiday to ensure plants could stay open, while protecting the safety of employees and adhering to government regulations.
“SMIC needs to ensure that factory production runs 365 days a year and 24 hours a day to meet customers’ fabrication needs,” the company said in the post.
The company, which rivals Taiwan Semiconductor Manufacturing Co, has facilities in Tianjin, Shenzhen, Beijing, and Shanghai.
Nina Kao, TSMC’s spokeswoman, told Reuters that the company currently “maintains partial operation” in China and it plans to resume full operation on Feb 10.
POSSIBLE DELAYS
TCL Corp, makers of display panels and televisions, said on Monday that while the lines at its China Star Optoelectronics Technology Unit (CSOT) for LCD screens “operate non-stop all-year round,” its Wuhan factories can expect delays in manufacturing materials supply.
BOE Technology Group Co Ltd, another Chinese maker of displays, told state media outlet Global Times that one of its plants at Wuhan had encountered a supply shortage due to amid the virus.
Research firm TrendForce, which tracks the global memory sector, reported that plants at Changxin Memory Technologies Co Ltd (CXMT), based in a city close to Wuhan, and Xinxin Semiconductor Manufacturing Co Ltd, another memory company based in Wuhan, were continuing their operations.
The two companies did not immediately respond to emailed requests for comment.
Overseas parts makers with factories in China have also continued production.
Samsung Electronics has not seen a production disruption at its chip factory in Xi’an despite the coronavirus outbreak, two people familiar with the matter told Reuters.
They did not give further details.
A Samsung Electronics representative confirmed that the plant had been running as usual, saying production had not stopped during the Lunar New Year holiday.
Representatives of Samsung Display, SK Hynix and LG Display also said they were running their Chinese factories as usual.
DRAMexChange wrote in a research note that it expected the virus to have no immediate impact on memory prices, though it could delay planned expansions for some companies.
However, one Samsung source said the virus could still affect supply and demand.
“It is common sense that if the situation is prolonged, that it will hurt the industry. But I don’t know how long it will last,” the company source told Reuters.
The company restarted manufacturing after the Lunar New Year holiday in line with a special exemption that allows certain critical industries to remain in operation, despite Beijing’s call to halt all work in some cities and provinces.
The spokesman said most of the production was in , a city in the southern province of Guangdong.
Various provinces and cities in China have called for factories to halt work, though companies in certain industries can remain in operation while others can apply for an exemption
A notice in Shanghai, for example, says that business involved in producing food supplies, medical supplies or sectors relevant to the national economy.
Other companies have also kept production running, in some cases even through the New Year, in a sign of the critical importance Beijing places on its domestic tech supply chain, a subject of friction with the United States
Yangtze Memory Technologies Co Ltd (YMTC), a state-backed maker of flash memory chips based in Wuhan – the city where the virus outbreak began – confirmed that it had not ceased production.
“At present, production and operations at YMTC are proceeding normally and in an orderly manner,” a company spokesman wrote in a statement.
The spokesman said no employees had been confirmed as infection cases, and the company had enacted certain isolation measures and partitions to ensure the safety of employees.
State media reported that the chip maker did not cease operations over the Lunar New Year holiday.
Meanwhile, Semiconductor Manufacturing International Corp (SMIC) also kept production running through the holiday break.
In a post on social media, the company said it organised a work group before the holiday to ensure plants could stay open, while protecting the safety of employees and adhering to government regulations.
“SMIC needs to ensure that factory production runs 365 days a year and 24 hours a day to meet customers’ fabrication needs,” the company said in the post.
The company, which rivals Taiwan Semiconductor Manufacturing Co, has facilities in Tianjin, Shenzhen, Beijing, and Shanghai.
Nina Kao, TSMC’s spokeswoman, told Reuters that the company currently “maintains partial operation” in China and it plans to resume full operation on Feb 10.
POSSIBLE DELAYS
TCL Corp, makers of display panels and televisions, said on Monday that while the lines at its China Star Optoelectronics Technology Unit (CSOT) for LCD screens “operate non-stop all-year round,” its Wuhan factories can expect delays in manufacturing materials supply.
BOE Technology Group Co Ltd, another Chinese maker of displays, told state media outlet Global Times that one of its plants at Wuhan had encountered a supply shortage due to amid the virus.
Research firm TrendForce, which tracks the global memory sector, reported that plants at Changxin Memory Technologies Co Ltd (CXMT), based in a city close to Wuhan, and Xinxin Semiconductor Manufacturing Co Ltd, another memory company based in Wuhan, were continuing their operations.
The two companies did not immediately respond to emailed requests for comment.
Overseas parts makers with factories in China have also continued production.
Samsung Electronics has not seen a production disruption at its chip factory in Xi’an despite the coronavirus outbreak, two people familiar with the matter told Reuters.
They did not give further details.
A Samsung Electronics representative confirmed that the plant had been running as usual, saying production had not stopped during the Lunar New Year holiday.
Representatives of Samsung Display, SK Hynix and LG Display also said they were running their Chinese factories as usual.
DRAMexChange wrote in a research note that it expected the virus to have no immediate impact on memory prices, though it could delay planned expansions for some companies.
However, one Samsung source said the virus could still affect supply and demand.
“It is common sense that if the situation is prolonged, that it will hurt the industry. But I don’t know how long it will last,” the company source told Reuters.
https://www.marketscreener.com/TCL-CORPORATION-6497076/news/Huawei-Chinese-chip-makers-keep-factories-humming-despite-virus-outbreak-29930081/?countview=0
Two-thirds of China’s economy remains closed
More than a dozen Chinese provinces have announced
an extension of the current Lunar New Year holiday by more than a week
as the nation attempts to halt the rapidly spreading coronavirus that
has so far claimed 362 lives, all but one in China.
The areas accounted for almost 69% of China’s gross domestic product in 2019, according to Bloomberg estimates.
Economists now expect that this virus will deal a
more severe blow to the economy in the near term than the SARS epidemic,
which subtracted an estimated 0.8 percentage point from GDP growth in
2003.
Previously: Nearly $400B wiped off of China’s stock market (Feb. 03 2020)
https://seekingalpha.com/news/3537127-two-thirds-of-chinas-economy-remains-closed
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