Oxford professor: Possible coronavirus vaccine could show efficacy by June

Sir John Bell, the Regius Professor of Medicine at Oxford University, said Sunday that researchers at the university working on a potential vaccine for the coronavirus would likely have an idea of its efficacy by June.
Bell told NBC’s Chuck Todd on “Meet the Press” that researchers hope to generate enough data from Phase Two trials to “get evidence that the vaccine has efficacy by the beginning of June.”
Bell called the chances of success in developing a vaccine “pretty good,” adding “we are gradually reeling it in, bit by bit and as every day goes by, the likelihood of success goes up.”
If the disease “peters out in the U.K.,” Bell added, “we have sites already in play in other parts of the world where it’s active.”
“Coronavirus doesn’t mutate at the pace of flu as far as we can see but it’s also quite a tricky virus in terms of dictating long-term immune responses to it and as a result I suspect we may need to have relatively regular vaccinations against coronavirus going into the future,” Bell added. “That of course remains to be seen but that’s my bet at the moment, is that this is likely to be a seasonal coronavirus vaccine.”

The Oxford team, he added, is making safety a priority even as it fast-tracks potential vaccines, saying the researchers have done pre-clinical primate studies and taken other precautions, ensuring that “we’re being very careful.”
“I think we’ve got reason to believe that the efficacy, the efficacy of the vaccine in terms of generating strong antibody responses is probably going to be OK. The real question is whether the safety profile’s going to be fine. So that’s actually the main focus of the clinical studies,” he said.
https://thehill.com/homenews/sunday-talk-shows/495865-oxford-professor-possible-coronavirus-vaccine-could-show-efficacy

Gottlieb: Mitigation ‘didn’t work as well as we expected’

Former FDA Commissioner Scott Gottlieb said Sunday that measures put in place to mitigate the spread of the coronavirus did not work as well as public health experts expected.
“When you look across the country, it’s really a mixed bag,” Gottlieb said on CBS’s “Face the Nation.”

He said cases are falling in the tri-state area around New York City, which he noted is driving much of the national statistics since the region has such a large outbreak.
“But when you back out what’s happening in New York…around the nation, hospitalizations and new cases continue to rise. There’s about 20 states where we see a rising number of new cases,” he said.
Gottlieb also named a handful of states where the number of cases are still rising, including Tennessee and Texas, which have started lifting restrictions.
“While mitigation didn’t fail, I think it’s fair to say it didn’t work as well as we expected. We expected we’d start seeing more significant declines in new case and deaths around the nation at this point, and we’re just not seeing that,” he said.
Gottlieb said there may be 100,000 coronavirus-related deaths in the U.S. by June. There have been 66,415 deaths in the U.S. so far, based on data compiled by Johns Hopkins University.
“It’s really hard to predict beyond June,” he said.
https://thehill.com/policy/healthcare/495862-gottlieb-mitigation-didnt-work-as-well-as-we-expected

Gilead CEO: Covid-19 drug to be deployed to ‘most urgent’ patients this week

The CEO of Gilead Sciences said that remdesivir, a new drug granted emergency authorization to treat COVID-19, will be sent to the patients most in need early this week.
“We are now firmly focussed on getting this medicine to the most urgent patients around the country here in the United States,” Daniel O’Day said on CBS’s “Face the Nation.”
“We intend to get that to patients in the early part of this next week, beginning to work with the government which will determine which cities are most vulnerable and where the patients are that need this medicine,” he added.

Face The Nation ✔ @FaceTheNation

NEWS: @GileadSciences Daniel O’Day tells @margbrennan that #Remdesivir will be deployed to “most urgent” patients at the beginning of next week following the drug’s emergency use authorization on Friday. $GILD

The Food and Drug Administration (FDA) announced last Friday the drug received an emergency use authorization as treatment for COVID-19 after it showed promising results during a clinical trial.
The trial found that hospitalized patients with advanced COVID-19 who received remdesivir, an antiviral medicine, recovered in 11 days instead of the 15 days it took patients who were placed on a placebo.
The drug is still being studied, but the emergency use authorization allows it to be administered by prescription while it is still being studied.
https://thehill.com/policy/healthcare/495870-gilead-ceo-coronavirus-drug-will-be-deployed-to-most-urgent-patients-this

‘About two to three weeks to see’ whether early reopenings cause Covid-19 spike

Tom Inglesby, the director of the Johns Hopkins Center for Health Security, said on Sunday that the coronavirus’ incubation period meant it would take some time for any spike in infections due to relaxed restrictions to become apparent.
“It’s going to take about two to three weeks for us to begin to see trends that come out of the changes in social distancing,” Inglesby said on NBC’s “Meet the Press.” “A measure taken this morning, you probably won’t see a change in hospitalization rates or ICU capacity until two or three weeks from now. So that’s the nature of the disease, it’s going to take a little time for things to get into the system.”
Inglesby said that expanding testing capacity and contact tracing would also be vital in the weeks ahead to determine the rate of mild or asymptomatic cases.
“In the coming weeks and months we need to get a much better handle on the number of mild and moderate cases of disease we have. The good news is that many, many people do not get seriously ill with this disease,” he said. “The bad news is we’re not capturing those people in terms of numbers for the country and if we don’t know who they are we can’t break their chains of transmission.”
Asked by host Chuck Todd about the possibility of a second wave of the virus in the fall coinciding with the flu season, Inglesby said that “before we even get to the fall I am worried we will have small waves around the country in various places for the coming months.”
“Hopefully we won’t but … if we stopped social distancing tomorrow we would recreate the conditions that existed in this country in February and March,” Inglesby added.
“Don’t call it a lull,” he said.
https://thehill.com/homenews/sunday-talk-shows/495864-public-health-expert-its-going-to-take-about-two-to-three-weeks-to

Mass. Walmart Ravaged By COVID, 21% Of Employees Infected, Store Closed

Nearly 21% of the 391 employees at a Massachusetts Walmart have tested positive for COVID-19, reported WCVB-TV Boston, citing statements from local officials on Saturday.
According to WCVB’s Josh Brogadir on Sunday morning, “Walmart in Worcester normally open at 7AM but remains closed after #coronavirus outbreak.”

Josh Brogadir ✔ @JoshBrogadirTV

Walmart in Worcester normally open at 7AM but remains closed after #coronavirus outbreak.
• total of 81 positive cases of 391 (20.7%) employees tested
• city inspection Tues found not all workers wore masks
• update expected at city briefing today at 4:30PM#WCVB

17

7:10 AM – May 3, 2020

Brogadir said a total of 81 employees tested positive for the virus out of 391, which equates to 20.7% of the workforce at the store have become infected. The store was shut down by Worcester health officials on Wednesday (April 29) after dozens of employees tested positive.
WCVB says Walmart hired an independent professional cleaning company to disinfect the Worcester store.
“Our inspectional services department will inspect the facility to make sure that the cleaning was done in compliance with our guidelines,” said Worcester City Manager Ed Augustus.
Augustus said the store would not reopen until “it has been professionally cleaned and all employees have been tested for coronavirus.”
He said the store had confirmed cases over the last three weeks, but a majority occurred in the previous week.

Last week, a Walmart spokesperson said the Worcester store would be closed for one day to undergo a deep cleaning. However, about five days later, the store remains closed.
Other big-box retailers and Amazon warehouses have had a rash of outbreaks over the last several months. Employees at Target and Whole Foods, as well as Amazon, Instacart, FedEx, and Walmart, walked off the job on Friday afternoon (May 1) and protested over working conditions, lack of hazard pay, and how their employers are not providing them with proper health equipment during the pandemic.
As President Trump attempts to reopen the crashed American economy, the deadliest day of the pandemic was just recorded on Friday, with more than 2900 deaths. Dozens of states have unveiled re-opening plans, as it seems a premature reopening could trigger a second coronavirus wave.
https://www.zerohedge.com/health/massachusetts-walmart-ravaged-covid-21-employees-infected-store-closed

Birx: ‘Devastatingly worrisome’ protesters don’t do social distancing

White House coronavirus task force coordinator Deborah Birx on Sunday said it was “devastatingly worrisome” that those protesting at state Capitols against stay-at-home orders did not wear masks or practice social distancing, warning that they could unknowingly transmit the novel coronavirus to at-risk relatives.
“It’s devastatingly worrisome to me personally because if they go home and they infect their grandmother or grandfather who has a comorbid condition and they have a serious or very unfortunate outcome they will feel guilty for the rest of their lives. So we need to protect each other at the same time as we’re voicing our discontent,” Birx said on “Fox News Sunday.”

Protests took place in at least 10 states over the weekend, with demonstrators calling on their governors to reopen businesses. Hundreds of protesters, some of them armed, demonstrated at the Michigan Statehouse on Thursday, eventually crowding inside to demand Gov. Gretchen Whitmer (D) allow public life to resume.
President Trump tweeted his support for those protesters, calling on Whitmer to “talk to them” and “make a deal.”
Birx, asked by Fox News’s Chris Wallace about whether reopening businesses such hair salons was safe, said it was “safer” if both parties wore masks but added that “we’ve made it clear that that’s not a good phase one activity, and I think the president’s made it clear when he discussed the case in Georgia.”
Georgia Gov. Brian Kemp (R) was one of the first governors to announce coronavirus restrictions would be lifted in late April, prompting pushback from both President Trump and Rep. Doug Collins (R-Ga.), a close Trump ally who is running for Sen. Kelly Loeffler’s (R-Ga.) Senate seat.
Since then, a number of states have also opted to include salons in the first wave of businesses to be allowed to reopen, with some safety requirements.
Asked by Wallace whether the U.S. was “past the peak” or “on the downslope” when it comes to infections, Birx noted that “every single metro area and every single outbreak across the country is different.”
“We are encouraged that the New York and New Jersey metro areas are starting to see a decline after a long flat curve,” she said.
Federal guidelines call on states to wait for a 14-day period of continually declining cases before moving to phase one and then each subsequent stage of reopening, which no state has met as of Sunday.
https://thehill.com/homenews/sunday-talk-shows/495846-birx-stay-at-home-protesters-not-social-distancing-is

Biotech week ahead, May 4

Biotech stocks started last week on a strong note but the upward momentum slowed through the week. The week saw a slew of earnings from big pharma names, including Merck & Co., Inc. MRK 2.05% and Pfizer Inc. PFE 1.65%. Merck disappointed by lowering its outlook, although sell-side stayed positive on the prospects.
Presentations at the American Association of Cancer Research Virtual Conference created some volatility. Verastem Inc VSTM 7.41% became a casualty of “not-so-impressive” clinical data on its Phase 1 asset VS-6766 that targets KRAS mutant advanced solid tumors. The stock shed about 57% to a low of $1.77  before recovering some lost ground.
Here are the key catalysts for the unfolding week.

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Conferences

SunTrust Robinson Humphrey 6th Annual Life Sciences Summit (Virtual Conference): May 5–6
Maxim Group M-Vest Infectious Disease Virtual Conference: May 5

Clinical Readouts

Adverum Biotechnologies Inc ADVM 1.27% is scheduled to present new data from the OPTIC Phase1 clinical trial of ADVM-022 intravitreal gene therapy in wet age-related macular degeneration. The call discussing the results is scheduled for Monday afternoon.
Auris Medical Holding Ltd EARS 4.34% is due to release top-line data from the completed Phase 1b AM-201 trial in early May. AM-201 is being evaluated in antipsychotic-induced weight gain.
Early Q2 Schedule
Ovid Therapeutics Inc OVID 8.79%: Phase 2 top-line data for OV101 in Fragile X syndrome
Iterum Therapeutics PLC ITRM 5.37%: Phase 3 data for Sulopenem in uncomplicated and complicated urinary tract infections
Enanta Pharmaceuticals Inc ENTA 2.39%: data from our INTREPID study of EDP-305 in patients with primary biliary cholangitis

Earnings

Monday
• Marinus Pharmaceuticals Inc MRNS 1.96% (before the market open)
• Minerva Neurosciences Inc NERV 4.68% (before the market open)
• Epizyme Inc EPZM 4.31% (before the market open)
• SI-Bone Inc SIBN 3.4% (after the market close)
• Corcept Therapeutics Incorporated CORT 3.63% (after the market close)
• Chembio Diagnostics Inc CEMI (after the market close)
• GenMark Diagnostics, Inc GNMK 0.72% (after the market close)
• Kura Oncology Inc KURA 4.6% (after the market close)
• Varian Medical Systems, Inc. VAR 2.54% (after the market close)
• Fulgent Genetics Inc FLGT 5.95% (after the market close)

Tuesday
• Oxford Immunotec Global PLC OXFD 3.29% (before the market open)
• Karyopharm Therapeutics Inc KPTI 12.29% (before the market open)
• Haemonetics Corporation HAE 2.52% (before the market open)
• Antares Pharma Inc ATRS 0.62% (before the market open)
• Harvard Bioscience, Inc. HBIO 5.09% (before the market open)
• Vericel Corp VCEL 3.38% (before the market open)
• Regeneron Pharmaceuticals Inc REGN 0.07% (before the market open)
• Neuronetics Inc STIM 8.4% (before the market open)
• Mallinckrodt PLC MNK 17.49% (before the market open)
• Akebia Therapeutics Inc AKBA 1.48% (before the market open)
• Agile Therapeutics Inc AGRX 14.23% (after the market close)
• Aquestive Therapeutics Inc AQST 3.25% (after the market close)
• Akcea Therapeutics Inc AKCA 11.31% (after the market close)
• Acorda Therapeutics Inc ACOR 7.28% (after the market close)
• Axonics Modulation Technologies Inc AXNX 3.31% (after the market close)
• Synthetic Biologics Inc SYN 3.65% (after the market close)
• T2 Biosystems Inc TTOO 1.12% (after the market close)
• Iovance Biotherapeutics Inc IOVA 0.47% (after the market close)
• MacroGenics Inc MGNX 7.22% (after the market close)
• Zogenix, Inc. ZGNX 5.74% (after the market close)
• Jazz Pharmaceuticals PLC JAZZ 0.6% (after the market close)
• Exelixis, Inc. EXEL 2.41% (after the market close)
• Myriad Genetics, Inc. MYGN 4.27% (after the market close)
• Inspire Medical Systems Inc INSP 4.26% (after the market close)
• Rigel Pharmaceuticals, Inc. RIGL 4.47% (after the market close)
• Supernus Pharmaceuticals Inc SUPN 0.77% (after the market close)
• Nevro Corp NVRO 5.42% (after the market close)
• Clovis Oncology Inc CLVS 5.91% (after the market close)
• InVitae Corp NVTA 9.16% (after the market close)
• Cytosorbents Corp CTSO 0.47% (after the market close)
• Cardiovascular Systems Inc CSII 4.05% (after the market close)
• Cerus Corporation CERS 8.62% (after the market close)
• Deciphera Pharmaceuticals Inc DCPH 9.68% (after the market close)
• Incyte Corporation INCY 0.37% (after the market close)
• Orthopediatrics Corp KIDS 8.97% (after the market close)
Wednesday
• Eyepoint Pharmaceuticals Inc EYPT 2.56% (before the market open)
• Horizon Therapeutics PLC HZNP 1.17% (before the market open)
• Constellation Pharmaceuticals Inc CNST 0.64% (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY 2.07% (before the market open)
• IVERIC bio Inc ISEE 6.7% (before the market open)
• Blueprint Medicines Corp BPMC 2.86% (before the market open)
• BioCryst Pharmaceuticals, Inc. BCRX 9.46% (before the market open)
• Strongbridge Biopharma plc SBBP 7.69% (before the market open)
• Evofem Biosciences, Inc. EVFM 5.49% (before the market open)
• Neurocrine Biosciences, Inc. NBIX 2.6% (before the market open)
• Jounce Therapeutics Inc JNCE 0.61% (before the market open)
• PPD Inc PPD 4.94% (before the market open)
• Zoetis Inc ZTS 1.19% (before the market open)
• Ionis Pharmaceuticals Inc IONS 0.38% (before the market open)
• TherapeuticsMD Inc TXMD 12.66% (before the market open)
• Avanos Medical Inc AVNS 0.13% (before the market open)
• Aerie Pharmaceuticals Inc AERI 6.17% (after the close)
• Allogene Therapeutics Inc ALLO 1.56% (after the close)
• ADMA Biologics Inc ADMA 2.03% (after the close)
• Alexion Pharmaceuticals, Inc. ALXN 3.31% (after the close)
• AxoGen, Inc Common Stock AXGN 0.92% (after the close)
• Global Blood Therapeutics Inc GBT 2.91% (after the close)
• Pacific Biosciences of California PACB 1.36% (after the close)
• Theravance Biopharma Inc TBPH 8.26% (after the close)
• BioTelemetry Inc BEAT 2.57% (after the close)
• Bio-Rad Laboratories, Inc. BIO 1.52% (after the close)
• Veracyte Inc VCYT 2.97% (after the close)
• Ligand Pharmaceuticals Inc. LGND 5.65% (after the close)
• Precigen Inc PGEN 11.67% (after the close)
• Ironwood Pharmaceuticals, Inc. IRWD 3.6% (after the close)
• OraSure Technologies, Inc. OSUR 5.65% (after the close)
• NuVasive, Inc. NUVA 3.84% (after the close)
• Sarepta Therapeutics Inc SRPT 3.85% (after the close)
• Natera Inc NTRA 5.32% (after the close)
• Vanda Pharmaceuticals Inc. VNDA 1.3% (after the close)
• Qiagen NV QGEN 0.06% (after the close)
• Enanta Pharmaceuticals Inc ENTA 2.39% (after the close)
• Esperion Therapeutics Inc ESPR 5.43% (after the close)
• G1 Therapeutics Inc GTHX 6.32% (after the close)
• Quidel Corporation QDEL 0.17% (after the close)
• Cytokinetics, Inc. CYTK 4.1% (after the close)
• MannKind Corporation MNKD 3.85% (after the close)
Thursday
• Integra Lifesciences Holdings Corp IART 0.47% (before the market open)
• Intra-Cellular Therapies Inc ITCI 5.15% (before the market open)
• Endo International PLC ENDP 3.7% (before the market open)
• Xeris Pharmaceuticals Inc XERS 9.44% (before the market open)
• Moderna Inc MRNA 4.22% (before the market open)
• Syros Pharmaceuticals Inc SYRS 0.24% (before the market open)
• Elanco Animal Health Inc ELAN 2.75% (before the market open)
• Athenex Inc ATNX 3.36% (before the market open)
• Aldeyra Therapeutics Inc ALDX 11.43% (before the market open)
• Albireo Pharma Inc ALBO 5.03% (before the market open)
• ANI Pharmaceuticals Inc ANIP 3.05% (before the market open)
• Agenus Inc AGEN 7.69% (before the market open)
• Amicus Therapeutics, Inc. FOLD 4.32% (before the market open)
• Brainstorm Cell Therapeutics Inc BCLI 1.79% (before the market open)
• Bristol-Myers Squibb Co BMY 1.33% (before the market open)
• Progenics Pharmaceuticals, Inc. PGNX 6.6% (before the market open)
• X4 Pharmaceuticals Inc XFOR 4.83% (before the market open)
• Miragen Therapeutics Inc MGEN 3.28% (before the market open)
• Kala Pharmaceuticals Inc KALA 3.31% (before the market open)
• Seres Therapeutics Inc MCRB 4.89% (before the market open)
• Intellia Therapeutics Inc NTLA 6.31% (before the market open)
• Momenta Pharmaceuticals, Inc. MNTA 5.39% (before the market open)
• Editas Medicine Inc EDIT 3.98% (before the market open)
• Pacira Biosciences Inc PCRX 6.68% (before the market open)
• Syndax Pharmaceuticals Inc SNDX 0.89% (after the close)
• Tricida Inc TCDA 6.08% (after the close)
• Helius Medical Technologies Inc HSDT 11.87% (after the close)
• Twist Bioscience Corp TWST 4.49% (after the close)
• Athersys Inc ATHX 6.52% (after the close)
• Accelerate Diagnostics Inc AXDX 5.41% (after the close)
• Adamas Pharmaceuticals Inc ADMS 1.55% (after the close)
• Arena Pharmaceuticals, Inc. ARNA 2.94% (after the close)
• Anika Therapeutics Inc ANIK 2.77% (after the close)
• Arrowhead Pharmaceuticals Inc ARWR 5.43% (after the close)
• ACADIA Pharmaceuticals Inc. ACAD 7% (after the close)
• Calithera Biosciences Inc CALA 4.73% (after the close)
• BioDelivery Sciences International, Inc. BDSI 2.63% (after the close)
• Puma Biotechnology Inc PBYI 5.67% (after the close)
• Coherus Biosciences Inc CHRS 3.43% (after the close)
• Kindred Biosciences Inc KIN 3.39% (after the close)
• PDL BioPharma Inc PDLI 0.88% (after the close)
• Rockwell Medical Inc RMTI 7.3% (after the close)
• Penumbra Inc PEN 3.5% (after the close)
• Pfenex Inc PFNX 5.76% (after the close)
• ZIOPHARM Oncology Inc. ZIOP 9.29% (after the close)
• NovaBay Pharmaceuticals, Inc. NBY 2.57% (after the close)
• ICU Medical Inc ICUI 0.68% (after the close)
• Nektar Therapeutics NKTR 5.96% (after the close)
• Savara Inc SVRA 4.56% (after the close)
• Sunesis Pharmaceuticals, Inc. SNSS 10.38% (after the close)
• OptiNose Inc OPTN 3.47% (after the close)
• Eloxx Pharmaceuticals Inc ELOX 4.79% (after the close)
• Five Prime Therapeutics Inc FPRX 11.59% (after the close)
• Flexion Therapeutics Inc FLXN 9.77% (after the close)
• FibroGen Inc FGEN 5.18% (after the close)
• Globus Medical Inc GMED 3.92% (after the close)
• Guardant Health Inc GH 4.52% (after the close)
• OpGen Inc OPGN 3.06% (after the close)
• Lineage Cell Therapeutics Inc LCTX 5.27% (after the close)
• Dynavax Technologies Corporation DVAX 1.18% (after the close)
• Chiasma Inc CHMA 3.87% (after the close)
• Collegium Pharmaceutical Inc COLL 10.98% (after the close)
• Dicerna Pharmaceuticals Inc DRNA 1.17% (after the close)
• Caladrius Biosciences Inc CLBS 16.36% (after the close)
• Glaukos Corp GKOS 1.08% (after the close)
• Celcuity Inc CELC 7.99% (after the close)
• Codexis, Inc. CDXS 5.08% (after the close)
• CytomX Therapeutics Inc CTMX 8.62% (after the close)
• Insulet Corporation PODD 2.42% (after the close)
Friday
• Meridian Bioscience, Inc. VIVO 1.17% (before the market open)
• Mersana Therapeutics Inc MRSN 8.86% (before the market open)
• Ocular Therapeutix Inc OCUL 0.17% (before the market open)
https://www.benzinga.com/general/biotech/20/05/15926105/the-week-ahead-in-biotech-smid-cap-earnings-news-flow-picks-up-pace