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Tuesday, October 4, 2022

Cidara Gets $11.1 Million Milestone Payment from Mundipharma

 Milestone payment triggered by European Medicines Agency acceptance of marketing authorization application for rezafungin

Company eligible to receive up to an additional $108M in milestones from multiple existing partnerships based on successful completion of activities planned for the next two years

https://finance.yahoo.com/news/cidara-therapeutics-receives-11-1-120000785.html

KalVista stops hereditary angioedema Phase 2 trial

 Safety signals observed will not yield targeted product profile –

- No impact on Sebetralstat expected safety profile or Phase 3 KONFIDENT trial –

- Oral Factor XIIa program to become primary focus for HAE prophylaxis -

https://finance.yahoo.com/news/kalvista-pharmaceuticals-announces-termination-kvd824-103000419.html

Gilead upped to Overweight from Neutral by JPMorgan

 Target to $80 from $72

https://finviz.com/quote.ashx?t=GILD

Monday, October 3, 2022

'Arizona clinic has workaround for abortion pill ban'

 A Phoenix abortion clinic has come up with a way for patients who can end their pregnancy using a pill to get the medication quickly without running afoul of a resurrected Arizona law that bans most abortions.

Under the arrangement that began Monday, patients will have an ultrasound in Arizona, get a prescription through a telehealth appointment with a California doctor and then have it mailed to a post office in a California border town for pickup, all for free.

While not as easy as before an Arizona judge ruled that a pre-statehood law criminalizing nearly all abortions could be enforced nearly two weeks ago, the process saves an overnight trip to a major California city with an abortion clinic. And it is more accessible than the previous workaround used by Camelback Family Planning in Phoenix, which was to have a doctor in Sweden prescribe the pills and a pharmacy in India mail them to Arizona. That could take up to three weeks.

Ashleigh Feiring, a nurse at the clinic, said the cost of the pills will be covered by the Abortion Fund of Arizona, which is helping women pay for out-of-state access to abortions. Women can use a pill for an abortion until the 12th week of pregnancy. Pills and surgical abortions were legal until about 24 weeks until the U.S. Supreme Court struck down Roe v. Wade in June and allowed states to ban all abortions.

The Food and Drug Administration earlier this year permanently removed rules requiring in-person consultations with a provider before women can receive a medication abortion, allowing women to have a telehealth appointment and get the pills through the mail.

But Arizona has a law that bans mailing the pills, as well as the law that bans all abortions unless the life of the mother is in jeopardy. That has led clinics to make arrangements with clinics in New Mexico and California to treat patients who wanted to access the abortion pill as well as those more than 12 weeks along who need a surgical abortion.

At Camelback Family Planning, Feiring said they are not worried about doing ultrasounds and post-abortion care for those who use the pill to have an abortion.

“We’re not providing abortions,” Feiring said. “We’re just giving people information.”

Those who get the pills mailed to one of three California towns along the border with Arizona would pick them up with the post office and take the first medication there before returning home and taking the second medicine. They would return to the clinic in about a week for a follow-up exam.

Cathi Herrod, president of the social conservative organization Center for Arizona Policy and the architect of many of Arizona’s tough abortion restrictions, slammed the proposal.

“The plan for abortion pills shows a stunning disregard for the health and well-being of the mother,” Herrod said.

Despite the FDA approval, Herrod argues that abortion pills have significant consequences and women need an in-person exam and follow-up care.

“I’m not surprised that the abortion industry would care more about their bottom line and about selling pills than they would about taking care of women still,” she said.

Planned Parenthood Arizona said it has a team of patient navigators to inform them of their options, including having and keeping the baby, putting it up for adoption, or going out of state for an abortion, according to President and CEO Brittany Fonteno.

If the patient decides to have an abortion but can’t afford the new costs, Planned Parenthood will work with the patient to arrange for care. Help with the added expenses will come from either Planned Parenthood funds or money from the two abortion funds in the state. This will pay for travel, lodging, child care and other needs.

“It’s doing everything that we have within our power to break down those barriers to care,” Fonteno said. Planned Parenthood was the largest provider in the state before the ban.

Arizona is among several Republican-led states that bar delivery of abortion pills though the mail. It is one of 14 states with near-total abortion bans that the Supreme Court allowed when it overturned Roe.

About 13,000 Arizona women had abortions last year, about half with a pill. Most occurred before the 15th week of pregnancy.

https://apnews.com/article/abortion-health-arizona-california-medication-2cc48f943f339d1959b6ca89883fd2f4

'It’s flu vaccine time and seniors need revved-up shots'

Doctors have a message for vaccine-weary Americans: Don’t skip your flu shot this fall -- and seniors, ask for a special extra-strength kind.

After flu hit historically low levels during the COVID-19 pandemic, it may be poised for a comeback. The main clue: A nasty flu season just ended in Australia.

While there’s no way to predict if the U.S. will be as hard-hit, “last year we were going into flu season not knowing if flu was around or not. This year we know flu is back,” said influenza specialist Richard Webby of St. Jude Children’s Research Hospital in Memphis.

Annual flu shots are recommended starting with 6-month-old babies. Flu is most dangerous for people 65 and older, young children, pregnant women and people with certain health problems including heart and lung diseases.

Here’s what to know:

REVVED-UP SHOTS FOR SENIORS

As people get older, their immune system doesn’t respond as strongly to standard flu vaccination. This year, people 65 or older are urged to get a special kind for extra protection.

There are three choices. Fluzone High-Dose and Flublok each contain higher doses of the main anti-flu ingredient. The other option is Fluad Adjuvanted, which has a regular dosage but contains a special ingredient that helps boost people’s immune response.

Seniors can ask what kind their doctor carries. But most flu vaccinations are given in pharmacies and some drugstore websites, such as CVS, automatically direct people to locations offering senior doses if their birth date shows they qualify.

Webby advised making sure older relatives and friends know about the senior shots, in case they’re not told when they seek vaccination.

“They should at least ask, ‘Do you have the shots that are better for me?’” Webby said. “The bottom line is they do work better” for this age group.

If a location is out of senior-targeted doses, it’s better to get a standard flu shot than to skip vaccination, according to the Centers for Disease Control and Prevention.

All flu vaccines in the U.S. -- including types for people younger than 65 -- are “quadrivalent,” meaning they guard against four different flu strains. Younger people have choices, too, including shots for those with egg allergies and a nasal spray version called FluMist.


WHY FLU EXPERTS ARE ON ALERT

Australia just experienced its worst flu season in five years and what happens in Southern Hemisphere winters often foreshadows what Northern countries can expect, said Dr. Andrew Pekosz of the Johns Hopkins Bloomberg School of Public Health.

And people have largely abandoned masking and distancing precautions that earlier in the pandemic also helped prevent the spread of other respiratory bugs like the flu.

“This poses a risk especially to young children who may not have had much if any previous exposure to influenza viruses prior to this season,” Pekosz added.

“This year we will have a true influenza season like we saw before the pandemic,” said Dr. Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis.

He said children’s hospitals already are seeing an unusual early spike in other respiratory infections including RSV, or respiratory syncytial virus, and worries flu likewise will strike earlier than usual — like it did in Australia.

The CDC advises a flu vaccine by the end of October but says they can be given any time during flu season. It takes about two weeks for protection to set in.

The U.S. expects 173 million to 183 million doses this year. And yes, you can get a flu shot and an updated COVID-19 booster at the same time — one in each arm to lessen soreness.

FLU SHOTS OF THE FUTURE

The companies that make the two most widely used COVID-19 vaccines now are testing flu shots made with the same technology. One reason: When influenza mutates, the recipes of so-called mRNA vaccines could be updated more quickly than today’s flu shots, most of which are made by growing influenza virus in chicken eggs.

Pfizer and its partner BioNTech are recruiting 25,000 healthy U.S. adults to receive either its experimental influenza shot or a regular kind, to see how effective the new approach proves this flu season.

Rival Moderna tested its version in about 6,000 people in Australia, Argentina and other countries during the Southern Hemisphere’s flu season and is awaiting results.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.


https://apnews.com/article/flu-shot-timing-recommendation-b7b5f65bc52a8f98b902750bed928fea

Norwegian Cruise Line eliminating COVID-19 testing, masking and vaccination requirements

 Norwegian Cruise Line announced Monday that it is removing all COVID-19 resting, masking and vaccination requirements effective Tuesday."Health and safety are always our first priority; in fact, we were the health and safety leaders from the very start of the pandemic," said Harry Sommer, Norwegian Cruise Line president and chief executive officer. "Many travelers have been patiently waiting to take their long-awaited vacation at sea and we cannot wait to celebrate their return."

The cruise line says its decision was based on the "significant, positive progress in the public health environment" in a press release. The company believes its updated health and safety guidelines are now more aligned with other global travel organizations. 

Despite the easing of COVID-19-related protocols, NCL will continue to follow travel guidelines required by destinations it visits. 

For all country-specific travel requirements, travelers should visit www.ncl.com/travel-requirements-by-country

Guests can also visit www.ncl.com/freestyle-cruise/cruise-travel-documents for more information about the required travel documentation they will need for their NCL voyage.

https://www.foxbusiness.com/retail/norwegian-cruise-line-eliminating-covid-19-testing-masking-vaccination-requirements

Cross Country Acquires Mint Medical Physician Staffing,, Lotus Medical Staffing

 Cross Country Healthcare, Inc. (the "Company") (Nasdaq: CCRN), a market-leading tech-enabled workforce solutions platform and advisory firm, today announced that the Company has closed its acquisition of substantially all of the assets and certain liabilities of Mint Medical Physician Staffing, LP ("Mint") and Lotus Medical Staffing LLC ("Lotus").

For over 25 years, Mint has placed thousands of highly qualified physicians, nurse practitioners, and physician assistants in locum tenens positions throughout the country. The organization specializes in hospitalist, emergency medicine, radiology, urgent care, occupational medicine, primary care, and telemedicine placements. Lotus is a boutique agency specializing in anesthesia and surgical specialties for both locum tenens and permanent placements. It staffs operating rooms throughout the U.S. with qualified providers who maximize their clinical skills and leadership experience.

https://finance.yahoo.com/news/cross-country-healthcare-closes-acquisitions-212000288.html