A new variant of the coronavirus has been confirmed in Michigan.
The India variant of the virus, also known as B.1.617 has been confirmed in Clinton County, according to the Michigan Department of Health and Human Services.
As of April 29, there have been more than 6,000 confirmed cases of different variants in Michigan.
Brazilian pharmaceutical associations on Friday called for lawmakers to reject a bill that seeks to suspend COVID-19 vaccine patents, saying it could spark international retaliation and reduce medical supplies in Latin America's biggest country.
Brazil's Senate passed the proposal on Thursday night, sending it to the lower house for consideration.
The bill's backers say the emergency measure is needed due to a shortage of shots and a grave outbreak in Brazil, where over 400,000 people have died from the virus.
The government of President Jair Bolsonaro has publicly opposed calls to suspend patent protections, arguing they could endanger talks with vaccine producers.
In a joint statement, five of Brazil's leading pharmaceutical associations sided with his administration.
"The approval of a bill that allows for the weakening of intellectual property could lead to international retaliation and reduce the supply of pharmaceutical inputs," it said. "We cannot support measures that could generate more instability and scenarios that may have irreversible consequences, in the short, medium and long term for Brazil."
Brazil has signed vaccine supply deals with AstraZeneca , China's Sinovac Biotech Ltd, Pfizer Inc and Johnson & Johnson. AstraZeneca and Pfizer declined to comment, while Johnson & Johnson directed Reuters to the associations' statement. Sinovac did not immediately respond.
A senior pharmaceutical executive in Brazil, who was involved in COVID-19 vaccine talks, said the bill was "very poorly thought through" and "sends a poor message."
The executive, who asked to speak anonymously due to ongoing relationships with the government, said the legislation could especially hurt U.S. firms, which hampering Brasilia's efforts to improve relations with Washington.
In a Friday statement on the bill, Brazil's Health Ministry said the priority is to strengthen the country's infrastructure to produce more vaccines domestically.
The presidential press office did not respond to a request for comment.
The legislation passed by the Senate would oblige patent holders to provide authorities with all the information needed to produce COVID-19 vaccines and medicines. Then, if the government were to call a state of emergency, they could be produced locally under a government-mandated arrangement.
It remains to be seen whether lower house lawmakers will pass the bill.
CVS Health Corp. on Friday said it would be expanding its no-cost, community-based screening program to 14 new metropolitan areas this year.
Project Health is expected to begin offering service in Phoenix, Baton Rouge and New Orleans, Jackson, Miss., Cleveland and several other metro areas, CVS Health said.
The company also said it would launch four mobile units this year "to increase program's reach to areas of significant need."
Project Health offers free biometric screenings at CVS Pharmacy locations, which include blood pressure, cholesterol, glucose level and body mass index, the company said. Participants are given the opportunity to meet with a nurse-practitioner who can give referrals for treatment and advice on follow-up care, the company said.
Kyu Rhee, CVS Health's SVP and chief medical officer, said, "Over the last 15 years, Project Health has been extremely successful in connecting people to the health information and follow-up care they need to address the chronic conditions in many health disparity populations. As we expand the program this year, we will be able to dramatically increase our impact, ability to reduce health disparities and promote health equity."
The Biden administration said ON Friday it is extending face mask requirements across all U.S. transportation networks through Sept. 13 to address the spread of COVID-19.
The U.S. Transportation Security Administration requirements that took effect Feb. 1 were to set to expire May 11. They cover workers and travelers at airports, on board commercial aircraft, on over-the-road buses, and on commuter bus and rail systems through Sept. 13.
Astrazeneca today confirmed a substantial delay for the US filing of its Covid-19 vaccine, saying this would be made "within weeks". The first half of April had been the initial target. Astra's chief executive, Pascal Soriot, denied that there were problems, saying it was simply taking time to gather the huge package, which will encompass ex-US trials and real-world data. Speaking on a media call, executives said AZD1222 would be travelling down an emergency use authorisation route, although they will submit a full BLA if required. Given that the US has few vaccine supply problems, this longer path cannot be ruled out. This questions the logic of pursuing US approval in the first place, but the importance of the FDA’s validation can probably not be overstated in the wake of concerns over lack of safety and controversial data disclosures. In a robust defence of Astra’s vaccine programme, Mr Soriot said “we don’t regret anything”, and denied over-promising on the quantities that could be delivered. The vaccine is still in high demand, he told reporters. “Everywhere, countries have told us they still want the totality of what they ordered, and they want it delivered even faster.”
The Health Ministry has identified 41 new cases of the Indian coronavirus variant in Israel, including four in people who have been vaccinated against COVID-19.
Israel's genomic sequencing system found that 24 of those infected with the variant, which experts say may be more contagious than other variants, had returned recently from abroad. The other 17 contracted it via community transmission, including five schoolchildren. The Health Ministry and the IDF Home Front Command are carrying out widespread testing at the schools where the children are enrolled.
Twenty-one of the people who tested positive for the variant are foreign nationals. Last week, Israel banned entry to tourists from India over concerns about the variant's spread and the severe increase in cases there. As part of the new restrictions, only 300 Indian caregivers and students will be allowed to enter the country per month. They will be required to quarantine at coronavirus hotels designated for those coming from India, unless they have either recovered from or were vaccinated against COVID-19 in Israel.
A Health Ministry statement said that new restrictions which would forbid Israelis from traveling to countries with high infection rates (save for exceptional cases) are awaiting approval from the relevant ministries before it can be sent to government approval. Israelis returning from these countries would also need to quarantine, even if they have been vaccinated against or recovered from COVID-19. Foreign nationals from these countries would also not be allowed to enter Israel, and those who have received permission to do so would have to quarantine at designated hotels, as is the case with arrivals from India.
Last month some 1,000 people entered Israel from India, and only about a quarter of them were vaccinated. Among those who entered, 63 tested positive for the virus, but not all of them had necessarily been infected by the Indian variant.
The Indian variant is of concern to experts because it consist of two mutations of its protein, which could make it more resistant to the coronavirus vaccine. Last month, the Indian Health Ministry reported on a strain of the virus that includes two genetic changes and constitutes a kind of “union” of two variants previously known as E484Q and L452R.
However, because samples collected from throughout India have shown that the most dominant variant in the country is the British variant, the prevailing view is that the new strain of the virus is not behind the latest outbreak in India, which is rapidly spreading across the country.
The Israeli Health Ministry also identified eight new cases of the South African variant, seven of the New York variant, two of the California variant, one of the St. Petersburg variant and one case of an additional British variant.
Although most of the coronavirus restrictions in Israel have been rolled back in recent weeks due to the drop in infections, entrance to the country is still being controlled. Israelis who enter without a vaccination certificate must quarantine at home, while those who recovered or were vaccinated in Israel do not have to quarantine, but must receive a negative result from the rapid coronavirus test now being administered to everyone entering Israel via Ben-Gurion Airport.
With several new immuno-oncology drugs on their way to the U.S. from Chinese biopharma companies, the already crowded PD-1/L1 market about to get even more so. And that's put Opdivo developer Bristol Myers Squibb on notice.
While Bristol Myers isn’t paranoid about new PD-1 competition, the risk of commoditization—as newer entrants undercut established drugs on price—could be a bigger problem that “we need to stay on top of,” the company’s chief commercial officer Chris Boerner said on a conference call Thursday.
At least three Chinese-made PD-1s are looking to launch in the U.S. in the next three years, with U.S. partners in Novartis, Eli Lilly and Coherus BioSciences. Although none of the drugs has proven superior to the currently available meds, the new entrants are expected to offer discounted prices to win market share.
BMS is paying attention to the up-and-coming drugs, Boerner said, but it's not so concerned about competition on the merits. A price-driven battle might be more disruptive.
Low cost isn't the only thing that drives commoditization, Boerner said. Payers, physicians and patients also have to consider products interchangeable.
“The risk of both of these things coming together likely varies by geography, healthcare system and maybe even by therapeutic setting, but we pay very close attention to this,” he said. At least for now, the greatest risks don’t overlap with Opdivo’s largest markets, he added.
Opdivo is the second best-selling PD-1/L1 checkpoint inhibitor among seven existing options. Under pressure from Merck & Co.’s market-leading Keytruda, the drug has hit a growth bottleneck lately. During the first quarter, it brought in sales of $1.72 billion, down 3% year over year—after a similar year-over-year decline in 2020.
Bristol blamed COVID-19 for part of that decline, particularly internationally. In the U.S., the drug maintains a low double-digit share in the biggest area, first-line non-small cell lung cancer.
The company argues Opdivo will start growing again this year, thanks to a strategy of churning out new data and winning new approvals that can help the med defend itself against the competition.
These include a combo with Exelixis’ Cabometyx in previously untreated kidney cancer and with chemotherapy in previously untreated stomach cancer, as well as potential launches in post-surgery esophageal cancer and post-surgery muscle-invasive bladder cancer.
As most metastatic cancer fields fill up with competition, PD-1/L1 developers are looking for approvals in newly diagnosed patients before and after surgery. Boerner noted that the treatment rate for some of those uses—known as adjuvant and neo-adjuvant—remain relatively low, so even after it wins those approvals, sales will likely ramp up slowly.
Meanwhile, Bristol’s looking to introduce its third checkpoint inhibitor in addition to Opdivo and CTLA4 inhibitor Opdivo. A fixed combo of Opdivo and investigational LAG-3 antibody relatlimab recently topped solo Opdivo in first-line melanoma.
Currently, the Opdivo-Yervoy combo takes up about 35% to 40% of front-line melanoma share, and single-agent I-O use constitutes another 30%. With relatlimab, the company’s aiming to tap into the rest of the market, Boerner said.
The company’s also eyeing the front-line NSCLC market, having launched an early study adding chemotherapy to the Opdivo-relatlimab pair, with the hope of starting a phase 3 trial by the end of the year, Bristol’s chief medical officer Samit Hirawat said on the call.
In addition, Bristol recently launched two CAR-T cell therapies, CD19-targeted Breyanzi and BCMA-targeted Abecma. Both drugs require designated treatment centers for administration. So far, 55 sites for Breyanzi and more than 40 for Abecma have been activated.
All told, Bristol saw sales increase 3% year over year to $11.1 billion in the first quarter. Multiple myeloma drug Revlimid led the pack with a Q1 haul of $2.94 billion, followed by oral blood thinner Eliquis, which turned in $2.89 billion. Both drugs reported growth.
