<Weekly Highlight>
US will soon launch talks with WTO to overcome COVID vaccine IP issues[1] (5/3)
The US top trade negotiator will begin talks with the World Trade Organization (WTO) on ways to overcome intellectual property issues that are keeping critically needed COVID-19 vaccines from being more widely distributed worldwide.
The White House has been under pressure in recent weeks to join an effort from lawmakers at home and governments abroad to waive patent rules for the vaccines so that poorer countries can begin to produce their own generic versions of the shots to vaccinate their populations.
US Trade Representative Katherine Tai will be starting talks with WTO on how they can get this vaccine more widely distributed, more widely licensed, more widely shared.
The recent increase of Covid-19 cases in India and other developing nations is adding momentum to a push to suspend intellectual-property restrictions on vaccines. Some 60 developing countries, led by India and South Africa, are drafting a new proposal to waive the World Trade Organization’s intellectual-property rules. The new proposal will be put to the organization in the next few days.
Pharmaceutical companies, which are quickly scaling up production to meet global demand, say waiving the intellectual property on the vaccines wouldn’t solve supply problems in the short term because contract producers lack familiarity with new technology behind the shots.
<COVID-19 News>
Sanofi to aid Moderna on final steps in manufacturing coronavirus vaccine[2] (4/26)
Sanofi will help Moderna fill and finish vials of its coronavirus vaccine under an agreement to manufacture up to 200 million doses at a plant in New Jersey.
Fill and finish describes the final steps of the production process, in which the vaccine product is siphoned into individual vials, capped and labeled for distribution.
The deal should help Moderna expand capacity through the later stages of manufacturing, but Sanofi won't help with earlier steps of making raw materials or vaccine product.
At-home Covid-19 tests might cost too much for regular use[3] (4/28)
Covid-19 tests for people to use to get quick results at home are finally becoming available to buy at pharmacies and retailers. Yet an obstacle might stand in the way of regular use. There are concerns that at-home Covid-19 test kits, which are sold at approximately $20 for a pack of two, is too pricey for frequent use.
The tests are expected to be valuable tools for checking symptoms, but lowering the price will be crucial if people are going to take the tests regularly.
AstraZeneca struggles with data needed for Covid-19 vaccine’s approval[4] (4/29)
AstraZeneca has struggled to gather full data necessary to apply for US approval of its Covid-19 vaccine.
One especially time-consuming task has been compiling British data from almost four months of vaccinations in the U.K., including efficacy, virus-transmission and safety statistics, people close to the process say.
Moderna plans to triple coronavirus vaccine production next year[5] (4/29)
Moderna may be able to supply as many as 3 billion doses of its coronavirus vaccine next year. It announced plans for a series of investments that it says will increase capacity at its U.S. production facilities and overseas manufacturing partners.
The total number of shots will depend on how many it supplies at the currently authorized dose versus pediatric or booster formulations, which could require a lower dose.
The investments will increase drug substance production by 50% at the company's U.S. sites and double capacity at a Lonza factory in Switzerland and a Rovi plant in Spain.
Novavax receives an extra $147M from legacy Warp Speed program[6] (4/30)
Novavax received millions of dollars from the Operation Warp Speed (a program by the US government to speed up COVID-19 vaccine development) for its vaccine trials against COVID-19 last year, and it was given an additional $147.34 million bringing its total from the program to $1.74 billion.
<Industry News>
Merck, Bristol Myers, and Roche to face FDA’s scrutiny for PD-1 accelerated approvals[7] (4/27)
In a three-day meeting, a panel of external experts convened by the FDA will discuss whether the agency should consider clawing back accelerated approvals from three immuno-oncology agents—Merck’s Keytruda, Bristol Myers Squibb’s Opdivo, and Roche’s Tecentriq.
The companies had received conditional nods based on early data showing they could shrink tumors or slow disease progression, but they have since failed to show the treatments could help patients live longer in confirmatory trials.
Each of the drugs have the following indications:
Roche’s Tecentriq: PD-L1-positive metastatic triple-negative breast cancer (TNBC)
Merck’s Keytruda: Monotherapy for patients with previously untreated bladder cancer who are not eligible for other therapies
BMS’ Opdivo: Liver cancer patients who’ve been previously treated with Bayer’s Nexavar
NIH develops a mobile app to screen for autism using eye-tracking tech[8] (4/27)
An NIH-developed smartphone app, which is still in the prototype phase, was shown in an NIH-funded study to be able to accurately distinguish between toddlers with and without autism by analyzing their eye movements while viewing social stimuli.
The NIH app uses a smartphone or tablet’s front-facing camera to record children’s eye movements as they watch videos of people smiling, making eye contact and having conversations. Toys like spinning tops and bubbles are also included in the videos to determine whether a child focuses more on humans and social stimuli or objects.
Biogen to offer early access to ALS drug starting in July[9] (4/27)
After months of holding its ground on not offering an experimental ALS drug to patients outside of clinical trials, Biogen is laying out a plan to offer early access.
The treatment, tofersen, is in a phase 3 study in 178 patients with amyotrophic lateral sclerosis (ALS) stemming from mutations in the SOD1 gene. After talking it over with regulators, clinical trial investigators, ethicists and patient advocates, the company will now offer tofersen to patients with this form of ALS starting in mid-July.
In the two-part program, Biogen will begin with the patients whose disease is worsening the fastest in mid-July. Later, if the drug proves safe and effective when the study reads out, the company will offer the drug to the broader population of patients with SOD1-ALS under an Early Access Program. The company hopes to roll out the latter part of the program in the fall.
Pfizer buys infectious disease biotech Amplyx[10] (4/28)
Pfizer has bought privately held Amplyx Pharmaceuticals for an undisclosed sum, gaining experimental antifungal and antiviral treatments as the world's attention turns more toward infectious diseases.
Amplyx's most advanced treatment is an antifungal called fosmanogepix, which the companies claim offers a new way to treat potentially life-threatening invasive infections caused by molds and yeasts.
After $600M sales hit from pandemic, Merck's open to 'all forms' of M&A deals[11] (4/29)
With Merck's sales dropping from the pandemic and the company becoming increasingly reliant on its immuno-oncology therapy candidate Keytruda, the company’s executive team unveiled a willingness to expand through M&A.
Merck’s vaccine business suffered particularly as the COVID-19 vaccine rollout reached a high in the US. Merck’s sales of its HPV shot and polysaccharide pneumococcal vaccine dropped 16% and 33%, respectively.
The company will soon have extra cash from its spinoff product, which is expected to be $9 billion.
Bristol Myers on alert for potential immuno-oncology pricing decline as 3rd launch is near[12] (4/29)
New immune-oncology drugs are expected to reach the US market from Chinese biopharma companies. This could be a problem for Bristol Myers Squibb because newer market entrants could undercut established drugs on price.
At least three Chinese-made PD-1s are looking to launch in the U.S. in the next three years, with U.S. partners in Novartis, Eli Lilly and Coherus BioSciences. Although none of the drugs has proven superior to the currently available meds, the new entrants are expected to offer discounted prices to win market share.
AstraZeneca diabetes med Farxiga sees big expansion into kidney disease[13] (4/30)
AstraZeneca's diabetes drug Farxiga stormed the heart failure market with a first-in-class approval last year, and now it received FDA approval to treat chronic kidney disease (CKD) in patients without diabetes.
With that CKD approval in hand, Farxiga is on the lead against Eli Lilly and Boehringer Ingelheim’s SGLT2 rival Jardiance, which isn't expecting data from its kidney disease outcomes trial until 2022.
Roivant Sciences to go public with a SPAC in a $611M deal[14] (5/3)
Roivant Sciences is heading for the public markets by merging with a special purpose acquisition company, or SPAC, and raising $611 million in the process. The deal is expected to close in the 3rd quarter and the combined company will trade on the NASDAQ under the ticker “ROIV”
Roivant will receive up to $411 million from the SPAC, Montes Archimedes Acquisition Corp., as well as $200 million through a private round from investors.
Once the deal closes, Roivant will have about $2.3 billion in cash.
<Policies & Announcements>
CMS proposes to enhance the medical workforce in rural and underserved communities to support COVID-19 recovery and beyond[15] (4/27)
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (CMS-1752-P) today for inpatient and long-term care hospitals.
This proposal builds on the Biden Administration’s key priorities to close health care equity gaps and provide greater accessibility to care.
Major provisions in the proposed rule would fund medical residency positions in hospitals in rural and underserved communities to address workforce shortages and require hospitals to report COVID-19 vaccination rates among their workers to contain the spread of the virus.
CMS is proposing to distribute 1,000 additional physician residency slots to qualifying hospitals, phasing in 200 slots per year over five years. Additional funding for these slots are estimated to total $0.3B each year.
U.S. Department of Health and Human Services announces additional Biden Administration staff appointments[16] (4/27)
The new appointees will join career officials throughout the agency. There are 10 new appointees in the Office of: the Secretary; Intergovernmental and External Affairs; Assistant Secretary for Public Affairs; Assistant Secretary for Legislation; Assistant Secretary for Health; Administration for Children and Families; Centers for Medicare and Medicaid Services; Food and Drug Administration.
HHS announces $1 Billion from American Rescue Plan for construction and renovation projects at health centers[17] (4/27)
Under the American Rescue Plans, the US Department of Health and Human Services announced the availability of $1B to support health centers’ major construction and renovation projects across the countries.
Health centers that receive this funding will be able to use it for COVID-19 related capital needs and to construct new facilities, renovate and expand existing facilities, and purchase new equipment.
HHS releases new Buprenorphine Practice Guidelines, expanding access to treatment for Opioid use disorder[18] (4/27)
In an effort to get evidenced-based treatment to more Americans with opioid use disorder, the Department of Health and Human Services (HHS) is releasing new buprenorphine practice guidelines that among other things, remove a longtime requirement tied to training, which some practitioners have cited as a barrier to treating more people.
The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder provides eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, who are state licensed and registered by the DEA to prescribe controlled substances, an exemption from certain statutory certification requirements related to training, counseling and other ancillary services.
FDA takes action for failure to submit required clinical trial results information to ClinicalTrials.Gov[19] (4/28)
The Food and Drug Administration has issued its first notice of noncompliance to a company for failing to submit details of a study to a federal database, citing biotech company Acceleron Pharma.
The agency said it acted after warning the company in July that it had failed to properly report the results of a study of the drug dalantercept in patients with kidney cancer. The FDA said Acceleron has 30 days to act before facing penalties, including civil fines.
The FDA made an official announcement regarding this requirement, stating “Federal law requires that responsible parties, typically trial sponsors, register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.”
Government of Canada funds two new projects to encourage vaccine uptake in Canada[20] (4/29)
Canada’s Ministry of Health announced a $2.25 million investment through the Immunization Partnership Fund (IPF) for two projects to support vaccination efforts. These projects will support vaccine uptake by ensuring Canadians have access to credible information on vaccination, as well as equipping healthcare providers and Canadians with proven strategies to manage pain and fear during vaccination.
HHS awards over $32 million in American Rescue Plan funding to expand COVID-19 training and support for health centers[21] (4/29)
Under the American Rescue plan by the US Department of Health and Human Services, the Health Resources and Services Administration (HRSA) awarded over $32 million to 122 organizations that provide training and technical assistance support to HRSA Health Center Program-supported health centers nationwide.
These organizations will use the funds to provide health centers with critical COVID-19 related training, technical assistance, and health information technology support.
FDA approves higher dosage of Naloxone Nasal Spray to treat Opioid overdose[22] (4/30)
The FDA announced the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose, which delivers 8mg of naloxone into the nasal cavity as opposed to previously approved 2mg and 4mg products.
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.
FDA’s action meets another critical need in combatting opioid overdose, which has been one of the top priorities of the FDA. FDA is committed to addressing the opioid crisis with a focus on decreasing exposure to opioids and preventing new addiction.
Opioid crisis background[23]: in 2019, nearly 50,000 people in the US died from opioid overdose, due to misuse of and addiction to opioids. Such include prescription pain relievers, heroin, and synthetic opioids such as fentanyl. The CDC estimates that the total economic burden of prescription opioid misuse in the US is $78.5 billion a year.
FDA approves AstraZeneca’s treatment for chronic kidney disease[24] (4/30)
The FDA approved Farxiga oral tablets to reduce the risk of kidney function decline, failure, cardiovascular death and hospitalization in adults with chronic kidney disease who are at risk of disease progression.
Farxiga received Fast Track, Breakthrough Therapy, and Priority Review designation for the indication.
Farxiga was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise.
CMS to adopt rules to lower health care costs in 2022 Federal Health Insurance Marketplace Plans[25] (4/30)
The Centers for Medicare & Medicaid Services (CMS) adopted new provisions to lower maximum out-of-pocket costs to consumers by $400, while increasing competition and improving the consumer experience for millions of Americans who will rely on the Federal Health Insurance Marketplaces in plan year 2022.
These actions demonstrate a strong commitment by the Biden-Harris Administration to protect and build on the Affordable Care Act (ACA).
Other provisions are to help consumers more easily distinguish between plan options and increase opportunities to qualify for future special enrollment periods (SEPs).
HHS launches new reimbursement program for COVID-19 vaccine administration fees not covered by insurance[26] (5/3)
HHS is announcing a new program covering costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing.
The COVID-19 Coverage Assistant Fund (CAF), is focusing on instances where individuals have insurance, but vaccines are either not covered or are but typically with patient cost-sharing. To address these gaps, the CAF will be compensating providers for eligible claims, at national Medicare rates which increased in March to reflect newer information on the true costs associated with administering the vaccines.
[1]https://www.theweek.in/news/world/2021/05/03/us-to-soon-launch-talks-with-wto-to-overcome-covid-vaccine-ip-issues.html https://www.wsj.com/articles/indias-covid-19-crisis-raises-pressure-to-waive-vaccine-patents-11619861401 [2]https://www.biopharmadive.com/news/sanofi-deal-moderna-manufacture-coronavirus-vaccine/599022/ [3]https://www.wsj.com/articles/at-home-covid-19-tests-might-cost-too-much-for-regular-use-11619602221 [4]https://www.wsj.com/articles/astrazeneca-struggles-with-data-needed-for-covid-19-vaccines-approval-11619721317 [5]https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-3-billion-doses/599253/ [6]https://www.fiercebiotech.com/biotech/novavax-handed-extra-147m-from-legacy-warp-speed-program-as-spotlight-shines-brighter [7]https://www.fiercepharma.com/pharma/merck-bristol-myers-roche-to-face-fda-scrutiny-for-pd-1-l1-accelerated-approvals-at-adcom-a [8]https://www.fiercebiotech.com/medtech/eyes-have-it-nih-prototype-app-screens-for-autism-by-tracking-toddlers-visual-movements [9]https://www.fiercebiotech.com/biotech/biogen-to-offer-early-access-to-experimental-als-drug-starting-july [10]https://www.biopharmadive.com/news/pfizer-acquire-amplyx-infectious-disease/599212/ [11]https://www.fiercepharma.com/pharma/merck-says-m-a-isn-t-off-table-as-q1-sales-take-pandemic-hit [12]https://www.fiercepharma.com/pharma/bristol-myers-to-stay-top-potential-pd-1-pricing-war-as-its-3rd-checkpoint-inhibitor-launch [13]https://www.fiercepharma.com/pharma/astrazeneca-s-farxiga-wins-landmark-kidney-disease-nod-after-january-priority-review [14]https://www.fiercebiotech.com/biotech/roivant-catches-spac-wave-to-wall-street-611m-deal [15]https://www.cms.gov/newsroom/press-releases/cms-proposes-enhance-medical-workforce-rural-and-underserved-communities-support-covid-19-recovery [16]https://www.hhs.gov/about/news/2021/04/27/us-department-of-health-and-human-services-announces-additional-biden-administration-staff-appointments.html [17]https://www.hhs.gov/about/news/2021/04/27/hhs-announces-1-billion-dollar-from-american-rescue-plan-for-construction-and-renovation-projects-at-health-centers.html [18]https://www.hhs.gov/about/news/2021/04/27/hhs-releases-new-buprenorphine-practice-guidelines-expanding-access-to-treatment-for-opioid-use-disorder.html [19]https://www.fda.gov/news-events/press-announcements/fda-takes-action-failure-submit-required-clinical-trial-results-information-clinicaltrialsgov [20]https://www.canada.ca/en/public-health/news/2021/04/government-of-canada-funds-two-new-projects-to-encourage-vaccine-uptake-in-canada.html [21]https://www.hhs.gov/about/news/2021/04/29/hhs-awards-over-32-million-american-rescue-plan-funding-expand-covid-19-training-support-health-centers.html [22]https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose [23]https://www.drugabuse.gov/drug-topics/opioids/opioid-overdose-crisis [24]https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-chronic-kidney-disease [25]https://www.cms.gov/newsroom/press-releases/cms-adopt-rules-lower-health-care-costs-2022-federal-health-insurance-marketplace-plans [26]https://www.hhs.gov/about/news/2021/05/03/hhs-launches-new-reimbursement-program-for-covid19-vaccine-adminsitration-fees-not-covered-by-insurance.html