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Wednesday, January 5, 2022

FOMC Minutes Shows Hawkish Fed Hiking 'Faster Than Anticipated,' Warn Of Omicron Risks

 Since December 15th's FOMC statement, bonds have been battered, the dollar is down modestly while stocks and gold are up strongly....

Source: Bloomberg

The short-end of the yield curve has risen dramatically, pricing in the new hawkish dot-plot offered by The Fed (for 2022) with a 73% chance of Fed hikes by March 2022 now ((from 40% pre-FOMC)...

Source: Bloomberg

Interestingly though, the market has rejected The Fed's longer-term dots, presumably pricing in a policy-error/reversal...

Source: Bloomberg

All of which leaves the market desperately seeking clues today on the accelerated taper and timing of lift-off and trajectory of rate-hikes among the Minutes.

On the liftoff timing and pace of rate-hikes:

"Participants generally noted that, given their individual outlooks for the economy, the labor market, and inflation, it may become warranted to increase the federal funds rate sooner or at a faster pace than participants had earlier anticipated. Some participants also noted that it could be appropriate to begin to reduce the size of the Federal Reserve’s balance sheet relatively soon after beginning to raise the federal funds rate. Some participants judged that a less accommodative future stance of policy would likely be warranted and that the Committee should convey a strong commitment to address elevated inflation pressures."

Policymakers thought changes in Fed Funds Rate should be primary means for adjusting stance of policy.

Some participants also remarked that there could be circumstances in which it would be appropriate for the Committee to raise the target range for the federal funds rate before maximum employment had been fully achieved - for example, if the Committee judged that its employment and price-stability goals were not complementary in light of economic developments and that inflation pressures and inflation expectations were moving materially and persistently higher in a way that could impede the attainment of the Committee's longer-run goals.

On Omicron's impact:

“In particular, the possibility that COVID-19 cases could continue to rise steeply, especially if the Omicron variant proves to be vaccine resistant, was seen as an important source of downside risk to activity, while the possibility of more severe and persistent supply issues was viewed as an additional downside risk to activity and as an upside risk to inflation.”

"Members also agreed that, with the emergence of the Omicron variant, it was appropriate to note the risk of new variants of the virus in their assessment of risks to the economic outlook."

On normalization:

“Participants also judged the Federal Reserve to be better positioned for normalization than in the past.

On Inflation:

In their comments on inflation expectations, some participants discussed the risk that recent elevated levels of inflation could increase the public's longer-term expectations for inflation to a level above that consistent with the Committee's longer-run inflation objective.

A few participants, however, noted that long-term inflation expectations remained well anchored, citing stable readings of market-based inflation compensation measures or the generally low level of longer-term bond yields.

On labor market:

Committee's assessments of maximum employment, a condition most participants judged could be met relatively soon if the recent pace of labor market improvements continued.

Several participants remarked that they viewed labor market conditions as already largely consistent with maximum employment.

Additionally, a key thing to understand from the Minutes is that there was a wide variety of views on when to start shrinking the balance sheet.

“almost all participants agreed that it would likely be appropriate to initiate balance sheet runoff at some point after the first increase in the target range for the federal funds rate.”

*  *  *

Read the full Minutes below:

Docs Refused to Pay the Cyber Attack Ransom — and Suffered

 Ransomware attacks are driving some small practices out of business. Michigan-based Brookside ENT and Hearing Center, a two-physician practice, closed its doors in 2019 after a ransomware attack. The criminals locked their computer system and files and then demanded a $6500 ransom to restore access. The practice took the advice of law enforcement and refused to pay. The attackers wiped the computer systems clean — destroying all patient records, appointment schedules, and financial information. Rather than rebuild the entire practice, the two doctors took early retirement.

Wood Ranch Medical, in Simi, California, a small primary care practice, decided to shut its doors in 2019 after a ransomware attack damaged their servers and backup files, which affected more than 5000 patient records. The criminals demanded a ransom to restore the technology and records, but the owners refused to pay. They couldn't rebuild the system without the backup files, so they shuttered their business.

Several large practices have also been attacked by ransomware, including Imperial Health in Louisiana in 2019, that may have compromised more than 110,000 records. The practice didn't pay the ransom and had access to their backup files and the resources to rebuild their computer systems and stay in business.

Medical practices of all sizes have experienced ransomware attacks. More than 551 healthcare ransomware attacks were reported to the federal US Department of Health and Human Services' (HHS') Office of Civil Rights in 2021 (as of November 30), and over 40 million individuals faced exposure of their protected health information.

All it takes is one employee clicking on a link or embedded file in an email to launch malware. A vicious code locks the electronic health record (EHR) system, and your practice grinds to a halt.

Cyber criminals demand a ransom in bitcoin to unlock the files. They may even threaten to post private patient data publicly or sell it on the dark web to get you to pay up.

But, is paying a ransom necessary or wise? What other steps should you take? Here's what cyber security experts say criminals look for in targets, how they infiltrate and attack, and how you should respond and prevent future attacks.

How Does It Happen?

Email is a popular way for criminals to hack into a system. Criminals often research company websites and impersonate a company executive and send a legitimate-looking "phishing" email to employees hoping that someone will click on it and launch a malware attack.

Drex DeFord

Recently, cyber criminals found an easier way to infiltrate that doesn't require identifying targets to gain access, says Drex DeFord, executive healthcare strategist at CrowdStrike, a cybersecurity technology company in Sunnyvale, California.

"Instead of hacking into the system, cyber criminals are just logging in. Most likely, they have acquired a user's credentials (username/password) from another source — possibly purchasing it from the dark web, the part of the Internet that criminals use, through an 'access broker,' an organization that specializes in collecting and selling these kinds of credentials," says DeFord.

After a ransomware attack last August on Eskenazi Health in Indianapolis, forensic investigators discovered that the criminals had logged into the IT system in May and had disabled security protections that could have detected their presence before they launched their cyberattack, according to a statement.

Responding to a Ransomware Attack

When employees or the IT department suspect a ransomware attack is underway, cyber experts recommend isolating the "infected" part of the network, shutting down the computer system to prevent further damage, and securing backups.

Soon afterward, cyber criminals typically communicate their ransom demand electronically with instructions for payment. One practice described seeing a "skull and bones image" on their laptops with a link to instructions to pay the ransom demand in bitcoin.

Kathy Hughes

Although you never want to pay criminals, it's ultimately a business decision that every organization that's affected by ransomware has to make, says Kathy Hughes, chief information security officer at Northwell Health in New York. "They need to weigh the cost and impact from paying a ransom against what they are able to recover, how long will it take, and how much will it cost," she says.

While it may be tempting to pay a small ransom, such as $5000, cyber experts warn that it doesn't guarantee full access to the original data. About one third (34%) of healthcare organizations whose data were encrypted paid the ransom to get their data back, according to a June 2021 HHS Report on Ransomware Trends. However, only 69% of the encrypted data was restored, the report states.

Criminals may also demand another payment, called "double extortion," by threatening to post any extracted private patient or employee data on the dark web, says Hughes.

Practices sometimes choose not to pay the ransom when they know they can restore the backup files and rebuild the system for less than the ransom amount. However, it can take weeks to rebuild a fully operational IT system; meanwhile, the organization is losing thousands of dollars in patient revenue.

Criminals may retaliate against a practice that doesn't pay the ransom by wiping the hard drives clean or posting the extracted medical, financial, and demographic data of patients on the dark web. Patients whose information has been extracted have filed class-action lawsuits against medical practices and organizations such as Scripps Health, in San Diego, California, claiming that they should have done more to keep their private information safe.

Experts also advise reporting the attack to local law enforcement, who may have cyber security experts on staff who will come on site and investigate the nature of the attack. They may also request help from the FBI's professional cyber security team.

Having a cyber insurance policy may help offset some of the costs of an attack. However, make sure you have a good cyber security program, advises DeFord.

He suggests that small practices partner with large health systems that can donate their cyber security technology and related services legally under the updated Stark safe harbor rules. Otherwise, they may not meet the insurer's requirements, or they may have to pay significantly higher rates.

Who Is an Easy Target?

Cyber criminals look for easy targets, says Hughes. "A lot of threat actors are not targeting a specific practice — they're simply throwing out a net and looking for vulnerable systems on the internet."

Small medical practices are particularly vulnerable to ransomware attacks because they lack the resources to pay for dedicated IT or cyber security staff, says Hughes, who oversees security for more than 800 outpatient practices. They're not replacing outdated or unsupported equipment, applying regular "patches" that fix, update, or improve operating systems, application software, and Internet browsers, or using password controls.

As large practices or health systems acquire medical practices with different EHR systems, security can be more challenging. Hughes says, "Our goal at Northwell is always to get them onto our standard platform, where we use best practices for technology and security controls. In the world of security, having fewer EHR systems is better so there are fewer things to watch, fewer systems to patch, and fewer servers to monitor. From our point of view, it makes sense to have a standardized and streamlined system."

Still, some practices may feel strongly about using their EHR system, says Hughes. When that happens, "We at least bring them up to our security standards by having them implement password controls and regular patches. We communicate and collaborate with them constantly to get them to a more secure posture."

Cyber security lapses may have increased during the pandemic when practices had to pivot rapidly to allow administrative staff to work remotely and clinical staff to use telehealth with patients.

"In the rush to get people out of the building during the pandemic, healthcare organizations bent many of their own rules on remote access. As they moved quickly to new telehealth solutions, they skipped steps like auditing new vendors and cyber-testing new equipment and software. Many organizations are still cleaning up the security 'exceptions' they made earlier in the pandemic," says DeFord.

Hackers Are Sophisticated Criminals

"The version of a hacker a lot of us grew up with — someone in a basement hacking into your environment and possibly deploying ransomware — isn't accurate," says DeFord. What experts know now is that these cyber criminals operate more like companies that have hired, trained, and developed people to be stealth-like — getting inside your network without being detected.

"They are more sophisticated than the healthcare organizations they often target," adds DeFord. "Their developers write the encryption software; they use chatbots to make paying the ransom easy and refer to the people they ransom as clients, because it's a lucrative business," says DeFord.

These groups also have specialized roles — one may come in and map your network's vulnerabilities and sell that information to another group that is good at extracting data and that sells that information to another group that is good at setting off ransomware and negotiation, says DeFord. "By the time a ransomware attack occurs, we often find that the bad guys have owned the network for at least 6 months."

Patient records are attractive targets because the information can be sold on the dark web, the part of the internet that's unavailable to search engines and requires an anonymous browser called Tor to gain access, says Hughes.

Criminals steal patient identifiers such as social security numbers and birthdates, payment or insurance information, as well as medical histories and prescription data. Other people buy the information for fraudulent purposes, such as filing false tax returns, obtaining medical services, and opening credit cards, says Hughes.

Lately, criminal gangs appear to be targeting the IT or EHR systems that practices rely for clinical care and making them unavailable. By locking EHR files or databases and holding them for ransom, criminals hope practices will be more likely to pay, says Hughes.

They also don't want to get caught, and this tactic "gets them in and out faster" than extracting and posting patient data, although criminals may use that as a threat to extort a ransom payment, says Hughes.

Fines for Lax Privacy/Security

Breaches of patient records have consequences that include being investigated by federal or state authorities for potential HIPAA privacy and security violations and fines. Recently, the HHS announced a $1.5 million settlement — the largest to date — with Athens Orthopedic Clinic, PA, in Georgia for not complying with the HIPAA rules.

When breaches of 500 or more patient records occur, medical groups are required to notify the HHS Office of Civil Rights (OCR) within 60 days, as well as all the affected patients and the media. Some organizations offer free credit monitoring and identity theft protection services to their patients.

Information about the breaches, including company names and the number of affected individuals, is posted publicly on what cyber experts often call "OCR's wall of shame."

Strengthen Your Defenses

The FBI and the HHS warned healthcare professionals and organizations in 2020 about the threat of increasing cyberattacks and urged them to take precautions to protect their networks.

Here's five actions you can take:

  • Back-up your files to the cloud or off-site services and test that the restoration works.

  • Implement user training with simulated phishing attacks so the staffwill recognize suspiciousemails and avoid actions that could launch malware attacks.

  • Ensure strong password controls and that systems are regularly patched.

  • Require multifactor authentication for remote access to IT networks.

  • Set anti-virus/anti-malware programs to conduct regular scans of IT network assets using up-to-date signatures.

Novel Antidepressant Shows Promise as Add-On Therapy

 Adjunctive treatment with the novel oral medication REL-1017 (esmethadone) is effective in adults with major depressive disorder (MDD) who have failed other antidepressants, new research suggests.

REL-1017, from Relmada Therapeutics, is a novel N-methyl-D-aspartate receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission.

Results from a phase 2a study showed rapid "therapeutic efficacy," with a statistical difference by day 4, and was "robust," with an effect size of 0.7 to 1. The positive outcome was also sustained for at least 1 week after treatment discontinuation, co-investigator Paolo L. Manfredi, MD, chief scientific officer, Relmada Therapeutics, noted.

"Considering that the available traditional antidepressants have an average effect size around 0.3, this novel, potential rapid-acting antidepressant...holds great promise for millions of patients suffering from depression," Manfredi told Medscape Medical News.

These results were obtained with a "very well-tolerated once-daily oral NMDAR antagonist, without the dissociative effects seen with ketamine," he added.

The findings were published online December 22 in The American Journal of Psychiatry.

"Clear Need" for Better Therapies

It is estimated that more than half of patients with MDD fail to respond adequately following their first standard antidepressant treatment. In addition, responses are often delayed by 4 to 8 weeks after starting an antidepressant.

Therefore, there is a "clear need" to develop drugs for MDD that act quickly and with improved efficacy, the investigators note.

The phase 2a study of REL-1017 enrolled 62 adult patients (45% women) aged 18 to 65 years with moderate to severe MDD and no significant psychiatric comorbidity. All had failed to benefit from one to three standard antidepressant treatments in their current major depressive episode.

The researchers evaluated two doses of REL-1017 (25 mg and 50 mg once daily) vs placebo given as adjunctive treatment. The assigned treatment lasted 7 days.

The primary study objectives were safety and tolerability. Results showed no serious adverse events (AEs), and no patients experienced treatment-emergent AEs that led to the stopping of treatment.

In addition, patients receiving the active drug experienced mild or moderate transient AEs comparable to placebo, with no opioid, dissociative, or psychotomimetic symptoms, or withdrawal effects when treatment ended.

The most common AEs reported were headacheconstipation, nausea, and sleepiness.

Significant Efficacy

The primary efficacy endpoint was the Montgomery–Ã…sberg Depression Scale (MADRS) score.

Mean MADRS score at baseline was 33.8 in the placebo group vs 32.9 in the REL-1017 25-mg group and 35.2 in the REL-1017 50-mg group.

MADRS scores showed improvement on day 4 of treatment in both REL-1017 groups, and the improvement continued through day 7 (last dose) and day 14 (7 days after the last dose), with ≤ .0308 and effect sizes ranging from 0.7 to 1.0.

Mean change from baseline in MADRS scores showed more improvement at the end of the dosing period for both dosing groups (-16.8 with 25 mg and -16.6 with 50 mg) vs -8.8 with placebo.

Results of the other efficacy endpoints of Symptoms of Depression Questionnaire (SDQ) score and Clinical Global Impressions severity scale (CGI-S) and improvement scale (CGI-I) scores were similar to that of the MADRS.

Remission rates (defined as a MADRS score ≤10) on day 14, the last day of efficacy assessment, were 5% with placebo vs 31% (= .035) with REL-1017 25 mg and 39% (= .01) with REL-1017 50 mg.

The number needed to treat to achieve remission on day 14 was four with the 25-mg dose and three with the 50-mg dose.

Phase 3 trials to confirm the efficacy and safety of REL-1017 are in progress, with topline results expected later this year, the investigators report.

The study was funded by Relmada Therapeutics. Manfredi has received personal fees and/or held stock ownership from Relmada. Disclosures for the other investigators are fully listed in the original article.

Am J Psychiatry. Published online December 22, 2021. Abstract

https://www.medscape.com/viewarticle/966088

IncellDx’s Chronic COVID Treatment Center Partners with ARISE MD Integrative Medicine & Surgery to Evaluate Novel Therapy

 IncellDx’s Chronic COVID Treatment Center (CCTC) (www.covidlonghaulers.com) and ARISE™ MD Integrative Medicine & Surgery announced today a new partnership to evaluate CCR5 antagonists and statins as a potential therapeutic treatment approach for chronic COVID, also known as long COVID or post-acute sequelae of COVID-19 (PASC).

In a randomized, placebo controlled trial led by co-Investigator Adam Miller, MD, CEO, Medical Director, ARISE, a combination of maraviroc, a CCR5 antagonist, and a commonly administered statin, atorvastatin, will be evaluated for its efficacy in alleviating PASC symptoms.

In the trial, under an Enriched Enrollment Randomized Withdrawal (EERW) design, patients who experience symptomatic improvement with maraviroc and atorvastatin in an open label phase will enter a second phase and be randomized to continue active treatment or placebo.

The study aims to support clinical approaches developed by IncellDx’s Chronic COVID Treatment Center, which has enrolled more than 12,000 patients and published multiple articles on the application of precision medicine and biomarkers to determine the underlying pathways involved in PASC.

“At CCTC, we provide consultation to physicians across the country who are treating patients with chronic COVID,” said internist and physician Eric Osgood MD, physician, CCTC. “We are excited to partner with Dr. Miller to further evaluate the clinical observation that a biomarker-driven, precision medicine approach can result in improvement of long COVID symptoms as well as resolution of abnormal cytokine profiles that may be the underlying cause of this condition. In continuing to advance new research into diagnostic criteria and clinical approaches to treatment, we aim to provide lasting symptom alleviation in patients with PASC.”

“Based on outcomes we observe in long COVID patients being treated under the CCTC program protocol, we believe this condition can be objectively assessed and that addressing immune disruption from PASC may be central to its treatment,” said Dr. Miller. “Through this study, we aim to assess whether reducing the activity of CCR5 in the body with the use of CCR5 antagonists can play an important role in treatment of long COVID. We’ll also be evaluating the potential for the IncellDx Long Hauler Index, or LHI, to provide important diagnostic information about this condition that can inform treatment. We’re very excited about the potential of this study to validate clinical application of IncellDx’s LHI and a novel combination therapeutic approach leveraging already commonly used medicines.”

About IncellDx

IncellDx is a precision medicine company advancing novel diagnostics and prognostics to better understand and treat infectious disease and cancer. The company’s innovative technology platform enables simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers. The company launched the Chronic COVID Treatment Center to apply precision medicine approaches to evaluate, characterize and more effectively address chronic COVID.

About the Long Hauler Index

The Long Hauler Index or LHI was developed and patented by IncellDx to provide an objective method of identifying patients suffering from long COVID or PASC. The LHI assesses cytokines and chemokines believed to cytokine storm conditions and chronic COVID patients (often referred to as COVID "long haulers").

https://www.businesswire.com/news/home/20211118006240/en/IncellDx%E2%80%99s-Chronic-COVID-Treatment-Center-Partners-with-ARISE-MD-Integrative-Medicine-Surgery-to-Evaluate-Novel-Therapeutic-Approach-to-Chronic-COVID

FDA approval tracker: December

 After a tough 2021, Novartis finally caught a break with the approval of Leqvio, its long-awaited cholesterol-lowering therapy. With a list price of $6,500 per year, the drug is being pitched at around the same level as the incumbent PCSK9 MAbs; early sales could indicate whether the long-acting therapy can become Novartis’s biggest ever drug, as predicted by chief executive officer Vas Narasimhan. Meanwhile, both Leo Pharma and Astrazeneca/Amgen look set to have a tough time going up against Dupixent in different indications, with Adbry and Tezspire, respectively. Efficacy data with Adbry in atopic dermatitis did not impress, while Tezspire is only approved for severe asthma, versus Dupixent’s moderate-to-severe label. Leerink analysts reckon that Tezspire will be initially reserved for low-eosinophil patients who cannot receive Dupixent or other asthma biologics, putting pre-approval sellside predictions in doubt. Merck & Co could also struggle to compete with its Covid-19 antiviral molnupiravir, which got an EUA the day after Pfizer’s Paxlovid; unlike molnu, the latter sailed through without an adcom. Molnu is destined to be a last-ditch option due to lacklustre efficacy plus concerns about potential foetal toxicity and the possibility that it could accelerate viral evolution.

Notable first-time US approval decisions in December
ProjectCompanyIndication(s)2026 SBI ($m)Outcome
Tezspire (tezepelumab)Astrazeneca/
Amgen
Severe asthma (eosinophilic & non-eosinophilic)2,040Approved early (was guided to Q1)
Leqvio
(inclisiran)
Novartis/
Alnylam
Adults with HeFH or ASCVD on maximally tolerated statins who need additional LDL-C lowering2,026*Approved early (had been due Jan 1)
Vyvgart
(efgartigimod)
ArgenxMyasthenia gravis1,752Approved
AXS-05AxsomeMajor depressive disorder893No decision yet  
Tarpeyo
(nefecon)
CalliditasIgA nephropathy630**Approved (accelerated)
RecorlevXeris Biopharma (via Strongbridge)Cushing's syndrome255Approved early (had been due Jan 1)
Eohilia
(TAK-721)
TakedaEosinophilic esophagitis188CRL (additional study requested)
Libervant (diazepam) buccal film AquestiveManagement of seizure clusters172Decision delayed
IlluccixTelixProstate cancer imaging98Approved
Xaciato
(DARE-BV1)
Dare BioscienceBacterial vaginosis28**Approved
Entadfi
(tadfin)
VeruBenign prostatic hyperplasia18Approved
Adbry (tralokinumab)Leo PharmaAtopic dermatitis-Approved
BrixadiBraeburnOpioid use disorder-CRL (deficiencies at 3rd party manufacturing facility)
EpsolaySol-GelPapulopustular rosacea-Pre-approval inspection set for February
LV-101LevoHyperphagia and behavioural distress associated with Prader-Willi syndrome-No decision yet; negative FDA panel meeting in November
*SBI not split out; **Includes undisclosed partner sales. ASCVD=clinical atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolaemia. Source: Evaluate Pharma & company releases.

 

 
Advisory committee meetings in December
ProjectCompanyIndicationOutcome
Bardoxolone methylReataChronic kidney disease caused by Alport syndrome13-0 against approval
Source: Evaluate Pharma, FDA adcom calendar.

 

 
Supplementary and other notable approval decisions in December
ProductCompanyIndication (clinical trial)Outcome
Yusimry (CHS-1420/
Humira biosimilar)
CoherusPlaque psoriasis, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, rheumatoid arthritis and Crohn's diseaseApproved
Keytruda Merck & CoAdjuvant treatment stage IIB/C melanoma following complete resection (Keynote-716)Approved
CaplytaIntra-Cellular TherapiesBipolar disorder as monotherapy and adjunctive therapy (Study 402, 404)Approved
OtezlaAmgenMild-to-moderate plaque psoriasis (Advance)Approved
Orencia + calcineurin inhibitor + methotrexateBristol Myers SquibbPrevention of acute graft versus host disease (ph2 ABA2)Approved
OxbrytaGlobal Blood TherapeuticsSickle cell disease in children ages 4-11, age-appropriate dispersible tablet dosage formApproved
Apretude (cabotegravir extended-release injectable suspension)Viiv (GSK/Pfizer/Shionogi joint venture)Long-acting injectable for HIV prevention, for use every two months (HPTN 083, HPTN 084)Approved
XeljanzPfizerAnkylosing spondylitis (A3921120)Approved
RinvoqAbbviePsoriatic arthritis (Select-PsA1 & Select-PsA2)Approved
OlumiantLillyAtopic dermatitis (Breeze-AD programme)No decision yet
Kyprolis +
Darzalex Faspro
AmgenAdults with r/r multiple myeloma with 1-3 lines of previous therapy (Pleiades)Approved
ZynrelefHeronSoft tissue or periarticular instillation to product postsurgical analgesia in various surgical proceduresApproved
CutaquigOctapharmaPaediatric pts aged ≥2 with primary humoral immunodeficiency Approved
Rituxan + chemoRocheChildren 6 months to <18 years with previously untreated, advanced CD20+ DLBCL, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukaemia (Inter-B-NHL Ritux)Approved
XareltoJ&JTreatment and prevention of blood clots in pts aged <18; prevention of blood clots in pts aged ≥2 with congenital heart disease who have had Fontan procedure Approved
CosentyxNovartisChildren/adolescents with enthesitis-related & psoriatic arthritis (Junipera)Approved
RexultiOtsukaSchizophrenia in pts aged ≥13Approved
Rezvoglar (Lantus biosimilar)Eli Lilly

Adults and paediatric patients with type 1 diabetes and adults with type 2 diabetes

Approved
Source: Evaluate Pharma & company releases. 

 

 
FDA Covid-19 EUAs
ProductCompanyIndication
MolnupiravirMerck & CoTreatment of high-risk adults with mild-to-moderate Covid-19, if no alternatives available or appropriate
PaxlovidPfizerTreatment of high-risk pts aged ≥12 with mild-to-moderate Covid-19
Evusheld (AZD7442)AstrazenecaPre-exposure prophylaxis in certain individuals
Source: Evaluate Pharma & company releases. 

https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/us-fda-approval-tracker-december

Amgen cut to Neutral from Buy by B of A

 Target to $255 from $285

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