SEEKING APPROVAL FOR USE IN ACTIVE IMMUNIZATION AGAINST INFECTION BY MEASLES, MUMPS AND RUBELLA (MMR)
Monday, August 2, 2021
UAE rolls out Sinopharm Covid-19 vaccine to children aged 3-17
The United Arab Emirates will start providing China's Sinopharm Covid-19 vaccine to children aged 3-17, the UAE government said on Twitter on Monday.
It cited the health ministry as saying the decision comes after clinical trials and extensive evaluations, without providing any details. Authorities said in June the trial would monitor the immune response of 900 children.
The Gulf Arab state, which has among the world's highest immunisation rates, was already providing the Pfizer-BioNTech vaccine for children aged 12-15.
The health ministry said on Sunday that 78.95% of the UAE population of roughly 9 million had received one vaccine dose while 70.57% had been fully vaccinated.
The UAE, the region's tourism and trade hub, registered 1,519 new Coronavirus infections on Sunday to take its total to 682,377 cases and 1,951 deaths. It does not provide a breakdown for each of its seven emirates.
It led Phase III clinical trials of the vaccine produced by China's state-owned drugmaker Sinopharm and has started manufacturing it under a joint venture between Sinopharm and Abu Dhabi-based technology company Group 42.
It led Phase III clinical trials of the vaccine produced by China's state-owned drugmaker Sinopharm and has started manufacturing it under a joint venture between Sinopharm and Abu Dhabi-based technology company Group 42.
Combining AstraZeneca and MRNA COVID-19 Vaccines Is Effective -Danish Study
Combining AstraZeneca's COVID-19 vaccine with a second dose from either Pfizer-BioNTech or Moderna's jab provides "good protection", Denmark's State Serum Institute said on Monday.
A growing number of countries are looking at switching to different COVID-19 vaccines for second doses, a measure particularly necessary in Denmark after health authorities discontinued inoculations with AstraZeneca's vaccine in April over rare side-effect concerns.
More than 144,000 Danes, mostly frontline personnel in the health sector and the elderly, received their first jab with AstraZeneca's vaccine but were subsequently vaccinated with either Pfizer-BioNTech or Moderna's shots.
"The study shows that fourteen days after a combined vaccination program, the risk of infection with SARS-CoV-2 is reduced by 88% compared to unvaccinated individuals," the State Serum Institute (SSI) said.
That is a "high efficacy", SSI added, comparable to the 90% efficacy rate of two doses from Pfizer-BioNTech's vaccine, confirmed in a different Danish study.
The study, published last week, covered a span of more than five months between February and June this year, a period in which the Alpha-variant of the coronavirus was predominant.
It could not conclude whether the same protection applied to the Delta-variant, which is now the most widespread in Denmark.
It also provided no efficacy data on COVID-19 related deaths or hospitalisations, since none took place following the combined vaccination programme.
J&J says still in talks with Indian govt on COVID-19 vaccine
Johnson & Johnson said on Monday it was still in talks with the Indian government over its COVID-19 vaccine after the country's drug regulator announced the company had pulled its proposal seeking an accelerated approval for local trials.
India had, in May https://www.reuters.com/world/india/india-posts-daily-rise-covid-19-cases-211298-2021-05-27, scrapped local trials for "well-established" foreign coronavirus vaccines as it tried to hasten vaccination rollouts to fight a second wave of infections.
"We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our COVID-19 vaccine to India," Johnson & Johnson said in an emailed statement.
The Indian junior health minister said last week that a team had been formed to engage with vaccine makers.
"This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity," Bharati Pravin Pawar had said. https://www.reuters.com/world/india/legal-wrangles-hold-up-us-vaccine-donations-india-2021-07-28
The Central Drugs Standard Control Organisation (CDSCO) did not immediately respond to Reuters' requests for comments on Monday.
As of July 28, only 10% of India's adult population of about 944 million people had been inoculated with both doses, with 47% receiving at least one shot.
Johnson & Johnson is yet to request a full approval for its shot with the U.S. Food and Drug Administration, while Pfizer Inc and partner BioNTech SE, and Moderna Inc have already sought full approval of their vaccines.
In India, the drug regulator had in June given emergency use authorisation to Moderna's vaccine.
https://news.yahoo.com/indias-drug-regulator-says-j-075338382.html
Republican report says coronavirus leaked from Chinese lab; scientists still probing origins
A preponderance of evidence proves the virus that caused the COVID-19 pandemic leaked from a Chinese research facility, said a report by U.S. Republicans released on Monday, a conclusion that U.S. intelligence agencies have not reached.
The report also cited "ample evidence" that Wuhan Institute of Virology (WIV) scientists - aided by U.S. experts and Chinese and U.S. government funds - were working to modify coronaviruses to infect humans and such manipulation could be hidden.
Representative Mike McCaul, the top Republican on the House Foreign Affairs Committee, released the report by the panel's Republican staff. It urged a bipartisan investigation into the origins of the COVID-19 coronavirus pandemic that has killed 4.4 million people worldwide. (Graphic on global cases and deaths) https://tmsnrt.rs/34pvUyi
China denies a genetically modified coronavirus leaked from the facility in Wuhan - where the first COVID-19 cases were detected in 2019 - a leading but unproven theory among some experts. Beijing also denies allegations of a cover-up.
Other experts suspect the pandemic was caused by an animal virus likely transmitted to humans at a seafood market near the WIV.
"We now believe it's time to completely dismiss the wet market as the source," said the report. "We also believe the preponderance of the evidence proves the virus did leak from the WIV and that it did so sometime before September 12, 2019."
The report cited what it called new and under-reported information about safety protocols at the lab, including a July 2019 request for a $1.5 million overhaul of a hazardous waste treatment system for the facility, which was less than two years old.
In April, the top U.S. intelligence agency said it concurred with the scientific consensus that the virus was not man-made or genetically modified.
U.S. President Joe Biden in May ordered U.S. intelligence agencies to accelerate their hunt for the origins of the virus and report back in 90 days.
A source familiar with current intelligence assessments said the U.S. intelligence community has not reached any conclusion whether the virus came from animals or the WIV.
https://news.yahoo.com/u-republican-report-says-coronavirus-040529174.html
US FDA approval tracker: July
Last month saw plenty of setbacks for companies gunning for US approvals, with four complete response letters as well as a number of delays to Pdufa dates. One group that has been held up is Chemocentryx, which will now have to wait until October for the decision on Vynpenta for ANCA-associated vasculitis. The new date was given after Chemocentryx submitted a filing amendment intended to address issues raised during an earlier panel meeting. Having already been delayed to the third quarter, decisions on Jak inhibitors from Pfizer, Lilly and Abbvie have been pushed back again as the US regulators continue to review the safety profile of Pfizer's Xeljanz. The FDA has not given any guidance as to when the reviews might be completed. On a more positive note, Merck & Co’s Keytruda added more indications to its armoury, including neoadjuvant and adjuvant use in triple-negative breast cancer. However, the drug's accelerated approval in third-line gastric cancer was voluntarily withdrawn following an FDA-backed panel meeting in April.
| Notable first-time US approval decisions in July | ||||
|---|---|---|---|---|
| Project | Company | Indication(s) | 2026e sales by indication ($m) | Outcome |
| Kerendia (finerenone) | Bayer | CKD and type 2 diabetes | 896 | Approved |
| Rezurock (belumosudil/ KD025) | Kadmon | Chronic graft vs host disease | 863 | Approved (~6wks early) |
| Vaxneuvance (V114) | Merck & Co/Ligand | Pneumococcal infection vaccine (adults) | 786 | Approved |
| Ibsrela (tenapanor) | Ardelyx | Control of serum phosphorus in adult patients with CKD | 701 | CRL |
| Vynpenta (avacopan) | Chemocentryx | ANCA-associated vasculitis | 639 | Delayed to October 7 |
| Saphnelo (anifrolumab) | Astrazeneca | Moderate to severe SLE | 488 | Approved |
| Bylvay (odevixibat) | Albireo | Progressive familial intrahepatic cholestasis | 299 | Approved |
| Sulopenem etzadroxil/probenecid (oral sulopenem) | Iterum | uUTIs | 220 | CRL |
| Retifanlimab | Incyte | Squamous cell carcinoma of the anal canal | 80 | CRL |
| Dalvance | Abbvie | Acute bacterial skin and skin structure infections in paediatric patients | 40 | Approved |
| Teplizumab (PRV-031) | Provention Bio | Delay or prevention of type 1 diabetes in at-risk individuals | - | CRL |
| Leukotac (inolimomab) | Gruppo Mediolanum farmaceutici | Acute steroid-resistant graft vs host disease | - | No decision yet |
| Twyneo | Sol-Gel | Acne | - | Approved |
| Fexinidazole | Sanofi/Drugs for Neglected Diseases initiative | All-oral treatment for sleeping sickness | - | Approved |
| Source: Evaluate Pharma & company releases. | ||||
| Advisory committee meeting in July | ||||
|---|---|---|---|---|
| Project | Company | Indication | 2026e sales by indication ($bn) | Outcome |
| Evrenzo (roxadustat) | Astrazeneca/ Fibrogen/Astellas | Anaemia due to CKD in adult patients not on dialysis and on dialysis | 2.6* | The committee voted 12-2 against approval in pts on dialysis and 13-1 against approval for pts not on dialysis |
| Source: Evaluate Pharma & company releases. *Forecasts prior to adcom. | ||||
| Supplementary and other notable approval decisions in July | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Abrocitinib | Pfizer | Atopic dermatitis | Delayed |
| Xeljanz | Pfizer | Ankylosing spondylitis | Delayed |
| Olumiant | Lilly | Atopic dermatitis | Delayed |
| Rinvoq | Abbvie | Atopic dermatitis | Delayed |
| Keytruda | Merck & Co | Locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation (Keynote-629) | Approved |
| Keytruda + Lenvima | Merck & Co/Eisai | Advanced endometrial carcinoma that is not MSI-H or dMMR (Confirmatory study Keynote-775) | Approved (~6wks early) |
| Keytruda | Merck & Co | High-risk early-stage triple-negative breast cancer plus chemo as neoadjuvant treatment and then as a single agent as adjuvant treatment after surgery (Keynote-522) | Approved |
| Keytruda | Merck & Co | Full approval triple-negative breast cancer (≥10% PD-L1 expressers) (Confirmatory study Keynote-522, originally granted in Nov 2020 based on Keynote-355) | Approved |
| Padcev | Seagen/Astellas | Regular approval and expanded indication in adult patients with locally advanced or met urothelial cancer who are ineligible for cisplatin-containing chemo (EV-301, EV-201) | Approved (~1mo early) |
| Darzalex Faspro + pomalidomide + dexamethasone | J&J | Adult multiple myeloma patients who have received at least one prior line of therapy (Apollo) | Approved |
| Octagram 10% | Octapharma | Dermatomyositis in adults (Proderm) | Approved |
| Prograf | Astellas | Prevention of organ rejection in adult and paediatric lung transplant recipients. | Approved |
| Bydureon BCise (exenatide extended-release) | Astrazeneca | Once-weekly injectable suspension for type 2 diabetes in paediatric patients ages 10 years and older (BCB114) | Approved |
| Shingrix | Glaxosmithkline | Prevention of shingles in immunocompromised adults | Approved |
| Semglee (Lantus biosimilar) | Viatris | Improve glycaemic control in adults and children with Type 1 diabetes and in adults with Type 2 diabetes (interchangeable label) | Approved |
| Botox | Abbvie | Label to include eight new muscles for the treatment of upper limb spasticity in adults | Approved |
| Nucala | Glaxosmithkline | Chronic rhinosinusitis with nasal polyps (Synapse) | Approved |
| Source: Evaluate Pharma & company releases. | |||
| Voluntarily withdrawn accelerated approvals | ||
|---|---|---|
| Product | Company | Withdrawn indication |
| Keytruda | Merck & Co | 3L (PD-L1 ≥1%) gastric/GEJ adenocarcinoma |
| Opdivo | Bristol Myers Squibb | 2L hepatocellular |
| Source: Company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-july-0 | ||
Subscribe to:
Posts (Atom)