Target to $24 from $4
Thursday, March 11, 2021
Full authorization of Bharat-Ocugen vax eyed: India regulator panel
The subject expert committee (SEC) of the Indian drug regulator will meet on Thursday to consider Bharat Biotech International’s proposal to remove its jabs from ‘clinical trial mode’, which, if successful, may boost uptake of the indigenous covid-19 .
PDS Biotech: COVID-19 Vaccine Development Consortium Backed by Brazil Ministry
Development and commercialization of novel T-cell activating vaccine to be performed in Brazil by consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on PDS Biotech’s proprietary Versamune® T-cell activating technology, today announced that its COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica, has received a commitment from the Secretary for Research and Scientific Training of the MCTI to fund up to approximately US$60 million to support the clinical development and commercialization of a novel, Versamune®-based, second generation COVID-19 vaccine in Brazil.
MCTI intends to start making the funds available to prepare to perform a combined Phase 1/2 clinical trial, upon authorization by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (Anvisa) to initiate the proposed Versamune®-based COVID-19 vaccine clinical program in Brazil.
https://finance.yahoo.com/news/pds-biotech-announces-covid-19-133000244.html
AstraZeneca use can continue pending blood clot probe: EMA
European countries can keep using AstraZeneca's coronavirus vaccine during an investigation into cases of blood clots that prompted Denmark, Norway and Iceland to suspend jabs, the EU's drug regulator said on Thursday.
There had been 30 cases of 'thromboembolic events' among five million people who've had the jab so far in Europe, the Amsterdam-based European Medicines Agency (EMA) said in a statement.
"The position of EMA's safety committee... is that the vaccine's benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing," the EMA said.
"There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine."
Denmark, Norway and Iceland on Thursday temporarily suspended the use of AstraZeneca's COVID-19 vaccine over concerns about patients developing post-jab blood clots.
The EMA said Denmark's decision was a "precautionary measure while a full investigation is ongoing into reports of blood clots in people who received the vaccine, including one case in Denmark where a person died".
Of the 30 blood-clot cases across Europe, it said that "the number of thromboembolic events in vaccinated people is no higher than the number seen in the general population".
The EMA covers the 27-nation EU plus Norway, Iceland and Lichtenstein.
Italy's medicine regulator said Thursday it was banning a batch of the AstraZeneca/Oxford coronavirus vaccine over the issue.
Austria announced it had suspended the use of a different AstraZeneca batch, after a 49-year-old nurse died of severe blood coagulation days after receiving the shot.
Estonia, Latvia, Lithuania and Luxembourg have also suspended the use of the same batch as Austria.
https://medicalxpress.com/news/2021-03-astrazeneca-pending-blood-clot-probe.html
Atossa Gets FDA Safe to Proceed Letter for Treatment of Ovarian Cancer
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases today announced the FDA has issued a “Safe to Proceed” letter under their Expanded Access Pathway, permitting the use of Atossa’s oral Endoxifen as a treatment in an ovarian cancer patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief.
“Dr. Goff recently contacted Atossa with an interest in gaining access to our Endoxifen under the FDA’s expanded access, or compassionate use, program for one of her patients,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “The patient has recurrent ovarian cancer and recently underwent functional molecular genomic testing, using 3D tumor organoid cultures grown in the laboratory from the patient’s tumor. The organoid testing revealed that the combination of Endoxifen and alpelisib produced an exceptional tumor response. We are gratified to be able to help this patient and are anxious to follow her response to this drug combination. If the drug combination shows promise in this patient, Atossa will consider doing additional clinical studies in patients with ovarian cancer.”
Under the FDA expanded access program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient. Approval from the Institutional Review Board (IRB) must be obtained prior to providing oral Endoxifen to this patient.
https://finance.yahoo.com/news/atossa-therapeutics-announces-receipt-fda-143000339.html
Sidecar Health Expands Disruptive Health Insurance Offering to Utah
Sidecar Health, the company dedicated to providing simple and transparent insurance options based on doctors’ cash prices, today announced it is available to consumers in Utah. Consumers in 16 states will now have access to Sidecar Health’s flexible and affordable insurance solutions.
“By introducing Sidecar Health to consumers in Utah, we’re giving residents of the state the option to take advantage of a new approach to quality health coverage that is based on the power of cash,” said Patrick Quigley, CEO of Sidecar Health. “With the average cost of monthly health insurance premiums in Utah nearly $500, our presence will provide a much-needed solution to those who are uninsured and for people looking to save money and take control of their healthcare costs.”
Sidecar Health works on the straightforward principle that everyone has the right to take control of their own healthcare and to pay only the “cash price” for the services they need. Members can choose from a selection of customized plans to meet their individual needs. By paying the cash price, customers get 40% savings on healthcare services compared to insurance-negotiated rates, without network restraints or surprise bills. Members also receive a Sidecar Health Visa card, which they can use to pay at the point of service.
With the addition of Utah, Sidecar Health is now available to nearly 42% of the U.S. population, with plans to roll out to several more states this year. While this state launch coincides with the extended Affordable Care Act signup period, Sidecar Health plans are available to consumers year-round. Sidecar Health is also available in Alabama, Arkansas, Arizona, Florida, Georgia, Indiana, Kentucky, Maryland, Mississippi, Ohio, Oklahoma, North Carolina, South Carolina, Tennessee and Texas.
Longeveron: FDA OKs Lomecel-B for Compassionate Use in Child Hypoplastic Left Heart Syndrome
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the U.S. Food & Drug Administration (FDA) has granted expanded access approval for the administration of Longeveron’s investigational cell therapy Lomecel-B to a child with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under cGMP in Longeveron’s cell processing facility in Miami, Florida. Dr. Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Ann & Robert H. Lurie Children’s Hospital of Chicago will administer Lomecel-B during a reconstructive cardiac surgery procedure.
FDA’s Expanded Access program, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The Lurie Children’s Hospital Internal Review Board (IRB) also reviewed and approved the protocol.
Dr. Kaushal was the first surgeon in the United States to administer allogeneic MSCs to a baby with HLHS. "The rationale for this approach is to improve the functioning of the right ventricle, the only ventricle in these babies, through regeneration of cardiac tissue. Our goal is to make it pump as strongly as a normal left ventricle," says Dr. Kaushal. "We are grateful to FDA, Lurie Children’s Hospital IRB, and Longeveron for making this happen, and we are hoping this therapy will be a game-changer for this baby and others in the future.”
“Our goal is to provide a new way to treat HLHS and we believe, based on previous studies, that the MSCs in Lomecel-B may improve ventricular and vascular function,” stated Geoff Green, CEO of Longeveron.
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