LONDON, Nov 23 (Reuters) – Britain medicines regulator said on Monday it would aim to make a decision on Pfizer and BioNTech’s COVID-19 vaccine candidate “in the shortest time possible” after receiving additional data about the shot.
“It is our job now to rigorously assess these data and the evidence submitted on the vaccine’s safety, quality and effectiveness,” said June Raine, chief executive of Britain’s Medicines and Healthcare products Regulatory Agency.
“As we have received this data through a rolling review, we have already started our analysis and will aim to make a decision in the shortest time possible, without compromising the thoroughness of our review.” (Reporting by Michael Holden; editing by Sarah Young)
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China has defended its decision to oust four pro-democracy lawmakers from Hong Kong as “the right medicine” for the city, blasting foreign governments for “meddling” in domestic issues that are none of its business.
“The plain fact is that it is exactly these politicians who have arbitrarily meddled with China’s internal affairs,” said the Chinese foreign ministry in a statement. “It is these politicians who have breached their international obligations.”
Pandemonium erupted in Hong Kong’s parliament this week as 15 pro-democracy lawmakers resigned in protest after government officials dismissed four of their colleagues on alleged national security grounds, yet another step in a broader crackdown from Beijing to quash dissent.
Many foreign governments have condemned China for dismissing the lawmakers.
The UK on Thursday declared China to be in formal breach of the Sino-British Joint Declaration, a UN-registered treaty meant to preserve Hong Kong’s freedoms after the former British colony was returned to Beijing rule under the Communist Party.
Unseating four pro-democracy lawmakers, however, amounted to a “clear breach” of that agreement, said Foreign Secretary Dominic Raab.
“Beijing has eliminated nearly all of Hong Kong’s promised autonomy, as it neuters democratic processes and legal traditions that have been the bedrock of Hong Kong’s stability and prosperity,” said US secretary of state Mike Pompeo.
“Once again, the [Chinese Communist Party’s] twisted vision of patriotism is a pretext to stifle freedom and the call for democracy.”
China has long sought to wrest control of Hong Kong, where protest movements over eroding freedoms have erupted every few years since Beijing resumed control of the territory from Britain in 1997.
Discontent peaked last year when millions of Hong Kong people took to the streets, disrupting the city with mass protests that often ended in violence with police firing tear gas and rubber bullets.
Demonstrations abated with the coronavirus pandemic, and after a sweeping national security law was imposed by Beijing this summer. The law criminalises acts authorities deem as secession, subversion, terrorism and foreign collusion, punishable by up to life in prison.
This story was published in partnership with The 19th, a nonprofit, nonpartisan newsroom reporting on gender, politics and policy.
A top pediatric hospital has agreed to stop performing certain types of genital surgeries on intersex children if they are too young to meaningfully consent— a decision that activists say could be a watershed moment for intersex rights.
A spokesperson for Boston Children’s Hospital told The 19th that it “will not perform clitoroplasty or vaginoplasty in patients who are too young to participate in a meaningful discussion of the implications of these surgeries, unless anatomical differences threaten the physical health of the child.” The decision came from the hospital’s behavioral health, endocrinology and urology program.
Each year, about 1.7 percent of people are born intersex, or people with sexual or reproductive anatomy that doesn’t neatly align into a binary of male or female. Some people develop those anatomical traits in adolescence or childhood, while others are born with them.
Boston Children’s Hospital says it will no longer perform certain intersex surgeries on children too young to consent, unless their health is in danger. (Photo: AP File Photo)
For decades, the standard medical protocol was to use surgery and hormonal therapy to try to change intersex children’s physical appearance. Clitoroplasties, the surgical creation of a clitoris (which can involve reducing its size), and vaginoplasty, which involves constructing a vagina, are two such surgeries. Activists have been protesting these practices for decades, and — though legal worldwide — they have been condemned by the United Nations, Amnesty International and Human Rights Watch.
Boston Children’s decision could reflect a turning point, activists said. It comes on the heels of a similar move by the Ann and Robert H. Lurie Children’s Hospital of Chicago, which announced in July it would suspend such intersex surgeries.
“One hospital was cool, but people might be like, ‘Oh, that’s an anomaly.’ Now that there are two hospitals, people in the community are going to feel more ability to pressure their hospitals to do the same,” said Pidgeon Pagonis, co-founder of the Intersex Justice Project.
Advocates are pushing for similar changes in other major cities, including New York, Seattle, Philadelphia, Los Angeles and Oklahoma City, Pagonis said. Both New York City Human Rights Commissioner Carmelyn Malalis and its former health commissioner Oxiris Barbot have also spoken out against performing intersex surgeries in children.
Still, Boston Children’s change isn’t exhaustive. The hospital has not indicated it will drop other intersex surgeries, including gonadectomies, which constitute the removal of certain reproductive glands, or phalloplasties, which enlarge penises.
“Vaginoplasties and cliteroctomies are very destructive, and it’s very welcome news,” Pagonis said. “But it means there’s still more work to do.”
There are a host of physical consequences to intersex surgeries: loss of sexual sensation, incontinence, fertility problems and pain during intercourse are just a few. And beyond physical consequences, intersex surgeries can have lifelong pyschological impact.
There are cases when surgery
Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.
The week was a quiet one from the perspective of news flow. Johnson & Johnson (NYSE: JNJ) was in the news for both right and wrong reasons. The company’s Phase 3 trial of its coronavirus vaccine was paused due to a trial participant contracting an unexplained illness. On a positive note, the company reported solid quarterly results and lifted its guidance.
Pfizer Inc. (NYSE: PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate.
Avenue Therapeutics Inc (NASDAQ: ATXI) shares fell from $11 to just under $4 after FDA rejected its opioid pain drug on safety concerns.
Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) and Cyclerion Therapeutics Inc (NASDAQ: CYCN) shelving alpha-1 antitrypsin deficiency and sickle cell disease studies, respectively.
The week witnessed Nasdaq debuts by six biopharma companies, which collectively raised about $650 million in gross proceeds.
Here are the key catalysts for the unfolding week.
American College of Chest Physicians’ CHEST Annual Meeting 2020, being held virtually: Oct. 18-21
The Prostate Cancer Foundation’s 27th Annual Scientific Retreat: Oct. 20-23
IDWeek 2020: Oct. 20-25
American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25 (early programs scheduled for Oct. 19-21)
32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium: Oct. 24-25
Zosano Pharma Corp’s (NASDAQ: ZSAN) NDA for its migraine drug Qtrypta has a PDUFA action date of Oct. 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision by the d-day seems unlikely.
The FDA is set to rule on Spectrum Pharmaceuticals, Inc.’s (NASDAQ: SPPI) BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.
Pfizer Inc. (NYSE: PFE) is scheduled to present at the ID Week 2020 full results of the pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.
Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) will present at the ASN meeting results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.
Omeros Corporation (NASDAQ: OMER) is due to present final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation, in the form of a webcast, is scheduled for Oct. 22.
Mustang Bio Inc (NASDAQ: MBIO), founded by Fortress Biotech (NASDAQ: FBIO), is scheduled to present at the Prostate Cancer Foundation’s annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for Oct. 23.
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