CDC proposes opioid prescribing guidelines that give doctors more flexibility

 The Centers for Disease Control and Prevention (CDC) on Thursday released draft updated guidelines for prescribing opioids that would give doctors more flexibility as the medical community seeks to find a balance between treating pain and fighting addiction.

Guidelines issued in 2016 included specific recommendations, including often limiting opioid prescriptions for acute pain to three days and not exceeding a dose of the equivalent of 90 milligrams of morphine per day.  

The new proposed guidelines shy away from specific numbers and instead more broadly urge doctors to exercise caution when prescribing opioids.  

“Clinicians should prescribe the lowest dosage to achieve expected effects” when patients begin taking opioids, the guidelines state.  

If possible, they recommend that “nonopioid therapies are preferred for subacute and chronic pain.” 

“We've built in flexibility so that there's not a one-size-fits-all approach," Christopher Jones, acting director of the CDC's National Center for Injury Prevention and Control, told USA Today. 

The previous specific thresholds, he added, “were essentially taken out of context beyond [their] intent and applied as rigid laws, regulations and policies.” 

The previous guidelines drew controversy amid complaints that some chronic pain patients who needed opioids were being denied the proper treatment, even as opioid prescriptions fell.

The opioid crisis has in some cases also shifted from prescription drugs to illicit ones like heroin or fentanyl.  

Drug overdose deaths have been rising at an alarming rate. The CDC said in November that 100,306 people died from drug overdoses in the 12-month period ending in April 2021. That was an increase of 28.5 percent from the 78,056 deaths the year before.  

The new CDC guidelines are a draft and are now open for comment.

https://thehill.com/policy/healthcare/593670-cdc-proposes-new-opioid-prescribing-guidelines-seeking-more-flexibility

Bayer gets FDA fast track status for next-generation blood thinner

 Germany's Bayer has won fast-track status from U.S. drugs regulators for a new blood thinner designed to prevent certain types of strokes, as it seeks to follow up on the success of its anticoagulant Xarelto.

In a statement on Thursday, Bayer said the Food and Drug Administration granted fast track designation for the review of drug candidate asundexian when tested to prevent a repeat in patients that suffered a non-cardioembolic stroke from clogged vessels.

Bayer's best-selling stroke prevention pill Xarelto, in which partner Johnson & Johnson holds some rights, will lose patent protection around 2026. 

https://finance.yahoo.com/news/bayer-gets-fda-fast-track-081645008.html

In final analysis, J&J's underdog vaccine offers only 52.9% protection against Covid

 It’s long been established that the single-shot vaccine produced by J&J is nowhere near as effective as two doses of the mRNA vaccine — initially viewed as a tradeoff between accessibility and efficacy.

But as scientists revealed in their final analysis of J&J’s Phase III study, the vaccine may be even less effective in the longer term.

After tracking about 39,000 participants for a median of four months (8,940 of whom had at least six months of follow-up), researchers concluded in a paper published on the New England Journal of Medicine:

A single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe–critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer.

Looking at least 28 days after administration, 3 Covid-19–related deaths occurred in the vaccine group (all in participants who were ≥60 years of age), as compared with 17 in the placebo group.

Covid-19 roundup: FDA addresses risk of excessive bleeding after J&J vaccine; Novavax vaccine gets OK in South Korea 

They noted that the original strain of SARS-CoV-2 and variants like Alpha, Beta and Lambda were responsible for many of the infections and severe cases, whereas Delta and Omicron were not prevalent during the double-blind.

The study was conducted across multiple countries including the US, South Africa, Brazil and Peru.

The relatively low efficacy would come as little surprise. Given their superior profiles, Pfizer/BioNTech and Moderna’s vaccines have emerged as the preferred choice in places that can afford options, and a rare side effect — risks of blood clot — has pushed the CDC to recommend the two mRNA shots over J&J’s jab. The FDA made a similar recommendation about boosters.

Still, the underwhelming data follow a streak of setbacks for J&J, including a chaotic episode with its contract manufacturer, Emergent, as it tried to ramp up production early in the pandemic. And a recent pause in production at a key Dutch plant, as reported by the New York Times, raised new questions.

For those who are allergic to ingredients of the mRNA vaccine, though, it remains the only option — and the same might be true for countries that find it hard to distribute or store other shots. In its NEJM publication, J&J signaled it will continue to focus on delivering its vaccine to the developing world.

Overall, our findings indicate that a single dose of Ad26.COV2.S provided protection against severe disease and hospitalization, which could be important in regions requiring mass vaccination or in populations with poor adherence to two-dose prime regimens, and support the use of Ad26.COV2.S in the ongoing effort against the global Covid-19 pandemic.

https://endpts.com/in-final-analysis-jjs-underdog-vaccine-offers-only-52-9-protection-against-covid-19/

Acadia Pharma upped to Buy from Neutral by Wainwright

 Target $36

https://finviz.com/quote.ashx?t=ACAD&ty=c&ta=1&p=d

Kymera started at Overweight by Wells Fargo

 Target $62

https://finviz.com/quote.ashx?t=KYMR&ty=c&ta=1&p=d

Arvinas started at Overweight by Wells Fargo

 Target $98

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

AstraZeneca dumps late-phase, next-gen COVID-19 vaccine

 Events have overtaken AstraZeneca’s next-generation beta variant COVID-19 vaccine. After moving the prospect into phase 2/3 last year, AstraZeneca saw beta fall down the list of the most worrying variants, culminating in today’s decision to dump the AZD2816 vaccine candidate.

The removal (PDF) of AZD2816 from the pipeline follows the conclusion of work that persuaded AstraZeneca to stick with Vaxzevria, its first-generation vaccine, rather than push ahead with plans to seek authorization for its beta-specific sibling. AstraZeneca's decision is underpinned by AZD2816's lack of differentiation against the now-dominant omicron.

“Vaxzevria was exactly the same—there was no meaningful difference between immunogenicity of 2816 and Vaxzevria. It meant there was no need to switch from one to the other because obviously switching vaccines at this stage is not an easy thing, from a manufacturing perspective, capacity perspective. It would have to be really considerably better to make that switch,” Mene Pangalos, EVP biopharmaceuticals R&D at AstraZeneca, said.

When beta was identified in October 2020, it represented the most worrying COVID-19 variant yet from an immune escape perspective. The virus has 10 changes across the spike protein and was soon shown to render first-generation vaccines less effective, with the efficacy of Novavax’s vaccine falling from 89% in the U.K. to 49% in beta-dominated South Africa. 

AstraZeneca responded by tweaking its Vaxzevria in light of the small genetic differences between beta and the original SARS-CoV-2. At one point, the development of a beta-specific vaccine looked like a prudent move. Beta established itself in South Africa and was making inroads into some European countries around the time that AstraZeneca began its AZD2816 trial. However, first delta and then omicron swept beta away around the world, significantly reducing the need for a vaccine specifically against the once-worrisome variant. 

AstraZeneca dosed the first subjects in the phase 2/3 clinical trial in June, marking the start of a study that ultimately enrolled more than 2,800 people to evaluate the effect of its beta vaccine and its original Vaxzevria product in multiple different contexts. Investigators gave AZD2816 to unvaccinated individuals and to people who had previously received either Vaxzevria or an mRNA vaccine against COVID-19.

The rise and fall of AZD2816 offers a cautionary tale for Moderna and Pfizer, which have recently moved omicron-specific vaccines into clinical development. While omicron is far more prevalent than beta ever was, the pace with which it displaced delta, and the fact it differs so much from that formerly dominant variant, shows any jab against a specific form of SARS-CoV-2 could be rendered obsolete before it gets to market.

AstraZeneca disclosed the termination of AZD2816 in a quarterly update that also saw it remove a clutch of earlier-stage programs from its pipeline. The Big Pharma disclosed the divestitures of cholesterol drug MEDI5884, which it recently offloaded to Regio Biosciences, and an antibody for preventing pneumonia caused by Staphylococcus aureus. Both assets were in phase 2. Another phase 2 project, solid tumor candidate AZD2811, got the chop, as did three phase 1 programs, including the push to develop inhaled JAK inhibitor AZD0449 for use in patients with asthma.

https://www.fiercebiotech.com/biotech/astrazeneca-dumps-late-phase-next-gen-covid-19-vaccine-calling-time-a-beta-player-omicron