Biotech week ahead, Jan. 18

 Biotech stocks posted losses for the third straight week, as the sector reacted to broader market weakness and announcements out of the 2022 JPMorgan Healthcare conference.

Swiss biotech Molecular Partners AG (NASDAQ:MOLN) was among the best-performing stocks in the past week following the release of positive Phase 2 data for partnered COVID-19 antiviral treatment.

Ahead of the fourth-quarter reporting season, preannouncements continued to dominate biotech news.

The week also witnessed the debut of Hillstream Biopharma, Inc. (NASDAQ:HILS) following its initial public offering, which raised $15 million in gross proceeds for the oncology-focused company.

Here are the key catalysts that could move stocks in the unfolding week:

Conferences

Winter Clinical Dermatology Conference: Jan. 14-19, in Koloa, Hawaii

American Society of Clinical Oncology, or ASCO, Gastrointestinal Cancers Symposium: Jan. 20 – 22 (hybrid format, in San Francisco, California & virtual)

Société Francophone du Nerf Périphérique, or SFNP, Annual Meeting: Jan. 21-22, in Paris, France

Clinical Data Readouts/Presentations

Dermatology Conference Presentations

ASLAN Pharmaceuticals Limited (NASDAQ:ASLN): results from the dose escalation portion of the completed Phase 1b Proof-of-Concept study of ASLAN004 in atopic dermatitis

ASCO-GI Conference Presentations

Cardiff Oncology, Inc. (NASDAQ:CRDF): updated data from its lead clinical program in KRAS-mutated metastatic colorectal cancer; Ahead of the presentation, the company is scheduled to host a conference call and webcast Tuesday, at 5 pm, to discuss the data.

Panbela Therapeutics, Inc. (NASDAQ:PBLA): efficacy of SBP-101, administered in combination with gemcitabine and nab-paclitaxel, as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma; The full abstract will be made available on Tuesday, at 5 pm.

AstraZeneca PLC (NASDAQ:AZN): results from the HIMALAYA Phase 3 trial of tremelimumab added to Imfinzi in 1st-line unresectable liver cancer and results from the TOPAZ-1 Phase 3 trial for Imfinzi plus chemotherapy in advanced biliary tract cancer (both due Friday)

Tyme Technologies, Inc. (NASDAQ:TYME): results from the Phase 2/3 study of SM-88 in patients with metastatic pancreatic cancer

ImmunityBio, Inc. (NASDAQ:IBRX): Phase 2 data for t-haNK and Anktiva in pancreatic cancer

SFNP Meeting Presentations

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY): full 18-month results from the HELIOS-A Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis; The management will discuss the data via a conference call on Friday at 8:30 am.

Earnings

Intuitive Surgical, Inc. (NASDAQ:ISRG) (Thursday, after the close)

IPOs

IPO Pricing

New Jersey-based Samsara Vision, Inc. (NASDAQ:SMSA) has filed a preliminary prospectus with the SEC related to its proposed initial public offering of 4.17 million shares. The medical device company that focuses on treatments for late-stage conditions of the retina expects the IPO to be priced between $5 and $7. It has applied for listing its common stock on the Nasdaq under the ticker symbol SMSA.

Washington-based Modular Medical, Inc. (NASDAQ:MODD) is planning a $2.402-million-share IPO. The stock is presently traded on the over-the-counter market and quoted on the OTCQB market under the symbol "MODD." On Jan. 10, the last reported sale price of the common stock was $12.49 per share.

Modular Medical is a development stage medical device company focused on the design, development, and commercialization of an insulin pump using modernized technology to increase pump adoption in the diabetes marketplace. The company has applied to list its common stock on the Nasdaq Capital Market under the symbol "MODD."

Florida-based Jupiter Neurosciences, Inc. (NASDAD: JUNS) is offering 3.33 million units, each unit consisting of one share of its common stock, and one warrant to purchase one share of its common stock at an exercise price per share of $6. The company said it intends to apply to list its common stock and warrants on the Nasdaq under the symbols "JUNS" and "JUNSW" respectively.

The company has developed a unique resveratrol platform product called Jotrol, primarily targeting treatment of neuro-inflammation.

IPO Quiet Period Expiry

NEXGEL, Inc. (NASDAQ:NXGL)

https://markets.businessinsider.com/news/stocks/the-week-ahead-in-biotech-jan-16-22-focus-on-data-presentations-and-ipos-in-holiday-shortened-week-1031104902

Unilever to weigh raising offer for GSK's consumer assets

 Unilever Plc has held talks with banks about additional financing for a potential sweetened offer for GlaxoSmithKline Plc's consumer products division, Bloomberg reported https://www.bloomberg.com/news/articles/2022-01-16/unilever-is-said-to-weigh-raising-offer-for-glaxo-consumer-unit?sref=WJKVI5nK on Sunday, citing people familiar with the matter.

Unilever and GSK did not immediately respond to Reuters' requests for comment.

The news came a day after GSK said it had rejected a 50-billion-pound ($68.37 billion) offer from Unilever for the consumer goods arm. GSK said it had received three bids from Unilever, the latest on Dec. 20.

Unilever could eventually sell some non-core assets from the GSK portfolio to buyers including private equity firms, which could help fund an acquisition, the Bloomberg report added.

https://www.marketscreener.com/news/latest/Unilever-to-weigh-raising-offer-for-GSK-s-consumer-assets-Bloomberg--37561643/

UK SELF-ISOLATION LAW TO BE SCRAPPED IN MOVE TO ‘LEARNING TO LIVE WITH COVID’

 SELF-ISOLATION LAW SET TO BE SCRAPPED IN UK IN FAVOUR OF MOVE TOWARDS ‘LEARNING TO LIVE WITH COVID’ - THE TELEGRAPH

https://www.marketscreener.com/news/latest/SELF-ISOLATION-LAW-SET-TO-BE-SCRAPPED-IN-UK-IN-FAVOUR-OF-MOVE-TOWARDS-LEARNING-TO-LIVE-WITH-COVID--37561654/

GSK And Pfizer Hold Out For 60 Bln Stg Bid For Consumer Health Unit

 GSK AND PFIZER HOLD OUT FOR £60BN BID FOR CONSUMER HEALTH UNIT - FT

* INVESTORS PUSH FOR HIGHER PRICE OR SPIN-OFF AFTER REJECTING UNILEVER’S £50 BILLION OFFER-

https://www.marketscreener.com/news/latest/GSK-And-Pfizer-Hold-Out-For-60-Bln-Stg-Bid-For-Consumer-Health-Unit-FT--37561694/

Florida won’t enforce federal health care worker vaccine mandate

 The Supreme Court has ruled. The Biden administration’s vaccine mandate on health care workers will go into effect.

Except Florida won’t do its part to enforce it.

The rule requires employees at federally regulated health care facilities like hospitals and long-term care facilities to be vaccinated. It conflicts with a state law passed in November that limited employers’ ability to mandate vaccines.

If health care companies decide not to abide by the Biden administration’s requirement that 100 percent of workers be vaccinated or qualify for an approved exemption, they risk losing Medicare or Medicaid funding. Both federal programs are major funding sources for health care providers.

If those companies enact the federal vaccine mandate without offering employees a series of broad, state-specified exemptions, firms with fewer than 100 employees risk a $10,000 state fine every time they fire a worker for being unvaccinated. For larger companies, the fine would be $50,000 per violation.

“This does put facilities in a dilemma,” Kristen Knapp, a spokesperson for the Florida Health Care Association, which represents nearly 600 long-term care facilities in the state, wrote in an email.

The state’s Agency for Health Care Administration has a role to play in enforcing the federal vaccine requirement, which the White House says applies to more than 10 million health care workers nationally. On Dec. 28, the Centers for Medicare and Medicaid Services directed the state agency to survey relevant facilities to ask whether they are complying with the federal rule.

DeSantis’ administration is refusing. In a Jan. 4 memo, agency secretary Simone Marstiller told health care providers her agency would not ask companies whether they were following the federal rule. Instead, the agency would follow state law.

Thursday’s Supreme Court ruling doesn’t appear to change the DeSantis administration’s stance.

“The state of Florida is not going to serve as the Biden administration’s biomedical police,” Christina Pushaw, a spokesperson for DeSantis, wrote in an email Thursday.

Some state hospitals are preparing to follow the federal rule. Karen Barrera, a spokesperson for Tampa General Hospital, wrote in an emailed statement that the facility “will be required to comply.”

Others chains had mandates of their own before the state or government enacted mandate rules, although some paused or backed off them amid the legal wrangling. The hospital chain Ascension announced a mandate over the summer, only to back off of the policy in Florida following the November change in state law. Baptist Health South Florida reported that 94 percent of its workforce got vaccinated after it put a mandate in place in August.

Still others are reviewing their options in light of the Supreme Court decision. Central Florida’s Baycare and Miami’s Jackson Health System, which did not have mandates, are huddling to evaluate their options, according to spokespersons for those companies.

Florida Hospital Association CEO Mary Mayhew said in a statement that hospitals “must comply with this federal vaccine requirement” in order to ensure no lapse in critical Medicare funding.

At a news conference Thursday in Panama City, DeSantis called the federal mandate for health care workers “insane, especially given the ineffectiveness of these shots to actually stop transmission between individuals.” He also said the mandates were contributing to labor shortages in the health care industry, although he didn’t provide numbers.

Vaccine mandates could actually be helping to ease those shortages by ensuring infected health care workers are able to return to work faster than if they were unvaccinated and suffering more severe symptoms, said Marissa Baker, an assistant professor of occupational health at the University of Washington’s School of Public Health.

There’s also the risk that unvaccinated health care workers could spread COVID-19 in hospitals at a time when the omicron variant is driving record infection rates in Florida. Although the vaccines are not proving effective at stopping all transmission, they are still the most effective tool at the government’s disposal, said Derek Cummings, a professor and infectious disease epidemiologist at the University of Florida’s Emerging Pathogens Institute.

“Rather than saying, ‘If it’s not 100 percent effective, why use it at all?’ Another approach to take is ‘We’ll use that and other things,’” Cummings said.

The federal vaccine mandate does allow for exemptions based on a medical disability or a sincerely held religious belief. But the state’s law restricting vaccine mandates offers employees additional exemptions, including carve-outs for pregnancy or “anticipated pregnancy” and an exemption for those who have tested positive for COVID-19 in the past.

It’s unclear what, if any penalties, the state could face for not helping the federal government enforce its rule. A statement from a Centers for Medicare and Medicaid Services spokesperson did not address that question Friday.

However, the White House promised in a statement Thursday to enforce the rule. That could spell trouble for facilities that don’t abide by it. If facilities are not able to report that 100 percent of their employees have gotten at least a first dose of the vaccine or an exemption by Jan. 27, the federal government will begin issuing warnings. Eventually, if the facility does not comply with the rule, it could lose funding.

“Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance,” two officials from the Centers for Medicare and Medicaid Services wrote in a Dec. 28 memo.

The Supreme Court on Thursday did clarify the situation for most other Florida companies when it blocked a different Biden administration vaccine mandate. That rule, enacted by the Occupational Safety and Health Administration, would have required companies with 100 or more employees to have workers get vaccinated or tested weekly.

State law limiting vaccine mandates will apply to Florida companies outside the health care sector.

https://www.tampabay.com/news/health/2022/01/14/florida-wont-enforce-federal-health-care-worker-vaccine-mandate/

'Waste Of Time' To Keep Vaccinating People: Ex-Head Of UK Vaccine Taskforce

 by Alexander Zhang via The Epoch Times,

It is a “waste of time” to keep vaccinating people against the CCP (Chinese Communist Party) virus, the former chairman of Britain’s Vaccines Taskforce has said.

Dr. Clive Dix, who played a key role in helping pharmaceutical firms create the COVID-19 vaccines, told LBC radio on Jan. 16: “The Omicron variant is a relatively mild virus. And to just keep vaccinating people and thinking of doing it again to protect the population is, in my view, now a waste of time.”

Dix said the focus now should be on protecting vulnerable people, such as those over 60, 2 percent of whom remain unvaccinated.

“We should have a highly-focused approach to get those people vaccinated and anybody else who’s vulnerable,” he said.

Though he supports the ongoing booster campaign, he said he has been “critical” of boosting everybody as he is not convinced “it was needed or is needed” for younger people.

Dix said, “I think the thinking of the time was very much to stop infection and transmission where clearly these vaccines don’t do that.”

He said the government needs to be “very focused” on educating itself for the “future vaccination programme” next winter.

He suggested that an “immune status study” should be conducted to “understand exactly where everybody’s immunity is,” so that “by next winter, we can really have a policy of vaccination that’s educated, using the right vaccines at the right time for the right people.”

Dix told The Observer newspaper last week that mass vaccination against COVID-19 should come to an end and the UK should focus on managing it as an endemic disease like flu.

“We now need to manage disease, not virus spread,” he said.

“So stopping progression to severe disease in vulnerable groups is the future objective.”

The UK government’s medical advisers have already acknowledged that it is “untenable” to jab the population every three or six months.

Sir Patrick Vallance, the UK’s chief scientific adviser, said on Jan. 3 that it is not the government’s “long-term view” to give everyone a booster vaccine every few months.

Professor Andrew Pollard, director of the Oxford Vaccine Group and chair of the government’s Joint Committee on Vaccination and Immunisation (JCVI), told The Telegraph that it’s “not sustainable or affordable” to “vaccinate the planet every four to six months.”

On Jan. 7, the UK government’s vaccination advisory committee recommended against giving a fourth dose of COVID-19 vaccine to nursing home residents and people over 80.

The JCVI said the three doses of the vaccines are still providing “very good protection against severe disease,” and an immediate second booster dose to the most vulnerable would “provide only limited additional benefit against severe disease at this time.”

https://www.zerohedge.com/covid-19/waste-time-keep-vaccinating-people-ex-head-uk-vaccine-taskforce

Gottlieb: Biden administration made mistake in federalizing vaccine mandates

 Former Food and Drug Administration Commissioner Scott Gottlieb on Sunday said the Biden administration made a mistake by federalizing vaccine mandates “in ways that they didn’t have to.”

“I think once the federal government, the Biden administration, stepped in and federalized aspects of this response, they owned it and created a perception that they alone could fix it,” Gottlieb told moderator Margaret Brennan on CBS’s “Face the Nation.”

The Biden administration announced a vaccine-or-test mandate for all private employers with 100 or more employees in September, which the Supreme Court blocked last week.

The high court did, however, rule 5-4 that the vaccine-only mandate for health providers at federally funded facilities could be implemented.

Vaccine mandates have been a key point of friction in the country's coronavirus response, and a major point of criticism within Republican circles. Multiple GOP governors have made moves to reject the mandates in their states. 

Gottlieb on Sunday also said the administration made a mistake by blaming the Trump administration for problems involving the Centers for Disease Control and Prevention (CDC) and other health agencies, noting that the entities “had deep flaws.”

“I think the administration made some mistakes at a macro level. The first was buying into this prevailing narrative when they took office that a lot of the problems, if not all the problems at CDC and from the federal public health agencies, owed to the Trump's administration and their mishandling of those agencies,” Gottlieb said.

“Now, notwithstanding what the Trump administration did or didn't do to try to reform those agencies and interfere in their operations, the reality is those agencies had deep flaws and it made it hard to reform the agencies once you bought into that...macro narrative,” he added.

https://thehill.com/homenews/sunday-talk-shows/589965-gottlieb-says-biden-administration-made-mistake-in-federalizing