Indian biotech firm Panacea Biotec Ltd has agreed to produce 100 million doses of Russia’s Sputnik V COVID-19 vaccine annually, the Russian Direct Investment Fund (RDIF), which markets the shot internationally, said on Monday.
RDIF did not say when production would begin.
China reported its biggest daily jump in new COVID-19 cases in more than two months, as a city on the border with Myanmar in southwestern Yunnan province accounted for all new local cases.
Ruili’s local government put residents in its urban area under home quarantine, launched a massive testing drive and began restricting people from leaving and entering the city from last week after reporting COVID-19 patients.
The city accounted for all of the 15 new local cases reported on April 4. The total number of new COVID-19 infections, including imported infections originating from overseas, stood at 32, marking the highest total since Jan. 31.
Genetic analysis of the cases discovered in Ruili suggest the new local infections stem from viruses imported from Myanmar, state media reported. Of the new patients reported in the city, 11 of them were identified as Myanmar citizens.
Ruili is a key transit point for Yunnan province, which has struggled to monitor its rugged 4,000 km (2,500-mile) border with Laos, Myanmar and Vietnam for illegal immigration amid a wave of unauthorised crossings last year by people seeking a haven from the pandemic.
On Monday evening, city authorities announced three high risk and six medium risk areas in Ruili as of 7pm local time (1100 GMT), reported state broadcaster CCTV.
CCTV also reported that Ruili would conduct a second testing drive round from April 6 onwards, and that residents who had visited Jiegaoyu City, a jade market in one of the high risk areas, between March 15 and 29 would need to be quarantined at home.
Local authorities have also began a vaccination drive in Ruili in a bid to contain COVID-19 and build up herd immunity in the city.
The number of new asymptomatic cases, which China does not classify as confirmed cases, stood at 18, matching the total from a day earlier.
The total number of confirmed COVID-19 cases in mainland China now stands at 90,305, while the death toll remains unchanged at 4,636.
British Prime Minister Boris Johnson said on Monday everyone in England will be able to take a COVID-19 test twice a week in a new drive to track the pandemic as society reopens and the vaccine rollout continues at its rapid rate.
Johnson, who is expected to confirm plans to relaunch international travel and open sections of the economy later on Monday, said the new mass testing programme would break the chain of transmissions and spot cases without symptoms.
As much of Europe enters new lockdowns to tackle surging cases, Johnson has set out a staggered plan to ease restrictions in the coming months, a huge boost for one of the worst-hit countries during the pandemic.
“As we continue to make good progress on our vaccine programme and with our roadmap to cautiously easing restrictions underway, regular rapid testing is even more important to make sure those efforts are not wasted,” Johnson said in a statement.
Junior health minister Edward Argar said the tests would be sent to homes or businesses, or picked up from pharmacies or test centres. He said he was confident people would isolate.
“People are doing the right thing,” he told Sky News.
The increased testing will help health officials to track the pandemic as the country slowly reopens from a strict four-month lockdown.
Johnson is expected to confirm that all retail, outdoor hospitality and hairdressers can reopen on April 12 in England, while a traffic-light system for countries based on infection and vaccination levels will be used for international travel.
Vaccine passports are also being trial led for mass events.
Under the current plan international travel will not resume until May 17 at the earliest. The Financial Times said Johnson was not expected to set out a specific timeframe.
Scotland, Wales and Northern Ireland are following their own, similar paths out of a strict lockdown that was imposed at the beginning of this year.
Britain is able to pursue a recovery after it gave AstraZeneca and Pfizer shots to well over half the adult population. A reopening of schools in March has also not yet led to a spike in cases, despite increased testing.
Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), today announced that, following discussion with its co-development partner Takeda, MTEM will assume full rights to TAK-169 including taking control of clinical development from Takeda. In addition, MTEM announced the decision to discontinue development of MT-3724, MTEM’s only first-generation ETB. MTEM will focus on the clinical development of next-generation ETBs MT-5111, TAK-169, and MT-6402, as well as advancing next-generation preclinical ETB candidates against targets including CTLA-4, CD20, SLAMF-7 and CD45.
Takeda has communicated that its decision to turn over full rights of TAK-169, a second-generation ETB targeting CD38, was the result of Takeda’s ongoing portfolio prioritization. MTEM believes that TAK-169 is a potent molecule with a novel mechanism of action in multiple myeloma. It has demonstrated a favorable safety and efficacy profile in in vivo models and potency against daratumumab refractory patient samples. TAK-169 is in an ongoing Phase 1 study with dose escalation planned through six dose cohorts, in which the first patient was dosed in February 2020. To date, Takeda has enrolled and treated four subjects in the Phase 1 study. There have been no life-threatening toxicities, and no signs of capillary leak syndrome (CLS). The maximum tolerated dose (MTD) has not been reached, patient screening continues, and dose escalation is ongoing. One dose limiting toxicity (grade 2 myocarditis) was assessed in one subject. A mild elevation in Troponin I was noted in this subject after the third dose of TAK-169. No EKG or echocardiographic abnormalities and no clinical symptoms were noted. A stable elevation in high-sensitivity troponin was seen although no comparison to baseline was available as baseline levels were not required per protocol at the time. An independent radiologist and cardiologist reviewed the imaging in the case and concluded that there was weak to intermediate evidence of myocarditis. The subject had multiple pre-existing cardiac risk factors. No other cardiac adverse events were observed in any other subject. Pharmacokinetic and pharmacodynamic data of this first cohort have been in-line with predicted outcomes. MTEM looks forward to accelerating the full enrollment and completion of this safety and dose-finding study. MTEM’s manufacturing of TAK-169 has been qualified by Takeda and MTEM has sufficient TAK-169 drug supply to continue the Phase 1 study as planned. MTEM’s assumption of the full rights to TAK-169 is expected to result in cost savings in 2021 and MTEM’s guidance of cash runway into 2H23 is unchanged. Upon transfer of the full TAK-169 rights to MTEM, per the terms of the collaboration agreement, MTEM will owe Takeda low-single digit royalties on future net sales of TAK-169. MTEM anticipates that the transition of TAK-169 development from Takeda to MTEM will be conducted over the next 90 days.
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the commercial launch of an FDA Emergency Use Authorization-approved, in-licensed rapid point-of-care COVID-19/Flu A&B test, for use in decentralized and traditional testing settings. Product inventory is on-hand and immediately available for shipment to customers across the United States.
The rapid immunoassay test is approved for use in laboratories with a CLIA waiver license, produces results in 15 minutes and requires no instrumentation. The test simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections from a single swab.
https://finance.yahoo.com/news/chembio-announces-u-commercial-launch-213000838.html
Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. Food and Drug Administration (FDA) approved the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
Jack A, Khattar, president and chief executive officer of Rockville, Md.-based Supernus, said the company believes Qelbree (viloxazine extended-release capsules) is a unique alternative for the treatment of ADHD, which is often treated with medications that are considered a controlled substance.
“Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research,” Khattar said in a statement.
Qelbree, formerly known as SPN-812, is a serotonin norepinephrine modulating agent, a novel non-stimulant for the treatment of ADHD. The active ingredient in SPN-812, viloxazine hydrochloride, has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant, the company said.
The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.
Qelbree does come with a black-box warning. Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed. Qelbree should not be taken by patients that also take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines.
Supernus resubmitted its New Drug Application to the FDA in February after receiving a Complete Response Letter from the regulatory agency last year. In the CRL, the FDA raised concern about the company’s in-house laboratory that conducts analytical testing, which had recently moved to a new location. In the NDA resubmission Supernus removed reference to its in-house laboratory and addressed other contents of the CRL. Following the receipt of the CRL, Supernus and the FDA held a Type A meeting in January 2021 to discuss the CRL and the requirements for the NDA resubmission. Once the NDA was accepted, the FDA reclassified the NDA as a Class I review to expedite the evaluation of the medication.
Between the time the company received the CRL and resubmitted its NDA, Supernus announced positive topline Phase III results for Qelbree that showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance in adult patients. The data from this study will be used to support an additional indication for Qelbree. Supernus plans to file a supplemental New Drug Application to the FDA in the second half of 2021.
Emergent BioSolutions Inc. (NYSE:EBS) today announced that the Company continues to be on track with its manufacturing agreements related to COVID-19 vaccines and confirmed that there are no changes to its financial guidance for 2021. In addition, the Company received a contract modification to increase the original task order by $23 million from Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS).
The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility. In addition, Emergent expects to align with the U.S. government and AstraZeneca on a mutually agreed ramp down of manufacturing for AstraZeneca’s COVID-19 vaccine bulk drug substance.
“Emergent is actively working with the U.S. government to fulfill its policy objectives consistent with the Center for Innovation in Advanced Development and Manufacturing (CIADM) that was put in place under the Obama-Biden Administration in 2012,” said Robert G. Kramer, president and chief executive officer of Emergent. “This unique public-private partnership has been a key element in our ability to quickly scale up to produce COVID-19 vaccines at a current rate of more than one billion dose-equivalents annually.”
Emergent continues to own the facility and perform its contracts consistent with its obligations to all of its customers and in compliance with the regulatory standards promulgated by the FDA and all other applicable regulatory authorities.
